Podcasts about European Medicines Agency

GeoVax Labs (NASDAQ:GOVX) CEO David Dodd tells Proactive that the company is on track to initiate a pivotal phase 3 trial of its GEO-MVA mpox and smallpox vaccine candidate before the end of 2024. The CRO has been hired, trial sites have been identified, and the product has already been manufactured, packaged and released, ready to be administered to humans. Dodd explains that the European Medicines Agency granted GeoVax an expedited regulatory pathway, waiving the requirement for phase 1 and phase 2 clinical trials. Instead, the company only needs to conduct an immunobridging study comparing GEO-MVA against Bavarian Nordic's MVA-BN vaccine in healthy adults, measuring neutralising antibodies and conversion rate. The EMA justified this approach because GeoVax's MVA and Bavarian Nordic's MVA were derived from the same parental cell line, making them equivalent at origin, and because of a critical global supply shortage. Dodd describes a market gap of approximately 15 million doses in annual MVA demand versus what was supplied last year, noting that Bavarian Nordic is at manufacturing capacity with no apparent plans to expand. He says GeoVax aims to be the first additional supplier of MVA vaccine globally. The commercial route to market is through government procurement agencies and national stockpiles rather than a traditional drug launch. Dodd identifies stockpile buyers including the US Strategic National Stockpile, the UK biosecurity entity, Israel, Saudi Arabia, the EU through HERA, and Unicef via the Gavi Vaccine Alliance. He notes the vaccine is relevant not only for mpox but also as a defence against the potential weaponisation of smallpox. Read Proactive's Editorial Policy here: https://www.proactiveinvestors.co.uk/pages/editorialPolicy #GeoVax #GOVX #biotechnology #mpox #smallpox #infectiousdisease #clinicalstage #vaccinestock #biotech #investing

Actinogen Medical Ltd managing director and CEO Dr Steven Gourlay talked with Proactive about the company's June quarter progress, including preparations for the pivotal XanaMIA Alzheimer's disease trial topline results expected in November 2026. Gourlay said the fully enrolled Phase 2b/3 trial remained on schedule, with treatment, follow-up and data-cleaning activities continuing across participating sites. He described the upcoming readout as “a potentially transformational event for the company and for the clinical science, and for patients with Alzheimer's all around the world.” An independent Data Monitoring Committee completed its third review of safety data from all 247 trial participants and recommended that the study continue without amendment. Actinogen Medical ended the quarter with $16.7 million in cash. Chief Financial Officer Will Souter said the company's current funding position was expected to support operations beyond the XanaMIA results and into mid-2027. He also highlighted potential additional funding sources, including an anticipated research and development tax rebate and the possible exercise of listed and unlisted options. Gourlay also discussed positive depression trial data published in the British Journal of Psychiatry and the company's continuing engagement with regulators, including the US Food and Drug Administration and the European Medicines Agency. Visit Proactive's YouTube channel for more company interviews and market updates. Please give the video a like, subscribe to the channel and enable notifications for future content.

As quantum technologies continue to rapidly develop, in this event, Oscar Diez, Deputy Head of Unit for Quantum Technologies at the European Commission, will outline the role of the forthcoming European Quantum Act. Mr Diez will particularly discuss how the EU can support the transition from scientific excellence to industrial capacity, including access to infrastructures, scale-up, skills, supply chains and market uptake. Mr Diez will also reflect on how the Quantum Act and wider Quantum Europe Strategy can play a role in helping to promote Europe's competitiveness agenda and drive innovation in Europe. About the Speaker: Oscar Diez is the Deputy Head of Unit for Quantum Technologies at the European Commission, where he leads strategic initiatives to position Europe as a global leader in the quantum domain. Mr Diez is also an adjunct professor at IE University in Madrid. With a background in both academia and public sector innovation, he previously served as Head of the Datacentre at the European Medicines Agency in London. Dr. Diez holds a PhD in Computer Science from Universidad Politécnica de Madrid and a Master's in Open eGovernment from Stockholm University.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today we dive into some significant advancements reshaping the industry. Starting with a breakthrough in gene therapy, researchers have announced promising results from a Phase 1 clinical trial targeting a rare genetic disorder known as Leber congenital amaurosis. This disorder causes childhood blindness due to mutations in the RPE65 gene. The investigational therapy involves delivering a functional copy of the gene directly to retinal cells using an adeno-associated virus vector, showing substantial improvements in visual function for participants. This development not only brings hope to those affected by this condition but also underscores the growing potential of gene editing technologies in addressing previously untreatable genetic disorders. While these are early-stage results, they contribute to a growing body of evidence that gene therapy can effectively target and treat specific genetic abnormalities. In regulatory news, the FDA has granted accelerated approval to a novel small-molecule drug for the treatment of metastatic triple-negative breast cancer. This drug acts as an inhibitor of a specific kinase involved in cancer cell proliferation and has shown statistically significant improvements in progression-free survival compared to existing therapies. Triple-negative breast cancer is particularly challenging to treat due to its aggressive nature and lack of hormone receptors that typically guide treatment decisions. The approval marks a critical step forward, offering a new therapeutic option for patients with limited alternatives. As this treatment enters broader clinical use, ongoing post-marketing studies will be crucial in confirming its long-term efficacy and safety profile. Meanwhile, in Europe, the European Medicines Agency has recommended approval for an innovative biologic targeting severe asthma. This monoclonal antibody works by selectively binding to and inhibiting a cytokine involved in the inflammatory cascade that triggers asthma symptoms. Clinical trials demonstrated significant reductions in asthma exacerbations and improved lung function among patients who were inadequately controlled on standard therapies. With asthma affecting millions globally, advancements like these are essential for improving quality of life and reducing healthcare burdens associated with poorly controlled respiratory conditions. Turning our attention to Alzheimer's research, scientists have reported encouraging findings from a late-phase clinical trial evaluating a novel anti-amyloid antibody. The trial results indicate that the drug successfully slowed cognitive decline in patients with early-stage Alzheimer's disease. This aligns with the amyloid hypothesis, which suggests that amyloid-beta plaque accumulation in the brain is a driving factor in Alzheimer's pathology. Although previous attempts targeting amyloid have met with limited success, this latest trial offers renewed optimism for potentially modifying disease progression rather than just managing symptoms. On the topic of industry trends, there's been a notable increase in strategic partnerships between major pharmaceutical companies and emerging biotech firms specializing in mRNA technology. Following the unprecedented success of mRNA vaccines during the COVID-19 pandemic, there is considerable interest in exploring mRNA platforms for treating a wide range of diseases beyond infectious ones, including cancer and rare genetic disorders. These collaborations aim to leverage complementary strengths: established companies bring regulatory expertise and manufacturing capabilities, while biotech firms offer innovative technologies and nimble research approaches. The synergy could accelerate the development pipeline and bring transformative therapies to market more rapidly. Lastly, we explore an intriguing development in personalized medicine. A team of researchers has unveiled an AI-driven platform designed to optimize drug regimens tailored specifically to individual patients' genetic profiles. By integrating genomic data with machine learning algorithms, this tool can predict patient-specific responses to various treatments and suggest optimal dosing strategies. This approach holds promise not only for enhancing therapeutic efficacy but also for minimizing adverse effects by accounting for individual variability in drug metabolism and response. As we continue to witness rapid advancements across various sectors of pharma and biotech, it's clear that innovation is at the forefront of transforming patient care and addressing some of the most challenging medical conditions of our time. Thank you for joining us today on Pharma Daily. Stay tuned for more updates on groundbreaking research and pivotal industry developments shaping healthcare's future landscape.Support the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of impactful developments shaping the future of medical innovation and patient care. The landscape of pharmaceutical and biotech industries is currently experiencing notable shifts driven by scientific advancements, regulatory updates, and strategic collaborations. One of the more controversial events involves the retraction of a high-profile study in Nature Medicine. This study initially suggested that the timing of PD-1 inhibitor administration had significant impacts on survival rates for non-small cell lung cancer patients. Early-day administration was linked to improved outcomes compared to later in the day. However, after a four-month investigation, concerns over methodological validity led to its retraction. This incident serves as a stark reminder of the necessity for rigorous peer review and transparency in clinical research, which are essential for influencing treatment protocols effectively. In industry news, Eli Lilly has entered into a major $1.9 billion partnership with Abbisko Therapeutics to harness Abbisko's drug discovery capabilities, particularly in oncology. This collaboration highlights an increasing trend where Western pharmaceutical companies team up with Asian biotech firms to accelerate drug development and tap into innovative therapeutic platforms. Eli Lilly is also recalibrating its strategy for launching its oral obesity treatment, Foundayo, in Europe, as it navigates the complexities introduced by the Most Favored Nation pricing agreement with the U.S. This underscores a broader challenge within the industry: balancing pricing regulations with expanding access through digital health channels like telehealth. ADC Therapeutics is taking steps to address safety concerns surrounding its antibody-drug conjugate, Zynlonta, by reducing its workforce by 17%. This strategic realignment demonstrates the delicate balance companies must maintain between advancing promising therapies and ensuring patient safety through vigilant clinical oversight. On the regulatory front, Incyte's decision to drop its lawsuit against CMS over drug classification issues involving its JAK inhibitor Opzelura highlights ongoing negotiations between pharmaceutical companies and regulatory bodies. These classifications have direct implications for market access and reimbursement strategies. Shifting focus to infrastructure, Advancell's move to establish its U.S. headquarters near Boston for radiopharmaceutical production underscores an emphasis on localizing drug manufacturing facilities to enhance supply chain resilience. This decision aligns with broader efforts to support domestic clinical trials for innovative therapies targeting prostate cancer. In terms of technological innovation, Novartis has invested $105 million upfront in Antares Therapeutics to target historically undruggable cancer proteins through small molecule development. This move reflects an industry-wide push towards exploiting cutting-edge technologies like AI-driven drug discovery to meet unmet medical needs in oncology. Precision medicine continues to gain traction, exemplified by Abbott's partnership with AlzPath to develop blood-based diagnostic tests for Alzheimer's disease. Collaborations such as these are pivotal in enhancing early diagnosis and personalized treatment approaches for neurodegenerative disorders. Meanwhile, the industry's financial dynamics continue to evolve with significant fundraising activities. Serapha Bio's public debut through a reverse merger with Boundless Bio raised $230 million, highlighting a growing trend of utilizing reverse mergers as a pathway to public markets. This financial boost comes alongside their licensing of a gene editing technology from China, underscoring the global nature of biotech collaborations. In oncology, Eli Lilly's extended partnership with Abbisko Therapeutics underscores the ongoing commitment to precision medicine, aiming to harness small molecule innovations targeting specific cancer pathways. Concurrently, the European Medicines Agency approved Astellas' Padcev combined with Merck & Co.'s Keytruda for muscle-invasive bladder cancer treatment based on promising Phase 3 results. Ophthalmology research is also seeing substantial investment with Ollin Biosciences raising $330 million in Series B funding aimed at developing therapies that challenge existing treatments like Vabysmo for eye diseases. Such investments indicate strong confidence in novel therapies that could redefine standards in treating conditions like wet age-related macular degeneration. In conclusion, these developments reflect a vibrant biotech and pharma landscape characterized by strategic partnerships, innovative financing mechanisms, and regulatory milestones that collectively drive forward scientific progress and enhance therapeutic options available worldwide. As these sectors continue to evolve, integrating cutting-edge technologies like gene editing and precision oncology will be pivotal in shaping healthcare delivery's future trajectory while improving patient outcomes globally.Support the show

This CEO Wants To Help Your Nerves Heal Faster. Meet Adam Rogers CEO NervGen – NGEN GuestAdam Rogers, MD, Chair, President & Chief Executive Officer at NervGenAdam's BIO: Adam H. Rogers, MD, is the President and Chief Executive Officer of NervGen Pharma and has served as Chairman of the Company's Board of Directors since July 2025. Dr. Rogers has more than fifteen years of experience advancing novel therapies for diseases with significant unmet medical need. He is the Principal of Boston-based PFP Biosciences Holdings and previously co-founded Hemera Biosciences in 2010, a clinical-stage biotechnology company developing a one-time investigational gene therapy administered via outpatient intravitreal injection to preserve vision in patients with geographic atrophy, a late-stage and severe form of age-related macular degeneration. He served as Hemera's Chief Executive Officer from 2017 until December 2020, when the rights to its lead program were acquired by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. Earlier in his career, Dr. Rogers served as an Assistant Professor of Ophthalmology at the New England Eye Center at Tufts Medical Center and has authored numerous peer-reviewed publications. Dr. Rogers is a board-certified ophthalmologist specializing in diseases and surgery of the retina and vitreous and holds an MD from Emory University School of Medicine.Company Bio NervGen Pharma (NASDAQ: NGEN) is a clinical-stage biopharmaceutical company developing first-in-class neuroreparative therapeutics for spinal cord injury (SCI) and other neurotraumatic and neurologic conditions. The Company's mission is to transform the lives of individuals living with SCI by enabling the nervous system to repair itself. NervGen's lead therapeutic candidate, NVG-291, is a subcutaneously administered, neuroreparative peptide designed to target the inhibitory CSPG-PTPσ pathway. NVG-291 is the first pharmacologic candidate to improve function, independence, and quality of life in chronic tetraplegia, as demonstrated in the Phase 1b/2a CONNECT SCI study. NVG-291 has received Fast Track designation from the FDA and Orphan Drug designation from the European Medicines Agency for the treatment of SCI. Through NVG-291 and the Company's next-generation candidate, NVG-300, NervGen is pursuing a pharmacologic approach to transform the treatment paradigm for neurotraumatic and neurologic conditions with significant unmet medical need. For more information, visit www.nervgen.com and follow NervGen on X and LinkedIn.

