Podcasts about phase iii

We’re finally diving into Phase III of the High Republic project with George Mann’s novel Eye of Darkness. Join us as we discuss the state of the galaxy one year after the fall of Starlight Beacon, attempts to turn the Nihil into a government, and quibbles with the prose. For a list of Black-owned bookstores […]

This episode of the PeerDirect Medical News Podcast examines the rapidly expanding Ebola outbreak in Congo and concerns over weakening global public health infrastructure, reviews new Phase III obesity data showing substantial weight loss with Lilly's triple-agonist retatrutide, and highlights promising ASCO 2026 lung cancer data for a TROP2-directed ADC combined with pembrolizumab in frontline NSCLC.

We’re starting our read of Tales of Light and Life, a collection of short stories by the authors of the High Republic project. Join us as we discuss transitioning from Phase II to Phase III, Marda Ro sowing the seeds of the Nihil, and the aftermath of the fall of Starlight Beacon. For a list […]

Listen in to learn the latest on ART switch strategies for people living with virologically suppressed HIV. Hear from experts Chloe Orkin, MBChB, FRCP, MD, and Peter J. Ruane, MD, as they review how the recent approvals fit in the treatment landscape of 2-drug, single-tablet regimens. Stream on the go or follow along with our expert-curated slides.  Topics covered include:  Guideline recommendations on ART switch in the setting of virologic suppression Phase III clinical trial data supporting ART switch Individual considerations for ART switch Get access to all of our new podcasts by subscribing to the Decera Clinical Education Infectious Disease Podcast on Apple Podcasts, YouTube Music, or Spotify. Presenters: Chloe Orkin, MBChB, FRCP, MD Professor of Infection and Inequities Dean for Healthcare Transformation Faculty of Medicine and Dentistry Queen Mary University of London London, United Kingdom of Great Britain and Northern Ireland Honorary Consultant Physician Barts Health NHS Trust London, United Kingdom Peter J. Ruane, MD President Ruane Clinical Research Los Angeles, California Link to program page: https://bit.ly/3PkPoP4 Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

In this episode, Surani explores one of biotech's most controversial and ambitious frontiers: psychedelic medicine. At the center of the story is Compass Pathways, the London-based biotech attempting to bring synthetic psilocybin through the modern drug approval system for treatment-resistant depression. What began as a deeply personal mission for founders George and Katya Goldsmith has evolved into one of the most closely watched companies in mental health biotech, surviving both the psychedelic hype cycle and the broader biotech market crash. Surani speaks with CEO Kabir Nath to explore Compass's unusual financing journey, the rise of institutional interest from investors like Otsuka Pharmaceutical, and the company's pivotal Phase II and Phase III studies that may ultimately lead to the first FDA-approved psychedelic medicine. She is also joined by renowned neuropsychopharmacologist Professor David Nutt from Imperial College London to unpack the science, investor skepticism, regulatory concerns and implementation complexities surrounding psychedelics. Timestamps 00:01 — Introduction 02.00 — The Compass origin story: George and Katya Goldsmith, psilocybin, and building a biotech 07:00 — Early financing struggles, Peter Thiel, and why traditional biotech investors stayed away 08:30 — Otsuka, and the moment psychedelics entered the mainstream 11:00 — Compass IPOs into the biotech boom — then the market crashes 13:00 — The controversial Phase IIb results: remission rates, safety concerns, and investor backlash 21:00 — Kabir Nath joins Compass as CEO to launch the Phase III program 22:00 — Breaking down the Phase III data, durability questions, and FDA approval odds 26:00 — Lykos' FDA fiasco, psychotherapy, blinding debates, and the regulatory challenge for psychedelics 31:00 — Real-world rollout: J&Js Spravato, scalability, pricing, reimbursement, and Compass's future vision Founders' Story: Business Insider Article After On podcast: For any comments, questions or feedback you can connect directly with Surani Fernando on LinkedIn or email: raisingbiotech@gmail.com Title music composed by: Yrii Semchyshyn (Coma Media)

Two supplements. One morning stack. Nurse Doza breaks down why Liver Boost and Berberine Plus work better together — and how the Good Poops Protocol combines them with a gut-repair formula to support liver, gallbladder, blood sugar, and weight.  Today is the last day to save an extra 10% automatically on the full protocol. The Good Poops Protocol is a three-supplement system designed by Nurse Doza, DC, RN, FNP-C — combining Liver Boost (16-ingredient Phase I + II liver detox support), Berberine Plus (5x more bioavailable dihydroberberine for blood sugar and digestion), and Gut (L-Glutamine formula for intestinal lining and gut flora) — into one 60-day protocol. As discussed in this episode, when you support liver function and blood sugar management simultaneously, the downstream effects on digestion, weight, and overall health can be profound — and noticeable within days.

Solvonis Therapeutics PLC (LSE:SVNS) CEO Anthony Tennyson tells Proactive's Stephen Gunnion that 2025 was a transformational year, marked by the acquisition of Awakn Life Sciences, a strategic rebrand, and a sharp refocus on high-burden CNS disorders. The centrepiece of the conversation is lead programme SVN-001 and the decision to take it through phase III rather than pursue an early licensing deal. Tennyson is direct about the rationale: shareholder value is greater at the end of a successful phase III than before it. Phase II data for SVN-001 in severe alcohol use disorder showed meaningfully improved sobriety outcomes, and the broader pipeline — including SVN-002 and early-stage asset SVN-015 — continues to advance across addiction and psychiatry. Tennyson also flags improving conditions in the US, with growing regulatory and investor support providing a useful tailwind for the sector. For more insights and updates on emerging biotech companies, visit Proactive's YouTube channel, like this video, subscribe, and enable notifications so you never miss future content. #SolvonisTherapeutics #BiotechPipeline #CNSDisorders #DrugDevelopment #SVN001 #AlcoholUseDisorder #BiotechInvesting #PharmaInnovation #ClinicalTrials #HealthcareInnovation #AddictionTreatment #BiotechNews

hVIVO PLC (AIM:HVO) chief executive Yamin ‘Mo' Khan talked with Proactive's Stephen Gunnion about the company securing a landmark contract to deliver the world's first pivotal Phase III human challenge trial for ILiAD's whooping cough vaccine candidate. Khan explained that the agreement marks a major milestone for hVIVO, representing the largest contract in the company's history and involving the highest number of clinical participants it has ever managed. He highlighted the broader implications for patients, noting that human challenge trials can significantly accelerate the path to market for new treatments. “This has three major impacts,” Khan said, pointing to faster patient access, a transformative contract for hVIVO PLC, and a precedent-setting moment for the wider clinical trial industry. The study will use a human challenge model to assess vaccine efficacy in a controlled environment, addressing the unpredictability of whooping cough infection rates in traditional trials. Khan noted that regulators, including the FDA, MHRA and EMA, have aligned on the approach, enabling faster and more cost-effective development. He also emphasised hVIVO's unique positioning in the sector, stating, “We are the world leader when it comes to human challenge trials,” citing its experience conducting over 50 trials and inoculating more than 5,000 participants. The trial is expected to begin this year, with revenue contributions forecast across 2026 and 2027, enhancing both short- and mid-term visibility for the company. For more videos like this, visit Proactive's YouTube channel, give this video a like, subscribe to the channel and enable notifications for future content. #hVIVO #Biotech #ClinicalTrials #VaccineDevelopment #WhoopingCough #Phase3Trial #HumanChallengeTrial #ILiAD #PharmaNews #HealthcareInnovation #BiotechInvesting #LifeSciences

Some GEN editors were in sunny San Diego covering the hottest research, trends, and products from the American Association for Cancer Research meeting. We kick things off with news from America's Finest City, particularly around the growing role of AI in oncology. Then we dive into two new research studies. In the first, scientists used CRISPR to identify genes in primary CD4+ T cells that promote or restrict HIV infection. The second study described engineered implantable liver constructs that could eventually serve as a stopgap for patients waiting for donor transplants. Finally, the acquisitions keep coming as Eli Lilly scoops up CAR T cell therapy developer Kelonia for $7B. Also, Revolution Medicines has shared some impressive data from a Phase III trial of its pancreatic cancer drug. Join GEN editors Corinna Singleman, PhD, Fay Lin, PhD, Alex Philippidis, and Uduak Thomas for a discussion of the latest biotech and biopharma news. Listed below are links to the GEN stories referenced in this episode of Touching Base: AACR 2026: A Video Update from San Diego By Julianna LeMieux, PhD, and Damian Doherty, GEN, April 21, 2026AACR 2026 Video Update: Cancer Research Edges Toward an AI-Driven EraBy Fay Lin, PhD, and Jonathan Grinstein, PhD, GEN, April 22, 2026Using AI in Healthcare Ethically by Considering HumanityBy Corinna Singleman, PhD, IPM, November 18, 202510x Genomics Unveils Atera Spatial Platform at AACR Meeting By Julianna LeMieux, PhD, GEN, April 19, 2026CRISPR Screens Map Human T‑Cell Genes That Promote or Block HIV Infection GEN, April 20, 2026Synthetic Biology and Tissue Engineering Grow Liver Tissue In‑Body GEN, April 20, 2026 StockWatch: Revolution's Phase III Pancreatic Cancer Data Dazzles Investors, Analysts By Alex Philippidis, GEN Edge, April 19, 2026 Lilly to Acquire Kelonia for Up to $7B, Expanding Cancer Cell Therapy Pipeline By Alex Philippidis, GEN Edge, April 20, 2026Touching Base Podcast Hosted by Corinna Singleman, PhD Behind the Breakthroughs Hosted by Jonathan D. Grinstein, PhD Hosted on Acast. See acast.com/privacy for more information.

hVIVO has been selected to run the world's first pivotal Phase III human challenge trial in whooping cough, marking a major scientific milestone and its largest study to date. The contract strengthens revenue visibility into 2026–27 while underlining the growing importance of human challenge trials in accelerating vaccine approvals globally.

Send us Fan MailPaper Discussed in this Episode:Quantitative regression of qFibrosis with resmetirom: Exploratory histologic endpoints from the MAESTRO-NASH phase III clinical trial. Schattenberg JM, Bedossa P, Guy CD, et al. Journal of Hepatology 2026; https://doi.org/10.1016/j.jhep.2026.03.021.Episode Summary: In this deep dive, we explore how artificial intelligence is revolutionizing the way we measure liver disease recovery. We examine a groundbreaking 2026 Phase III clinical trial (MAESTRO-NASH) that compared traditional human pathologist staging against an AI-driven digital pathology tool called qFibrosis. The study forces us to reconsider our clinical gold standards by asking: what if AI can detect subtle biological healing that the experienced human eye completely misses?In This Episode, We Cover:• The Silent Epidemic: Understanding Metabolic dysfunction-associated steatohepatitis (MASH), a progressive, active form of fatty liver disease linked to cardiovascular risk and cirrhosis. We discuss why precisely tracking the reversal of liver fibrosis is crucial for patient outcomes.• The "Ordinal" Problem: Why the current "gold standard"—human pathologists assigning a simple ordinal score (like Stage F1, F2, or F3)—is subjective and fails to capture the dynamic, nuanced reality of fibrosis progression and regression.• The AI Microscope (SHG & qFibrosis): ◦ SHG (Second Harmonic Generation): An imaging technique that takes advantage of the physical properties of collagen to map out the three-dimensional architecture of the liver. ◦ qFibrosis: An AI-driven analysis tool that evaluates up to 184 distinct features of liver collagen (like string length, width, and intersections) across different regions of the liver lobule, providing a continuous, hyper-detailed assessment rather than a basic category.• The Showdown - Humans vs. AI: Using data from 966 patients in the MAESTRO-NASH trial, we compare how human pathologists and the AI evaluated liver biopsies at baseline and week 52 to test the efficacy of the drug resmetirom.• The AI's "Aha!" Moment (Seeing the Invisible): The most shocking finding of the study occurred in the "non-responder" group. Even when human consensus reads declared certain patients had no histological improvement, the AI detected significant, continuous reductions in liver fibrosis (qFC scores). The digital pathology tool was able to pick up on subthreshold, early matrix remodeling that was entirely invisible to standard manual scoring.• Mapping the Liver's Healing: The AI proved its biological accuracy by successfully linking its spatial data to real-world clinical outcomes. The AI found that specific regional changes—particularly in the portal tract—strongly correlated with non-invasive liver stiffness tests like Magnetic Resonance Elastography (MRE).Key Takeaway: AI isn't here to replace human pathologists; it is a hyper-sensitive tool designed to uncover hidden data patterns. By detecting continuous, region-specific changes in liver collagen, AI digital pathology can identify early therapeutic responses to MASH treatments that traditional staging misses, fundamentally changing how we track disease reversal and personalize medicineSupport the showGet the "Digital Pathology 101" FREE E-book and join us!

Pancreatic cancer remains one of the most difficult cancers to treat, largely because its dense tumor microenvironment makes it difficult for chemotherapy drugs to reach their target. This often leads to poor patient outcomes and underscores the urgent need for new therapeutic strategies to overcome these barriers. In this episode of Curing with Sound, Jae Young Lee, MD, PhD, professor and researcher at Seoul National University Hospital, shares his work exploring focused ultrasound as a noninvasive treatment option for pancreatic cancer. He explains how this technology creates subtle mechanical stress within the tumor, helping to open up its structure so chemotherapy can work more effectively. Dr. Lee also shares encouraging results from his Phase II clinical trial and looks ahead to a pivotal Phase III study, offering new hope for improving patient outcomes. Discussion highlights: A New Treatment Strategy: Focused ultrasound technology shows promise for addressing the unique challenges of pancreatic cancer, enabling precise tumor targeting while preserving critical surrounding structures. From Research to Reality: Learn how Seoul National University Hospital, a designated Focused Ultrasound Center of Excellence, is integrating this technology into clinical care while advancing research across oncology, neurosurgery, and pain management. Seoul National University Hospital Website EPISODE TRANSCRIPT ---------------------------- QUESTIONS? Email podcast@fusfoundation.org if you have a question or comment about the show, or if you would you like to connect about future guest appearances.  Email info@fusfoundation.org if you have questions about focused ultrasound or the Foundation.  FUSF SOCIAL MEDIA LinkedIn X Facebook Instagram TikTok YouTube FUSF WEBSITE https://www.fusfoundation.org FOCUSED ULTRASOUND TREATMENT SITES https://www.fusfoundation.org/the-technology/treatment-sites/ SIGN UP FOR OUR FREE NEWSLETTER https://www.fusfoundation.org/newsletter-signup/ READ THE LATEST NEWSLETTER https://www.fusfoundation.org/the-foundation/news-media/newsletter/ DOWNLOAD "THE TUMOR" BY JOHN GRISHAM (FREE E-BOOK) https://www.fusfoundation.org/read-the-tumor-by-john-grisham/    

This week, we’re wrapping up Path of Vengeance by Cavan Scott and discussing the manga Edge of Balance: Precedent. Join us as we discuss Marda’s character arc, transitioning into Phase III of the High Republic project, and our feelings about Phase II overall. For a list of Black-owned bookstores to order from, now and always, […]

