Podcasts about phase iii

Play Episode Listen Later Jan 13, 2026 15:09

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

ai story chinese must know wegovy phase iii scrip

2025 Medical Breakthroughs Wrap-Up: First Bladder Transplants, Gene Therapy for Skin Disease, Statin Alternatives, and Tattoo Safety Concerns

Ask Doctor Dawn

Play Episode Listen Later Jan 10, 2026 50:07

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.

Episode #484 -- Daddy Makes Boom Boom

Comics With Kenobi

Play Episode Listen Later Jan 7, 2026 41:16

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.

CRISPR Advances and Regulatory Shifts Drive Biotech Innovation

Physical Activity Researcher

Play Episode Listen Later Dec 31, 2025 4:31

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

/Highlights/ PA and Brain: Evolution | Recommendations | Harmonizing studies - Prof Kirk Erickson (Pt2)

Play Episode Listen Later Dec 20, 2025 24:11

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

Biotech Breakthroughs: Innovations Reshaping Patient Care

Physical Activity Researcher

Play Episode Listen Later Dec 19, 2025 6:31

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

/Highlights/ How Does Physical Activity Affect Brain and Cognitive Function - Prof Kirk Erickson (Pt1)

Play Episode Listen Later Dec 18, 2025 21:35

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

Lilly's Triple Triumph, Prasad's COVID Error, J&J's Surprise Voucher, M&A Targets

new york acast primary ses american society exposition r2 funders abbvie memorial sloan kettering cancer center phase iii rituximab

Play Episode Listen Later Dec 17, 2025 20:04

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.

ASH 2025 | EPCORE FL-1 phase III primary results: Epcoritamab with rituximab + lenalidomide (R2) vs R2 alone for R/R FL

Lymphoma Hub

Play Episode Listen Later Dec 11, 2025 6:37

During the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, December 6–9, 2025, Orlando, US, the Lymphoma Hub was pleased to speak with Lorenzo Falchi, Memorial Sloan Kettering Cancer Center, New York, US. We asked, What do the primary results from the EPCORE FL-1 trial tell us about epcoritamab + R2 vs R2 alone in patients with R/R FL?In this interview, Falchi highlights that epcoritamab and R2 do not have overlapping toxicities and that the combination may offer synergistic activity. He concludes that epcoritamab sets a new benchmark as a readily available treatment for patients with R/R FL.This educational resource is independently supported by AbbVie. All content was developed by SES in collaboration with an expert steering committee. Funders were allowed no influence on the content of this resource. Hosted on Acast. See acast.com/privacy for more information.