In this episode of the Cannabis Accounting Podcast, host Raymond Guns sits down with @marianalarrea.mlaw (Mariana Larrea), founder of MLA Legal and Consulting Boutique and STIGMA Hospitality Group, to map the global cannabis supply chain and explain why Mexico, with the most complete pharmaceutical-grade legal framework of any country, is still waiting for its market to move.Mariana has spent a decade at the intersection of international pharmaceutical law and cannabis regulation. She was part of the first citizen bill team to draft the federal cannabis law proposal for Mexico's Senate and Congress. She left Big Law to build a firm where every client gets direct involvement from the attorney who knows their business. She's been speaking internationally on cannabis markets for four years, from Germany to Iceland to Toronto.Mariana breaks down:

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of noteworthy advancements and challenges that are shifting the landscape of drug development and patient care. Starting with AstraZeneca and Daiichi Sankyo, their Trop2-directed antibody-drug conjugate, Datroway, has secured FDA approval for first-line treatment in triple-negative breast cancer. This form of cancer is notoriously aggressive and offers limited treatment options, making this approval a significant milestone. It positions Datroway as a key player in the ADC market targeting TNBC, highlighting the increasing role of antibody-drug conjugates in oncology. This advancement not only expands therapeutic options for patients but also emphasizes the growing importance of ADCs in effectively targeting cancer cells while sparing healthy tissues. In another exciting development, Merck and Kelun Biotech have reported on their SAC-TMT ADC, which when paired with Keytruda, shows a profound impact on PD-L1-positive non-small cell lung cancer patients. Their combination therapy demonstrated a remarkable 65% reduction in disease progression or death compared to Keytruda alone. Presented at the ASCO annual meeting, these findings could potentially revolutionize first-line treatments for NSCLC, further underscoring the promising therapeutic potential of combining ADCs with immunotherapies. However, AstraZeneca faced a setback with a novel breast cancer drug as an FDA advisory committee recommended against its approval. Interestingly, the European Medicines Agency provided a favorable opinion, illustrating the divergent regulatory landscapes across continents. Such discrepancies highlight the complex regulatory environment pharmaceutical companies must navigate and could influence strategic decisions regarding market focus. On the legal front, Eli Lilly is embroiled in controversy over an alleged $200 million rebate fraud scheme involving its diabetes drug, Trulicity. This situation sheds light on ongoing issues within pharmaceutical distribution channels and raises questions about compliance and oversight mechanisms necessary to prevent such financial misconduct. Meanwhile, industry dynamics continue to evolve as AbbVie announced workforce reductions in its Allergan Aesthetics unit. This move reflects broader trends where companies streamline operations to prioritize core competencies and promising therapeutic areas. From a regulatory perspective, Maat Pharma's decision to seek re-examination for its graft-versus-host disease medication underscores the iterative nature of drug approval processes. Persistence in addressing regulatory feedback remains crucial as companies strive for successful market entry. In obesity management, Novo Nordisk's oral GLP-1 receptor agonist, Wegovy, gains traction as a convenient treatment option. The shift towards oral medications could significantly improve patient adherence and outcomes by offering an easier alternative to injections. Biogen's decision to terminate its collaboration with Denali Therapeutics after unsuccessful phase 2 trials for a Parkinson's disease candidate highlights the inherent risks in neurological drug development. Rigorous clinical evaluation remains essential to ensure efficacy before advancing therapies further. Despite these advancements, challenges persist as Biogen and Denali's BIIB122 failed in phase 2b trials for idiopathic Parkinson's disease. This underscores the complexity of neurological disorders and emphasizes the need for continued innovation targeting LRRK2 kinase inhibitors. In the realm of CAR-T therapies, Novartis' T-Charge platform faces competition from emerging in vivo technologies. This competitive landscape demonstrates rapid evolution within cell therapy domains, aiming to enhance efficacy and accessibility for patients. Meanwhile, strategic mergers and acquisitions continue as Liminatus Pharma acquires CAR-T biotech Innocsai for $320 million, underscoring sustained interest in oncology cell therapies. Switching gears to Eli Lilly's recent Phase 3 TRIUMPH-1 trial results for retatrutide, they reveal promising weight loss outcomes comparable to bariatric surgery. As a triple hormone receptor agonist targeting GLP-1, retatrutide holds significant potential in addressing obesity—a condition with profound public health implications. Medtronic's acquisition of SPR Therapeutics to enhance its chronic pain portfolio reflects a focus on minimally invasive treatments. Financially, Research Alliance III raised $75 million through a SPAC IPO targeting mergers with China-based biotech firms, signaling increased global collaboration within the sector. Dandelion Health's $14 million Series A funding aims to advance clinical intelligence platforms that could transform drug development through data analytics. Finally, Moderna's mRNA-based flu vaccine is set for review by the FDA's vaccine advisory committee after overcoming initial regulatory hurdles. This scrutiny highlights ongoing challenges faced by novel vaccine technologies within rigorous regulatory environments. In summary, these developments illustrate an industry at the forefront of scientific innovation while grappling with regulatory complexities and operational challenges. From antibody-drug conjugates and immunotherapy combinations to gene editing and advanced cell therapies, there's a clear commitment to improving patient outcomes through novel scientific approaches. As these trends evolve, they promise to redefine treatment landscapes across various therapeutic areas—offering new opportunities for scientific advancements and enhanced patient care worldwide.Support the show

From airport security chaos to COVID vaccine dangers and international missile threats, the mainstream narrative is leaving Americans in the dark. In this episode: Democrats' push to defund ICE and CBP, and the consequences for airport security and national safety. How embalmers and scientists documented COVID vaccine-induced blood clots — and were silenced by social media censorship. European studies confirming vaccine-linked clotting, while U.S. media downplayed the risk. Iran's missile capabilities revealed after media initially dismissed Trump's intelligence claims. The personal trauma narratives of Democratic politicians and how media frames “childhood adversity.” A deep dive into censorship, political messaging, and the truths the mainstream media won't tell you. ⚡ EPISODE SUMMARY ICE at Airports: Minority Leader Hakim Jeffries' warnings vs. real-world enforcement; tips to survive untrained ICE deployment. Defunding Enforcement: How defunding ICE/CBP impacts border security, airport lines, and public safety. COVID Vaccine Clots: Embalmers' video evidence, FBI censorship, and European studies finally revealing VITT antibody patterns. Iran Missile Threats: Trump's intelligence on Iran's long-range missiles, media dismissals, and the Diego Garcia strike. Media Bias: How mainstream outlets amplify foreign sources over U.S. intelligence and underreport real risks. Political Trauma: Democrat leaders discuss childhood struggles, divorce, and parental trauma, reframed as political narratives.

Send a textDr. Sharron Gargosky, Ph.D. is Chief Clinical Officer of Spinogenix, Inc. ( https://spinogenix.com/ ), a clinical-stage company pioneering a new class of therapeutics designed to reverse synaptic loss and dysfunction in the brain.Spinogenix is advancing two first-in-class oral small molecules. Tazbentetol is a synaptic regenerative therapy shown to regrow brain synapses — the vital connections between neurons. Clinical data have demonstrated rapid and significant improvements in memory and thinking in Alzheimer's disease, as well as clinically meaningful slowing of disease progression in ALS. The therapy is also being evaluated in schizophrenia, with a Phase 2 trial underway. Tazbentetol has received Orphan Drug Designation from both the U.S. FDA and the European Medicines Agency for ALS, and the company has established an Expanded Access Program to provide investigational treatment options to eligible ALS patients.Spinogenix's second program, SPG601, is a synaptic corrective therapy for Fragile X Syndrome — the leading inherited cause of intellectual disability and a known genetic driver of autism. Clinical data have shown normalization of abnormal brain activity patterns and improvements in attention and focus. SPG601 has received Orphan Drug and Fast Track Designations and is advancing toward late-stage development.Dr. Gargosky brings more than 25 years of global development leadership experience across small molecules, biologics, cell therapies, and diagnostics. She has overseen regulatory, CMC, non-clinical, clinical, and medical affairs programs across more than 15 countries, and has led multiple orphan and accelerated approval pathways.Previously, Dr. Gargosky held senior leadership roles at OncoSec Medical, Prima Biomed, Hyperion Therapeutics, Pfizer, and served in academia at Stanford University and Oregon Health & Science University.#Spinogenix #SynapticRegeneration #FragileX #AlzheimersResearch #ALSResearch #Neuroscience #BrainHealth #BiotechInnovation #Synaptopathy #ClinicalTrials #RegenerativeMedicine #Neurodevelopment #SharronGargoskySupport the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we'll delve into a series of remarkable advancements and regulatory evolutions shaping the landscape of medicine.One of the most significant recent developments involves Boehringer Ingelheim's drug Hernexeos, which has seen a rapid expansion in its use as a first-line treatment for non-small cell lung cancer (NSCLC). This expansion was made possible through the FDA's Commissioner's National Priority Voucher, an initiative designed to fast-track the approval of treatments addressing critical needs. This rapid progression highlights a commitment to accelerating access to crucial oncological treatments, emphasizing the role of accelerated regulatory pathways in swiftly delivering innovative therapies to patients who need them the most.In oncology, a combination therapy involving Padcev and Keytruda is showing promising results in improving overall survival rates for patients with muscle-invasive bladder cancer who are eligible for cisplatin. However, the continuously evolving landscape of treatment options for this cancer type means that further evaluation is necessary. This scenario highlights the ever-changing nature of oncology strategies and the ongoing need for clinical validation to determine the most effective treatment regimens.Switching gears to immunology, UCB's Bimzelx has reached a significant sales milestone, reflecting its growing influence in treating multiple indications. This success points to an expanding market for immunology therapeutics, as the industry remains focused on developing blockbuster treatments that can serve various conditions effectively.On the regulatory front, Moderna's combination influenza/COVID-19 vaccine has received a positive review from the European Medicines Agency's Committee for Medicinal Products for Human Use. This green light exemplifies the EU's dedication to thorough scientific evaluations. It contrasts with the FDA, which has exhibited hesitancy in this area, highlighting how varying regulatory approaches can affect drug availability in different regions.The field of HIV treatment is also seeing progress with GSK's ViiV division confirming the efficacy of its long-acting Cabenuva regimen for adolescents over a 96-week period. This long-acting regimen provides an alternative to daily oral therapies, potentially improving adherence and outcomes among younger populations—a crucial factor in managing chronic conditions effectively.Meanwhile, legal developments are stirring as the debate over "skinny labeling" for generic drugs reaches a pivotal point. The U.S. Supreme Court is being urged to overturn a ruling that endangers this pathway, highlighting the fine balance between fostering generic drug competition and protecting pharmaceutical innovation. In related legislative discussions, a Senate hearing focused on the FDA's rare disease review process has brought to light concerns about bureaucratic obstacles that may slow innovation. There is a call from stakeholders for more streamlined processes to ensure timely access to treatments for rare diseases—a sentiment echoed by many in the industry.The burgeoning field of CAR-T cell therapies continues to make waves, especially against solid tumors. Recent preclinical studies have shown potential efficacy in eradicating solid tumors in mice models. Despite these promising findings, significant regulatory challenges remain, and streamlining approval processes could accelerate their clinical application.In other significant news within the industry, Novartis has completed its acquisition of Avidity Biosciences for $12 billion, leading to the creation of Atrium Therapeutics. With a capitalization of $270 million, Atrium emerges with two promising preclinical candidates targeting cardiovascular conditions, signaling potential advSupport the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Let's dive into the latest happenings in this dynamic industry.Starting with a look at the projected launch of top drugs anticipated in 2026, it's fascinating to see how these developments are poised to influence the market. These drugs could collectively generate a substantial $45.9 billion in annual sales by 2032, underscoring their economic impact and potential to address unmet medical needs. This reflects a robust pipeline of innovative treatments, marking significant therapeutic advancements on the horizon.Regulatory actions continue to be a pivotal force in shaping market dynamics. The FDA's recent issuance of complete response letters to Aquestive Therapeutics and Pharming resulted in contrasting market reactions, with Aquestive's shares rising while Pharming's declined. This scenario highlights the critical role of regulatory decisions in shaping company fortunes and investor confidence. Additionally, the FDA has introduced a precheck manufacturing program aimed at streamlining domestic drug production processes. This initiative is part of a broader trend to bolster U.S. pharmaceutical manufacturing capabilities amid global supply chain concerns, reflecting an effort to reduce complexities associated with setting up manufacturing plants domestically.In the realm of policy debates, there's notable discord among Trump administration officials over the future of COVID-19 vaccines in the U.S. market. This internal division could have far-reaching implications for public health strategies and vaccine accessibility, emphasizing ongoing challenges in pandemic management and policy alignment.Turning to scientific innovation, Daiichi Sankyo's development of antibody-drug conjugates (ADCs) has faced some setbacks. The company has discontinued an internal next-wave candidate and is experiencing delays in pivotal phase 3 trial readouts for its AstraZeneca-partnered candidate, Datroway. Despite these challenges, ADCs remain a promising area of oncology research due to their targeted therapeutic potential.Positive regulatory feedback from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has provided a boost for companies like Novo Nordisk and Amgen. Novo Nordisk received approval for semaglutide for non-alcoholic steatohepatitis (NASH), highlighting its potential to address this liver disease with limited treatment options. Conversely, Amgen's Tavneos faces a re-review due to data integrity concerns, illustrating the rigorous scrutiny that accompanies pharmaceutical approvals and the importance of maintaining data integrity throughout development.Sanofi's pipeline reflects mixed outcomes as its GCS inhibitor failed a phase 3 trial for Fabry disease but showed promise in Gaucher disease. This underscores the inherent uncertainties and challenges faced in drug development, where promising candidates may not always meet clinical expectations.In broader scientific research, AstraZeneca identified 22 genes potentially linked to chronic diseases following Epstein-Barr virus infection. This finding advances our understanding of viral pathogenesis and its long-term health impacts, potentially guiding future therapeutic interventions.These developments illustrate a dynamic landscape where scientific innovation, regulatory oversight, and market forces converge to shape the future of healthcare. Breakthrough technologies and new therapeutic approaches hold promise for improving patient care and advancing drug development. However, navigating complex regulatory environments and addressing data integrity concerns remain critical challenges that companies must overcome to bring these innovations to market successfully.On another front, Roche's substantial $1.7 billion deal with Sanegene marks its re-engageSupport the show