Dr Deb Muth 00:03Well, welcome back to Let’s Talk Wellness Now. I am your host, Dr. Deb. And what is the most talked-about peptides in functional medicine? aren’t actually FDA approved. Not because they don’t work, but because no one’s funded the research to prove it yet. The truth is, some of the compounds that dominate wellness forums, BPC-157, TB-500, thymosin beta-4, epitalin, occupy a fascinating space between breakthrough science and unregulated experimentation. In today’s episode, we’re stepping into that grey zone, the world of investigational peptides, to separate mechanism from marketing. I’m going to walk you through the science that actually shows and where it stops, how to evaluate claims when human data don’t yet exist, and the quality, purity, and safety red flags that you need to recognise. Dr Deb Muth 01:06I created it in a previous episode, so go check that one out. And why honesty is the most important prescription in peptide medicine. If you’ve ever wondered whether these research-only peptides are the frontier of healing or the next functional medicine fad, this episode is for you. So grab your cup of tea or coffee, get comfortable, and let’s talk about what it really means to use peptides that are promising but still under investigation. So we’re going to break just for a second here and have a word from our sponsor. It is because of them that we stay on the air. So thank you for this. And we will be right back. Did you know sweating can literally heal your cells? Infrared saunas don’t just relax you. They detox your body, balance hormones, and boost mitochondrial energy. I’m obsessed with my Health Tech sauna. And right now, you can save $500 with my code at healthtechhealth.com slash dr-muth-req-25. Dr. Deb Muth 02:15All right, guys, welcome back. Let’s dive into investigational peptides, the evidence gap. So the following peptides we’re about ready to discuss are extensively in integrative, functional, and regenerative medicine circles. They may have intriguing mechanisms and promising preclinical data. However, they lack FDA approval, and the evidence quality varies dramatically. from interesting preliminary research to essentially no human data at all. And this distinction is really critical for maintaining scientific integrity. So let’s talk about immune-modulating peptides. There’s thymus and alpha-1, and this is an international story on the thymic peptides. Thymusin alpha-1, known as TA1, is marketed internationally as zidaxin. Dr. Deb Muth 03:16It’s a 28-amino acid polypeptide originally isolated from thymusin fraction 5, which was extracted from bovine thymus tissue. Modern production uses synthetic peptide synthesis. The thymus gland is located behind the sternum and is the primary site for T cell maturation, and thymic peptides like TA1 play roles in human system development and regulation. Now, I love thymus peptides. I love thymus glandular products. I’ve used thymus glandular products for decades. Ground-up animal thymus gland is basically what it is. There are a couple of different supplement companies that I’ve used over the years that are amazing with this. And they do a fantastic job, and they really do help to support the immune system. So when thymus peptides came out, it was really exciting because it took the whole idea of thymus support to a new level. Dr. Deb Muth 04:17The mechanism actually behind the thymus in alpha-1 is complex and involves multiple aspects of immune function. At the cellular level, TA1 enhances T cell maturation and differentiation, particularly the development of helper T cells and cytotoxic T cells. It modulates T cell receptor expression and can influence the balance between Th1 cell-mediated immunity and Th2 humoral immunity responses. And it also enhances the natural killer cell activity and modulates dendritic cell function, which are critical for antigen presentation. and initiation of adaptive immune responses. And on the cytokine level, TA1 influences production of interleukin-2, IL-2, interferon gamma, IFN-γ, and interleukin-10, IL-10. Dr. Deb Muth 05:19These create immune modulatory rather than simple immune stimulatory effects. This is a very important distinction because TA1 appears to help balance the immune system rather than simply ramping this up, which theoretically makes it safer in conditions where immune overstimulation would be a problem, such as an autoimmune disease. Hashimoto’s, autoimmune, lupus, Sjogren’s, any of those autoimmune diseases, we don’t want to overstimulate their immune system. So you want to use a product like this that’s non-stimulating. Now, the regulatory status on TA1 is geographically variable and represents one of the challenges in discussing this peptide with patients. It is not FDA-approved in the United States. However, it is approved in several other countries for specific conditions. Dr. Deb Muth 06:19In Italy, it’s approved for the treatment of chronic hepatitis B and hepatitis C. In China, it’s approved for chronic hepatitis B and adjunct immune compromised patients receiving vaccinations or suffering from certain infections. It has an orphan drug designation in the United States for certain cancer indications, but its designation does not constitute approval. It simply provides regulatory incentives for further development. So the evidence base for thymosin alpha-1 is substantial in some areas but comes primarily from non-US populations and research groups, which creates challenges in evaluating quality and generalizable information. So in hepatitis B and C, multiple clinical trials, many conducted in China and Italy, have examined TA1 as an adjunct to antiviral therapy. Dr. Deb Muth 07:21A meta-analysis by Wu and colleagues published in the Journal of Viral Hepatitis in 2013 examined 23 randomized controlled trials, including over 2,000 patients with chronic hepatitis B. The analysis found that combining TA1 with nucleoside analogs like LAMVDUDE or an and TCAVAR improved the hepatitis antigen seroconversion rates by HBV DNA clearance compared to its nucleoside analogs alone. And the effect sizes were modest but statistically significant, with the HBE-AG seroconversion rates improving from about 24% with antivirals alone to 38% in combined therapy. Now in hepatitis C, early trials before the development of direct-acting antivirals showed that TA1 combined with interferon alpha improved sustained virological responses, and compared to interferon alpha, Dr. Deb Muth 08:30Furon alone, particularly in difficult-to-treat populations like those with a genotype one or a high viral load. However, the advent of highly effective direct acting antivirals that achieve SRV rates, sorry, SVR rates exceeding 95%, the role of TA1 in hepatitis C has become less clear. Now in sepsis and critical illness, more recent interest has focused on TA1 in severe cases of sepsis and septic shock. Ren and colleagues published a systematic review and meta-analysis in the Frontiers of Immunology in 2022, analyzing 18 randomized controlled trials, including 1787 patients with severe sepsis or septic shock the pooled analysis showed that ta1 administration was associated with reduced 28-day mortality relative risk at 0.70 meaning a 30 reduction in mortality compared to the standard care alone and the effect appeared Dr. Deb Muth 09:39most pronounced in patients with sepsis-induced immunosuppression measured by HLA-DR expression in monocytes. Now, this is amazing because going forward, we’re going to talk about something that’s commonly known as cytokine storm. Now, cytokine storm really became apparent since 2020 with the viral infection that we’re dealing with in the world today. But they were already looking at this kind of cytokine storm produced by sepsis or sepsis-induced immunosuppression. And it triggered this hyperinflammatory response called the cytokine storm. And many patients who survived the initial phase of the immune suppressed stata, characterized by a T cell exhaustion, reduced antigen presentation, and increased susceptibility to secondary infections. Thymusin alpha-1, TA1, may help restore this immune competence in this phase. However, it’s important to note that patient selection and timing are critical. Dr. Deb Muth 10:43Giving this immune stimulant during a hyperinflammatory phase could theoretically worsen outcomes. So you don’t want to give it to them while they’re in the flare up or the sepsis or the infection, but given to them during the immunosuppression phase afterwards might be beneficial. Now there is also some cancer immunotherapy that we see with TA1 and has been studied as an adjunct in cancer treatment with the hypothesis that it could enhance immune surveillance and response to tumors. And a comprehensive review of Garci and colleagues published in Expert Opinion on Biological Therapy in 2007 examined multiple trials in melanoma, lung cancer, hepatocellular carcinoma, and other malignancies. And the results were mixed. Some trials showed improvement in the immune parameters, increased CD4 in T-cells. improved lymphocyte proliferation responses and some actually showed trends toward improved progression free survival but overall survival benefits were inconsistent and the heterogeneity of the cancer types treatment protocols and outcome measures makes a definitive conclusion difficult as a vaccine adjunct several studies particularly from china have examined ta1 as an adjunct to enhance vaccine responses Dr. Deb Muth 12:11in immune-compromised populations, including the elderly, dialysis patients, and transplant recipients. The rationale is sound. These populations often mount suboptimal antibody responses to vaccines, and TA1’s immune-enhancing effects might improve protection. There are small trials. They have shown improvement in seroconversion rates of hepatitis B vaccines and influenza vaccine in these populations. And though large-scale confirmatory studies are limited, there is a possibility here. Now, on their safety profile, one of the appealing aspects of thymusin alpha-A TA1 is that it’s apparently favorable safety profile in clinical trials. There are some injection site reactions with a little redness, a mild discomfort, and most commonly reported adverse effects. is that their severe adverse events attributable to TA1 have been rare in published trials. However, comprehensive long-term safety data are limited Dr. Deb Muth 13:13And theoretically, concern exists that immune modulation could potentially trigger or exasperate autoimmune conditions in susceptible individuals. Though this hasn’t been clearly demonstrated in clinical trials, integrative medicine considerations for integrative practitioners concerning the thymus and alpha-1, several factors require careful thought. First, sourcing and quality control are critical concerns. Since it’s not FDA approved, TA1 available in the United States typically will come from a compounding pharmacy or an international supplier with variable quality assurance. And pharmaceutical grade product with certificates of analysis showing purity, sterility, and endotoxin testing is essential, but it is readily available from many of these companies. Second, patient selection matters immensely. TA1 should be considered in complex cases where conventional approaches have been insufficient, such as chronic viral infections not responding adequately Dr. Deb Muth 14:21to standard antivirals, post-viral syndromes with evidence of immune dysfunction, cancer patients with immune suppression in consultation with oncology, and it should generally be avoided in active autoimmune disease unless there’s a compelling rationale and close monitoring. Now, TA1 is not a standalone therapy. In cases of chronic viral infection, Comprehensive immune support includes addressing nutritional deficiencies, optimizing vitamin D levels to be between 50 and 80, adequate zinc, selenium, and vitamin A, optimizing gut health since 80% of our immune function is in the gut, you need to optimize gut function. Managing stress from the HPA access dysfunction, chronic cortisol elevation, suppression, and immunity, ensuring adequate sleep, immune memory consolidations during sleep, addressing any metabolic dysfunction, insulin resistance, repairs in the immune function, and the bottom line on thymus and alpha-1 is Dr. Deb Muth 15:26is that it represents legitimate medicine in other countries with a substantial evidence base in specific contexts, but it remains experimental in the U.S., and practitioners using it should provide comprehensive, informed consent about its regulatory status, evidence quality, and source verification. while ensuring it’s part of comprehensive protocols. It is not a magic bullet. And again, what you’re gonna hear me say quite often here is that many of these peptides should be used in conjunction with something else. They should not be used alone. And can peptides be stacked? The answer is yes, they can. So if somebody has an insulin resistance, or a metabolic dysfunction, they can tier TA1 with a GLP-1 like terzepatide or semiglutide. That is not a problem to do that. You need to just work with a practitioner that understands how to do that effectively. So let’s look at BPC-157. Dr. Deb Muth 16:26This is a phenomenon I love BPC-157. Let’s separate it from marketing to actual mechanism of actions here. So BPC-157 stands for Body Protection Compound 157. It is a chain of 15 amino acids that are described as a partial sequence of body protection compound, a protein found in human gastric juice. It has become one of the most hyped peptides in regenerative medicine inside the athletic performance and biohacking communities with claims ranging from healing tendons and ligaments to repairing gut lining or reversing organ damage. The challenge is separating the legitimate mechanisms of science from the marketing hype. The proposed mechanism of BPC-157 are biologically plausible and intriguing. The research suggests that it may influence several growth factor pathways, including vascular endothelial growth factor, VEGF, which promotes new blood vessel formation and has improved better supply of blood flow to injured tissues, theoretically accelerating healing. Dr. Deb Muth 17:40It may also affect fibrous blast growth factor, FGF, and transforming growth factor beta, TGF beta pathways. both involved in tissue repair and remodeling. And some studies actually suggest that BPC-157 modulates inflammatory cascades, potentially reducing excessive inflammation while promoting the resolution phase that allows tissue rebuilding. Now I want to talk just a few moments here about these different tests that we’re talking about tgf beta veg f for those of you who are in our mold world you are very familiar with these uh lab tests we do this to see if you have a mold exposure what’s happening to your body and it’s been very challenging to try to heal this part of the mold illness and manipulate these VEGFs and TGF betas. And so with the fact that BPC helps us modulate this inflammatory cascade, BPC can be very helpful in the world of mold or mycotoxin illness in repairing those parts of the body that have been damaged by the mycotoxins. Dr. Deb Muth 18:48Now there is animal research on BPC-157. It is extensive and primarily from a research group led by pre-drag, oh, I can never say these names, Cyrek at the University of Zagreb in Croatia. Published studies in animal models have shown accelerated healing in a remarkable variety of injury types. A 2011 paper by Chang and colleagues in the Journal of Applied Physiology demonstrated that BPC-157 improved therapy tendon healing in rats with Achilles tendon injuries, and the treated rats showed increased tendon outgrowth, better cell survival in the injured area, enhanced cell migration to the injury site, and improved biochemical strength of the healed tendon compared to controls. Multiple other animal studies have shown similar promising effects. Ligament tears, healing faster in rabbits, muscle damage recovering more quickly in rodent models, gastric ulcers healing in rats given experimental induced ulcerations, inflammatory bowel lesions improving in mouse models of colitis, and even bone to tendon healing showing enhancement in animal studies. Dr. Deb Muth 20:02The breadth of injury types showing benefit in preclinical models explains the enthusiasm of this peptide. However, this is critical. These animal studies, primarily in rodents and rabbits, animal models of injury healing don’t reliably translate to human clinical outcomes. And the doses used in these animal studies when converted to human equivalent doses vary widely. And optimal human dosing is completely unknown at this point. it is all considered experimental and perhaps most importantly there are essentially no peer-reviewed controlled clinical trials in human published in humans published in major medical journals in a 2001 review of arthroscopy and the journal of arthroscopic and related surgery specifically examined in the evidence of bpc 157 and other peptides in musculoskeletal medicine The authors concluded bluntly that BPC-157 lacks evidence from randomized controlled trials and has an unknown safety profile in humans. Dr. Deb Muth 21:09 They emphasized that the jump from animal data to recommending peptides for humans use bypasses the fundamental requirement for Phase I safety studies, Phase II dose-finding studies, and Phase III efficacy trials that would establish whether BPC-157 actually works in humans and whether or not it’s safe. The absence of human safety data is particularly concerning given BPC-157’s proposed mechanisms. Peptides that influence growth factor signaling and angiogenesis could theoretically have off-target effects. Uncontrolled angiogenesis, for instance, is a hallmark of cancer progression. Tumors require blood vessel formation to grow beyond a certain size. And while there’s no evidence that BPC 157 promotes cancer, The complete absence of long term human safety studies means we simply don’t know. This isn’t fear mongering. It’s acknowledging uncertainty and uncertainty exists and understanding that if you’re choosing to use peptides like BPC 157, you are doing it in an experimental model. Dr. Deb Muth 22:17We’re experimenting with the doses that are being used. And there is potential for it to cause cancer cells in your body to grow. And you need to be aware of this and understand the risks that you’re taking when you’re using an investigational or off label use peptide. Now, quality control issues with BPC also exist. It’s not FDA approved for any indication in the US. It’s not approved in any major regulatory jurisdiction worldwide. It’s marketed as a research chemical explicitly to bypass FDA oversight. And commercial sources selling BPC-157 range from compounding pharmacies, which have some quality standards but are not FDA inspected. You can take that for what you want to believe on that one. to overseas suppliers operating with absolutely no quality assurance whatsoever. If you are choosing to use BPC-157, you have to understand who’s manufacturing it for you, where you are getting it from, how pure it is. Dr. Deb Muth 23:26You want to make sure that you have the certificate of analysis and that it does not contain bacterial endotoxins that can contaminate the peptide or degrade the peptide and cause other issues for you. So when you talk about peptides with patients regarding BPC-157 or if you’re listening to this and you’re already using BPC-157 or other peptides, that are quote-unquote not for human consumption, an evidence-based response acknowledges both the appeal and the limitations. And you want to talk about the animal data that’s definitely showing some progress and some potential, but we don’t know what we don’t know in humans. If people are willing to take that risk, that is up to them to do that. But using BPC right now is experimental and people need to be aware of that. Are there evidence-based alternatives for patients with tendon or ligament injuries? Dr. Deb Muth 24:26And there are. There’s PRP, which has been studied in multiple randomized controlled trials. for conditions like lateral epicondylitis, tennis elbow, Achilles issues, patellar issues, knee issues. However, I want to caution you on this too. So the study that was done by Cox and colleagues in muscles, ligaments, and tendons in the Journal of 2014 showed modest benefits in pain and function compared to controls. And though the effects vary by injury type, PRP preparations can be helpful. You have to understand that a lot of times when people are doing PRP injections in their office, they are not doing it exactly the same way it was done in the study. And not to mention, if you’re using your own PRP to heal a ligament or a tendon or help your arthritis and you’re 60 or 70 years old, That is not good quality protein rich plasma. It is old protein rich plasma. And you’re not going to see necessarily the same benefits that you would see if you were using placental tissue or umbilical tissue. Dr. Deb Muth 25:33You also want to address the nutritional deficiencies or support that’s needed for connective tissue healing. And these are collagen peptides dosed at 15 grams a day. And this has been shown in a study by Shaw and colleagues in the American Journal of Clinical Nutrition in 2017 to augment collagen synthesis when combined with intermittent loading. Vitamin C is also an essential cofactor for collagen production and stabilization of collagen structure at a dose of around 500 to 1000 milligrams a day to support this process. You also need to have good adequate intake of copper and zinc. These are cofactors in collagen. Silica is also important. This comes from horsetail extract. This provides additional support as well. So more importantly, I think remembering that rehabilitation matters as well. Doing these protocols without doing some rehab is not going to get you where you want to go. Dr. Deb Muth 26:33There’s a research study by Alfredson and others for Achilles tendinopathy using the control lengthening of muscle tendon units under load to promote tendon remodeling and healing. These protocols have solid evidence and cost nothing beyond professional guidance from a physical therapist. They are important for patients seeking cutting edge regenerative approaches. Stem cell therapies, growth factors, concentrates derived from patients’ own tissues like PRP. These have a lot of good endogenous materials and they have good safety profiles. BPC-157 represents the perfect example of how promising Preclinical science gets marketed far beyond the evidence and it may eventually prove to be valuable. I think it will. But right now that determination does require some human studies and hopefully with the administration that we have right now and Bobby Kennedy, we will actually start to see some of that occur. Now the next peptide I want to talk about is TB4, thymus and beta-4. Dr. Deb Muth 27:36This is a wound healing peptide. It is a 43 amino acid peptide that’s naturally present in virtually all human cells except red blood cells. It’s actually one of the most abundant peptides in the human body, particularly concentrated in blood platelets, wound fluid, and many tissues. It’s naturally ubiquity makes it mechanistically interesting. The body wouldn’t produce it in such abundance if it didn’t serve a function. So the primary role of TB4 involves building G-actin. It’s a form of monomeric actin. And it’s structural protein that forms the microfilaments within the cells, providing cellular structure and enabling cell movement. TB4 prevents from F-actin filaments. I’m not going to talk too much about this. It’s really critical for wound healing as cells need to migrate into the injury sites. Dr. Deb Muth 28:37so the cell shape changes and the cellular response to the injury. So think of this as though you tore your meniscus and the body created all this TB4 to come to that injury to try to heal that site. That’s exactly what the TB4 is doing inside the body when there’s an injury. It’s been shown in research to help produce new blood vessel formation, promote endothelial cells, It helps modulate inflammatory cytokines, potentially reducing TNF-alpha, IL-1, and possibly protecting in programmed cell death, which we call apoptosis. And some studies suggest that it is