E194: The Digital Twin Revolution: Reimagining Clinical Trials

AI For Pharma Growth

Play Episode Listen Later Dec 3, 2025 30:05

In this episode, we explore one of the most disruptive advancements currently reshaping the pharmaceutical and biotech industry: AI-powered digital twins for clinical trials.Our guest, Aaron Smith, PhD — Founder and Head of Machine Learning at Unlearn.AI — breaks down how digital twins and generative AI are transforming drug development by enabling faster, smaller, and more efficient clinical trials.Unlearn.AI builds digital twin models: virtual patient replicas created using clinical trial data, registry data, and real-world data. These digital twins allow researchers to simulate how a patient's disease will progress under standard care, long before a clinical trial is completed. When combined with randomized controlled trials, this technology reduces data variability, increases trial power, and can dramatically shrink sample sizes and timelines.Some pharma companies are already estimating a six-month reduction in time-to-market, with millions saved in development and operational costs.What You'll LearnWhat digital twins are and how they simulate patient outcomes using real-world clinical data.How AI is enabling smaller Phase III trials without sacrificing statistical power.Why digital twins are helping pharma identify which patients are most likely to benefit from specific treatments.The biggest barriers to adopting AI in drug development (hint: it's not the regulators — it's culture).Trends shaping the future of clinical trials and precision medicine over the next 10 years.Digital twins reduce variability and increase power by predicting how each patient would progress under standard care.The approach (called Prognostic Covariate Adjustment / ProCova) can be used in traditional randomized controlled trials.Pharma partners expect significant reductions in trial timelines and costs.AI enables precision trial design by identifying the most prognostic patient features and outcome measures.About the PodcastAI for Pharma Growth is a podcast focused on exploring how artificial intelligence can revolutionise healthcare by addressing disparities and creating equitable systems. Join us as we unpack groundbreaking technologies, real-world applications, and expert insights to inspire a healthier, more equitable future.This show brings together leading experts and changemakers to demystify AI and show how it's being used to transform healthcare. Whether you're in the medical field, technology sector, or just curious about AI's role in social good, this podcast offers valuable insights.AI For Pharma Growth is the podcast from pioneering Pharma Artificial Intelligence entrepreneur Dr. Andree Bates created to help organisations understand how the use of AI based technologies can easily save them time and grow their brands and business. This show blends deep experience in the sector with demystifying AI for all pharma people, from start up biotech right through to Big Pharma. In this podcast Dr Andree will teach you the tried and true secrets to building a pharma company using AI that anyone can use, at any budget. As the author of many peer-reviewed journals and having addressed over 500 industry conferences across the globe, Dr Andree Bates uses her obsession with all things AI and futuretech to help you to navigate through the, sometimes confusing but, magical world of AI powered tools to grow pharma businesses. This podcast features many experts who have developed powerful AI powered tools that are the secret behind some time saving and supercharged revenue generating business results. Those who share their stories and expertise show how AI can be applied to sales, marketing, production, social media, psychology, customer insights and so...

head ai digital revolution machine learning reimagining big pharma pharma clinical trials unlearn digital twins aaron smith phase iii

Immutep – 2025 Progress and Outlook

Latest Interviews - Finance News Network

Play Episode Listen Later Dec 3, 2025

03 Dec 2025 - Phase III momentum, clinical updates and what's ahead

progress outlook phase iii

Breast Cancer — Microlearning Activity 2 with Dr Priyanka Sharma: 2025 ESMO Annual Meeting Updates

Research To Practice | Oncology Videos

Play Episode Listen Later Dec 2, 2025 14:47

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

Ep. 338 - Semaglutide's Alzheimer's Miss. Plus: Vaccine Policy, Cell, Gene Therapy Funding

BioCentury This Week

Play Episode Listen Later Dec 2, 2025 29:46 Transcription Available

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

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Scrip's Five Must-Know Things - Dec. 1, 2025

Play Episode Listen Later Dec 1, 2025 14:59

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

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New Nasal Vaccines, Korro Stock Dips, J&J and Merck Acquisitions, and Dyno GATC

Touching Base

Play Episode Listen Later Nov 20, 2025 41:50

Nasal vaccines show new promise for human papillomavirus (HPV) to address cervical cancer and whooping cough. In business news, Korro's stock craters 81% as AATD interim Phase I/II results miss expectations. Additionally, Johnson & Johnson acquires Halda to expand their cancer pipeline while Merck acquires Cidara to boost antivirals. Lastly, the inaugural Genetic Agency Technology Conference (GATC) hosted by Dyno Therapeutics brought together a diverse group of researchers, entrepreneurs, and patient advocates to discuss the mission of genetic agency, or an individual's ability to take action at the genetic level to live a healthier life. Join GEN editors Corinna Singleman, PhD, Alex Philippidis, Fay Lin, PhD, 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: Cervical Cancer May Be Treatable with Intranasal Nanogel Vaccine GEN, November 15, 2025Novel Nasal Spray Vaccine for Pertussis Shows Promise By Corinna Singleman, PhD, GEN, November 12, 2025 StockWatch: Korro Craters 81% on Data; Patient Death Sours Analysts on Intellia By Alex Philippidis, GENEdge, November 16, 2025J&J Expands Cancer Pipeline with $3B Halda Acquisition By Alex Philippidis, GENEdge, November 18, 2025Merck to Acquire Cidara for $9.2B, Bolstering Antiviral Pipeline By Alex Philippidis, GEN, November 15, 2025 AI Meets Genetic Agency at Dyno GATC 2025By Fay Lin, PhD, GENEdge, November 14, 2025Genetic Agency on Display at GATC 2025By Kevin Davies, PhD, and Fay Lin, PhD, GEN, November 13, 2025Dyno GATC Announces AI Agents, Muscle Capsid, and Manufacturing PartnerBy Fay Lin, PhD, GEN Edge, November 11, 2025 Touching 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.