In the second episode of this two-part series, Drs. Justin Abbatemarco, Valérie Biousse, and Nancy J. Newman discuss the risk of non-arteritic ischemic optic neuropathy and how to counsel patients around GLP-1 medications.  Show transcript:  Dr. Justin Abbatemarco: Hello and welcome back. This is Justin Abbatemarco again with Valarie Biousse and Nancy Newman talking about non-arteritic ischemic optic neuropathy. I think the other major point that we had a discussion in the podcast was around the GLP-1 medications, which you mentioned have been truly life-changing for diabetes management and obesity. Can we talk about the risk of non-arteritic ischemic optic neuropathy and how you're counseling patients around this class of medications? Dr. Nancy J. Newman:  Absolutely. This is probably one of the most difficult things we are dealing with because it is something that is in process and progress right now. We don't have all the information yet, but it would appear that there is likely a small association of about slightly less than two times risk in patients who are taking these medications of having NAION with a resultant still very, very small overall risk. And it is not necessarily causal. This has prompted the European Medicines Agency to say that these patients should have their GLP-1 RAs stopped if they have NAION. Our own FDA and certainly the American Academy of Ophthalmology and the North American Neuro-Ophthalmology Society have not taken that step, but have suggested that this be shared decision-making, not only with the person who makes this diagnosis of an NAION in the patient, but with their primary care doctor or the provider who has felt that a GLP-1 receptor agonist is important for this patient's treatment and health. Dr. Justin Abbatemarco: More to come. We're going to have you back to have discussions as we learn more and better understand the disease and how we help our patients with both their diagnosis and treatment. Thank you so much for your time. 

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with two experts in European regulation and evidence of new medicines: Steffen Thirstrup: Chief Medical Officer at European Medicines Agency. Richard Bergstrom: Head of Policy at IQVIA. They compare regulatory benefit-risk decisions with HTA’s comparative effectiveness and economics, unpack the role of conditional versus accelerated approvals, debate surrogate endpoints versus overall survival, and explore how real-world evidence, patient experience data, and joint scientific advice can make adaptive approaches workable across Europe, including through the European Health Data Space and joint clinical assessments. Key Topics Regulatory Versus HTA: Benefit-risk focus, added benefit comparisons, joint clinical assessments. Conditional Approvals: Surrogate endpoints, confirmatory commitments, withdrawal, or label narrowing. Endpoints & Outcomes: Overall survival pressure, validated biomarkers, patient experience relevance. Real-world Evidence: Registries and randomized rollout, data quality limits, outcomes-based contracting lessons. Adaptive Pathways & Data Space: Early joint advice, platform and sandbox tools, European Health Data Space. Opinions expressed are those of the speakers.See omnystudio.com/listener for privacy information.

Send us a textAls bestuurslid en woordvoerster van Farmers Defence Force maakt Sieta van Keimpema zich hard voor de agrarische sector. Ze is hier vandaag te gast om over Bovaer te spreken, het voeradditief voor koeien dat methaanuitstoot moet verminderen. Wat is het en welke gevolgen heeft Bovaer voor mens en dier?Data-analist Wouter Aukema analyseerde de enorme databestanden van de European Medicines Agency, EMA, niet alleen over de bijwerkingen van de Covid-19 injecties, maar ook andere medicaties. Daarbij ontdekte hij grote discrepanties. Dat EMA zijn analyses niet in dank afnam, is af te leiden uit de e-mail die de organisatie hem onlangs stuurde.Willem Engel houdt nauwlettend de actualiteiten in de gaten vanuit zijn rol als maatschappij-criticus. Sinds de verkiezingen gaan er diverse berichten rond op social media die suggereren dat verkiezingsfraude is gepleegd. Met name een bericht van Geert Wilders is vaak gedeeld. Is er reden tot zorg? Willem Engel deelt zijn visie rondom het stemproces.Beatriz Carnevali is een Venezolaanse taaldocente. Ze was in Caracas toen Nicolás Maduro in januari geïnaugureerd werd en is hier om een nieuw licht op de situatie in Venezuela te schijnen; een geluid dat tot nog toe onderbelicht bleef. Support the showWaardeer je deze video('s)? Like deze video, abonneer je op ons kanaal en steun de onafhankelijke journalistiek van blckbx met een donatieWil je op de hoogte blijven?Telegram - https://t.me/blckbxtvTwitter - / blckbxnews Facebook - / blckbx.tv Instagram - ...

This week in review covers 5 episodes from October 20 to October 24, featuring major developments in pharmaceutical and biotech industries including strategic acquisitions, regulatory updates, and clinical trial results.Episodes included:1. Pharma Innovations: AI's Impact and Strategic Shifts2. Strategic Acquisitions and AI Revolutionize Pharma Landscape3. Industry Shifts: Novo Nordisk's Revamp & ADC Breakthroughs4. Transformative Advances in Precision Oncology and ADCs5. Transformative Oncology Breakthroughs and Regulatory ShiftsKey topics covered:- Strategic acquisitions and partnerships- Regulatory updates and FDA approvals- Clinical trial results and breakthroughs- Industry trends and market developmentsStay informed with Pharma Daily's comprehensive coverage of the pharmaceutical and biotech world.Support the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we'll delve into a series of remarkable advancements and strategic movements shaping the landscape of healthcare. Let's start with a recent spotlight on the European Society for Medical Oncology Congress 2025, where key clinical trial outcomes have emerged, potentially reshaping future treatment protocols.AstraZeneca made waves with its Phase 3 trial results for Imfinzi, a PD-L1 inhibitor, in high-risk non-muscle invasive bladder cancer. The findings suggest that Imfinzi stands strong against Pfizer's PD-1 candidate, Sasanlimab. This is particularly noteworthy as bladder cancer has historically had limited non-invasive treatment options. The implications for patient care are substantial, providing hope for improved management of this form of cancer and possibly influencing treatment standards.Meanwhile, Eli Lilly's Verzenio marked another success at the ESMO Congress with its overall survival win in early breast cancer cases. This victory enhances Verzenio's standing within the CDK4/6 inhibitor class, suggesting increased adoption in clinical settings. The demonstration of extended survival benefits not only strengthens Verzenio's competitive position but also contributes to setting a new standard of care in early breast cancer treatment.On the regulatory front, Sanofi encountered mixed outcomes from the European Medicines Agency's Committee for Medicinal Products for Human Use. While Rezurock was not recommended as a third-line treatment for chronic graft-versus-host disease, this decision underscores the stringent regulatory processes companies navigate despite existing market success in other regions like the U.S.In a significant move by the FDA to expedite drug approvals, nine companies including Merck KGaA and Regeneron received priority review vouchers. These vouchers allow a shortened review timeline, reflecting an ongoing trend towards accelerating drug availability to address unmet medical needs swiftly.In terms of strategic developments, EMD Serono—Merck KGaA's U.S. branch—has unveiled a major discount initiative for its IVF treatments on the TrumpRx platform. This aligns with broader efforts to make fertility treatments more accessible amidst rising demand and economic pressures.The metabolic dysfunction-associated steatohepatitis (MASH) arena is also witnessing robust interest with over $10 billion recently reported in mergers and acquisitions. This surge indicates confidence among Big Pharma players in MASH as a lucrative therapeutic field ripe for innovation and development.In response to competitive pressures and operational challenges, Kezar Life Sciences is preparing for layoffs following the FDA's decision to cancel a critical meeting related to its R&D program. This situation illustrates the volatile dynamics within biotech firms where regulatory decisions can significantly impact corporate strategies and workforce stability.Overall, these developments reflect an industry characterized by rapid innovation, strategic realignments, and an evolving regulatory framework. The implications for patient care are substantial as these scientific advancements promise enhanced treatment options across various therapeutic areas.Switching gears to scientific developments, Bristol Myers Squibb has reported promising results from early-stage trials of its EGFRxHER3 antibody-drug conjugate. Demonstrating a 55% overall response rate, this positions BMS to potentially gain a competitive edge in the ADC market—a sector valued for targeting cancer cells while minimizing side effects on healthy tissues.Strategic partnerships continue to shape industry growth and innovation. Roche has secured a deal with Hansoh Pharmaceutical worth up to $1.45 billion for global rights to an experimental ADC outside Greater China. SimilSupport the show

This week on The Conscious Consultant Hour, Sam welcomes psychopharmacologist and author, Anton Gomez-Escolar MSc, MPH, MIR.Anton is a psychopharmacologist who works on psychedelic research, drug education, and harm reduction. He is the founder of the social media channel @Drogopedia, author of several peer-reviewed scientific articles on psychedelics and three published books on the topic, including The Psychedelic Reawakening.He has worked at public health and drug organizations like the European Union Drugs Agency (EUDA), Kosmicare and Energy Control, and has presented on psychedelics at several international scientific conferences and policy forums, including the European Parliament and the United Nations, being also invited to several important European meetings on psychedelics held at institutions like the European Medicines Agency, the Spanish Government or the European College of Neuropsychopharmacology.He is a member of the UNAD Global Drug Policy Commission, and cofounder and board member of the Spanish Society of Psychedelic Medicine (SEMPsi), the inawe Foundation for psychedelic research and education, and the Psychedelic Society of Madrid.We will be exploring the benefits, risks, and growing acceptance of modern psychedelic therapy.Tune in and share all of your questions and comments about psychedelic medicines on our YouTube livestream or on our Facebook page.https://amzn.to/3V88zLhSupport this podcast at — https://redcircle.com/the-conscious-consultant-hour8505/donationsAdvertising Inquiries: https://redcircle.com/brandsPrivacy & Opt-Out: https://redcircle.com/privacy

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. The European Medicines Agency's CHMP did not recommend approving Elevidys for ambulatory patients with Duchenne muscular dystrophy, dealing a blow to Sarepta. FDA is rumored to request new data for Elevidys, leading to uncertainty as FDA considers a new study for the drug. In other news, Eli Lilly commits $856 million to Gate Bioscience for a new class of medicines, while Rocket trims headcount and pipeline focus. Roche also drops an early obesity asset as layoffs continue in the biopharma industry, with companies like Adicet optimizing their pipelines. Novartis makes a billion-dollar drug discovery deal with Matchpoint, and the FDA opens a pilot run of the commissioner voucher program.Stay tuned for more updates on the latest developments in the pharmaceutical and biotech world.