cardioprotective in its effects in animal models of myocardial infarction, so heart attack, and neuroprotective in other models for brain injury. Now, these remain to be preliminary, but they are being seen. So the regulatory status on TB4 can create some confusion. Dr. Deb Muth 29:40The natural TB4 molecule itself is not FDA approved as a drug. However, TB4 based drug candidates called RGN259, formerly TB4, has been in the development by regen tree for corneal injuries of the dry eye disease. And as of recent updates, this drug is completed phase three trials for its neurotrophic keratopathy, severe corneal condition. But the FDA approval is still pending. So that means that the most advanced TB4-based pharmaceuticals hasn’t yet crossed the finish line for approval. The commercial peptide market further muddies the picture with TB500, which is often described as the synthetic fragment of TB4. However, this extract’s relationship between TB500 and TB4 varies depending on the source. Dr. Deb Muth 30:41So some claim that TB500 is identical to TB4, but positions 1 through 4 suggest it’s a different fragment. and the quality control across suppliers is not existent. So this confusion is part of why recommending TB500 becomes problematic for practitioners and patients, often because they aren’t certain what molecule they’re actually getting. The evidence base for TB4 in humans is limited, primarily to eye research, and the studies from Sohn’s and colleagues published in journals like Vitamins and Hormones in 2016 have examined topical TB4 for corneal injuries and neurotrophic keratopathy, dry eye, and other surface diseases. Now, these studies showed some promise in promoting this, and there is, however, a topical application to the cornea that is vastly different from a systemic injection. So for systemic use in wound healing, musculoskeletal issues, Dr. Deb Muth 31:42cardiac protection, neuroprotection, human clinical trials. There is scarce to non-existent evidence in humans. Most of the evidence remains in animal models or cell culture studies. And a review by Flip and colleagues in the Journal of Investigational Dermatology in 2006 detailed TB4’s effects on the matrix remodeling during wound repair in animal models, showing effects on collagen disposition, granulation, tissue reformation, and wound contraction. Another review by Ho and colleagues in expert opinion on biological therapy in 2007 discussed TB4’s potential in tissue regeneration and regenerative medicine, but noted the field remained largely blank. preclinical. So this is really important again to understand that there is just not enough human data. So there is a concern with cell division and migration. This theoretically exists Dr. Deb Muth 32:45for the potential effects on cancer cells, which would also rely on migration and division and other intended consequences of disrupting normal cellular architecture. These aren’t proven risks, but they are unexplored questions that we need to be aware of when we’re using peptides. This can cause cancerous tissue to grow. Very similar to what we talked about with BPC-157. These are also sold as research chemicals. There is no FDA oversight. So purity, potency, contaminations all still exist for these peptides. Now from an integrative perspective, the natural presence of TB4 in wound fluid and its biological roles in healing are legitimate science. in presence does not equal therapeutic utility. The body tightly regulates where and when and how much TB4 is present through natural production and bypassing that regulation with external dosing may or may not cause us to have beneficial or introduce risk. Dr. Deb Muth 33:49So we need to know that this is experimental use. Those people who are seeking wound healing and tissue repair the evidence-based approach of the body’s own capacity to heal is huge definitely want to be increasing your protein intake optimizing your zinc copper vitamin c and vitamin a and then managing glucose is really important during this time as well so let’s talk about a fun topic now and that’s growth hormone secretagogues this is the anti-aging hype machine these peptides in this category are things like semoralin ipameralin cjc 1220 1295 and others and among the most aggressively marketed in anti-aging and longevity medicine they all share a common goal stimulating the pituitary gland to release more growth hormone and the appeal is understandable. GH levels decline with age, and this decline is associated with increased fat mass, decreased lean muscle, reduced bone density, and other aspects of aging. Dr. Deb Muth 34:55The other times we’ll see growth hormone levels decline significantly is with chronic illness, and the logic is to restore youthful GH levels and youthful physiology. Now, semirelin from an FDA approved diagnostic to compound anti-aging product. Semirelin is a 29 amino acid peptide representing the first 29 amino acids of the full 44 amino acid human growth releasing hormone, GHRH. We talked about this on another episode of the podcast. And you can go back and listen to that one a little bit if you want. This fragment contains the complete biological activity of the full GHRH molecule and it binds to GHRH receptors in the anterior pituitary and stimulates growth releasing peptides, growth hormone releasing peptides. Semirelin was previously FDA approved as diagnostic testing of growth hormone secretion, essentially, to determine if the pituitary could still respond to GHRH stimulation in patients being evaluated for growth hormone deficiency. Dr. Deb Muth 36:06However, the manufacturer was discontinued and there was no longer an FDA approved semirelin product on the market in the United States. What exists now is semirelin available from compounding pharmacies used off label for anti-aging, body composition, and general growth hormone optimization purposes. This represents a significant gray area. Again, compounding medications serve a very important role, but they need to meet certain recommendations and regulations, as we’ve talked about in the past. You want to make sure that your compounding pharmacy that you’re obtaining semirelin from is qualified to do that, that they are doing best practices, and that you’re getting a good product. The theoretical advantage to semirelin over direct growth hormone administration is that it preserves more of the physiological growth hormone secretion patterns. Natural GH is released in pulses, primarily during sleep, not as a continuous elevation. Dr. Deb Muth 37:07So semirelin stimulates the pulses rather than providing a constant super physiological growth hormone level. And that pulsatile pattern is thought to reduce some of the side effects and metabolic concerns that we have with continuous growth hormone exposure. However, the evidence supporting semirelin for anti-aging and body composition in healthy adults is minimal. Most of the data comes from studies conducted in the 1990s when the FDA approved product existed. Not that that means it’s bad. We have drugs that have been in the market for over a hundred years that are still there, that still have the research and are still being used successfully and safely today. So we don’t want to let that really make us think that this product isn’t safe. So a 2006 review from Walker in Clinical Interventions of Aging suggested that semirelin might be a better approach than direct GH for adult onset growth hormone insufficiency, but they do acknowledge that the evidence was limited. Dr. Deb Muth 38:12And although we don’t have any large scale trials that we can examine for semirelin’s efficacy, it is now commonly prescribed. And the optimal dosing for anti-aging purposes is still unknown. It is considered experimental and it does vary from person to person, but it is still unstudied. The effects on cancer risk, cardiovascular disease, metabolic dysfunction over long time periods are also still unknown. I would argue that the side effects or the risk factors of not having growth hormone are equally as bad as the unknowns that we have here. We’re not looking to try to get super physiological doses. We’re trying to restore youthful GH levels. Typically, we’re not trying to restore back to a 20-year-old. We’re trying to restore back maybe 10 years. That is a better way of doing this. And I think that’s important for people to understand. Now, ipamirelin is the ghrelin mimicker. Dr. Deb Muth 39:12Ipamirelin is a pent-up peptide, five amino acid, that acts as a growth hormone secretagogue receptor, a GHS-R agonist. It mimics the action of ghrelin, the hunger hormone, that also stimulates growth hormone release. The proposed advantage over earlier secretagogues is that ipamirelin stimulates growth hormone release without significantly affecting cortisol, prolactin, or other glucose things, which can be increased by growth hormone secretagogues. The regulatory status is clear. Ipamirelin is not FDA approved for any indication. It’s sold as a research chemical. Human evidence is thin. It’s limited to single dose studies examining how quickly it’s absorbed and metabolized with minimal data on dosing and clinical outcomes. Now there are marketing claims for ipamirelin and they are extensive. Dr. Deb Muth 40:13It increases lean muscle mass, it decreases body fat, it improves sleep quality, faster recovery from workouts, enhanced injury healing, better skin quality. The evidence supporting these claims in humans is not available we don’t have it these are claims that are made by the effects that we know from growth hormone so it’s not necessarily a bad thing we know what growth hormone does we know growth hormone does all of these things if ipamorelin is a precursor to that it will obviously help improve those things making that correlation of what growth hormone does So there are safety concerns that mirror the same as any other growth hormone elevating therapy. It can cause fluid retention, joint pain, carpal tunnel syndrome, insulin resistance, glucose intolerance, and theoretically, can it increase calcium? cancer risks? It can because IGF-1 promotes cell proliferation and can inhibit apoptosis in cancer cells. Now remember, your body makes IGF-1. Dr. Deb Muth 41:15If it’s not making enough of it, that’s a problem. If it’s making too much of it, That’s a problem. So just understand that if you are adding these things, and especially in elevated doses, you are taking a potential risk. So there is also now CJC 1295 is a modified GHRH analog of 30 amino acid peptide based on GHRH structure, but with modifications. So it includes the addition of drug affinity complex, DACC, DAC, which involves conjugation with a small albumin binding molecule, dramatically extends the peptide’s half-life from minutes to as much as potentially a week or more. And this creates sustained growth hormone elevation rather than that pulsatile release. There are actually two versions of this. There’s CJC 1295 with DAC, longer acting version, and CJC 1295 without DAC, which is essentially a shorter duration of semirelin. Dr. Deb Muth 42:19And so when we’re comparing products, it is… only the difference between long acting and short acting. The human evidence for CJC 1295 is limited to a single published phase one study by Techman and colleagues in the Journal of Clinical Nutrition and Metabolism in 2006. And the study involves 18 healthy young adults showed that CJC 1295 with DAC produced a sustained elevation of GH and IGF-1 lasting several days after the injection. That’s essentially the entire published human evidence of this peptide. There are no phase two studies examining optimal dose. So that is all considered experimental. And there is no phase three studies examining clinical efficacy. So the sustained GH levels created by CJC 1295 with DAC raises specific concerns because the natural GH secretion It goes up and down, up and down, up and down. Dr. Deb Muth 43:19And that constant elevation may have a different metabolic and cellular effect. And we just really don’t know what that’s going to be yet. So we can understand that elevated IGF-1 levels can theoretically increase cancer concerns and metabolic risks. So rather than always injecting peptides, which are very expensive… You can do other things. And there was a study by Hartman and colleagues in the Journal of Clinical Endocrinology and Metabolism in 1992 that demonstrated the 48-hour fast increased integrated growth hormone secretion five-fold through increased GH levels. Now, the problem with this is fasting for 48 hours is a challenge. And how long is it going to increase the growth hormone secretion without causing issues? Or in general, how long is it going to go up? Dr. Deb Muth 44:19So we have to be cautious about that as well. Sleep optimization is non-negotiable. The majority of growth hormone secretion occurs during sleep, slow wave sleep, typically the first sleep cycle, and poor sleep quality or insufficient sleep typically. can dramatically affect your growth hormone levels. And then high intensity interval training, HIIT resistance training can stimulate growth hormone as well. This was seen in a study by Godfrey and colleagues in sports medicine in 2003 and was examined in exercise-induced growth hormone responses to athletes. So we definitely see these kinds of things. So let’s talk about some longevity peptides now. These expand the telomere. So there’s epitalin and epithalamin and when these are used in anti-aging they can produce some amazing results. Dr. Deb Muth 45:22So epitalin is a synthetic terapeptide, just four amino acids. It was originally synthesized as a simplified version of epithalamine. a pineal gland extract containing multiple peptides. The synthetic four amino acid version was created to isolate what researchers believed might be the active anti-aging component. The mechanism produced for epitalin centers on telomere and telomerase, Telomeres are protective caps at the end of the chromosomes consisting of repetitive DNA sequencing. And every time a cell divides, telomeres shorten slightly because DNA polymers cannot fully replicate the ends of the linear chromosomes. So this progressive shortening acts as a molecular clock. After 50 or 70 divisions, the telomeres become critically short, triggering a cellular senescence. Dr. Deb Muth 46:22This telomere shortening is one mechanism of cellular aging and telomeres in the enzyme that can rebuild telomeres by adding these caps back onto the end of the chromosome. It’s active in stem cells, germ cells, and unfortunately in about 85 to 90% of the cancer cells. In most adult somatic cells, telomerase is inactive or present at very low levels, allowing the telomeres to shorten with division. The research on epitalin suggests it might activate this telomeres act telomeres process primarily from a research group led by Vladimir in Russia. Vladimir Kavasan in Russia. He is a huge peptide researcher or was he passed away with publications dating back to the early 2000s and a study published in bio gerontology in 2000 by Kavasan Dr. Deb Muth 47:25and colleagues examined the effect of epitalin on the lifespan of fruit flies, and they treated fruit flies that showed a modest increase in mean and maximum lifespan compared to its controls by approximately 10 to 15% lifespan extension in some experimental groups. And there were other studies in 2003 that examined epitalamine in a female Swiss-derived mouse. This was done by Ann Simove and colleagues. And the researchers reported that epitalin treatment was associated with increased lifespan as well. And the most cited mechanistic work comes from cell culture studies. And that is also Cavason’s group that published this research in 2003, showing increased telomeres activity in cultured somatic cells again. More recently, between 20 and 25, the series of publications have continued to explore epithelial effects on telomere dynamics in cell cultures. Dr. Deb Muth 48:32So there is a lot of research that’s been done. The mass majority has been done on epithelin. And most of it has been done by a single research group in Russia. There is some restrictions on some of the cell culture data that we’re seeing. And it does show that epithelin sometimes can be described as a regulating hormone. Carcadian rhythm for melatonin production, which is derived by the penile extracts. And however the evidence for this affects minimally and mechanistically unclear, the pineal gland primarily functions as melatonin secretion in that light-dark cycles. So Epithalin or epitalin is not FDA approved. It is not approved for any major regulatory jurisdiction. It is sold as a research chemical only. Dr. Deb Muth 49:33So you need to follow the same safety profiles that we’ve talked about in other episodes and in today’s episodes. And when we’re talking about epithalin, and we’re excited about it being an anti-aging science, we should balance this with the honesty and the evidence of the quality of that evidence. We don’t know its safety effect. We don’t know if it’s going to increase the risk of cancer. We can’t verify that. And we need to be using it in an experimental use of unknown risks only. Of course, diet, physical activity, stress management, sleep quality, all of those things are important for us to be looking at when we’re looking at these peptides. Now, I want to get into some of the brain peptides. This is the nootrophic frontier. C-Max and C-Lank, there is Russian pharmacology that’s done. C-Max and C-Lank represent an interesting case study in how different regulatory environments and research traditions Dr. Deb Muth 50:36create challenges in evaluating this evidence. Both peptides were developed in Russia, are approved for their specific indications and have substantial Russian language and literature supporting their use. However, the FDA approval in the United States is still not there. C-Max is a seven amino acid. It’s a synthetic analog. It is a fragment, particularly ACTH 4 through 10. It’s sometimes called the melanocortin effects because it involves the melanocortin receptors of the central nervous system. CMAX was developed by the Institute of Molecular Genetics of Russia Academy of Sciences and is approved in Russia for several indications, including acute stroke, transient ischemic attacks, cognitive disorders. It has Russian approval and is based on clinical trials primarily in Russia. Dr. Deb Muth 51:39It does help to increase brain-derived neurotrophic factor, BDNF, a protein critical for neuroplasticity, the brain’s ability to form new connections and adapt to the challenges. BDNF supports neuronal survival and promotes growth of these new neurons. C-Max also influences neurotransmitter systems, particularly dopamine and serotonin, and there is some research that suggests it affects on metabolism as well, and endogenous opioid peptides that involve pain reception and mood regulation. So it has some good potentials there. There is also C-Link, which is a hepatopeptide structurally similar to Tufts’ and an immune modulatory peptide. It was also developed in Russia and was approved for anxiety disorders as a neurotropic. Its effects involve anxiolytic effects, possibly through the GABAnergic system or the GABA system of the brain, and immune modulation. Dr. Deb Muth 52:44The Russian research is examined by C-Link for anxiety disorders. and finding reductions in anxiety without sedation. There is a dependency potential or cognitive impairment does not exist like it does with benzodiazepines with C-Link. So that is really good. And they do report attention and memory improvement using C-Link. There is a study that was done in neuroscience and behavioral psychology in 2018 that examined C-Linx effects and proposed that it exerts cytoprotective effects through BDNF pathways similar to C-Max. So both of these are Russian research-based They’re not wrong or fraudulent. It’s just that they are from Russia and we all have our concerns with Russia. However, that does not necessarily mean their research doesn’t hold quality. Dr. Deb Muth 53:49Neither peptide is approved by the FDA, and so you are using this off-label. The same rules apply for all of the other peptides that we’ve talked about that are produced off label. You want to do the same things that you would do with anything else. Good protein, omegas, B vitamins, acetylcarnitine, exercise, sleep, all of that still applies when we’re using these peptides. So I want to talk briefly about clinical decision and framework when we’re looking at this. First and foremost, we always want to go to FDA-approved peptides. Secondly, we would look at international approval with peptides that are established in other countries but lack FDA approval. And then preclinical evidence only or experimental peptides. These can be used, but they are not ethically recommended in the traditional medicine world. Dr. Deb Muth 54:50 If patients use them, we need to have appropriate counseling about the evidence surrounding them, the safety, and where to find them. how to find them and how to ask for these certificates of analysis. So I think it’s really good that we were exploring all these peptides and understanding what they are. There’s a lot of controversy out there. There’s a lot of concern out there. And what we can say with confidence is that peptides are powerful biological signaling molecules. Some peptide based medications, semi-glutide, triseptide, PT 141, Lupron that are all FDA approved. can dramatically improve outcomes in patients that are obviously selected for the correct ones. There are many other peptides that we address that are integrative and longevity space in the regenerative medicine. These peptides are all experimental. That does not automatically make them wrong. Dr. Deb Muth 55:50It just means that we need to be honest about what we’re doing with them and we need to be cautious with the patients so that they can make a decision to be part of an experimental study. in looking at how to use these peptides. So peptides are tools like any other tools. They work best in the hands of skilled people, and they are applied to appropriate situations, integrating into comprehensive approaches that address root causes. The most powerful peptide administered to a patient with untreated inflammation, hormonal chaos, nutritional deficiencies, and disorders of sleep will disappoint. The simplest evidence-based interventions apply. to a patient whose foundational physiology has been optimized. And this is the art of the science of peptide, right? If done right, respecting both the power of these molecules and the complexity of human beings that we are privileged to serve can make a difference in their lives. So thank you for listening to this episode. Dr. Deb Muth 56:52I hope this was helpful. If you can know of somebody that might benefit from this, please like, share, and subscribe. It means a lot to us. And I hope you join us for our next episode of Let’s Talk Wellness Now. Welcome to Let’s Talk Wellness Now, where we bring expert insights directly to you. Please note that the views and information shared by our guests are their own and do not necessarily reflect those of Let’s Talk Wellness Now, its management, or our partners. Each affiliate, sponsor, and partner is an independent entity with its own perspectives. Today’s content is provided for informational and educational purposes only and should not be considered specific advice, whether financial, medical, or legal. While we strive to present accurate and useful information, we cannot guarantee its completeness or relevance to your unique circumstances. We encourage you to consult with a qualified professional to address your individual needs. Dr. Deb Muth 57:54Your use of information from this broadcast is entirely at your own risk. By continuing to listen, you agree to indemnify and hold Let’s Talk Wellness Now and its associates harmless from any claims or damages arising from the use of this content. We may update this disclaimer at any time and changes will take effect immediately upon posting or broadcast. Thank you for tuning in. We hope you find this episode both insightful and thought-provoking. Listener discretion is advised.The post Episode 258 – Investigational Peptides: What's Promising, What's Hype & What You Must Know first appeared on Let's Talk Wellness Now.

