American pharmacist, Union Army officer, businessman, philanthropist
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A Washington Post investigation found that Eli Lilly and Novo Nordisk paid more than $270 million to physicians and other prescribers between 2018 and 2025. On The Gist Healthcare Podcast, Washington Post data reporter Lydia Sidhom discusses how the companies' outreach has expanded across the medical community and what the federal data can and cannot tell us about those payments. Further reading: The largely hidden force helping drive America's craze for weight-loss drugs (Washington Post) Hosted on Acast. See acast.com/privacy for more information.
Raul Shah is very bullish on the future of GLP-1s due to accelerating demand trends generating a "mania" effect in the market. He points to the superiority Eli Lilly (LLY) has demonstrated through earnings and weighs if Novo (NVO) has a chance to catch up. Raul maintains that Hims & Hers (HIMS) is an unsung winner in the space. Tom White offers an example options trade for Eli Lilly. ======== Schwab Network ========Empowering every investor and trader, every market day.Subscribe to the Market Minute newsletter - https://schwabnetwork.com/subscribeDownload the iOS app - https://apps.apple.com/us/app/schwab-network/id1460719185Download the Amazon Fire Tv App - https://www.amazon.com/schwab-Network/dp/B08JJRQG9T/Watch on Sling - https://watch.sling.com/1/channel/bb1b75050268416e82a557ff6387bff3/browseWatch on Vizio - https://www.vizio.com/en/watchfreeplus/catalog/live-tv-channels/3123029569/schwab-networkFollow us on X – https://twitter.com/schwabnetworkFollow us on Facebook – https://www.facebook.com/schwabnetworkFollow us on LinkedIn - https://www.linkedin.com/company/schwab-network/About Schwab Network - About | Schwab Network
In this episode of Psychiatric Pharmacy Pulse, host Megan Maroney, PharmD, BCPP, FAAPP, speaks with Danielle Stutzman, PharmD, BCPP, clinical assistant professor at the University of Colorado Skaggs School of Pharmacy and assistant adjunct professor at the Child and Adolescent Mental Health Division of the Department of Psychiatry at the University of Colorado School of Medicine, and member of the American Association of Psychiatric Pharmacists Board of Directors, about where centanafadine (Simtriyo; Otsuka Pharmaceutical) fits into attention-deficit/hyperactivity disorder (ADHD) pharmacotherapy. Centanafadine received FDA approval in July 2026 as a norepinephrine-dopamine-serotonin reuptake inhibitor (NDSRI) for ADHD in both pediatric and adult patients, with DEA scheduling still pending. Maroney and Stutzman note its mechanism is not entirely novel, drawing comparisons to tricyclic antidepressants, atomoxetine (Eli Lilly), and viloxazine (Qelbree; Supernus Pharmaceuticals, Inc). A pooled meta-analysis of 4 phase 3 trials plus a phase 2b crossover study found a Hedges' g effect size of about 0.37 for overall symptom severity versus placebo, a modest result that falls short of typical stimulant effect sizes of 0.8 to 1.0, though executive functioning outcomes on caregiver-rated scales appeared more promising.Safety data showed a nonsignificant increase in adverse effects (AEs) overall (pooled risk ratio, 1.29), with appetite suppression, nausea, and rash among the most common issues. Rash was the leading cause of study discontinuation in the youngest age group. Indirect comparisons suggested centanafadine may carry a lower risk of insomnia than methylphenidate and fewer AEs than atomoxetine and viloxazine, though lisdexamfetamine (Vyvanse; Takeda Pharmaceuticals) remained more effective. A boxed warning for suicidal ideation applies, which is consistent with other ADHD medications.Practical advantages discussed include a lack of reliance on cytochrome P450 metabolism, lower drug interaction risk than atomoxetine or viloxazine, and capsules that can be opened and sprinkled on applesauce, yogurt, or orange juice. Centanafadine did increase caffeine exposure roughly 2-fold, warranting patient counseling. Both Maroney and Stutzman positioned the drug as a potential second-line option for patients who are not candidates for stimulants or who have not tolerated or responded to first-line therapies.To provide feedback or suggest topics of discussion for Psychiatric Pharmacy Pulse, please reach out to Gillian McGovern, Editor (gmcgovern@pharmacytimes.com).REFERENCES1. Mattingly GW, Turkoglu O, Chang D, Ward C, Skubiak T, Zhang Z, Cutler AJ. 52-week open-label safety and tolerability study of centanafadine sustained release in adults with attention-deficit/hyperactivity disorder. J Clin Psychopharmacol. 