A drug named Palforzia has been approved by the European Medicines Agency, but currently there is no planned timeline to roll it out in this country. Some parents are travelling abroad at their own expense to access the treatment in countries like the UK, Germany and the USA. Reporter Una Kelly has more.

Genflow Biosciences PLC (LSE:GENF, OTCQB:GENFF) CEO Dr Eric Leire talked with Proactive's Stephen Gunnion about the company's upcoming clinical trial application in Europe for its MASH (metabolic dysfunction-associated steatohepatitis) therapy, GF-1002. Leire explained that Genflow is prioritising the European Medicines Agency over the FDA as it seeks clinical trial authorisation (CTA) for its GF-1002 programme. He emphasised the importance of this milestone in building company value, stating: “To have proof of efficacy in humans is super important for us to move as fast as possible to clinical trial authorisation.” The company is working with Belgian-based CDMO Exothera on the CMC part of the filing, and Leire said results so far have exceeded expectations. He also highlighted the dual-CRO strategy involving Physiogenex and Accelera to address both early and late-stage MASH models. This approach aims to provide flexibility when engaging with regulators about the most effective path forward. In a second update, Leire said the protocol for Genflow's GF-1004 dog trial has been amended. The changes relate to the infusion rate of the gene therapy, intended to ensure consistency and future usability by private veterinarians. This is seen as a key step toward a potential partnership with an animal health company, which would bring non-dilutive funding to the business. Leire also mentioned supportive market tailwinds from upcoming FCA regulatory changes. For more biotech updates, visit Proactive's YouTube channel. Don't forget to like this video, subscribe, and hit the notification bell to stay informed. #GenflowBiosciences #MASH #BiotechNews #GeneTherapy #ClinicalTrials #GF1002 #PharmaUpdates #AnimalHealth #NonDilutiveFunding #BiotechInvesting #GLP1 #MetabolicDisease #ProactiveInvestors

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

HSE MidWest's Patient Advocate says he's shocked and concerned over the continued lack of access to cancer medicines here. A new report from the Irish Pharmaceutical Healthcare Association shows that just 25% of new cancer medicines are available in Ireland, the second-lowest rate in Europe. Of the 56 oncology medicines licensed by the European Medicines Agency since 2020, just 14 are available here. Lahinch-based Healthcare Campaigner John Wall who's living with Prostate Cancer and has been forced to travelled abroad for treatment has been telling Clare FM's Daragh Dolan that patient outcomes are suffering as a result.