Audio roundup of selected biopharma industry content from Scrip over the business week ended Mar.13, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – Roche faces giredestrant Phase III setback; founders exit BioNTech; Ipsen to withdraw Tazverik; tough times for Bayer; and another boost for UCB's Bimzelx. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-LMR3CRGKRFDWLHTOSBRDCRM7GE/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Featuring an interview with Dr Hanny Al-Samkari, including the following topics: VAYHIT1: A multicenter randomized, double-blind, Phase III trial evaluating ianalumab versus placebo in addition to first-line corticosteroids for patients with primary immune thrombocytopenia (ITP) (0:00) Secondary analysis results from VAYHIT3, a Phase II study of ianalumab for patients with primary ITP previously treated with at least 2 lines of therapy (8:15) Improved health-related quality of life and bleeding scores with the oral Bruton tyrosine kinase inhibitor rilzabrutinib in the open-label period of the multicenter Phase III LUNA 3 study for adults with ITP (12:23) Romiplostim for chemotherapy-induced thrombocytopenia in patients with colorectal, gastroesophageal and pancreatic cancer: A global Phase III randomized, placebo-controlled trial (16:01) CME information and select publications

Synopsis: Addiction is often misunderstood as a failure of willpower—but emerging science increasingly shows it may be deeply rooted in biology. In this episode of Biotech 2050, recorded during JPM 2026 in San Francisco, host Alok Tayi speaks with Cary Claiborne, CEO of Adial Pharmaceuticals, about a new precision-medicine approach to tackling one of the world's most widespread and undertreated conditions: alcohol use disorder. Cary shares the personal and professional journey that brought him into addiction medicine—from a career in finance at global corporations to helping take pioneering biotech companies public and ultimately leading Adial's mission to address addiction through science. After losing a close family member to addiction, Cary became determined to focus his work on diseases where innovation could create meaningful societal impact. The discussion explores Adial's genetically targeted therapy, designed to reduce alcohol cravings without requiring patients to stop drinking entirely. Cary explains how their repurposed low-dose therapy, paired with a simple cheek-swab diagnostic test, could help identify the patients most likely to benefit—bringing a precision-medicine framework to addiction treatment, an area that has seen little therapeutic innovation in more than two decades. Alok and Cary also examine the broader landscape of addiction science, the societal costs of untreated alcohol use disorder, and how AI-driven clinical simulations are helping design smarter Phase III trials. Looking ahead, Cary discusses how this scientific platform could expand into other impulse-driven conditions, including opioid addiction, gambling, and compulsive behaviors. It's a compelling conversation about precision psychiatry, addiction medicine, and the future of neuropsychiatric drug development. Biography: Cary Claiborne was named Chief Executive Officer of Adial Pharmaceuticals in August 2022 after previously being appointed Chief Operating Officer in December 2021 and being named to the Board of Directors. Mr. Claiborne previously served as Chief Financial Officer (CFO) and board member of Indivior PLC, a publicly traded specialty pharmaceutical company developing medicines to treat addiction and serious mental illnesses. Among his accomplishments, Mr. Claiborne led the company's spin off from its then parent company, Reckitt Benckiser, to become an independent, listed company. While at Indivior, he established and oversaw corporate reporting, internal audit, tax, treasury, external audit, and information technology. Prior to joining Indivior, Mr. Claiborne served as the CFO of Sucampo Pharmaceuticals, Inc., a global biopharmaceutical company, which was later sold to Mallinckrodt. Before joining Sucampo, Mr. Claiborne served as CFO and Corporate Secretary of Osiris Therapeutics, Inc., and oversaw corporate finance during the company's initial public offering. He graduated from Rutgers University with a B.A. in Business Administration and from Villanova University with an M.B.A. and was a National Association of Corporate Directors (NACD) Governance Fellow.