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Morning Briefing: Apollo Rising: Collective Mining and the Tungsten Opportunity

Mining Stock Daily

Play Episode Listen Later Nov 10, 2025 10:14

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.

Pfizer and Novo Battle Over Metsera, Tidmarsh Fights FDA Exit, UniQure and Sarepta Face Setbacks

Play Episode Listen Later Nov 5, 2025 26:26

Many of the top stories of 2025 are currently being written. We're on the edge of our keyboards, watching and waiting as Pfizer and Novo Nordisk duke it out over the right to acquire glittery obesity startup Metsera. In the latest development, Pfizer raised its original bid of around $7.27 billion to about $8.1 billion on Monday—only to be usurped again by the indefatigable Novo, which upped its own bid to a cool $10 billion. Meanwhile, the unprecedented drama in the uppermost ranks of the FDA—another top story of 2025—continues as CDER Director George Tidmarsh exits the agency. Tidmarsh reportedly resigned Sunday after being placed on administrative leave amid an investigation into his “personal conduct” at the agency. On Monday, however, Tidmarsh told Endpoints News that he was “second-guessing” his decision. Speaking of the FDA, the regulator appears to have done its own 180—on uniQure's investigational gene therapy for Huntington's disease, three-year data from which sent the biotech's stock into the stratosphere just five weeks ago. Despite previous agreements on protocols and statistical analyses, the agency “no longer agrees” that Phase I/II data for AMT-130 are adequate to provide primary evidence for the application, uniQure said, throwing the timeline for the BLA into question. Another gene therapy player, Sarepta Therapeutics, took a hit this week, as two of its Duchenne muscular dystrophy drugs, Vyondys 53 and Amondys 45, failed a confirmatory trial. Sarepta still plans to file for full approval of the two exon-skipping therapies, however, based on what it called “encouraging trends” in efficacy. Finally, on the genetic medicine front, CBER director Vinay Prasad teased an upcoming paper that will detail the regulator's thinking and a new approach to gene editing approvals. On top of all that, Q3 earnings continue to roll in, with Pfizer, Eli Lilly, Vertex, Bristol Myers Squibb, AbbVie, and more reporting results. One more thing: Have you ever wanted to know more about the inner workings of the Biogen-Eisai Alzheimer's partnership? Check out this profile on BioSpace 40 under 40 honoree Neena Bitritto-Garg, Eisai alum and current CEO of Ensho Therapeutics.

Scrip's Five Must-Know Things - Nov. 4, 2025

Play Episode Listen Later Nov 4, 2025 13:00

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

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Novartis' Big Buy, Q3 Earnings, Regeneron's Dropped Cell Therapy, More