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

About two years ago, we released a podcast with Dr. Thomas Wadden of the University of Pennsylvania describing work on a new generation of medications to treat diabetes and obesity. They were really taking the field by storm. Since then, much more is known since many additional studies have been published and so many people have been using the drugs. So many, in fact, the market value of the Danish company, Novo Nordisk, one of the two major companies selling the drugs, has gone up. It is now greater than the entire budget of the country of Denmark. This single company is responsible for about half of Denmark's economic expansion this year. So, a lot of people are now taking the drugs and this is a great time for an update on the drugs. And we're fortunate to have two of the world's leading experts join us: Dr. Wadden, Professor of Psychology and Psychiatry at the University of Pennsylvania School of Medicine and the inaugural Albert J. Stunkard Professor of Psychiatry at Penn. Joining us as well as Dr. Robert Kushner, a physician and professor of medicine at Northwestern University and a pioneer in testing treatments for obesity. Interview Summary Tom, you and I were colleagues at Penn decades ago. And I got frustrated the treatments for obesity didn't work very well. People tended to regain the weight. And I turned my attention to prevention and policy. But you hung in there and I admired you for that patience and persistence. And Bob, the same for you. You worked on this tenacious problem for many years. But for both of you, your patience has been rewarded with what seems to me to be a seismic shift in the way obesity and diabetes can be treated. Tom, I'll begin with you. Is this as big of a deal as it seems to me? Well, I think it is as big of a deal as it seems to you. These medications have had a huge impact on improving the treatment of type 2 diabetes, but particularly the management of obesity. With older medications, patients lost about 7 percent of their starting weight. If you weighed 200 pounds, you'd lose about 15 pounds. That was also true of our best diet and exercise programs. You would lose about 7 percent on those programs with rigorous effort. But with the new medications, patients are now losing about 15 to 20 percent of their starting body weight at approximately one year. And that's a 30-to-40-pound loss for a person who started at 200 pounds. And with these larger weight losses, we get larger improvements in health in terms of complications of obesity. So, to quote a good friend of mine, Bob Kushner, these medications have been a real game changer. Thanks for putting that in perspective. I mean, we're talking about not just little incremental changes in what treatments can produce, which is what we've seen for years. But just orders of magnitude of change, which is really nice to see. So, Bob what are these medications that we're talking about? What are the names of the drugs and how do they work? Well, Kelly, this transformation of obesity really came about by finding the target that is really highly effective for obesity. It's called the gut brain axis. And when it comes to the gut it's starting off with a naturally occurring gut hormone called GLP 1. I think everyone in the country's heard of GLP 1. It's released after we eat, and it helps the pancreas produce insulin, slows the stomach release of food, and reduces appetite. And that's where the obesity story comes in. So pharmaceutical companies have taken this hormone and synthesized it, something similar to GLP 1. It mimics the action of GLP 1. So, you could actually take it and give it back and have it injected so it augments or highlights this hormonal effect. Now, that same process of mimicking a hormone is used for another gut hormone called GIP that also reduces appetite. These two hormones are the backbone of the currently available medication. There's two on the market. One is called Semaglutide. That's a GLP 1 analog. Trade name is Wegovy. Now, it's also marketed for diabetes. Tom talked about how it is used for diabetes and increases insulin. That trade name is Ozempic. That's also familiar with everyone around the country. The other one that combined GLP 1 and GIP, these two gut hormones, so it's a dual agonist, the trade name for obesity is called Zep Bound, and the same compound for diabetes is called Mounjaro. These are terms that are becoming familiar, I think, to everyone in the country. Tom mentioned some about the, how much weight people lose on these drugs, but what sort of medical changes occur? Just to reiterate what Tom said, I'll say it in another way. For Semaglutide one third of individuals are losing 20 percent of their body weight in these trials. For Tirzepatide, it even outpaces that. And I got a third of individuals losing a quarter of their body weight. These are unheard of weight losses. And with these weight losses and these independent effects from weight, what we're seeing in the trials and in the clinic is that blood pressure goes down, blood sugar goes down, blood fats like triglyceride go down, inflammation in the body goes down, because we marked that with CRP, as well as improvement in quality of life, which we'll probably get to. But really interesting stuff is coming out over the past year or two or so, that it is improving the function of people living with congestive heart failure, a particular form called a preserved ejection fraction. We're seeing improvements in sleep apnea. Think of all the people who are on these CPAP machines every night. We're seeing significant improvements in the symptoms of sleep apnea and the apneic events. And lastly, a SELECT trial came out, that's what it was called, came out last year. Which for the very first time, Kelly, found improvements in cardiovascular disease, like having a heart attack, stroke, or dying of cardiovascular disease in people living with obesity and already have cardiovascular disease. That's called secondary prevention. That, Tom, is the game changer. Bob, I'd like to go back to Tom in a minute but let me ask you one clarifying question about what you just said. That's a remarkable array of biological medical benefits from these drugs. Just incredible. And the question is, are they all attributable to the weight loss or is there something else going on? Like if somebody lost equal amounts of weight by some other means, would these same changes be occurring? Those studies are still going on. It's very good. We're thinking it's a dual effect. It's the profound amount of weight loss, as Tom said. Fifteen to 21 to even 25 percent of average body weight. That is driving a lot of the benefits. But there also appear to be additional effects or weight independent effects that are working outside of that weight. We're seeing improvements in kidney function, improvement in heart disease, blood clotting, inflammation. And those are likely due to the gut hormone effect independent of the weight itself. That still needs to be sorted out. That's called a mitigation analysis where we try to separate out the effects of these drugs. And that work is still underway. Tom, one of the most vexing problems, over the decades that people have been working on treatments for obesity, has been long term results. And I'm curious about how long have people been followed on these drugs now? What are the results? And what was the picture before then? How do what we see now compared to what you saw before? The study that Bob just mentioned, the SELECT trial followed people for four years on Semaglutide. And patients achieve their maximal weight loss at about one year and they lost 10 percent of their weight. And when they were followed up at four years still on treatment, they still maintained a 10 percent weight loss. That 10 percent is smaller than in most of the trials, where it was a 15 percent loss. But Dr. Tim Garvey showed that his patients in a smaller trial lost about 15 percent at one year and while still on medication kept off the full 15 percent. I think part of the reason the weight loss in SELECT were smaller is because the study enrolled a lot of men. Men are losing less weight on this medication than women. But to your question about how these results compare to the results of earlier treatment, well with behavioral treatment, diet, and exercise back in the 70s beyond, people lost this 7 or 8 percent of weight. And then most people on average regain their weight over one to three years. And the same was true of medication. People often stopped these earlier medications after 6 to 12 months, in part because they're frustrated the losses weren't larger. Some people were also worried about the side effects. But the long and short is once you stop taking the medication, people would tend to regain their weight. And some of this weight regain may be attributable to people returning to their prior eating and activity habits. But one of the things we've learned over the past 20 years is that part of the weight regain seems to be attributable to changes in the body's metabolism. And you know that when you lose weight, you're resting metabolic rate, which is the number of calories your body burns at rest to maintain basic bodily functions. Your resting metabolic rate decreases by 10 to 15 percent. But also, your energy expenditure, the calories you burn during exercise decreases. And that may decrease by as much as 20 to 30 percent. So, people are left having to really watch their calories very carefully because of their lower calorie requirements in order to keep off their lost body weight. I think one thing these new drugs may do is to attenuate the drop both in resting metabolic rate and energy expenditure during physical activity. But the long and short of it is that if you stay on these new medications long term, you'll keep off your body weight. And you'll probably keep it off primarily because of improvements in your appetite, so you have less hunger. And as a result, you're eating less food. I'd like to come back to that in a minute. But let me ask a question. If a person loses weight, and then their body starts putting biological pressure on them to regain, how come? You know, it's disadvantageous for their survival and their health to have the excess weight. Why would the body do that? Well, our bodies evolved in an environment of food scarcity, and our physiology evolved to protect us against starvation. First, by allowing us to store body fat, a source of energy when food is not available. And second, the body's capacity to lower its metabolism, or the rate at which calories are burned to maintain these basic functions like body temperature and heart rate. That provided protection against food scarcity. But Kelly, you have described better than anybody else that these ancient genes that regulate energy expenditure and metabolism are now a terrible mismatch for an environment in which food is plentiful, high in calories, and available 24 by 7. The body evolved to protect us from starvation, but not from eating past our calorie needs. And so, it's this mismatch between our evolution and our appetite and our body regulation in the current, what you have called toxic food environment, when you can eat just all the time. I guess you could think about humans evolving over thousands of years and biology adapting to circumstances where food was uncertain and unpredictable. But this modern environment has happened really pretty rapidly and maybe evolution just hasn't had a chance to catch up. We're still existing with those ancient genes that are disadvantageous in this kind of environment. Bob back to the drugs. What are the side effects of the drugs? Kelly, they're primarily gastrointestinal. These are symptoms like nausea, diarrhea, constipation, heartburn, and vomiting. Not great, but they're generally considered mild to moderate, and temporary. And they primarily occur early during the first four to five months when the medications are slowly dose escalated. And we've learned, most importantly, how to mitigate or reduce those side effects to help people stay on the drug. Examples would be your prescriber would slow the dose escalation. So. if you're having some nausea at a particular dose, we wait another month or two. The other, very importantly, is we have found that diet significantly impacts these side effects. When we counsel patients on these medications, along with that comes recommendations for dietary changes, such as reducing fatty food and greasy food. Reducing the amount of food you're consuming. Planning your meals in advance. Keeping well hydrated. And very importantly, do not go out for a celebration or go out to meals on the day that you inject or at least the first two days. Because you're not going to tolerate the drug very well. We use that therapeutically. So, if you want to get control on the weekends, you may want to take your injection on a Friday. However, if weekends are your time out with friends and you want to socialize, don't take it on a Friday. Same thing comes with a personal trainer, by the way. If you're going to have a personal trainer on a Monday where he's going to overwork you, don't take the injection the day before. You'll likely be nauseated, you're not eating, you're not hydrating. So actually, there's a lot that goes into not only when to take the dose and how to take the dose, but how to take it to the best ability to tolerate it. Two questions based on what you said. One is you talked about these are possible side effects, but how common are they? I mean, how many people suffer from these? Well, the trials show about 25 to 45 percent or so of individuals actually say they have these symptoms. And again, we ask them mild, moderate, severe. Most of them are mild to moderate. Some of them linger. However, they really do peak during the dose escalation. So, working with your prescriber during that period of time closely, keeping contact with them on how to reduce those side effects and how you're doing out of medication is extremely important. And the second thing I wanted to ask related to that is I've heard that there's a rare but serious potential side effect around the issue of stomach paralysis. Can you tell us something about that? I mentioned earlier, Kelly, that these medications slow gastric emptying. That's pretty much in everybody. In some individuals who may be predisposed to this, they develop something called ileus, and that's the medical term for gastric paralysis. And that can happen in individuals, let's say who have a scleroderma, who have longstanding diabetes or other gastrointestinal problems where the stomach really stopped peristalsis. In other words, it's moving. That's typically presented by vomiting and really unable to move the food along. We really haven't seen much of that. We looked at the safety data in a SELECT trial that Tom mentioned, which was 17,000 individuals, about 8,000 or so in each group. We really did not see a significant increase in the ileus or what you're talking about in that patient population. Okay, thanks. Tom had alluded to this before, Bob, but I wanted to ask you. How do you think about these medicines? If somebody takes them, and then they stop using the medicines and they gain the weight back. Is that a sign that the medicine works or doesn't work? And is this the kind of a chronic use drug like you might take for blood pressure or cholesterol? That's a great way of setting up for that. And I like to frame it thinking of it as a chronic progressive disease, just like diabetes or hypertension. We know that when you have those conditions, asthma could be another one or inflammatory bowel disease, where you really take a medication long term to keep the disease or condition under control. And we are currently thinking of obesity as a chronic disease with dysfunctional appetite and fat that is deposited in other organs, causing medical problems and so on. If you think of it as a chronic disease, you would naturally start thinking of it, like others, that medication is used long term. However, obesity appeared to be different. And working with patients, they still have this sense 'that's my fault, I know I can do it, I don't want to be on medication for the rest of my life for this.' So, we have our work cut out for us. One thing I can say from the trials, and Tom knows this because he was involved in them. If we suddenly stop the medication, that's how these trials were definitely done, either blindly or not blindly, you suddenly stop the medication, most, if not all of the participants in these trials start to regain weight. However, in a clinical practice, that is not how we work. We don't stop medication suddenly with patients. We go slowly. We down dose the medication. We may change to another medication. We may use intermittent therapy. So that is work that's currently under development. We don't know exactly how to counsel patients regarding long term use of the medications. I think we need to double down on lifestyle modification and counseling that I'm sure Tom is going to get into. This is really work ahead of us, how to maintain medication, who needs to be on it long term, and how do we actually manage patients. Tom, you're the leading expert in the world on lifestyle change in the context of obesity management. I mean, thinking about what people do with their diet, their physical activity, what kind of thinking they have related to the weight loss. And you talked about that just a moment ago. Why can't one just count on the drugs to do their magic and not have to worry about these things? Well, first, I think you can count on the drugs to do a large part of the magic. And you may be surprised to hear me say that. But with our former behavioral treatments of diet and exercise, we spent a lot of time trying to help people identify how many calories they were consuming. And they did that by recording their food intake either in paper and pencil or with an app. And the whole focus of treatment was trying to help people achieve a 500 calorie a day deficit. That took a lot of work. These medications, just by virtue of turning down your appetite and turning down your responsiveness to the food environment, take away the need for a lot of that work, which is a real blessing. But the question that comes up is, okay, people are eating less food. But what are they eating? Do these medications help you eat a healthier diet with more fruits and vegetables, with lean protein? Do you migrate from a high fat, high sugar diet to a Mediterranean diet, or to a DASH like diet? And the answer is, we don't know. But obviously you would like people to migrate to a diet that's going to be healthier for you from a cardiovascular standpoint, from a cancer risk reduction standpoint. One of the principal things that people need to do on these medications is to make sure they get plenty of protein. And so, guidance is that you should have about 1 gram of dietary protein for every kilogram of body weight. If you're somebody who weighs 100 kilograms, you should get 100 grams of protein. And what you're doing is giving people a lot of dietary protein to prevent the loss of bodily protein during rapid weight loss. You did a [00:20:00] lot of research with me back in the 80s on very low-calorie diets, and that was the underpinning of treatment. Give people a lot of dietary protein, prevent the loss of bodily protein. The other side of the equation is just physical activity, and it's a very good question about whether these medications and the weight loss they induce will help people be more physically active. I think that they will. Nonetheless for most people, you need to plan an activity schedule where you adopt new activities, whether it's walking more or going to the gym. And one thing that could be particularly helpful is strength training, because strength training could mitigate some of the loss of muscle mass, which is likely to occur with these medications. So, there's still plenty to learn about what is the optimal lifestyle program, but I think people, if they want to be at optimal health will increase their physical activity and eat a diet of fruits and vegetables, leaner protein, and less ultra processed foods. Well, isn't it true that eating a healthy diet and being physically active have benefits beyond their impact on your ability to lose the weight? You're getting kind of this wonderful double benefit, aren't you? I believe that is true. I think you're going to find that there are independent benefits of being physical activity upon your cardiovascular health. There are independent benefits of the food that you're eating in terms of reducing the risk of heart attack and of cancer, which has become such a hot topic. So, yes how you exercise and what you eat makes a difference, even if you're losing weight. Well, plus there's probably the triple one, if you will, from the psychological benefit of doing those things, that you do those things, you feel virtuous, that helps you adhere better as you go forward, and these things all come together in a nice picture when they're working. Tom, let's talk more about the psychology of these things. You being a psychologist, you've spent a lot of time doing research on this topic. And of course, you've got a lot of clinical experience with people. So as people are losing weight and using these drugs, what do they experience? And I'm thinking particularly about a study you published recently, and Bob was a coauthor on that study that addressed mental health outcomes. What do people experience and what did you find in that study? I think the first things people experience is improvements in their physical function. That you do find as you've lost weight that you've got less pain in your knees, you've got more energy, it's easier to get up the stairs, it's easier to play with the children or the grandchildren. That goes a long way toward making people feel better in terms of their self-efficacy, their agency in the life. Big, big improvement there. And then, unquestionably, people when they're losing a lot of weight tend to feel better about their appearance in some cases. They're happy that they can buy what they consider to be more fashionable clothes. They get compliments from friends. So, all of those things are positive. I'm not sure that weight loss is going to change your personality per se, or change your temperament, but it is going to give you these physical benefits and some psychological benefits with it. We were happy to find in the study you mentioned that was conducted with Bob that when people are taking these medications, they don't appear to be at an increased risk of developing symptoms of depression or symptoms of suicidal ideation. There were some initial reports of concern about that, but the analysis of the randomized trials that we conducted on Semaglutide show that there is no greater likelihood of developing depression or sadness or suicidal ideation on the medication versus the placebo. And then the FDA and the European Medicines Agency have done a full review of all post marketing reports. So, reports coming from doctors and the experience with their patients. And in looking at those data the FDA and the European Medicines Agency have said, we don't find a causal link between these medications and suicidal ideation. With that said, it's still important that if you're somebody who's taking these medications and you start them, and all of a sudden you do feel depressed, or all of a sudden you do have thoughts like, maybe I'd be better off if I weren't alive any longer, you need to talk to your primary care doctor immediately. Because it is always possible somebody's having an idiosyncratic reaction to these medications. It's just as possible the person would have that reaction without being on a medication. You know, that, that can happen. People with overweight and obesity are at higher risk of depression and anxiety disorders. So, it's always going to be hard to tease apart what are the effects of a new medication versus what are just the effects of weight, excess weight, on your mood and wellbeing. You know, you made me think of something as you were just speaking. Some people may experience negative effects during weight loss, but overall, the effects are highly positive and people are feeling good about themselves. They're able to do more things. They fit in better clothes. They're getting good feedback from their environment and people they know. And then, of course, there's all the medical benefit that makes people feel better, both psychologically and physically. Yet there's still such a strong tendency for people to regain weight after they've lost. And it just reinforces the fact that, the point that you made earlier, that there are biological processes at work that govern weight and tendency to regain. And there really is no shame in taking the drug. I mean, if you have high blood pressure, there's no shame in taking the drug. Or high cholesterol or anything else, because there's a biological process going on that puts you at risk. The same thing occurs here, so I hope the de-shaming, obesity in the first place, and diabetes, of course, and then the use of these medications in particular might help more people get the benefits that is available for them. I recommend that people think about their weight as a biologically regulated event. Very much like your body temperature is a biologically regulated event, as is your blood pressure and your heart rate. And I will ask people to realize that there are genetic contributors to your body weight. just as there are to your height. If somebody says, I just feel so bad about being overweight I'll just talk with them about their family history of weight and see that it runs in the family. Then I'll talk to them about their height. Do you feel bad about being six feet tall, to a male? No, that's fine. Well, that that's not based upon your willpower. That's based upon your genes, which you received. And so, your weight, it's similarly based. And if we can use medications to help control weight, cholesterol, blood pressure, blood sugar, let's do that. It's just we live in a time where we're fortunate to have the ability to add medications to help people control health complications including weight. Bob, there are several of the drugs available. How does one think about picking between them? Well, you know, in an ideal medical encounter, the prescriber is going to take into consideration all the factors of prescribing a medication, like any other medication, diabetes, hypertension, you name the condition. Those are things like contraindication to use. What other medical problems does the patient have that may benefit the patient. Patient preferences, of course and side effects, safety, allergies, and then we have cost. And I'll tell you, Kelly, because of our current environment, it's this last factor, cost, that's the most dominant factor when it comes to prescribing medication. I'll have a patient walk in my room, I'll look at the electronic medical record, body mass index, medical problems. I already know in my head what is going to be the most effective medication. That's what we're talking about today. Unfortunately, I then look at the patient insurance, which is also on the electronic medical record, and I see something like Medicaid or Medicare. I already know that it's not going to be covered. It is really quite unfortunate but ideally all these factors go into consideration. Patients often come in and say, I've heard about Ozempic am I a candidate for it, when can I get it? And unfortunately, it's not that simple, of course. And those are types of decisions the prescriber goes through in order to come to a decision, called shared decision making with the patient. Bob, when I asked you the initial question about these drugs, you were mentioning the trade name drugs like Mounjaro and Ozempic and those are made by basically two big pharmaceutical companies, Novo Nordisk and Eli Lilly. But there are compounded versions of these that have hit the scene. Can you explain what that means and what are your thoughts about the use of those medications? So compounding is actually pretty commonly done. It's been approved by the FDA for quite some time. I think most people are familiar with the idea of compounding pharmacies when you have a child that must take a tablet in a liquid form. The pharmacy may compound it to adapt to the child. Or you have an allergy to an ingredient so the pharmacy will compound that same active ingredient so you can take it safely. It's been approved for long periods of time. Anytime a drug is deemed in shortage by the FDA, but in high need by the public, compounding of that trade drug is allowed. And that's exactly what happened with both Semaglutide and Tirzepatide. And of course, that led to this compounding frenzy across the country with telehealth partnering up with different compounding pharmacies. It's basically making this active ingredient. They get a recipe elsewhere, they don't get it from the company, they get this recipe and then they make the drug or compound it themselves, and then they can sell it at a lower cost. I think it's been helpful for people to get the drug at a lower cost. However, buyer beware, because not all compounded pharmacies are the same. The FDA does not closely regulate these compounded pharmacies regarding quality assurance, best practice, and so forth. You have to know where that drug is coming from. Kelly, it's worth noting that just last week, ZepBound and Mounjaro came off the shortage list. You no longer can compound that and I just read in the New York Times today or yesterday that the industry that supports compounding pharmacies is suing the FDA to allow them to continue to compound it. I'm not sure where that's going to go. I mean, Eli Lilly has made this drug. However, Wegovy still is in shortage and that one is still allowed to be compounded. Let's talk a little bit more about costs because this is such a big determinant of whether people use the drugs or not. Bob, you mentioned the high cost, but Tom, how much do the drugs cost and is there any way of predicting what Bob just mentioned with the FDA? If the compounded versions can't be used because there's no longer a shortage, will that decrease pressure on the companies to keep the main drug less expensive. I mean, how do you think that'll all work out? But I guess my main question is how much these things cost and what's covered by insurance? Well first how much do the drugs cost? They cost too much. Semaglutide, known in retail as Wegovy, is $1,300 a month if you do not have insurance that covers it. I believe that Tirzepatide, known as ZepBound, is about $1,000 a month if you don't have insurance that covers that. Both these drugs sometimes have coupons that bring the price down. But still, if you're going to be looking at out of pocket costs of $600 or $700 or $800 a month. Very few people can afford that. The people who most need these medications are people often who are coming from lower incomes. So, in terms of just the future of having these medications be affordable to people, I would hope we're going to see that insurance companies are going to cover them more frequently. I'm really waiting to see if Medicare is going to set the example and say, yes, we will cover these medications for anybody with a BMI of 40 or a BMI of 35 with comorbidities. At this point, Medicare says, we will only pay for this drug if you have a history of heart attack and stroke, because we know the drug is going to improve your life expectancy. But if you don't have that history, you don't qualify. I hope we'll see that. Medicaid actually does cover these medications in some states. It's a state-by-state variation. Short of that, I think we're going to have to have studies showing that people are on these medications for a long time, I mean, three to five years probably will be the window, that they do have a reduction in the expenses for other health expenditures. And as a result, insurers will see, yes, it makes sense to treat excess weight because I can save on the cost of type 2 diabetes or sleep apnea and the like. Some early studies I think that you brought to my attention say the drugs are not cost neutral in the short-term basis of one to two years. I think you're going to have to look longer term. Then I think that there should be competition in the marketplace. As more drugs come online, the drug prices should come down because more will be available. There'll be greater production. Semaglutide, the first drug was $1,300. Zepbound, the second drug Tirzepatide, $1,000. Maybe the third drug will be $800. Maybe the fourth will be $500. And they'll put pressure on each other. But I don't know that to be a fact. That's just my hope. Neither of you as an economist or, nor do you work with the companies that we're talking about. But you mentioned that the high cost puts them out of reach for almost everybody. Why does it make sense for the companies to charge so much then? I mean, wouldn't it make sense to cut the price in half or by two thirds? And then so many more people would use them that the company would up ahead in the long run. Explain that to me. That's what you would think, for sure. And I think that what's happened right now is that is a shortage of these drugs. They cannot produce enough of them. Part of that is the manufacturing of the injector pens that are used to dispense the drug to yourself. I know that Novo Nordisk is building more factories to address this. I assume that Lilly will do the same thing. I hope that over time we will have a larger supply that will allow more people to get on the medication and I hope that the price would come down. Of course, in the U. S. we pay the highest drug prices in the world. Fortunately, given some of the legislation passed, Medicare will be able to negotiate the prices of some of these drugs now. And I think they will negotiate on these drugs, and that would bring prices down across the board. Boy, you know, the companies have to make some pretty interesting decisions, don't they? Because you've alluded to the fact that there are new drugs coming down the road. I'm assuming some of those might be developed and made by companies other than the two that we're talking about. So, so investing in a whole new plant to make more of these things when you've got these competitor drugs coming down the road are some interesting business issues. And that's not really the topic of what we're going to talk about, but it leads to my final question that I wanted to ask both of you. What do you think the future will bring? And what do you see in terms of the pipeline? What will people be doing a year from now or 2 or 5? And, you know, it's hard to have a crystal ball with this, but you two have been, you know, really pioneers and experts on this for many years. You better than anybody probably can answer this question. Bob, let me start with you. What do you think the future will bring? Well, Kelly, I previously mentioned that we finally have this new therapeutic target called the gut brain axis that we didn't know about. And that has really ushered in a whole new range of potential medications. And we're really only at the beginning of this transformation. So not only do we have this GLP 1 and GIP, we have other gut hormones that are also effective not only for weight loss, but other beneficial effects in the body, which will become household names, probably called amylin and glucagon that joins GLP 1. And we not only have these monotherapies like GLP 1 alone, we are now getting triagonists. So, we've got GIP, GLP 1, and glucagon together, which is even amplifying the effect even further. We are also developing oral forms of GLP 1 that in the future you could presumably take a tablet once a day, which will also help bring the cost down significantly and make it more available for individuals. We also have a new generation of medications being developed which is muscle sparing. Tom talked about the importance of being strong and physical function. And with the loss of lean body mass, which occurs with any time you lose weight, you can also lose muscle mass. There's drugs that are also going in that direction. But lastly, let me mention, Kelly, I spend a lot of my time in education. I think the exciting breakthroughs will not be meaningful to the patient unless the professional, the provider and the patient are able to have a nonjudgmental informative discussion during the encounter without stigma, without bias. Talk about the continuum of care available for you, someone living with obesity, and get the medications to the patient. Without that, medications over really sit on the shelf. And we have a lot of more work to do in that area. You know, among the many reasons I admire the both of you is that you've, you've paid a lot of attention to that issue that you just mentioned. You know, what it's like to live with obesity and what people are experiencing and how the stigma and the discrimination can just have devastating consequences. The fact that you're sensitive to those issues and that you're pushing to de-stigmatize these conditions among the general public, but also health care professionals, is really going to be a valuable advance. Thank you for that sensitivity. Tom, what do you think? If you appear into the crystal ball? What does it look like? I would have to agree with Bob that we're going to have so many different medications that we will be able to combine together that we're going to see that it's more than possible to achieve weight losses of 25 to 30 percent of initial body weight. Which is just astonishing to think that pharmaceuticals will be able to achieve what you achieve now with bariatric surgery. I think that it's just, just an extraordinary development. Just so pleased to be able to participate in the development of these drugs at this stage of career. I still see a concern, though, about the stigmatization of weight loss medications. I think we're going to need an enormous dose of medical education to help doctors realize that obesity is a disease. It's a different disease than some of the illnesses that you treat because, yes, it is so influenced by the environment. And if we could change the environment, as you've argued so eloquently, we could control a lot of the cases of overweight and obesity. But we've been unable to control the environment. Now we're taking a course that we have medications to control it. And so, let's use those medications just as we use medications to treat diabetes. We could control diabetes if the food environment was better. A lot of medical education to get doctors on board to say, yes, this is a disease that deserves to be treated with medication they will share that with their patients. They will reassure their patients that the drugs are safe. And that they're going to be safe long term for you to take. And then I hope that society as a whole will pick up that message that, yes, obesity and overweight are diseases that deserve to be treated the same way we treat other chronic illnesses. That's a tall order, but I think we're moving in that direction. BIOS Robert Kushner is Professor of Medicine and Medical Education at Northwestern University Feinberg School of Medicine, and Director of the Center for Lifestyle Medicine in Chicago, IL, USA. After finishing a residency in Internal Medicine at Northwestern University, he went on to complete a post-graduate fellowship in Clinical Nutrition and earned a Master's degree in Clinical Nutrition and Nutritional Biology from the University of Chicago. Dr. Kushner is past-President of The Obesity Society (TOS), the American Society for Parenteral and Enteral Nutrition (ASPEN), the American Board of Physician Nutrition Specialists (ABPNS), past-Chair of the American Board of Obesity Medicine (ABOM), and Co-Editor of Current Obesity Reports. He was awarded the ‘2016 Clinician-of-the-Year Award' by The Obesity Society and John X. Thomas Best Teachers of Feinberg Award at Northwestern University Feinberg School of Medicine in 2017. Dr. Kushner has authored over 250 original articles, reviews, books and book chapters covering medical nutrition, medical nutrition education, and obesity, and is an internationally recognized expert on the care of patients who are overweight or obese. He is author/editor of multiple books including Dr. Kushner's Personality Type Diet (St. Martin's Griffin Press, 2003; iuniverse, 2008), Fitness Unleashed (Three Rivers Press, 2006), Counseling Overweight Adults: The Lifestyle Patterns Approach and Tool Kit (Academy of Nutrition and Dietetics, 2009) and editor of the American Medical Association's (AMA) Assessment and Management of Adult Obesity: A Primer for Physicians (2003). Current books include Practical Manual of Clinical Obesity (Wiley-Blackwell, 2013), Treatment of the Obese Patient, 2nd Edition (Springer, 2014), Nutrition and Bariatric Surgery (CRC Press, 2015), Lifestyle Medicine: A Manual for Clinical Practice (Springer, 2016), and Obesity Medicine, Medical Clinics of North America (Elsevier, 2018). He is author of the upcoming book, Six Factors to Fit: Weight Loss that Works for You! (Academy of Nutrition and Dietetics, December, 2019). Thomas A. Wadden is a clinical psychologist and educator who is known for his research on the treatment of obesity by methods that include lifestyle modification, pharmacotherapy, and bariatric surgery. He is the Albert J. Stunkard Professor of Psychology in Psychiatry at the Perelman School of Medicine at the University of Pennsylvania and former director of the university's Center for Weight and Eating Disorders. He also is visiting professor of psychology at Haverford College. Wadden has published more than 550 peer-reviewed scientific papers and abstracts, as well as 7 edited books. Over the course of his career, he has served on expert panels for the National Institutes of Health, the Federal Trade Commission, the Department of Veterans Affairs, and the U.S. House of Representatives. His research has been recognized by awards from several organizations including the Association for the Advancement of Behavior Therapy and The Obesity Society. Wadden is a fellow of the Academy of Behavioral Medicine Research, the College of Physicians of Philadelphia, the Obesity Society, and Society of Behavioral Medicine. In 2015, the Obesity Society created the Thomas A. Wadden Award for Distinguished Mentorship, recognizing his education of scientists and practitioners in the field of obesity.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.The European Medicines Agency approved a kidney disease-related label expansion for Novo Nordisk's Ozempic, a GLP-1 drug, after a study showed a reduced risk of death by 20%. Keros suspended two arms of a hypertension study due to safety concerns, causing their stock to plummet. Pfizer's Ibrance showed improved survival in a new breast cancer indication, positioning it as a competitor to Novartis.Executives from Pfizer and Eli Lilly expressed optimism about collaborating with the incoming administration after dining with Trump. In other news, former Cytodyn officials were found guilty of securities fraud, Candel stock soared on promising phase III prostate cancer data, and several companies announced staff layoffs. Pharma M&A spending has been low this year, with only one deal exceeding $5 billion. These developments in the pharmaceutical industry highlight the importance of safety concerns and regulatory approvals in drug development. Stay tuned for more updates on the latest news in Pharma and Biotech.