Featuring an interview with Dr Hanny Al-Samkari, including the following topics: Mechanism of action and toxicity of the monoclonal antibody ianalumab (0:00) Primary results from VAYHIT2, a randomized, double-blind Phase III trial of ianalumab with eltrombopag for patients with primary immune thrombocytopenia (ITP) after failure of first-line corticosteroid treatment (7:32) Mechanism of action and toxicity of the Bruton tyrosine kinase inhibitor rilzabrutinib (11:52) Reduction in corticosteroid use with rilzabrutinib and sustained response in adults with persistent or chronic ITP in the long-term extension period of the Phase III LUNA3 study (18:46) CME information and select publications

Kimchi One from Brightcore – Health Starts in the Gut Get 25% off – Use Code: AWK at https://mybrightcore.com/AndWeKnow Or call (888) 317-9941 for up to 50% OFF your order and Free Shipping!  —————— TriTails BEEF: Ribeye Special: http://trybeef.com/andweknow —————— Protect your investments with And We Know http://andweknow.com/gold Or call 720-605-3900, Tell them “LT” sent you. ————————— ➜ Our AWK Website: https://www.andweknow.com/ ➜ AWK Shirts and gifts: https://shop.andweknow.com/ ——  *DONATIONS SITE: https://bit.ly/2Lgdrh5 *Mail your gift to: And We Know 30650 Rancho California Rd STE D406-123 (or D406-126) Temecula, CA 92591 ➜ AWK Shirts and gifts: https://shop.andweknow.com/ ➜ Audio Bible https://www.biblegateway.com/audio/mclean/kjv/1John.3.16 Connect with us in the following ways: + DISCORD Fellows: https://discord.gg/kMt8R2FC4z

February 19, 2026: Your daily rundown of health and wellness news, in under 5 minutes. Today's top stories: Andrew Huberman calls retatrutide a potential trillion-dollar drug, showing 30% weight loss in Phase III trials with muscle preservation Lululemon launches Studio Yet. in LA, a three-week pop-up blending workouts with retail as stores become training extensions Garmin reports record Q4 revenue of $2.12B up 17%, with fitness segment climbing 42% driven by wearables demand Joe Vennare is heading to LA this week for the Connected Health & Fitness Summit to host a fireside chat with Fritz Lanman, CEO of Playlist (parent company of Mindbody and ClassPass), on AI in fitness and the anticipated $7.5B EGYM merger. If you're attending or based in LA and want to meet up, email team@fitt.co. More from Fitt: Fitt Insider breaks down the convergence of fitness, wellness, and healthcare — and what it means for business, culture, and capital. Subscribe to our newsletter → insider.fitt.co/subscribe Work with our recruiting firm → https://talent.fitt.co/ Follow us on Instagram → https://www.instagram.com/fittinsider/ Follow us on LinkedIn → linkedin.com/company/fittinsider Reach out → insider@fitt.co

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

Featuring an interview with Dr Terence Friedlander, including the following topics: Final analysis of the Phase III, open-label, randomized POTOMAC trial (0:00) KEYNOTE-905 trial: Perioperative enfortumab vedotin with pembrolizumab for muscle-invasive bladder cancer (MIBC) (5:25) The neoadjuvant gemcitabine intravesical system TAR-200 for patients with MIBC: Primary analysis of the SunRISe-4 trial (14:07) Circulating tumor DNA-guided therapies for MIBC (18:41) CME information and select publications

Novo Nordisk's new drug CagriSema has outperformed Ozempic in a recent Phase III trial for type 2 diabetes patients, according to Clinical Trials Arena. In the REIMAGINE 2 study, CagriSema reduced HbA1c levels by 1.91 percentage points and achieved 14.2 percent weight loss after 68 weeks, compared to 1.76 percentage points and 10.2 percent with Ozempic. No weight loss plateau occurred with CagriSema, and 43 percent of patients lost at least 15 percent of their body weight. Martin Holst Lange, Novo Nordisk's executive vice president and chief scientific officer, stated that combining semaglutide and cagrilintide delivers superior blood glucose control and weight reduction.Researchers are urging a more holistic approach to weight loss amid the Ozempic era, as reported by Medical Xpress on February 3. Experts like Martin Binks and Raedeh Basiri from George Mason University note that GLP-1 drugs such as Ozempic cause rapid weight loss but can lead to nutrient deficiencies, muscle loss, and struggles without proper nutrition, exercise, and psychological support. Many patients receive only prescriptions without multidisciplinary care, and access remains limited by cost and insurance gaps. Binks predicts broader availability with upcoming pill forms.A study highlighted by Science Daily on January 29 warns of rapid weight regain after stopping drugs like Ozempic, with people regaining about 0.4 kilograms per month, often faster than with diet and exercise alone. Heart health and diabetes risk improvements also reverse quickly, emphasizing the need for long-term strategies beyond medication.Oprah Winfrey has shared her experiences with GLP-1 medications, similar to Ozempic, in recent interviews covered by AOL and other outlets. At 71, she regrets not using them sooner, saying they silenced the food noise in her head and helped her view obesity as a disease, not a personal failure. She gained 20 pounds after stopping briefly but now sees these drugs as a lifelong tool, like blood pressure medication, and encourages others without shame.These developments show evolving options and cautions in weight loss treatments. Listeners, thanks for tuning in, please subscribe, and remember, this episode was brought to you by Quiet Please podcast networks. For more content like this, please go to Quiet Please dot Ai. Come back next week for more.Some great Deals https://amzn.to/49SJ3QsFor more check out http://www.quietplease.aiThis content was created in partnership and with the help of Artificial Intelligence AI

Dr. Iyad Alnahhas interviews Drs. David Schiff and Ranjit Bindra about their recent manuscript entitled "Phase I/II and Window-of-Opportunity Study of Pamiparib and Metronomic Temozolomide for Recurrent IDH Mutant Gliomas", published online in Neuro-Oncology in October 2025.

Today we explore the powerful presence of the Nihil — fearsome raiders who've thrown the galaxy into chaos. What makes them so dangerous? How do they challenge the Jedi and the Republic? We'll break down their role in Phase III of The High Republic and what their rise means for heroes and civilians alike. If you're curious about what makes the villains of this era tick, you'll love this deep dive. With twists waiting ahead, get ready — the path to the end gets darker and more thrilling!We hope you enjoy today's show. If you liked the show, please give it a five-star rating on whatever platform you use to consume your content. It really does help. If possible, share it with your friends and family. It would be greatly appreciated. And don't forget to favorite the show. That way, you will be notified every time we release a new episode. As always, thank you for taking the time to listen to this podcast. For people with any questions about the show. Please do not hesitate to email us ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠@swaa.audio@gmail.com.⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ We would love to hear from you. Follow us on our Social Media for more great content.For Merch, Extra Content, and uninterrupted episodes, visit ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.swaapodcast.com/⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠The story, art, and characters therein are the property of whoever holds the copyright to this material. We do not claim ownership of the source material. This podcast was produced for noncommercial use, to be enjoyed by ourselves, fellow fans, and the original creators as a tribute to Star Wars. Please support the official release.⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠StarWars, ⁠⁠⁠StarWarsPodcast, HighRepublic, JediTalk, GalacticJourney, ⁠⁠TemptationoftheForce,⁠⁠ StarWarsUniverse, TheForceIsStrong, SWAAcast, StarWarsAudiobooks, StarWarsFan, StarWarsCommunity, StarWarsLore, GalaxyFarFarAway, StarWarsStories, StarWarsLegends, JediLife, StarWarsLove, StarWarsSaga, StarWarsGeek, ExploreSta⁠⁠⁠⁠rWars⁠⁠⁠,⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠

Roche made the biggest splash this week so far, announcing on Tuesday that GLP-1/GIP injectable CT-388 led to 22.5%weight loss in a Phase II trial. These numbers appear to put CT-388, which Roche acquired in its $2.7 billion Carmot buy, in line with Eli Lilly's Zepbound, according to William Blair analysts. Roche plans to start a Phase III study of CT-388 in the first half of this year and is also pairing the drug with a therapy from Zealand Pharma, with the aim of offering a weight lossoption with fewer gastrointestinal side effects. Meanwhile, Baseline Therapeutics debuted to challenge Lilly with a Phase III–ready GLP-1 for alcohol use disorder.  In the vaccines sector, Moderna took perhaps the biggest action to date amid Health Secretary Robert F. Kennedy's anti-vaccine policies and rhetoric, last week announcing that the company will no longer run late-stage vaccine trials for infectious diseases. “You cannot make a return on investment if you don't have access to the U.S. market,” CEO Stéphane Bancel saidthe World Economic Forum at Davos, Switzerland. Pfizer CEO Albert Bourla, also speaking at Davos, called RFK Jr.'s rhetoric and policies on vaccines “anti-science.”  Finally, Sarepta released new data on Monday for Elevidys, the company's embattled gene therapy for neuromuscular disease Duchenne muscular dystrophy. Plus, check out up-and-coming treatments for Alzheimer's and Parkinson's.

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 landscape marked by significant scientific advancements, regulatory challenges, and strategic investments that are shaping the future of healthcare.Let's begin with Moderna's recent decision to halt its late-stage vaccine trials, a move reflective of a broader trend of vaccine hesitancy in the United States. Moderna's CEO Stéphane Bancel pointed to shifts in government policy and an increasing public skepticism towards vaccines as pivotal reasons for this decision. This development signals a potential slowdown in vaccine research and development investments across the industry. The implications are profound, as vaccine hesitancy could impact public health initiatives and the readiness to tackle future pandemics.In parallel developments, Sanofi is navigating its own set of challenges with its eczema treatment. Despite plans to file for FDA approval for its OX40 blocker following the Phase III COAST 2 trial, results were mixed, echoing earlier data that analysts found underwhelming. This situation highlights the inherent uncertainties in drug development and raises questions about the treatment's potential market success. As Sanofi persists, the broader industry is reminded of the complexities involved in bringing new therapies to market, particularly in dermatology where unmet needs remain significant.Meanwhile, Chinese biotech firm Corxel has secured an impressive $287 million in Series D1 funding to push forward its oral GLP-1 therapy, CX11. This funding will support its mid-stage development in the US and preparations for Phase III studies. The investment underscores a robust interest in GLP-1 therapies known for their efficacy in treating type 2 diabetes and obesity. The competitive landscape for these therapies is heating up, with major players vying for market dominance through novel delivery mechanisms and enhanced patient outcomes. Notably, Novo Nordisk's oral Wegovy is advancing while Eli Lilly's Orforglipron faces delays, highlighting the strategic importance of timely development and market entry in capturing lucrative opportunities within this therapeutic area.On the regulatory front, a notable legislative challenge has emerged with the failure to reauthorize the FDA's rare pediatric disease priority review voucher program for 2024. Advocates are calling for its reinstatement given its critical role in incentivizing the development of rare disease treatments through expedited review processes. Such regulatory changes underscore the delicate balance between encouraging innovation and ensuring rigorous standards, a dynamic that continuously shapes R&D strategies within the industry.In oncology, Bristol Myers Squibb is making headlines with an $850 million investment in Janux Therapeutics' tumor-activated drugs. This significant investment reaffirms BMS's commitment to pioneering cancer therapies that promise better patient outcomes through innovative mechanisms of action. The focus on oncology reflects a broader industry trend towards precision medicine and targeted treatments aimed at improving efficacy while minimizing side effects.As we pivot to manufacturing developments, Lotte Biologics is expanding its capabilities with plans to launch its Syracuse ADC hub by 2026. This expansion aligns with global efforts to enhance manufacturing quality and capacity, crucial factors as biopharmaceuticals become more complex and demand increases.Turning our attention to financial achievements within the industry, Samsung Biologics has reached a historic milestone by becoming the first Korean biopharmaceutical company to surpass a profit threshold of 2 trillion won ($1.36 billion). This accomplishment spotlights the growing influence of contract manufacturing organizations (CMOs) like Samsung BiologicsSupport the show

Roche/Genentech announced on June 15–16, 2025 that prasinezumab — an anti-α-synuclein monoclonal antibody — will enter Phase III trials for early Parkinson's disease after mixed but encouraging Phase II signals.  In this episode (watch on YouTube) we explain the biology behind α-synuclein targeting, summarize the PASADENA and PADOVA findings (what was missed and what looked promising), discuss safety issues and trial design challenges, and speak with experts/patients about realistic timelines and hopes for disease-modifying therapies To follow trials like this and to have customized information and results delivered to you directly, consider signing up to try Turnto and the AI sidekick Turny. Sign up here and use the promo code PDEDUCATION for a 10% discount: https://www.turnto.ai/sidekick?fpr=pdeducation Help to support this channel and out efforts to educate the world about Parkinson's Disease and get access to personalized content: https://www.youtube.com/channel/UC0g3abv8hkaqZbGD8y1dfYQ/join  https://www.patreon.com/pdeducation Please be sure to give support to our channel sponsors: Comfort Linen: https://comfortlinen.com/PARKINSONSDISEASEEDUCATION(15% off entire order when applying the code PARKINSONSDISEASEEDUCATION at checkout) Kizik Shoes: https://kizik.sjv.io/pdeducation Cure Hydration: https://lvnta.com/lv_XG06Rho8SSlXEq3qlV If you have products that you would like for me to review on the channel please send them here: Parkinson's Disease Education P.O. Box 1678 Broken Arrow, OK 74013 Medical Disclaimer All information, content, and material of this video is for informational purposes only and not intended to serve as a substitute for the consultation, diagnosis, and/or medical treatment of a qualified physician or healthcare provider. Affiliate disclaimer: Keep in mind that links used for recommended products may earn me a commission when you make purchases. However, this does not impact what products I recommend. If I recommend a specific product it is because it has been vetted by myself or based on personal use. #parkinson #parkinsonsawareness #parkinsonsdisease #parkinsons #prasinezumab #monoclonalantibodies #alphasynuclein

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into some of the most significant events shaping the industry, from innovative drug formulations and regulatory challenges to the dynamic IPO landscape and clinical trial outcomes.Starting with Novo Nordisk, their oral formulation of Wegovy is witnessing substantial uptake, showcasing a strong demand for novel obesity treatments. This rapid adoption underscores a competitive environment where companies like Eli Lilly, with its Zepbound launch, are vying for market share. The introduction of innovative delivery methods in obesity management not only drives immediate commercial success but also highlights a critical area of therapeutic advancement due to the rising global prevalence of obesity.From a regulatory perspective, alignment with bodies like the FDA remains crucial. Companies such as Beam Therapeutics and Cabaletta Bio emphasize this at events like the J.P. Morgan Healthcare Conference, highlighting the importance of clear regulatory pathways in ensuring the successful approval of promising therapies. Conversely, Atara Biotherapeutics' recent setback with an unexpected FDA rejection demonstrates the unpredictability inherent in regulatory processes, which can significantly impact drug development timelines.The IPO market in biotech remains vibrant despite broader market uncertainties. Noteworthy are Agomab Therapeutics and Spyglass Pharma, each preparing for substantial public offerings. Agomab focuses on ALK5 inhibitors for inflammatory diseases, while Spyglass advances drug delivery implants for chronic eye conditions. This wave of IPOs highlights investor confidence in innovative therapies that address unmet medical needs and reflects a broader trend toward precision medicine and novel treatment modalities.In clinical research, AbbVie and Genmab faced a setback when their bispecific antibody failed to meet a crucial endpoint in a Phase III lymphoma study. Such challenges underscore the high stakes involved in oncology drug development, where successes can significantly alter treatment paradigms, yet failures remind us of the inherent risks.Turning to Alzheimer's disease, there is palpable excitement around next-generation treatments under investigation. These candidates promise to reshape the landscape by offering new hope in a field where effective therapies are desperately needed. This is complemented by advancements in manufacturing capabilities recognized as essential to strategic planning beyond 2026, ensuring that production processes can scale efficiently to meet global demands.On the workforce front, Takeda's decision to reduce its U.S. headcount, impacting its neurology teams, reflects industry trends where resource allocation is increasingly focused on core growth areas. Such strategic recalibrations are part and parcel of navigating competitive pressures and evolving market demands.In another realm, ImmunityBio's Phase 1 results for its CD19 CAR-NK cell therapy offer promising insights into innovative oncology approaches. The use of natural killer cells engineered with chimeric antigen receptors could revolutionize cancer treatment by providing targeted therapeutic options for hematological malignancies and potentially solid tumors.Regulatory approvals also continue to shape industry dynamics. SOBI's Aspaveli receiving EU approval for rare kidney diseases marks significant progress in complement inhibition therapies. Meanwhile, Bayer's Eylea approval for retinal vein occlusion-related visual impairment reinforces the vital role of VEGF inhibitors in ophthalmology.Strategic collaborations are also making headlines, as seen with Abelzeta and AstraZeneca's expanded partnership on GPC3 CAR-T therapy through an acquisition focused on China rights. This move illustrates the global interest inSupport the show