Play Episode Listen Later Oct 29, 2025 26:36

Novartis started the week early with a Sunday afternoon announcement of the acquisition of neuromuscular drug developer Avidity Biosciences for $12B. That's the second biggest buy of the year after Johnson & Johnson's January acquisition of Intra-Cellular. The Avidity buy could read through positively to Dyne Therapeutics, as both are aiming to treat neuromuscular ailments with RNA-targeting therapies. Dyne shares have nearly doubled over the past month, jumping approximately 40% after Novartis' news dropped. The Avidity deal is the latest in an uptick on the pharma M&A front. Also this week, Eli Lilly doubled down on gene therapy with a pick up of Adverum Biotechnologies and its lead program for wet age-related macular degeneration. And Roche, which last month acquired 89bio in a $3.5 billion deal centered on a MASH candidate, said in its third-quarter earnings call on Thursday that more deals could be in the future. Finally, beyond the big guys, Leerink Partners predicts which small- to mid-cap firms might also be on the hunt for new pipeline goodies. Following the dealmaking news, Novartis held its earning call on Tuesday. CEO Vas Narasimhan downplayed the deals Pfizer, AstraZeneca and Amgen have made with the White House, saying they don't address the root of the drug pricing problem President Donald Trump hopes to solve. On other earnings calls, BioMarin announced plans to divest the hemophilia gene therapy Roctavian. Regeneron faced further questions about Eylea and issues with the Catalent plant that's been tripping up its regulatory applications. But the company didn't address last week's news that it was dropping a CAR T asset picked up from 2seventy bio. These are but two of the latest examples of underperforming assets in the cell and gene therapy space. BridgeBio had positive news for patients with limb-girdle muscular dystrophy this week after acing a Phase III trial for an investigational substrate supplementation therapy. Analysts predict the asset could be before the FDA later this year or early next.  Finally, with the U.S. government shutdown going on a month, BioSpace takes a look at how the FDA is operating.

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Scrip's Five Must-Know Things - Oct. 27, 2025

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Play Episode Listen Later Oct 27, 2025 17:13

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

50. Phase IV of The Change Leader's Roadmap- Design the Desired State

Ask Dr. Change

Play Episode Listen Later Oct 20, 2025 10:05

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.

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Ep138: Amyloid busters- the benefit and the burden

Pomegranate Health

Play Episode Listen Later Oct 8, 2025 56:04

Australia has just approved a second amyloid-targeting therapy for patients with incipient Alzheimer's dementia. Lecanemab (Leqembi) now joins donanemab (Kisunla) on the Australian Registry of Therapeutic Goods but the impact of both has been modest in Phase III trials to date. After 18 months of therapy they delay progression of disease, as quantified on neurocognitive tests, by around 5 months on average. For some, the prolonged independence and dignity will justify the $60,000 to $80,000 a year price tag for the drugs. But for the Pharmaceutical Benefits Advisory Committee “the high burden of [donanemab] treatment on both patients and the health system, combined with the risks and modest clinical impact, makes the drug unsuitable for PBS subsidy”. This burden includes specialist consults, gene screening, multiple MRI and PET brain scans, and delivery of monthly or fortnightly infusions, adding up to another $20,000 in costs. Even before considering these logistical requirements, Australian memory clinics don't have anywhere near the capacity to address the 245,000 new cases of early dementia or mild cognitive impairment every year. Advocates see these disease-modifying therapies as a turning point for dementia research and argue for further investment in the systems infrastructure needed to roll them out. Sceptics argue that the available evidence instead questions the importance of amyloidosis in the Alzheimer's disease cascade.GuestsProfessor Michael Woodward AM FRACP FANZSGM FAAG FAWMA (Austin Health, Melbourne; University of Melbourne) Dr Chrysanth Pulle FRACP (Prince Charles Hospital, Brisbane) Chapters 13:16 Time Saved16:18 Costs of treatment 26:44 IMJ paper on resourcing 39:10 Scepticism and stagingProductionProduced by Mic Cavazzini DPhil. Music licenced from Epidemic Sound ‘RGBA' and ‘Pulse Voyage' by Chill Cole, ‘A Forest Melody' by Tellsonic, ‘Axon Terminal' by Out to the World, ‘Organic Textures 2' by Johannes Bornlof and ‘Fugent' by Lupus Nocte. Image courtesy of Wikimedia Commons and University of Pittsburgh. Editorial feedback kindly provided by physicians of the podcast editorial group Ronaldo Piovezan, Aidan Tan, Hugh Murray, Joseph Lee, Rahul Barmanray, Simeon Wong and Sebastian Lambooy. Thanks also to Profs Bruce Campbell, Mike Parsons and Amy Brodtmann and registrars Jamie Bellinge and Karan Singh for additional insights into research methods. Please visit the Pomegranate Health web page for a transcript and supporting references. Login to MyCPD to record listening and reading as a prefilled learning activity. Subscribe to new episode email alerts or search for ‘Pomegranate Health' in Apple Podcasts, Spotify,Castbox or any podcasting app.