Die Themen in den Wissensnachrichten: +++ Uno fordert Staaten zum Stopfen von Methanlecks in Industrie auf +++ Masern breiten sich stark aus +++ KI-Omi nervt Telefonbetrüger +++**********Weiterführende Quellen zu dieser Folge:Update ErdeMethane emissions tracking system proves its worth, but action to plug leaks must accelerate/ UN environment programm, 15.11.2024Measles/ WHO, 14.11.2024Phone network employs AI "grandmother" to waste scammers' time with meandering conversations/ Techspot, 14.11.2024Leqembi recommended for treatment of early Alzheimer's disease/ European Medicines Agency, 14.11.2024Alle Quellen findet ihr hier.**********Ihr könnt uns auch auf diesen Kanälen folgen: TikTok auf&ab , TikTok wie_geht und Instagram .

アルツハイマー病治療薬「レカネマブ」【ロンドン時事】欧州連合の欧州医薬品庁は１４日、日本の製薬大手エーザイと米医薬品大手バイオジェンが開発したアルツハイマー病治療薬「レカネマブ」について、医薬品を評価する委員会が条件付きでの販売を承認するよう勧告したと発表した。 The European Medicines Agency said Thursday that its committee evaluating medical products has recommended partial approval of sales of lecanemab to treat Alzheimer's disease.