Picture this: a patient with early-stage breast cancer is sitting in front of you in the clinic. You are about to offer your expert management plan. The age-old question arises—should you really perform a sentinel lymph node biopsy, or could omission actually help this patient more? Today, we're tackling one of the hottest debates in modern breast cancer care.Should we rethink sentinel lymph node biopsy for select patients, and can skipping it actually improve quality of life without sacrificing cancer control? The stakes couldn't be higher—balancing accurate cancer staging and minimizing harm is the name of the game. Together, we're breaking down the latest evidence from the SOUND and INSEMA trials. What do these landmark studies mean for your patients, your practice, and the future of axillary management? Ready for a journal review that might just change your next consult? Hosts:- Rashmi Kumar, MD, PhDResident, University of Michigan General Surgery Residency ProgramTwitter/X: @RashmiJKumar- Melissa Pilewskie, MDAttending Breast Surgical Oncologist, Co-Director of the Weiser Family Center for Breast Cancer, Michigan Medicine Twitter/X: @MPilewskie- Stephanie Downs-Canner, MDAttending Breast Surgical Oncologist & Physician-Scientist, Memorial Sloan Kettering Cancer Center, Program Director of the Breast Surgical Oncology Fellowship Training Program Twitter/X: @SDownsCannerLearning Objectives:- Understand when and for whom it is safe and beneficial to omit sentinel lymph node biopsy (SLNB) in early-stage breast cancer patients.- Identify the risks associated with foregoing SLNB, including loss of nodal staging, and analyze how this impacts treatment selection and prognosis.- Review key findings from the SOUND and INSEMA trials and their influence on axillary management.- Discuss implications for adjuvant therapy, genomic profiling, and multidisciplinary clinical practice.- Recognize which patient populations should still receive SLNB, and the importance of individualized, multidisciplinary decision-making.References:- Gentilini OD, Botteri E, Sangalli C, et al. Sentinel Lymph Node Biopsy vs No Axillary Surgery in Patients With Small Breast Cancer and Negative Results on Ultrasonography of Axillary Lymph Nodes: The SOUND Randomized Clinical Trial. JAMA Oncol. 2023;9(11):1557–1564. doi:10.1001/jamaoncol.2023.3759 https://pubmed.ncbi.nlm.nih.gov/37733364/- Reimer T, Stachs A, Veselinovic K, et al. Axillary surgery in breast cancer – primary results of the INSEMA trial. N Eng J Med. 2024. doi:10.1056/NEJMoa2412063.https://pubmed.ncbi.nlm.nih.gov/39665649/- Sparano JA, Gray RJ, Makower DF, Albain KS, Saphner TJ, Badve SS, Wagner LI, Kaklamani VG, Keane MM, Gomez HL, Reddy PS, Goggins TF, Mayer IA, Toppmeyer DL, Brufsky AM, Goetz MP, Berenberg JL, Mahalcioiu C, Desbiens C, Hayes DF, Dees EC, Geyer CE Jr, Olson JA Jr, Wood WC, Lively T, Paik S, Ellis MJ, Abrams J, Sledge GW Jr. Clinical Outcomes in Early Breast Cancer With a High 21-Gene Recurrence Score of 26 to 100 Assigned to Adjuvant Chemotherapy Plus Endocrine Therapy: A Secondary Analysis of the TAILORx Randomized Clinical Trial. JAMA Oncol. 2020 Mar 1;6(3):367-374. doi: 10.1001/jamaoncol.2019.4794. PMID: 31566680; PMCID: PMC6777230. https://pubmed.ncbi.nlm.nih.gov/31566680/- Slamon DJ, Fasching PA, Hurvitz S, Chia S, Crown J, Martín M, Barrios CH, Bardia A, Im SA, Yardley DA, Untch M, Huang CS, Stroyakovskiy D, Xu B, Moroose RL, Loi S, Visco F, Bee-Munteanu V, Afenjar K, Fresco R, Taran T, Chakravartty A, Zarate JP, Lteif A, Hortobagyi GN. Rationale and trial design of NATALEE: a Phase III trial of adjuvant ribociclib + endocrine therapy versus endocrine therapy alone in patients with HR+/HER2- early breast cancer. Ther Adv Med Oncol. 2023 May 29;15:17588359231178125. doi: 10.1177/17588359231178125. Erratum in: Ther Adv Med Oncol. 2023 Sep 29;15:17588359231201818. doi: 10.1177/17588359231201818. PMID: 37275963; PMCID: PMC10233570. https://pubmed.ncbi.nlm.nih.gov/37275963/Sponsor Disclosure: Visit goremedical.com/btkpod to learn more about GORE® SYNECOR Biomaterial, including supporting references and disclaimers for the presented content. Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. Rx only Please visit https://behindtheknife.org to access other high-yield surgical education podcasts, videos and more.  If you liked this episode, check out our recent episodes here: https://behindtheknife.org/listenBehind the Knife Premium:General Surgery Oral Board Review Course: https://behindtheknife.org/premium/general-surgery-oral-board-reviewTrauma Surgery Video Atlas: https://behindtheknife.org/premium/trauma-surgery-video-atlasDominate Surgery: A High-Yield Guide to Your Surgery Clerkship: https://behindtheknife.org/premium/dominate-surgery-a-high-yield-guide-to-your-surgery-clerkshipDominate Surgery for APPs: A High-Yield Guide to Your Surgery Rotation: https://behindtheknife.org/premium/dominate-surgery-for-apps-a-high-yield-guide-to-your-surgery-rotationVascular Surgery Oral Board Review Course: https://behindtheknife.org/premium/vascular-surgery-oral-board-audio-reviewColorectal Surgery Oral Board Review Course: https://behindtheknife.org/premium/colorectal-surgery-oral-board-audio-reviewSurgical Oncology Oral Board Review Course: https://behindtheknife.org/premium/surgical-oncology-oral-board-audio-reviewCardiothoracic Oral Board Review Course: https://behindtheknife.org/premium/cardiothoracic-surgery-oral-board-audio-reviewDownload our App:Apple App Store: https://apps.apple.com/us/app/behind-the-knife/id1672420049Android/Google Play: https://play.google.com/store/apps/details?id=com.btk.app&hl=en_US

Audio roundup of selected biopharma industry content from Scrip over the business week ended January 9, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – oral Wegovy launches in the US; the biggest mid-cap catalysts in 2025; small cap pivots and zombie killers last year; commercial headwinds for last year's launches; and a look at Chinese firms' global Phase III activity. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-ZV4GVVROYBEN7I6DQBOMQ3A3XE/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Broadcast from KSQD, Santa Cruz on 1-08-2026: Dr. Dawn concludes her 2025 medical advances recap, noting that while GLP-1 weight loss drugs showed unexpected benefits for addiction, schizophrenia, and dementia risk, Novo Nordisk recently reported semaglutide had no effect on cognition in people with existing dementia or mild cognitive impairment. She describes the first successful human bladder transplant performed on May 4th. The 41-year-old recipient received both kidney and bladder due to the bladder's complex blood vessel network. Surgeons practiced on cadavers with active circulation before achieving success, opening pathways for future bladder-only transplants for the 84,000 Americans diagnosed with bladder cancer annually. An emailer follows up about purslane for cognitive health. Dr. Dawn reviewed the referenced studies and found neither actually supported claims about purslane and cognition—one discussed the Lyon Heart Study's Mediterranean diet, the other described antioxidant properties. She cautions listeners that websites citing "scientifically proven" claims often reference articles that don't support their assertions. An emailer asks about statin alternatives after developing severe muscle pain on both atorvastatin and rosuvastatin. Dr. Dawn suggests he shouldn't be on statins given his classic adverse reaction. She recommends ezetimibe plus oat bran for cholesterol, metformin for his elevated triglycerides indicating insulin resistance, and checking LDL particle size and inflammation markers. She emphasizes that cholesterol is a risk factor, not a disease, and treating 50 low-risk people for 10 years prevents only one heart attack. A caller discusses plaque formation theory, comparing it to calluses. Dr. Dawn explains Linus Pauling's similar hypothesis that plaque forms at vessel bifurcations to protect against turbulent blood flow damage. She warns against driving total cholesterol below 130, as it disrupts steroid hormone production. The caller shares his mother's near-fatal rhabdomyolysis from statins—muscle breakdown releasing myoglobin that clogs kidneys—and criticizes data transfer failures between hospital systems. An emailer reports four UTIs in two months at age 79. Dr. Dawn questions whether all were true infections, since vaginal contamination causes false positives on dipstick tests. For confirmed UTIs, she recommends D-mannose and cranberry to prevent bacterial adhesion, post-void residual ultrasound to check for incomplete emptying, lactobacillus probiotics, and vaginal DHEA (Intrarosa) to restore mucosal thickness and disease resistance. Dr. Dawn describes Stanford's Phase III trial for dystrophic epidermolysis bullosa, where defective collagen-7 causes skin layers to separate at the slightest touch. Researchers take patient skin biopsies, use retroviruses to insert corrected genes, grow credit-card-sized skin grafts over 25 days, then suture them onto wounds. At 48 weeks, 65% of treated wounds fully healed versus 7% of controls. She reports a Stanford study showing premature babies who heard recordings of their mothers reading for 2 hours 40 minutes daily developed more mature white matter in language pathways. The left arcuate fasciculus showed greater development than controls, demonstrating how early auditory stimulation shapes brain circuitry even in NICU settings. Dr. Dawn concludes with tattoo safety concerns. Modern vivid inks contain compounds developed for car paint and printer toner, including azo dyes that break down into carcinogenic aromatic amines—especially during laser removal. Pigment particles migrate to lymph nodes and persist in macrophages, causing prolonged inflammation. She advises those with tattoos to avoid laser removal, wear sunscreen, practice lymphatic hygiene, and reconsider extensive new tattoos.

It's a week for endings in this week's Star Wars comics as Marvel's Han Solo -- Hunt for the Falcon #5 (of 5) brings the unusually reflective but entertaining mini-series to a close, while leaving the door open for more stories about a maturing Han and his relationships with friends and family.In Dark Horse's Hyperspace Stories -- Tides of Terror #4 (of 4) Kit Fisto and his padawan, Nahdar, learn a little bit something about not just themselves and the Jedi, but the force, too.Comics Discussed This Week:Han Solo -- Hunt for the Falcon #5 (of 5)Hyperspace Stories: Tides of Terror #4 (of 4)Star Wars Comics New to Marvel Unlimited This Week:
Star Wars (Vol. 4) #6 (of 10)
News:On our Facebook and Bluesky pages are the updated covers for some upcoming Star Wars comics TPBs and omnibus editions from Marvel, including May 12's Star Wars: New Republic by Phil Noto, May 19's Doctor Aphra -- Chaos Agent by Ejikure and Al Williamson's Ord Mantell cover for the direct-market edition of Star Wars Legends: The Newspaper Strips Omnibus due out July 21.We've got previews of the upcoming Star Wars: The High Republic Adventures Phase II and Phase III collections from Dark Horse Comics on the Facebook and Bluesky pages.
Upcoming Star Wars comics, graphic novels and omnibuses:Jan. 14 _ Legacy of Vader #12Jan. 21 _ Star Wars (Vol. 4) #9Jan. 27 _ Darth Maul: Black, White & Red TPB (Collects 1-4)Feb. 11 _ Jar Jar Binks #1 One-Shot, Hyperspace Stories: The Bad Batch — Rogue Agents #2 (of 4)Feb. 17 _ Star Wars: Hidden Empire Omnibus (Collects HIdden Empire 1-5, Star Wars (Vol. 3) 26-36, Bounty Hunters 27-34, Darth Vader (Vol. 3) 28-32, Doctor Aphra (Vol. 2) 22-31 and 2022's Star Wars: Revelations #1)Feb. 18 _ Star Wars (Vol. 4) #10March 4 _ Shadow of Maul #1 (of 5)March 11 _ Hyperspace Stories: The Bad Batch — Rogue Agents #3 (of 4); The High Republic Adventures -- Pathfinders #1 (of 6)March 17 _ Star Wars Legends: The Empire Omnibus Vol. 4 (Collects Star Wars: Underworld - The Yavin Vassilika (2000) #1-5; Free Comic Book Day 2013: Star Wars #1; Star Wars: Empire (2002) #5-6, 8-13, 15; Star Wars: X-Wing Rogue Squadron (1995) #1/2; Star Wars: A New Hope - The Special Edition (1997) #1-4; Star Wars: Tag & Bink Are Dead (2001) #1; Star Wars Infinities: A New Hope (2001) #1-4; The Star Wars (2013) #0-8; material from Star Wars Tales (1999) #1-2, 4, 6, 8-10, 12, 14, 16, 19-20); Hyperspace Stories: Grievous OGNMarch 24 _ Tales From the Nightlands TPB (Collects 1-3); Hyperspace Stories: Codebreaker TPB (Collects 1-4) March 31 _ Legacy of Vader: The Reign of Kylo Ren Vol. 2 TPB (Collects 7-12)April 8 _ Hyperspace Stories: The Bad Batch -- Rogue Agents #4 (of 4)April 14 _ Jedi Knights Vol. 2 - A Higher Path TPB (Collects 6-10), Star Wars Visions TPB (Collects Visions -- Peach Momoko #1, Visions -- Takashi Okazaki #1, Peach Momoko's Story from Darth Vader -- Black, White & Red #1)April 21 _ The High Republic Phase III -- Trial of the Jedi Omnibus (Collects 2023's The High Republic 1-10, Revelations #1's High Republic story, The Acolyte — Kelnacca one-shot, Shadows of Starlight 1-4, Fear of the Jedi 1-5, The Finale #1: The Beacon one-shot); The Mandalorian -- Seasons One & Two (Collects #1-8 of both mini-series), Jedi Knights Vol. 2 TPB (Collects 6-10); Hyperspace Stories: Tides of Terror TPB (Collects 1-4)April 22 _ The High Republic Adventures — Pathfinders #2 (of 6)April 28 _ Han Solo -- Hunt for the Falcon TPB (Collects 1-5)May 5 _ The High Republic Adventures -- The Complete Phase II (1-8, Nameless Terror 1-4, Quest of the Jedi one-shot)May 12 _ Star Wars: New Republic (Collects 1-10, material from Free Comic Book Day 2025: Star Wars #1)May 19 _ Star Wars Legends: Legacy Omnibus Vol. 1 (Collects Star Wars: Legacy (2006) #0, 0-1/2, 1-36, 41); Doctor Aphra — Chaos Agent TPB (Collects 1-10)May 26 _ The High Republic Adventures -- The Complete Phase III Part 1 (Collects The High Republic Adventures (Phase III 1-10), Saber for Hire 1-4 and the Crash Landing and Crash and Burn one-shots)June 16 _ Star Wars Legends: The New Republic Omnibus Vol. 3 (Collects Star Wars: Crimson Empire (1997) #0-6, Star Wars: The Bounty Hunters - Kenix Kil (1999) #1, Star Wars: Crimson Empire II - Council of Blood (1998) #1-6, Star Wars: Crimson Empire III - Empire Lost (2011) #1-6, Star Wars: Jedi Academy - Leviathan (1998) #1-4, Star Wars: The Mixed-Up Droid (1995) #1, Star Wars: Union (1999) #1-4, Star Wars: Chewbacca (2000) #1-4, Star Wars: Invasion (2009) #0-5, Star Wars: Invasion - Rescues (2010) #1-6, Star Wars: Invasion - Revelations (2011) #1-5, Star Wars Handbook (1998) #2; material from Dark Horse Extra (1998) #21-24; Dark Horse Presents (2011) #1; Star Wars Tales (1999) #8, 11, 16-19, 21); The Art of Star Wars: A New Hope — The Manga Vol. 1June 30 _ The High Republic Adventures -- The Complete Phase III Part 2 (Collects The High Republic Adventures (Phase III) 11-20, Echoes of Fear 1-4, Dispatches From the Occlusion Zone 1-4 and the one-shots 2025 Annual, The Wedding Spectacular and The Battle of Eriadu)July 21 _ Star Wars Legends: The Newspaper Strips Omnibus (Collects Classic Star Wars: The Early Adventures (1994) #1-9, Classic Star Wars: Han Solo at Stars' End (1997) #1-3, Classic Star Wars (1992) #1-20, Classic Star Wars: A New Hope (1994) #1-2, Classic Star Wars: The Vandelhelm Mission (1995) #1, Star Wars newspaper strips "The Constancia Affair," "The Kashyyyk Depths" and "Planet of Kadril”); Star Wars Modern Era Epic Collection: The Screaming Citadel (Collects Star Wars (2015) #31-43, Star Wars Annual (2015) #3, Star Wars: The Screaming Citadel (2017) #1, Star Wars: Doctor Aphra (2016) #7-8)
Aug. 11 _ The Bad Batch — Rogue Agents TPB (Collects 1-4)Aug. 18 _ The Art of Star Wars: A New Hope -- The Manga Vol. 2----------------------------------------------------------------------------------------------------------------------------------------Star Wars Splash Page is a weekly podcast dedicated solely to contemporary Star Wars comics published by Marvel, Dark Horse and previously IDW, featuring views about the current week's comics, interviews with the writers, artists, colorists, letterers and editors who create them, as well as the latest details on publishing schedules, upcoming series and mini-series, so that you, the listener have more detail and context about the comics that are a vital part of Star Wars canon, lore and legends.