49. Phase III of The Change Leader's Roadmap: Assess the Situation to Determine Design Requirements

Ask Dr. Change

Play Episode Listen Later Oct 6, 2025 10:46

Phase III of The Change Leader's Roadmap: Assess the Situation to Determine Design Requirements enables the upcoming Design work for your project to be handled in the most informative and aligned way possible. In it, you are assessing relevant (four quadrant) aspects of the organization and its culture for what already support your desired future state, what blocks it and what might need to be added brand new. It also considers best practices from other organizations who have made this type of change, and importantly, requests input from your stakeholders and end-users. One unique addition to this phase is the determination of the leaders' boundary conditions for the solution--what are the “givens” or lines in the sand the design scenario must respect. All this helps to align the people doing the design to know what the solution needs to meet to be successful, your Design Requirements.Hosted by Ausha. See ausha.co/privacy-policy for more information.

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Sacred Jedi Texts - The High Republic: Phase III + The Overall Story

Source Pages: Obi-Wan Kenobi

Play Episode Listen Later Sep 23, 2025 72:47 Transcription Available

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

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CURE SYNGAP1 joins biotech investors in CAMP4 Tx's $100M Raise for ASO Program $CAMP #S10e182

SynGAP10 weekly 10 minute updates on SYNGAP1 (video)

Play Episode Listen Later Sep 10, 2025 9:57

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

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Scrip's Five Must-Know Things - September 5, 2025

Play Episode Listen Later Sep 8, 2025 15:40

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

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Pharma and Biotech Daily: Kennedy Faces Criticism, FDA Rejections, and Industry Deals

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Play Episode Listen Later Sep 8, 2025 0:56

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. During a Senate hearing, Robert F. Kennedy Jr. faced criticism for spreading anti-vaccine views and breaking promises regarding vaccines. The FDA released rejection letters for companies like Lykos Therapeutics, Stealth Biotherapeutics, and Regeneron. Ousted CDC director Susan Monarez accused Kennedy of firing her for not supporting Covid-19 recommendations from an advisory panel with "antivaccine rhetoric." Hengrui Pharmaceuticals signed lucrative deals with Merck and GSK, while the FDA promised to release future Complete Response Letters promptly. In other news, Sanofi's anti-OX40 blocker failed in a Phase III study, Gilead partnered with the US State Department for low-income countries, and AC Immune announced workforce cuts. Kennedy was accused of lying during the hearing, and the FDA released a new rare disease approval framework.

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261: The High Republic Adventures: Phase III comic series!!

Rogue Rebels Podcast

Play Episode Listen Later Sep 5, 2025 43:01

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

Star Wars The High Republic Adventures Phase III Dispatches from the Occlusion Zone Review CXXXXXIV

Star Wars Alliance

Play Episode Listen Later Sep 4, 2025 43:48 Transcription Available

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Star Wars The High Republic Adventures Phase III Echoes of Fear Review CXXXXXV

Star Wars Alliance

Play Episode Listen Later Sep 4, 2025 29:32 Transcription Available

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Star Wars Alliance The High Republic Adventures Phase III Dispatches from the Occlusion Zone Review CXXXXXIV

Geek Ultimate Alliance

Play Episode Listen Later Sep 4, 2025 43:48 Transcription Available

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Star Wars Alliance The High Republic Adventures Phase III Echoes of Fear Review CXXXXXV

Geek Ultimate Alliance

Play Episode Listen Later Sep 4, 2025 29:32 Transcription Available

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Star Wars The High Republic Adventures Phase III Vol. 4 Review CXXXXXIII

Star Wars Alliance

Play Episode Listen Later Aug 28, 2025 85:16 Transcription Available

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Star Wars Alliance The High Republic Adventures Phase III Vol. 4 Review CXXXXXIII

Geek Ultimate Alliance

Play Episode Listen Later Aug 28, 2025 85:16 Transcription Available

star wars alliance phase iii high republic adventures

Pharma and Biotech Daily: Cutting Through the Noise in the Ever-Evolving Industry