GET FREEZE DRIED BEEF HERE: https://wambeef.com/ Use Code WAMBEEF to save 25%! 10+ Year Shelf life & All Natural! GET HEIRLOOM SEEDS & NON GMO SURVIVAL FOOD HERE: https://heavensharvest.com/ USE Code WAM to save 5%! BUY GOLD HERE: https://firstnationalbullion.com/schedule-consult/ GET YOUR APRICOT SEEDS at the life-saving Richardson Nutritional Center HERE: https://rncstore.com/r?id=bg8qc1 Josh Sigurdson reports on the shocking details of European government statistics showing an incredible increase in excess deaths between week 21 of 2021 (the introduction of the Emergency Use Authorization of the Pfizer "covid" vaccine) and the fourth week of 2024. According to statistics, there was a negative rate of death for the first 21 weeks of 2021. Immediately after the EMA, deaths spiked to historic levels. The correlation is blatantly obvious. Children appear to have been most affected. The rate of excess death in children aged 0 to 14 years following week 21 of 2021 to the fourth week of 2024 was 335% or 42x according to the European Medicines Agency, looking at 26 European countries, NOT including Ukraine. We've already read hundreds of reports and studies on the effects of the so-called "covid vaccine" and the damage mRNA has done to tens of millions of people since the release of the deadly injections. From self assembling nano-particles to gene editing technology. From blood clots and myocarditis to turbo cancer and of course deadly auto-immune disorders. While people sit on their hands and fall for the latest plandemic hoax (bird flu, Monkeypox, Sloth Fever, Dengue, EEEV or whatever else they want you terrified of) we still have not seen justice for the mass murder of millions of people worldwide, especially children. The death rate actually sees an increase year over year despite people no longer getting covid injections on the regular due to a weakening body thanks to the mRNA injections. We will continue to see these numbers climb in the future unfortunately. We tried to warn people. The tragedy is also that this will likely be inter-generational. The children of those who've been injected are likely carrying severe future immune issues with them. Recently in Canada, 82 unvaccinated healthcare workers won an arbitration case against a hospital that fired them. The justice in minimal however and the fight to destroy the soul and consciousness of humanity continues in many different forms including new disease hoaxes in the path to the "Great Reset" and the tyrannical technocratic power shift we're entering into. Stay tuned for more from WAM! ORDER QUALITY MEAT TO YOUR DOOR HERE: https://wildpastures.com/promos/save-20-for-life/bonus15?oid=6&affid=321 Save 20% and get $15 off your FIRST order! Support your local farms and stay healthy! HELP SUPPORT US AS WE DOCUMENT HISTORY HERE: https://gogetfunding.com/help-wam-cover-history/ PayPal: ancientwonderstelevision@gmail.com FIND OUR CoinTree page here: https://cointr.ee/joshsigurdson JOIN US on SubscribeStar here: https://www.subscribestar.com/world-alternative-media For subscriber only content! Follow us on Twitter here: https://twitter.com/WorldAltMedia Pledge here! Just a dollar a month can help us alive! https://www.patreon.com/user?u=2652072&ty=h&u=2652072 BITCOIN ADDRESS: 18d1WEnYYhBRgZVbeyLr6UfiJhrQygcgNU World Alternative Media 2024

For decades, academic clinical trials consortia have collaborated to optimize outcomes for childhood cancers through evaluating incremental improvements in conventional multi modality treatment regimes. There are now increasing opportunities to partner with industry to test new medicines in academic-sponsored trials, but these collaborative studies rarely contribute to marketing authorizations. Under the auspices of the multistakeholder platform ACCELERATE, a working group of representatives was convened from clinical academia, the pharmaceutical industry, the European Medicines Agency, US Food and Drug Administration, and patient advocacy to explore why this is the case and to seek solutions to enable academic-sponsored trials to directly contribute to the licensing of new medicines. This presentation summarizes the group's findings and provides an industry perspective on how to move forward.Dr. Barry is a board-certified pediatrician and pediatric hematologist/oncologist with over 15 years of experience in drug development. Prior to joining Day One in 2021, she was the Global Clinical Lead for Pediatric Oncology at Pfizer, as well as Head of Pfizer's Pediatric Oncology Leadership Team where she oversaw more than 10 pediatric oncology clinical programs. She has also held previous roles at Genzyme and Millenium/Takeda focused on the development of oncology therapeutics in adults. Dr. Barry serves on the Industry Advisory Council for CureSearch and is a member of the ACCELERATE Platform Steering Committee. She is also a co-chair of the Children's Oncology Group Industry Relations Council. Dr. Barry is a graduate of the pediatric hematology/oncology fellowship program at the Dana Farber Cancer Institute and Children's Hospital Boston, and the pediatric residency program at Tufts. She received her M.D. at Yale University School of Medicine and also obtained a Masters in Medical Science degree from Harvard Medical School.

The world's first deaths from the mosquito-borne Oropouche virus have been recorded in Brazil. Two women have died from the illness in the state of Bahia in the northeast of the country.Claudia Hammond is joined by Dr Ayan Panja to discuss the implications of outbreaks of Oropouche across South and Central America.We also hear about the latest developments with Alzheimer's drug lecanemab as it's rejected for use by the EU's health regulator. The European Medicines Agency says the benefits of the drug don't counterbalance the risk of serious side effects, despite it being approved in the US earlier this year.Claudia and Ayan also look at both the psychology of languishing and whether loneliness leads to a higher risk of having a stroke.And we look at the research suggesting cycling to work can lead to an almost 50% lower risk of dying.Presenter: Claudia Hammond Producer: Dan Welsh

In today's episode, we cover some major stories in medical news:First up, the UK High Court has upheld a ban on puberty blockers for youth with gender dysphoria, citing a lack of evidence for their safety and effectiveness. While trans advocacy groups plan to appeal, the ruling limits use to clinical trials for now.Next, the European Medicines Agency has rejected a license for a promising new Alzheimer's drug called lacanumab over safety concerns, despite the drug showing ability to slow cognitive decline by 25% in trials. The setback is disappointing for many hoping for a treatment.Finally, an exciting development on the diagnostic front - a new blood test called AP's-2 has demonstrated over 90% accuracy in diagnosing early-stage Alzheimer's, outperforming primary care doctors. The test could revolutionize early detection if approved.

Dr. McCullough has made presentations on the advancement of medicine across the world and has been an invited lecturer at the New York Academy of Sciences, the National Institutes of Health, U.S. Food and Drug Administration (FDA), European Medicines Agency, and the U.S. Congressional Oversight Panel. Dr. McCullough begins the conversation with how Fauci lied to the people. The science they used was political science not peer reviewed science. The CDC,FDA and other lied about the vaccines, they do not work they actually make you sick. There are now more deaths from the vaccine then the covid. Disease X is already here, the [DS] already has vaccines standing by, but there are other cures that will protect you. 

BioSpace's Lori Ellis and Chantal Dresner are bringing live updates from #DIA2024 in San Diego this week where the first day kicked off with an inspiring story from Tom and Emily Whitehead of the Emily Whitehead Foundation, setting the tone for patient-centric discussions. The following panel featuring Emer Cooke, Chair, ICMRA an Executive Director, European Medicines Agency; Peter Marks, Director, CBER, FDA; Carsten Linnerman, CEO, Neogene Therapeutics, AstraZeneca Group; Dean Kamen, Founder, DEKA; and Stacy Hurt, Chief Patient Officer, Parexel emphasized the imperative of collaboration to improve outcomes, between regulatory bodies as well as with patients. Tune in this week to hear more from the event!

We begin discussing the Indiana primary results and how GOP primary voters clearly are not inspired to act on their beliefs and change the party one iota. Perhaps, this is why we have not had a reckoning on the COVID genocide. I'm joined today by British investigative journalist Sonia Elijah, who gives a spellbinding presentation on how European countries continue to cover up vaccine injuries just like in the U.S. Some countries are criminalizing dissent and others are erasing excess death data points in order to cover the crimes. However, as Sonia observes, new data curated from the European Medicines Agency's own pharmacovigilance program shows a shocking number of heart attacks and cancers spiking in recent years. It also shows that COVID itself was the number-one side effect of the COVID vaccines! Despite this happening out in the open, and AstraZeneca even taking its shot off the market, there is no mainstream political party in any country that is not bought out by the industry. Therefore, not only have the perpetrators not been punished, they are taking the road show on to cancer treatment where they plan to do the same thing they did with COVID ... of course, after having caused a sickening amount of cancer from their deadly shots. Learn more about your ad choices. Visit megaphone.fm/adchoices

Joining us on the latest episode of The Law of Tech Podcast is doctoral researcher at KU Leuven CiTiP – imec and an External Collaborating Expert on Data Protection of Big Data and Real-World Data at the European Medicines Agency. As the concept of accuracy is gaining momentum in the context of data and AI regulation, Elisabetta takes us on a journey to better understand its practical meaning and identify existing gaps in its implementation in her domain of expertise: healthcare innovation.  Want to know more? Take a listen to the podcast episode on your podcast platform of preference!

Neurology Today Editor-in-Chief Joseph E. Safdieh, MD, FAAN, highlights new stories reporting on the impact of SARS-CoV2 on dopamine neurons, a European Medicines Agency warning about valproate risks for men, and neurologists on the pros and cons of working locum tenens.

In this eye-opening episode, Coach Vinny and Dr. Eryn takes you on a journey through the social media jungle, exposing the 5 RED FLAGS you need to make sure you look out for!Sponsored by LEGION Athletics, with a special offer for listeners (use code RUSSO for 20% off and double points on every order), this episode is packed with insights to keep you informed and empowered. Supplements without Supporting Research: Discover why blindly investing in supplements without proper research is a risky game. We share the loopholes in FDA regulations and the potential health risks associated with unverified ingredients. Learn the truth behind the quick fixes promised by many supplement enthusiasts. Fake Weight Loss Drugs and Compounded Medications: Unveil the dangers of fake GLP-1 medications and compounded drugs. We shed light on the deceptive practices of some pharmacies, emphasizing the importance of FDA-approved medications. Stay informed about the European Medicines Agency's warning and the risks associated with fake medications. Influencers Out of Their Lane: Get fired up as We tackle influencers spreading misinformation. From life insurance salesmen turned genetic testing promoters to nutrition coaches with limited expertise, learn to identify red flags and navigate through the sea of scientific jargon. Promotion of Peptides: Delve into the world of peptides like tesamorelin and BPC-157. We break down the challenges in ensuring quality and equivalence in peptide drug products. Uncover the potential risks associated with these compounds and why caution is crucial when considering their use. Weight Loss Challenges by Fitness Coaches: Rethink your approach to weight loss challenges. We expose the flaws in generic, one-size-fits-all protocols, urging you to prioritize sustainable, long-term habits over quick fixes. Learn why extreme dieting and excessive exercise can lead to metabolic suppression and rebounds. Equip yourself with the knowledge to navigate the fitness landscape and make informed choices. Tune in now and share this episode with your friends to spread awareness about the pitfalls of social media misinformation. Coach VinnyEmail: vinny@balancedbodies.ioInstagram: vinnyrusso_balancedbodiesFacebook: Vinny Russo Dr. ErynEmail: dr.eryn@balancedbodies.ioInstagram: dr.eryn_balancedbodiesFacebook: Eryn Stansfield LEGION 20% OFF CODEGo to https://legionathletics.com/ and use the code RUSSO for 20% off your order!

2024-01-05 Our hosts Amir Kalali, Craig Lipset, and Jane Myles were joined by Aditi Hazra with Harvard Medical School for a compelling discussion around implementing resilience framework in clinical trials.Several references were discussed during the episode from the FDA and EMA.1) FDA-2023-D-3550: “Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies”https://www.federalregister.gov/documents/2023/09/21/2023-20474/considerations-for-the-conduct-of-clinical-trials-of-medical-products-during-major-disruptions-due2) European Medicines Agency: https://www.ema.europa.eu/en/impact-war-ukraine-methodological-aspects-ongoing-clinical-trials-scientific-guidelineFollow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

In response to an EU investigation, The European Medicines Agency has admitted that COVID-19 vaccines were never authorized to stop transmission. Meanwhile, new studies show a link between masking and getting COVID-19 infections and adherence to lockdowns and an increase in mental health issues.