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 fascinating stories that underscore the dynamic nature of our industry, where scientific innovation meets real-world application.Starting with a significant advancement in gene therapy, researchers have made remarkable progress in a novel approach to treating rare genetic disorders. This new methodology involves the use of CRISPR technology to edit genes directly within the human body, paving the way for potential cures once thought impossible. By targeting specific DNA sequences, scientists can now correct genetic mutations at their source. This breakthrough not only promises to transform the treatment landscape for rare diseases but also enhances our understanding of genetic disorders at a molecular level. The implications here extend beyond rare conditions, potentially offering new avenues for tackling more common genetic diseases in the future.Moving forward, let's discuss recent regulatory developments that have caught the industry's attention. The FDA has granted accelerated approval to a new oncology drug that shows promise in treating advanced forms of breast cancer. This decision was based on compelling clinical trial results demonstrating significant improvements in patient survival rates compared to existing therapies. The drug targets specific proteins involved in tumor growth, offering a more precise treatment option with potentially fewer side effects. This approval exemplifies how regulatory bodies are adapting to expedite access to life-saving treatments while ensuring rigorous safety and efficacy standards.In another noteworthy development, a Phase III clinical trial has yielded positive results for a novel Alzheimer's drug. The trial demonstrated that this drug significantly slows cognitive decline in patients with early-stage Alzheimer's disease. By targeting amyloid plaques in the brain, which are believed to contribute to neurodegeneration, this therapeutic approach represents a potential shift in how we treat this debilitating condition. These findings provide hope for millions affected by Alzheimer's and underscore the importance of continued investment in neuroscience research.Turning our attention to infectious diseases, there's exciting news from a biotech company focusing on vaccine development. They've announced encouraging preliminary data from trials of their new mRNA-based vaccine for respiratory syncytial virus (RSV). RSV is known for causing severe respiratory illness, particularly in infants and the elderly. The vaccine demonstrated robust immune responses and a favorable safety profile, suggesting it could become an important tool in preventing RSV infections globally. This development highlights the versatility of mRNA technology, which has already revolutionized COVID-19 vaccine design and holds promise for addressing various infectious diseases.In terms of industry trends, one cannot overlook the growing emphasis on personalized medicine. Recent advancements in biomarker research are enabling more tailored therapeutic approaches across multiple disease areas. By identifying specific genetic or molecular markers associated with diseases, healthcare providers can better predict patient responses to certain treatments. This shift towards precision medicine not only improves patient outcomes but also enhances healthcare efficiency by reducing trial-and-error prescribing.Lastly, we delve into an intriguing area of metabolic disorders where innovative therapeutic strategies are emerging. A biotech firm has developed a first-in-class oral medication for treating non-alcoholic steatohepatitis (NASH), a serious liver condition linked to obesity and metabolic syndrome. The drug works by modulating key metabolic pathways involved in liver inflammation and fibrSupport the show

Dr. Kirk Erickson is Director of Translational Neuroscience and Mardian J. Blair Endowed Chair of Neuroscience at the AdventHealth Research Institute, Neuroscience Institute. Dr. Erickson received his Ph.D. at the University of Illinois at Urbana-Champaign and was a post-doctoral scholar at the Beckman Institute for Advanced Science and Engineering. He was also a Professor of Psychology and Neuroscience at the University of Pittsburgh before starting at AdventHealth. Dr. Erickson's vast research program focuses on the effects of physical activity on brain health across the lifespan. This research has resulted in > 250 published articles and 15 book chapters. Dr. Erickson's research has been funded by numerous awards and grants from NIH, the Alzheimer's Association, and other organizations. He has been awarded a large multi-site Phase III clinical trial examining the impact of exercise on cognitive function in cognitively normal older adults. His research resulted in the prestigious Chancellor's Distinguished Research Award from the University of Pittsburgh. He was named a Fellow of the Academy of Behavioral Medicine Research in 2016, and a Distinguished Scientist Award by Murdoch University in 2018. He currently holds a Visiting Professor appointment at the University of Granada, Spain. Dr. Erickson was a member of the 2018 Physical Activity Guidelines Advisory Committee, and chair of the Brain Health subcommittee charged with developing the second edition of the Physical Activity Guidelines for Americans. His research has been featured in a long list of print, radio, and electronic media including the New York Times, CNN, BBC News, NPR, Time, and the Wall Street Journal.   This podcast episode is sponsored by Fibion Inc. | Better Sleep, Sedentary Behaviour and Physical Activity Research with Less Hassle --- Collect, store and manage SB and PA data easily and remotely - Discover ground-breaking Fibion SENS --- SB and PA measurements, analysis, and feedback made easy.  Learn more about Fibion Research --- Learn more about Fibion Sleep and Fibion Circadian Rhythm Solutions. --- Fibion Kids - Activity tracking designed for children. --- Collect self-report physical activity data easily and cost-effectively with Mimove. --- Explore our Wearables,  Experience sampling method (ESM), Sleep,  Heart rate variability (HRV), Sedentary Behavior and Physical Activity article collections for insights on related articles. --- Refer to our article "Physical Activity and Sedentary Behavior Measurements" for an exploration of active and sedentary lifestyle assessment methods. --- Learn about actigraphy in our guide: Exploring Actigraphy in Scientific Research: A Comprehensive Guide. --- Gain foundational ESM insights with "Introduction to Experience Sampling Method (ESM)" for a comprehensive overview. --- Explore accelerometer use in health research with our article "Measuring Physical Activity and Sedentary Behavior with Accelerometers ". --- For an introduction to the fundamental aspects of HRV, consider revisiting our Ultimate Guide to Heart Rate Variability. --- Follow the podcast on Twitter https://twitter.com/PA_Researcher Follow host Dr Olli Tikkanen on Twitter https://twitter.com/ollitikkanen Follow Fibion on Twitter https://twitter.com/fibion https://www.youtube.com/@PA_Researcher

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 groundbreaking advancements, revealing a landscape rich with scientific innovation and strategic maneuvers poised to impact patient care and the drug development pipeline.Let's start with Johnson & Johnson's recent FDA approval for a subcutaneous version of Rybrevant, their lung cancer medication. This new formulation offers a more convenient administration method compared to AstraZeneca's Tagrisso, intensifying competition in the non-small cell lung cancer market. The shift towards more patient-friendly delivery systems underscores the industry's commitment to enhancing treatment adherence and convenience. In contrast, Insmed faced a setback with its phase 2 trial for Brinsupri in treating chronic rhinosinusitis without nasal polyps. The discontinuation of this program highlights the unpredictable nature of clinical trials and emphasizes the need for rigorous scientific validation before advancing therapeutic candidates.Meanwhile, Lilly has shown promising results with its oral obesity pill, marking significant progress in weight management therapies. Patients transitioning from injectable GLP-1 therapies to Lilly's oral drug candidate maintained substantial weight loss, positioning Lilly favorably against Novo Nordisk's Wegovy. The potential for oral formulations to revolutionize treatment paradigms in chronic conditions cannot be understated. Lilly's progress in obesity treatment with its oral medication orforglipron further cements its competitive edge. Participants in their Phase III clinical trial maintained weight loss after switching from Wegovy or Zepbound to orforglipron, suggesting an efficacious oral alternative to injectable treatments and potentially enhancing patient adherence.On the regulatory front, the Biosecure Act's progression within a major defense spending bill could impose new challenges for life sciences companies with Chinese affiliations. This legislative shift reflects geopolitical tensions impacting global pharmaceutical collaborations and underscores the importance of regulatory compliance in international partnerships. Similarly, Intercept Pharmaceuticals' restructuring following the withdrawal of Ocaliva from the U.S. market is indicative of strategic pivots in response to regulatory hurdles and evolving market dynamics.In dermatology, Takeda's successful phase 3 trials for Zasocitinib highlight the competitive nature of drug development as multiple players vie for market share within therapeutic areas. Their anticipated 2026 FDA filing underscores the prolonged timelines involved in bringing novel therapies to market despite successful clinical outcomes.Public-private collaborations continue to play a crucial role in vaccine development, as evidenced by Moderna's pandemic influenza vaccine advancement into phase 3 trials with support from the Coalition for Epidemic Preparedness Innovations (CEPI). This $54 million investment illustrates ongoing efforts to bolster pandemic preparedness through innovative mRNA technologies. Meanwhile, Moderna's $54 million funding from CEPI to advance its bird flu vaccine highlights resilience amidst fluctuating governmental support. This endeavor leverages Moderna's mRNA technology platform, emphasizing mRNA's versatility across various infectious diseases.Shifting our focus slightly, medical groups have expressed opposition to changes in hepatitis B vaccination recommendations by the CDC for newborns. Such policy debates have significant implications for public health strategies and highlight ongoing discussions within medical communities regarding optimal vaccination protocols.GSK's strategic collaboration with Camp4 Therapeutics marks another key industry development. With an investment exceeding $400 million, GSK aims to Support the show

Dr. Kirk Erickson is Director of Translational Neuroscience and Mardian J. Blair Endowed Chair of Neuroscience at the AdventHealth Research Institute, Neuroscience Institute. Dr. Erickson received his Ph.D. at the University of Illinois at Urbana-Champaign and was a post-doctoral scholar at the Beckman Institute for Advanced Science and Engineering. He was also a Professor of Psychology and Neuroscience at the University of Pittsburgh before starting at AdventHealth. Dr. Erickson's vast research program focuses on the effects of physical activity on brain health across the lifespan. This research has resulted in > 250 published articles and 15 book chapters. Dr. Erickson's research has been funded by numerous awards and grants from NIH, the Alzheimer's Association, and other organizations. He has been awarded a large multi-site Phase III clinical trial examining the impact of exercise on cognitive function in cognitively normal older adults. His research resulted in the prestigious Chancellor's Distinguished Research Award from the University of Pittsburgh. He was named a Fellow of the Academy of Behavioral Medicine Research in 2016, and a Distinguished Scientist Award by Murdoch University in 2018. He currently holds a Visiting Professor appointment at the University of Granada, Spain. Dr. Erickson was a member of the 2018 Physical Activity Guidelines Advisory Committee, and chair of the Brain Health subcommittee charged with developing the second edition of the Physical Activity Guidelines for Americans. His research has been featured in a long list of print, radio, and electronic media including the New York Times, CNN, BBC News, NPR, Time, and the Wall Street Journal.   This podcast episode is sponsored by Fibion Inc. | Better Sleep, Sedentary Behaviour and Physical Activity Research with Less Hassle --- Collect, store and manage SB and PA data easily and remotely - Discover ground-breaking Fibion SENS --- SB and PA measurements, analysis, and feedback made easy.  Learn more about Fibion Research --- Learn more about Fibion Sleep and Fibion Circadian Rhythm Solutions. --- Fibion Kids - Activity tracking designed for children. --- Collect self-report physical activity data easily and cost-effectively with Mimove. --- Explore our Wearables,  Experience sampling method (ESM), Sleep,  Heart rate variability (HRV), Sedentary Behavior and Physical Activity article collections for insights on related articles. --- Refer to our article "Physical Activity and Sedentary Behavior Measurements" for an exploration of active and sedentary lifestyle assessment methods. --- Learn about actigraphy in our guide: Exploring Actigraphy in Scientific Research: A Comprehensive Guide. --- Gain foundational ESM insights with "Introduction to Experience Sampling Method (ESM)" for a comprehensive overview. --- Explore accelerometer use in health research with our article "Measuring Physical Activity and Sedentary Behavior with Accelerometers ". --- For an introduction to the fundamental aspects of HRV, consider revisiting our Ultimate Guide to Heart Rate Variability. --- Follow the podcast on Twitter https://twitter.com/PA_Researcher Follow host Dr Olli Tikkanen on Twitter https://twitter.com/ollitikkanen Follow Fibion on Twitter https://twitter.com/fibion https://www.youtube.com/@PA_Researcher

Eli Lilly is wrapping up 2025 with record-breaking weight loss in a late-stage trial for its triple hormone receptor agonist retatrutide. Results from the Phase III TRIUMPH-4 trial exceeded analyst expectations, leading BMO Capital markets to cleverly dub it “a true TRIUMPH.” Also in the weight loss arena, Zealand Pharma inked a deal with China's OTR Therapeutics worth up to $2.5 billion to collaborate on next-gen drugs for obesity and other metabolic diseases, and Rhythm Pharmaceuticals awaits a Dec. 20 FDA verdict for Imcivree in hypothalamic obesity.   Turning to the FDA, reports broke late last week that the agency was considering slapping a black box label—its strictest warning—on COVID-19 vaccines. Commissioner Marty Makary denied those reports on Monday, stating on Bloomberg TV that the FDA has “no plans” to make such a move. This follows an internal memo from Vinay Prasad leaked over Thanksgiving in which the CBER director claimed that “at least” 10 children have died “because of” COVID-19 vaccines. An internal safety review published last week refuted this conclusion, instead concluding that between zero and seven deaths could be linked to the shots.   Pfizer CEO Albert Bourla, for one, is tired of the recent rhetoric from HHS on vaccines and hopes they are “an anomaly” that will be corrected soon. With strong words about the administration's sentiment on vaccines, Bourla prominsed Pfizer's continued investment in vaccines despite declining revenue. Pfizer this week lowered its 2026 guidance to $62.5 billion in revenue, missing analyst consensus.  The FDA has also granted several approvals in the past week, to Amgen, Milestone Pharmaceuticals and AstraZeneca and Daiichi Sankyo. USAntibiotics also snagged a greenlight, for Augmentin XR, the first approval to be given under the agency's new Commissioner's National Priority Voucher (CNPV) program. Also this week, Johnson & Johnson scored a CNPV ticket—without even having to apply—for its investigational combo of Tecvayli plus Darzalex for relapsed or refractory multiple myeloma after the FDA was impressed by Phase III data.   In ClinicaSpace this week, we highlighted 5 of 2025's Defining Clinical Wins and The 5 Most Painful Clinical Trial Failures of 2025. This past week provided a few more on each front. In the winner's circle, Immunome's desmoid tumor drug and and Kyverna's CAR T for stiff person syndrome both aced pivotal trials, while Sanofi's MS drug tolebrutinib and Gilead and Arcus' TIGIT therapy domvanalimab each failed Phase III tests.   And in BioPharm Executive, we highlight 6 Biotechs That Could Be Big Pharma's Next M&A Target, and more M&A predictions for 2026.  