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Play Episode Listen Later Aug 28, 2025 1:25

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Regeneron's experimental drug for myasthenia gravis, cemdisiran, has shown promising results in a Phase III trial and the company is aiming to file for FDA approval by 2026. Pharmaceutical spending in China has reached record levels, with more than $48 billion spent in the first half of the year. Former FDA Commissioner Scott Gottlieb has raised concerns about the US losing its edge in biopharma innovation to China. Additionally, a drug program for a rare neurodegenerative disorder has been discontinued by Amylyx, while pharma companies are increasingly focusing on scientific research and partnerships. Lilly's obesity pill is heading to the FDA for approval, AbbVie is investing in psychedelics, and HHS has announced more changes in the industry. The pharmaceutical landscape is rapidly evolving with new developments and challenges arising.Pharma CEOs are facing increasing pressure amid political turmoil and public distrust over drug pricing. The industry spent over $48 billion in China in the first half of the year, with expectations of increased deal volume in the future. Legal experts are working to determine ownership rights of AI creations in biotech. Obesity treatments are being compared for effectiveness, while biotech companies are making strides in AI-driven manufacturing. Job opportunities in gene therapy and biostatistics are available.

Lilly's Obesity Pill Heads to the FDA, AbbVie Bets on Psychedelics, HHS Unveils More Change

Play Episode Listen Later Aug 27, 2025 22:40

Eli Lilly posted data Tuesday from a second Phase III trial of its oral weight loss therapy orforglipron, providing the company with all it needs to head to the FDA with a new drug application. For more in-depth discussion on the oral weight-loss space, check out a special episode of The Weekly. And stay tuned to BioSpace for more unique coverage of this market as we learn which investigational assets will make it across the regulatory finish line and which will join the weight-loss wasteland. On the business side of biopharma, AbbVie turned back to neuropsychiatric therapies this week, acquiring partner Gilgamesh Pharmaceuticals' lead depression candidate for $1.2 billion. The deal is a display of resilience for AbbVie in the neuropsychiatric space as well, after the stunning failure last November of schizophrenia asset emraclidine—picked up in its nearly $9 billion acquisition of Cerevel Therapeutics. And is the cooler late summer weather thawing the IPO market? Neuropsych-focused LB Pharma revealed in an SEC filing on Friday that it plans to take the plunge, ending a six-month stalemate in biotech IPOs. Finally, the Department of Health and Human Services (HHS) has been busy this past week. On Monday, the CDC named Retsef Levi—a known vaccine critic—to head the agency's COVID-19 immunization working group, just as reports surfaced that the Trump administration could be “within months” of banning the COVID-19 vaccine in the U.S. Meanwhile, the FDA issued new draft guidance for cancer drug developers that prioritizes the use of survival data, and the agency began publishing drug-related adverse event reports daily. HHS itself has also been the subject of recent headlines, announcing that it will no longer recognize employee unions, and last week, hundreds of HHS staffers penned an open letter calling on Secretary Kennedy to tone down what they called “dangerous and deceitful statements” that have fostered distrust against federal health workers, exposing them to physical harm. This followed the Aug. 8 shooting at CDC headquarters in Atlanta. Finally, multinational pharmaceutical companies spent more than $48 billion on partnerships with China in the first half of 2025 alone, according to a new report from IQVIA—more than in all of 2024.

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Oral Weight-Loss Race Heats Up as New Data From Lilly, Viking Reset Expectations

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Play Episode Listen Later Aug 26, 2025 17:54

Oral therapies are projected to account for 25% of the anti-obesity medication market by 2030—but first returns have largely disappointed. This month, shares of both Eli Lilly and Viking Therapeutics took a hit as investors reacted negatively to highly anticipated Phase III and Phase II results for their respective candidates.While the 9.1% placebo-adjusted weight loss generated by Lilly's orforglipron over 72 weeks was an efficacy miss by most analyst accounts, tolerability tripped up oral VK2735's otherwise best-case efficacy scenario—10.9% weight loss after just 13 weeks. These murky results have left observers wondering, just how game-changing these pills will be and which ones will be most effective?In such a hot space, Lilly's and Viking's results—which follow Novo Nordisk's new drug application for an oral form of Wegovy in May—are only the tip of the iceberg. Stay tuned to BioSpace for further in-depth coverage of the space as we learn which investigational assets will make it across the regulatory finish line and which will join the weight-loss wasteland.