Dr. Peter A. McCullough is board certified in internal medicine, cardiovascular diseases, and clinical lipidology. He cares for advanced patients with common medical problems including heart and kidney disease, lipid disorders, and diabetes. He has become an expert on COVID-19 and vaccine illnesses.After receiving a bachelor's degree from Baylor University, Dr. McCullough completed his medical degree as an Alpha Omega Alpha graduate from the University of Texas Southwestern Medical School. He went on to complete his internal medicine residency at the University of Washington, cardiology fellowship including service as Chief Fellow at William Beaumont Hospital, and master's degree in public health at the University of Michigan.Dr. McCullough has broadly published on a range of topics in medicine with > 1000 publications and > 660 citations in the National Library of Medicine. His works include the “Interface between Renal Disease and Cardiovascular Illness” in Braunwald's Heart Disease Textbook. Dr. McCullough has made presentations on the advancement of medicine across the world and has been an invited lecturer at the New York Academy of Sciences, the National Institutes of Health, U.S. Food and Drug Administration (FDA), and the European Medicines Agency. He has served as member or chair of data safety monitoring boards of dozens of randomized clinical trials.Since the outset of the pandemic, Dr. McCullough has been a leader in the medical response to the COVID-19 disaster and has published “Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection” the first synthesis of sequenced multidrug treatment of ambulatory patients infected with SARS-CoV-2 in the American Journal of Medicine and subsequently updated in Reviews in Cardiovascular Medicine. He has >60 peer-reviewed publications on the infection and has commented extensively on the medical response to the COVID-19 crisis in The Hill. Dr. McCullough has testified multiple times in the US Senate and in several State Senate Committees concerning early ambulatory treatment of high-risk patients with COVID-19 and the safety and theoretic efficacy of COVID-19 vaccination. Dr. McCullough welcomes post-COVID-19 patients into his practice and will help them through the range of post-infection complications and injuries resulting from COVID-19 vaccination.BOARD CERTIFICATIONS:Cardiovascular DiseaseAdvanced LipidologyInternal Medicine

Up to 80% of people with schizophrenia aren't aware they're experiencing early schizophrenia symptoms. Most people with schizophrenia go through a prodromal stage, where there's subtle changes in mood, thinking, and behavior. It's an evolution of the symptoms to come. Early indicators vary based on the age they start. An adult who develops schizophrenia will experience different signs than a child who develops the condition. Host Rachel Star Withers and cohost Gabe Howard explore the early signs of schizophrenia in children, teens, and adults. Joining to discuss the future of identifying biomarkers for schizophrenia is Carlos Larrauri, a psychiatric mental health nurse practitioner who also lives with schizophrenia. Mr. Larrauri co-chairs the steering committee for the Accelerating Medicines Partnership Program Schizophrenia AMP, which is working to identify early indicators of schizophrenia. To learn more -- or read the transcript -- please visit the official episode page. Our guest, Carlos A. Larrauri, MSN, is co-chair of the Accelerating Medicines Partnership® Schizophrenia (AMP® SCZ) and has formerly served on the National Alliance on Mental Illness (NAMI) and NAMI Miami-Dade County Board of Directors. Diagnosed with schizophrenia at 23 years old, access to quality mental health care, community-based treatment, and early intervention afforded him the best opportunity for recovery. Mr. Larrauri is pursuing a law degree at the University of Michigan Law School and a concurrent master in public administration at the Harvard Kennedy School, where he was Zuckerman Fellow at Harvard's Center for Public Leadership. He's board certified as a family nurse practitioner and psychiatric mental health nurse practitioner and formerly lectured at the University of Miami and Miami Dade College. Mr. Larrauri aspires to interface advocacy and research to reduce health inequities for people living with mental illness. To learn more about Carlos and his work, visit his website or his LinkedIn. The Accelerating Medicines Partnership® (AMP®) program—Schizophrenia (SCZ) is a public-private partnership between the National Institute of Mental Health (NIMH), the U.S. Food and Drug Administration (FDA), the European Medicines Agency, and multiple public and private organizations. Launched in 2020 and managed by the Foundation for the National Institutes of Health, the AMP SCZ program addresses the critical need for more effective treatments for people with schizophrenia and related mental health conditions. The overarching aim is to improve our understanding of disease pathways and identify new and better targets for treatment. Our host, Rachel Star Withers, creates videos documenting her schizophrenia, ways to manage and let others like her know they are not alone and can still live an amazing life. She has written Lil Broken Star: Understanding Schizophrenia for Kids and a tool for schizophrenics, To See in the Dark: Hallucination and Delusion Journal. Fun Fact: She has wrestled alligators. To learn more about Rachel, please visit her website, RachelStarLive.com. Our cohost, Gabe Howard, is an award-winning writer and speaker who lives with bipolar disorder. He is the author of the popular book, "Mental Illness is an Asshole and other Observations," available from Amazon; signed copies are also available directly from the author. Gabe makes his home in the suburbs of Columbus, Ohio. He lives with his supportive wife, Kendall, and a Miniature Schnauzer dog that he never wanted, but now can't imagine life without. To learn more about Gabe, please visit his website, gabehoward.com. Learn more about your ad choices. Visit megaphone.fm/adchoices

Thank you to everyone who sent me feedback on this podcast. This episode is based on a suggestion from Drew. In this episode, I discuss bioequivalence studies and generic drug development. I will refer to guidance documents from both the European Medicines Agency or EMA and the US Food and Drug Administration or FDA. First, I will start with a discussion of the definition of bioequivalence or BE. Then I will discuss the statistical basis for bioequivalence and how you can leverage that for study design. And I will end with some unique challenges related to bioequivalence. Throughout, I will give practical suggestions based on my experiences in the past with BE studies. Links discussed in the show: • EMA guidance on bioequivalence • FDA guidance on statistical approaches to bioequivalence (December 2022) • FDA statistical approaches to BE (January 2001) • FDA guidance on BE studies (2022) • FDA product-specific guidances on BE • Lecture from Helmut Schütz on finding intra-subject variability (or CV%) for power calculations • PowerTOST R Package • You can connect with me on LinkedIn and send me a message • Send me a message • Sign up for my newsletter Copyright Teuscher Solutions LLC All Rights Reserved

Sonia Elijah is an independent investigative journalist and former BBC researcher. She has written numerous forensic-style investigative reports, which have uncovered major conflicts of interest and malfeasance. In particular, her analytical reports on the Pfizer-BioNTech COVID-19 vaccine: the clinical and non clinical trial documents, as well as the vaccine safety reports compiled for the US Food and Drug Administration and European Medicines Agency, have received world-wide attention. Sonia's passion is to deep-dive into public interest stories, which the mainstream media avoids. In this conversation we learn some shocking truths about the truth behind the mRNA jabs, the betrayal of our regulatory bodies and the incredible harm being done to pregnant women and children as a result of these so called vaccines. Please see Sonia's Subtacks for links and references. Links - Please follow Sonia on twitter: ⁠Sonia Elijah Her substack can be found here ⁠Sonia Elijah Substack About Doc Malik: Orthopaedic surgeon Ahmad Malik is on a journey of discovery when it comes to health and wellness. Through honest conversations with captivating individuals, Ahmad explores an array of topics that profoundly impact our well-being and health. ⁠Subscribe to the show⁠ and join our mailing list. ⁠Support the show⁠ and have access to exclusive contents and perks.  To sponsor the Doc Malik Podcast contact us at ⁠hello@docmalik.com⁠  You can follow us on social media, we are on the following platforms: ⁠Twitter Ahmad⁠ | ⁠Twitter Podcast⁠ | ⁠Instagram Ahmad⁠ | ⁠Instagram Podcast

Sponsor special: Up to $2,500 of FREE silver AND a FREE safe on qualifying orders - Call 855-862-3377 or text “AMERICAN” to 6-5-5-3-2“Here we are three years into this, with a virus that has evolved into something that for most people is a common cold, shots that are expired because the variants they cover are all extinct—I mean, it's an absurdity that the shots are even on the market at all—and yet, we're still seeing brilliant physicians and educators and scientists being attacked for simply calling out the truth.”At the Front Line COVID-19 Critical Care (FLCCC) conference last month, I sat down with pathologist Dr. Ryan Cole to discuss autopsies and excess deaths rates allegedly related to the mRNA shot, and to dig into what has actually been found in the vials of these shots, as well as what studies are being done to differentiate between spike damage caused by the virus, versus the vaccine.“There are two dangerous things in these vials—that's a lipid nanoparticle, and a gene sequence that's making your body make foreign proteins,” says Cole. “When a FOIA request was done of the European Medicines Agency, they found out that these vials were only about 50 percent pure mRNA, meaning they can potentially code for these other proteins for which we don't even know what they're going to do. And instead of saying, ‘Yeah, you need to purify your product and make it better,' they said, ‘Okay, we'll lower the standard to 50 percent.'”We also discuss the curious emergence of what doctors are calling “turbo cancers,” and how they potentially relate to the COVID genetic vaccine.“What's happening is these cancers we are used to seeing, their growth patterns and their behavior are completely out of character … So ‘turbo cancer' is something that wasn't there and, all of a sudden, it's everywhere,” says Cole.He believes one of the biggest tragedies during the pandemic has been the loss of curiosity, and considers it tragic that so many people are afraid of having to pay a consequence for telling the truth.“All doctors and scientists agree when you censor the ones who don't. And so this construct in dialogue and free speech of not allowing a contrary voice to come into the conversation means science isn't being done. If you can question it, it's science. If you can't question it, it's propaganda,” says Cole.

Today on The Richard Syrett Show: Tracey Wilson, V.P. of Public Relations for the Canadian Coalition of Firearm Rights talks about the Trudeau Govt announcing an annual day against gun violence. Jay Goldberg, Ontario Director for the Canadian Taxpayers Federation discusses the mission cultural fund being cancelled. Heather Mason, founding member of caWsbar brings up the "Keep Prisons Single Protest". Cardiologist Dr. Peter McCullogh shares how the European Medicines Agency admitted that the COVID-19 jabs can have adverse effects on female fertility. Reporter for True North Andrew Lawton elaborates on David Johnston's refusal to resign despite a vote in the house. Matt Duffy, host of "Who Does Improv Anyway?" on Sauga 960, previews his new show.

The COVID mandates might have ended, but the human experimentation continues. I warn how companies and governments are about to unleash RSV vaccines that are just as deadly. The policies have still not changed. Next, we are joined by U.K. investigative journalist Sonia Elijah, who has discovered documents from Pfizer's partner BioNTech and the European Medicines Agency that show how they knew from day one that the shots are dangerous to all people, cause injuries in every organ system, are particularly concerning for pregnant women, spread through the mother's milk, and cause ubiquitous menstrual irregularities. To this day, they refuse to recognize the problems and have now created a permanent regulatory scheme in which any vaccine is innocent until proven 100% guilty, the opposite of the precautionary principle in the Nuremberg Code.   Learn more about your ad choices. Visit megaphone.fm/adchoices

This week we do our best to explain how next week's elections work (shout out to the water boards!), why the TV debates are between politicians who aren't standing in them and why Mark Rutte is shadow boxing with a 'leftist cloud'. Justice minister Dilan Yesilgöz is under pressure over failures in the crown witness protection system. The European Medicines Agency is displeased about the personal treatments Amsterdam city council plans to offer in its neighbourhood. In sport, there's good news in athletics, football, skating, cycling and baseball. And we report on the exotic invaders who are accused of tearing up the neighbourhood, holding raucous parties and driving up your energy bill.

About This Episode: Dr. McCullough is board certified in internal medicine, cardiovascular diseases, and clinical lipidology. After receiving a bachelor's degree from Baylor University, Dr. McCullough completed his medical degree as an Alpha Omega Alpha graduate from the University of Texas Southwestern Medical School. He went on to complete his internal medicine residency at the University of Washington, cardiology fellowship including service as Chief Fellow at William Beaumont Hospital, and master's degree in public health at the University of Michigan. Dr. McCullough has broadly published on a range of topics in medicine with more than 1000 publications and more than 600 citations in the National Library of Medicine. His works include the “Interface between Renal Disease and Cardiovascular Illness” in Braunwald's Heart Disease Textbook. His works have appeared in the New England Journal of Medicine, Journal of the American Medical Association, Lancet, British Medical Journal and other top-tier journals worldwide. He is the editor-in-chief of Reviews in Cardiovascular Medicine and senior associate editor of the American Journal of Cardiology. He serves on the editorial boards of multiple specialty journals. Dr. McCullough has made presentations on the advancement of medicine across the world and has been an invited lecturer at the New York Academy of Sciences, the National Institutes of Health, U.S. Food and Drug Administration (FDA), and the European Medicines Agency. He has served as member or chair of data safety monitoring boards of 24 randomized clinical trials. Since the outset of the pandemic, Dr. McCullough has been a leader in the medical response to the COVID-19 disaster and has published “Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection” the first synthesis of sequenced multidrug treatment of ambulatory patients infected with SARS-CoV-2 in the American Journal of Medicine and subsequently updated in Reviews in Cardiovascular Medicine. He has 35 peer-reviewed publications on the infection and has commented extensively on the medical response to the COVID-19 crisis in TheHill. On November 19, 2020, Dr. McCullough testified in the US Senate Committee on Homeland Security and Governmental Affairs concerning early ambulatory treatment of high-risk patients with COVID-19. Find out more about Dr. McCullough at: Help Dr Peter McCullough with legal IT travel cost - https://givesendgo.com/G2DR5 The McCullough report - https://www.americaoutloud.com/the-mccullough-report/ Twitter - https://twitter.com/P_McCulloughMD Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection  - https://pubmed.ncbi.nlm.nih.gov/32771461/ Treatment algorithm for COVID-19-like and confirmed COVID-19 illness in ambulatory patients at home in self-quarantine. - https://pubmed.ncbi.nlm.nih.gov/32771461/#&gid=article-figures&pid=figure-1-uid-0 Check out our YouTube Channel: Jeremyryanslatebiz See the Show Notes: www.jeremyryanslate.com/960 Sponsors: Gusto: This episode is sponsored by Gusto. Run your payroll the easy way, the same way we do at Command Your Brand. You'll get a. $100 Amazon Gift Card just for running your first payroll! http://www.jeremyryanslate.com/gusto MyPillow: Use the promo code: CYOL to get up to 60% off https://www.mypillow.com/ Audible: Get a free 30 day free trial and 1 free audiobook from thousands of available books. Right now I'm reading " Rigged: How the Media, Big Tech, and the Democrats Seized Our Elections" by Mollie Hemingway www.jeremyryanslate.com/book