Featuring an interview with Dr Priyanka Sharma, including the following topics: Patient-reported outcomes from the SERENA-6 trial of camizestrant with a CDK4/6 inhibitor for patients with HR-positive, HER2-negative advanced breast cancer and ESR1 mutations emerging during first-line endocrine-based therapy (0:00) Mayer E et al. Patient-reported outcomes (PROs) from the SERENA-6 trial of camizestrant (CAMI) + CDK4/6 inhibitor (CDK4/6i) for emergent ESR1m during first-line (1L) endocrine-based therapy and ahead of disease progression in patients (pts) with HR+/HER2– advanced breast cancer (ABC). ESMO 2025;Abstract 486MO. Imlunestrant and abemaciclib versus fulvestrant and abemaciclib for ER-positive, HER2-negative advanced breast cancer: An indirect treatment comparison of 3 Phase III trials (3:00) Bidard FC et al. Imlunestrant plus abemaciclib versus fulvestrant plus abemaciclib in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (ABC): An indirect treatment comparison (ITC) of three phase 3 trials. ESMO 2025;Abstract 496P . Giredestrant in the treatment of ER-positive, HER2-negative breast cancer: The Phase III evERA Breast Cancer and EMPRESS trials (5:39) Mayer E et al. Giredestrant (GIRE), an oral selective oestrogen receptor (ER) antagonist and degrader, + everolimus (E) in patients (pts) with ER-positive, HER2-negative advanced breast cancer (ER+, HER2– aBC) previously treated with a CDK4/6 inhibitor (i): Primary results of the phase III evERA BC trial. ESMO 2025;Abstract LBA16. Llombart-Cussac A et al. Preoperative window-of-opportunity study with giredestrant or tamoxifen (tam) in premenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) and Ki67≥10% early breast cancer (EBC): The EMPRESS study. ESMO 2025;Abstract 294MO. Capivasertib/fulvestrant as first- and second-line endocrine-based therapy for PIK3CA/AKT1/PTEN-altered HR-positive advanced breast cancer in the CAPItello-291 trial and gedatolisib/fulvestrant with or without palbociclib for HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer in the VIKTORIA-1 trial.(10:25) Rugo HS et al. Capivasertib plus fulvestrant as first and second-line endocrine-based therapy in PIK3CA/AKT1/PTEN-altered hormone receptor-positive advanced breast cancer: Subgroup analysis from the phase 3 CAPItello-291 trial. ESMO 2025;Abstract 526P. Hurvitz SA et al. Gedatolisib (geda) + fulvestrant ± palbociclib (palbo) vs fulvestrant in patients (pts) with HR+/ HER2-/PIK3CA wild-type (WT) advanced breast cancer (ABC): First results from VIKTORIA-1. ESMO 2025;Abstract LBA17. CME information and select publications

Novo Nordisk's highly anticipated data for semaglutide in Alzheimer's dashed hopes that the GLP-1 therapy could become a game changer in the disease. On the latest BioCentury This Week podcast, Executive Editor Selina Koch discusses the Phase III readout including what it says about the mechanism's use in the neurodegenerative disease, Novo's decision to skip Phase II and enroll a large patient group in a later stage trial, and what other datasets for GLP-1s in the indication have shown.Washington Editor Steve Usdin explains why FDA's new vaccine policies, driven by CBER Director Vinay Prasad, could have impacts more far-reaching than expected, including making it more difficult to develop or modify vaccines. And Lauren Martz, Executive Director of Biopharma Intelligence, analyzes the bleak investment outlook for cell and gene therapy companies in the U.S. and why China's biotech ecosystem offers a glimmer of hope for sponsors of these assets.View full story: https://www.biocentury.com/article/657721#Semaglutide #GLP1Therapies #VaccinePolicy #CellAndGeneTherapy #AlzheimersResearch00:00 - Introduction01:53 - Novo's Alzheimer's Miss13:19 - FDA's New Vaccine Policy19:53 - Funding C> BiotechsTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Audio roundup of selected biopharma industry content from Scrip over the business week ended November 28, 2025. In this episode: 2027 Medicare price cuts likely not as large as CMS estimates; Zai Lab leads DLL3 lung cancer ADC race; Phase II failure for J&J's Alzheimer's asset posdinemab; Bayer's positive Phase III data for asundexian in stroke; and Pfizer/Astellas's Padcev's first big win in bladder cancer study. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-R4RCDF2RXVGVHPEX2WQ7A3JVKU/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Kingfisher Metals reported additional drill and soil results from its 2025 program at the HWY 37 Project in British Columbia's Golden Triangle. Nevada King Gold Corp. reported final results from ten remaining holes of its Phase III drill program at the Silver Park East (SPE) target. Collective Mining announced that drilling is now fully underway at the high-grade, tungsten-rich zones of its **Apollo system**. Great Pacific Gold announced Phase 1 diamond drill results from the Sinivit target at its flagship Wild Dog Project in Papua New Guinea. First Mining Gold announced additional 2025 exploration results from the Miroir target at its Duparquet Gold Project in Quebec's Abitibi region. Foran Mining announced H2 2025 exploration results from the Tesla Zone at its McIlvenna Bay Project in Saskatchewan.This episode of Mining Stock Daily is brought to you by… Integra ResourcesIntegra is a growing precious metals producer in the Great Basin of the Western United States. Integra is focused on demonstrating profitability and operational excellence at its principal operating asset, the Florida Canyon Mine, located in Nevada. In addition, Integra is committed to advancing its flagship development-stage heap leach projects: the past producing DeLamar Project located in southwestern Idaho, and the Nevada North Project located in western Nevada. Learn more about the business and their high industry standards over at integraresources.comThe Mining Stock Daily morning briefing is produced by Clear Commodity Network. It is distributed throughout the world through your podcast network of choice, and by our friends at the Junior Mining Network. The information presented should not be considered investment advice. Mining stock daily and its affiliates are not responsible for any loss arising from any investment decision in connection with the material presented herein. Please do your own research or speak with a licensed financial representative before making any investment decisions.

Audio roundup of selected biopharma industry content from Scrip over the business week ended October 31, 2025. In this episode: third quarter dealmaking picks up; Novartis still has M&A firepower even after Avidity acquisition; Hanmi's obesity contender shows Phase III promise; NVIDIA partnership progresses Lilly's AI plans; and Lilly builds gene therapy push with Adverum buy. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-MQMX2YHSAVHBTJFR4RAEAYNFNQ/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Audio roundup of selected biopharma industry content from Scrip over the business week ended October 24, 2025. In this episode we focus on the most significant results presented at the European Society for Medical Oncology meeting in Berlin: Enhertu in early-stage breast cancer; Padcev/Keytruda in bladder cancer; Phase III wins for Pluvicto; Trodelvy and Datroway in breast cancer tussle; and Merck & Co. raises hopes in breast cancer. . Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-EWX3A6U4TBE5NPDYXHIJSWDO3A/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Phase IV of The Change Leader's Roadmap is the Design Phase, where you take your Design Requirements from Phase III to determine the best solution to meet the needs of the future state. This high-level overview is key to ensuring you have a four-quadrant solution that will sustain its value once implemented. Details of the Design Phase are further outlined in Episode 41 of Ask Dr. Change. It covers in-depth the process, structure and requirements of this phase. Review that to embellish this episode so that you ensure you are taking a Conscious Change Leadership approach to Design.Hosted by Ausha. See ausha.co/privacy-policy for more information.

The Stormwall has finally come down and the 4 SPaRC Jedi Council members have finally been able to escape the Occlusion Zone! Hayley and Brian are joined, as always, by James "Yodahew" Hewings and Todd "Suds" Sedlacek, this time to discuss Phase III of Star Wars: The High Republic, Trials of the Jedi, and also the overarching story of all 3 Phases, and what did and did not work in this massive multimedia endeavor. Plus James regales us with his "Ode To Geode". EMAIL: SPARCPODCAST@GMAIL.COMTWITTER: https://twitter.com/SourcePagesCastINSTAGRAM: https://www.instagram.com/thesourcepagespodcast/FACEBOOK: https://www.facebook.com/SPARCPODCASTSPaRC's Podcast Buddies:Across the Bifrost: The Mighty Thor - https://podcasts.apple.com/us/podcast/across-the-bifrost-the-mighty-thor-podcast/id1572200841Dan and Ian Have Questions - https://podcasts.apple.com/us/podcast/dan-and-ian-have-questions-podcast/id1587402809Commute: The Podcast - https://podcasts.apple.com/us/podcast/commute-the-podcast/id1552657624Segabits - https://segabits.com/Machtails From the Cantina - https://www.facebook.com/machtailsfromthecantina/Rebel Force Radio Presents "The Babu Freaks" - https://www.rebelforceradio.com/shows/category/BaJacked Kirby - https://podcasts.apple.com/us/podcast/jacked-kirby/id1248146026So Weird So Fun - https://podcasts.apple.com/us/podcast/so-weird-so-fun-swsf-friends-through-fandom/id1793135012Star Wars YOU-niverse - https://podcasts.apple.com/us/podcast/star-wars-you-niverse-podcast/id1704904756

Wednesday, September 10, 2025. Week 37. CAMP4 Press Release:  https://www.linkedin.com/posts/caleb-moore-4382704_syngap1-activity-7371545171047628800-zVqR   Let me tell you a story: EW Story, concern over viability of C4. Easy to follow financials, Mrkt Cap and Net assets of ~$40M.  Net income/EBITDA of -$12.6M in Q2.   Running Phase I / II trials and ramping up for Phase III, not cheap.  They need more than they had and capital is hard to get in this market. But here is the good part, the data is solid, the team is strong, and the SYNGAP1 Ecosystem is excited to have a first mover. SRF was thrilled to be invited, not just because we believe in C4, but because we wanted to send a meaningful signal to other investors that we are working closely with C4 and are eager to support their success.  I believe that our investment, while modest, sent that signal and helped this raise become oversubscribed. The board worked hard on this one. Now for hard questions: Are we conflicted? No.  We will transparently share info about all trials for products with good data.  ( See #S10e172 for ASGCT Data https://youtu.be/9xO1TcO1Eus )  Will other companies be upset?  Unlikely.  Stoke and Praxis are the only companies publicly working on SYNGAP1 that are close to this point and they are not worried about financial viability, but if they do want to do a raise for their SYNGAP1 program, they should certainly call us. What will other companies think? Indeed we are de-risking the disease by showing that our kids are modifiable with ASOs which are the majority of the therapies in scope.  This is a huge favor to others looking at this space.   Isn't this taking a risk with our funds?  Depends.  But if it is, it's a risk worth taking.  Remember we are the smallest investor, we only committed up to $1M, so other professional biotech investors put in $99M. What was the process?  C4 came to us, we decided it was worth talking to the board who had multiple discussions but we said yes in less than a week and that was last week. When is the trial? 2H26 Less than a year from now.  With this financing, I am sure of it. As I write this, the $CAMP stock closed up $0.80 or +40%.  Which is solid.  The market is starting to agree with the wise investors and SRF!  Yes we need a cure.  https://www.linkedin.com/posts/curesyngap1_savekramerdavis-activity-7371607032807763968-PVfG   See you Friday: Beacon of Hope September 12, 2025 - Boston, MA cureSYNGAP1.org/Beacon25   SOCIAL MATTERS - 4,311 LinkedIn.  https://www.linkedin.com/company/curesyngap1/  - 1,430 YouTube.  https://www.youtube.com/@CureSYNGAP1    - 11,286 Twitter https://twitter.com/cureSYNGAP1  - 46k Insta https://www.instagram.com/curesyngap1/    Episode 182 of #Syngap10 #CureSYNGAP1 #Advocate #PatientAdvocacy #UnmetNeed #SYNGAP1 #SynGAP #SynGAProMMiS

Audio roundup of selected biopharma industry content from Scrip over the business week ended September 5, 2025. In this episode: the US MASH market after Wegovy's approval; AstraZeneca and Mineralys in close hypertension race; United Therapeutics' Phase III win in IPF; Corsera aims to predict and prevent cardiovascular disease; and Ionis's RNA-targeted win in severe hypertriglyceridemia. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-RKP4E4CFGFGGXBRVXTI73V27U4/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Sal talks The High Republic Adventures Phase III comic mini-series!This is my FAVORITE comic series!Daniel José Older and Harvey Tolibao make a perfect comic team!Love lost! Found! and a Wedding Spectacular!!Farzala and Qort lead at the battle of Eriadu!Maz and her pirates! Crash and her crew!Tarkin family business!!Gavi and Driggit at The Battle of Eriadu!The Warden! The Nihil! And even a little Niv Drendow!Memorial to the fallen!Bookended by memories and music ⁠⁠⁠⁠⁠⁠⁠Check out the Rogue Rebels The High Republic playlist!!⁠⁠⁠⁠⁠⁠⁠Check out the Rogue Rebels Star Wars comics playlist!!⁠⁠⁠⁠⁠⁠⁠⁠Follow us EVERYWHERE!⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠@TheRogueRebels on Bluesky!⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠IG: @TheRogueRebels ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠The Rogue Rebels on FB⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠TikTok @TheRogueRebels

What if we could finally crack the code on treating brain cancer by opening the door that's blocked 98% of therapies? In this episode, Dr. Michael Canney, Chief Scientific Officer of Carthera, reveals how SonoCloud—a revolutionary ultrasound implant—temporarily opens the blood-brain barrier to deliver chemotherapy directly to tumors like glioblastoma. With over 100 patients enrolled in a Phase III trial across 40 global sites, this isn't just a bold idea—it's happening now. Michael also shares real-world lessons in scaling trials, FDA navigation, and aligning science with commercial success. If you're passionate about disruptive innovation in neuro-oncology, you'll want to hear how Carthera is changing the game.