The Capital Caravan With Kdeja (PHASE III)

Capital FM

Play Episode Listen Later Aug 24, 2025 102:19

I remember hearing these amapiano tracks back in 2020 - 2021 tough times but the music kept us going and still is. I'll call this one "night pulse" definitely amapiano that never sleeps.

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Pharma and Biotech Daily: Your Quick Update on Industry News and Developments

Play Episode Listen Later Aug 19, 2025 1:03

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Novo Nordisk's drug Wegovy has received approval for label expansion, potentially boosting its market performance. Tonix has also secured approval for a new fibromyalgia medication. Additionally, Novo has teamed up with GoodRx to provide lower prices for its drugs. Merck KGaA has made a significant investment of $2 billion in RNA-targeting technology through a collaboration with Skyhawk Therapeutics. On the sterilization front, Fedegari now offers tailored solutions for the pharmaceutical sector. In other updates, Pfizer's sickle cell therapy did not succeed in Phase III trials, while gene therapy company Kriya has raised an impressive $313 million. Kennedy has shown support for mRNA vaccines in cancer treatment. Bausch Health has closed a facility, Precigen has received FDA approval for an immunotherapy drug, and Eli Lilly has partnered with Superluminal in the obesity pipeline. Stay tuned for more industry news and developments.

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Scrip's Five Must-Know Things - August 15, 2025

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Play Episode Listen Later Aug 18, 2025 14:48

Audio roundup of selected biopharma industry content from Scrip over the business week ended August 15, 2025. In this episode: a look at the likely top drugs in 2030; Lilly CEO advocates US/Europe pricing rebalance; Insmed sees $5bn-plus market for Brinsupri; royalty deals go mainstream; Phase III win sets stage for Epkinly label expansion. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-365OXHOS2RFXHPEDQIURY6LFDI/ 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

Breaking Barriers

Med Tech Gurus

Play Episode Listen Later Aug 13, 2025 31:08

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.

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Shielding the Heart ❤️

Dr. Baliga's Internal Medicine Podcasts

Play Episode Listen Later Aug 13, 2025 4:07

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Ep. 314 - Prasad, Lilly Obesity, Acadia & Biosecure

BioCentury This Week

Play Episode Listen Later Aug 12, 2025 39:22 Transcription Available

Phase III data from Lilly's orforglipron in obesity fell short of investor expectations, but they appear to be enough to obtain approval and wide use. On the latest BioCentury This Week podcast, BioCentury's analysts discuss why the first-in-class oral small molecule GLP-1R agonist's clean safety profile and clear manufacturing advantage over oral peptides give the product a leg-up in the market.They then discuss Vinay Prasad's return to FDA after a brief hiatus, the revamped strategy of 32-year-old San Diego biotech Acadia Pharmaceuticals, and an attempt in the Senate to revive the Biosecure Act targeting China biotechs.Finally, the analysts preview this year's Back to School package, which reimagines FDA. At a time of unprecedented change in government agencies, BioCentury's 33rd Back to School asks what FDA could look like if it were reorganized from the ground up to create the regulator patients deserve and industry needs. View full story: https://www.biocentury.com/article/656727#orforglipron #CBER #VinayPrasad #AcadiaPharmaceuticals00:00 - Introduction00:49 - Prasad07:09 - Back to School12:29 - Lilly Obesity21:58 - Acadia's Comeback28:50 - Biosecure ActTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

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Pharma and Biotech Update: Roche drops obesity asset, Novartis strikes deal, AstraZeneca's Phase III win, and more!