2025;45(5):454-462. doi:10.1097/JCP.00000000000020202. Otsuka Pharmaceutical Development & Commercialization, Inc; Otsuka Pharmaceutical Co, Ltd. Otsuka receives FDA approval for first-in-class SIMTRIYO (centanafadine) for the treatment of attention-deficit/hyperactivity disorder. Otsuka US. July 24, 2026. Accessed September 16, 2026. https://www.otsuka-us.com/otsuka-shares-fda-review-update-for-centanafadine3. Adler LA, Adams J, Madera-McDonough J, et al. Efficacy, safety, and tolerability of centanafadine sustained-release tablets in adults with attention-deficit/hyperactivity disorder: results of 2 phase 3, randomized, double-blind, multicenter, placebo-controlled trials. J Clin Psychopharmacol. 2022;42(5):429-439. doi:10.1097/JCP.00000000000015754. Muneer MA, Naveed M, Amjad M, et al. Efficacy and safety of centanafadine in attention-deficit/hyperactivity disorder: a systematic review and meta-analysis of randomized controlled trials. Psychopharmacol Bull. 2026;56(3):47-65. https://pubmed.ncbi.nlm.nih.gov/42267239/5. Schein J, Cloutier M, Gauthier-Loiselle M, et al. Assessment of centanafadine in adults with attention-deficit/hyperactivity disorder: a matching-adjusted indirect comparison vs lisdexamfetamine dimesylate, atomoxetine hydrochloride, and viloxazine extended-release. J Manag Care Spec Pharm. 2024;30(6):528-540. doi:10.18553/jmcp.2024.30.6.5286. Stein MA. Editorial: centanafadine for adolescents with attention-deficit/hyperactivity disorder: is a broader mechanism of action better? J Am Acad Child Adolesc Psychiatry. 2026;65(6):764-765. doi:10.1016/j.jaac.2025.10.0207. Ward CL, Childress AC, Jin N, et al. Centanafadine for attention-deficit/hyperactivity disorder in adolescents: a randomized clinical trial. J Am Acad Child Adolesc Psychiatry. 2026;65(6):805-817. doi:10.1016/j.jaac.2025.06.023
How do you take a brand that inspires extraordinary loyalty on the inside and make the rest of the world understand why it matters?That's the challenge Ethan Braden took on when he became Vice President and Chief Marketing and Communications Officer at Texas A&M University three years ago.Texas A&M was already one of the largest and most influential universities in the country, with generations of fiercely loyal Aggies. But outside Texas, the story was very different. Research showed that 40% of Americans had either never heard of Texas A&M or had no association with it, and when asked what came to mind, the most common answers included football, sports and, remarkably, “nothing.” And Ethan saw an enormous brand opportunity.Tune in as Jim talks with Ethan about the playbook he has used to help transform the reputation of Texas A&M, building on lessons from more than a decade at Eli Lilly and five years leading marketing at Purdue University.Ethan shares why marketing should be an enterprise value creator rather than a communications function, how Texas A&M turned YouTube into a strategic storytelling engine generating more than 150 million views, and why unconventional partnerships with NASCAR, IndyCar, Dude Perfect, Buc-ee's and others are helping introduce the university to entirely new audiences.Plus, Ethan reflects on his unlikely journey from childhood gymnast to college football player to marketer, the career opportunity he didn't get that ultimately led him to Texas A&M, and why becoming a husband and father fundamentally changed his definition of ambition and success.—Meet The CMO Podcast On the RoadThe CMO Podcast will be on the road throughout early 2027, capturing conversations with the leaders shaping the future of marketing, leadership, and business. If you'll be attending one of these events, we'd love to connect. Let us know!Advertising Week New York | October 6BLINK Cincinnati | October 8ANA Masters of Marketing | October 20–22CES | January 5-7—Interested in partnering with The CMO Podcast?!Looking ahead to the rest of 2026 and into 2027, we're partnering with brands to create executive content platforms that extend far beyond a single event. From pop-up podcast studios and live recordings to executive roundtables, keynote conversations, and bespoke thought leadership programs, we work with partners to build meaningful experiences that connect with senior marketing leaders.Whether you'd like to partner with us at one of the industry's biggest marketing events or create a custom experience designed specifically for your brand, we'd love to explore what's possible. Reach out to learn how we can build something together.Email us at podcasts@vyve.co—Produced by vYveThe CMO Podcast is proudly produced by vYve Production, a full-service production and content studio specializing in podcasts, executive storytelling, branded content, and live experiences. vYve is a community of ambitious leaders dedicated to unlocking what's next in business and in life. Through executive coaching, transformative experiences, strategic content, and communities like The CMO Podcast, vYve helps entrepreneurs, corporate leaders, and teams grow their businesses, strengthen their leadership, and build meaningful connections that last.Learn more about vYve and The CMO Podcast community at www.vyve.co.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
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 significant strides and strategic maneuvers reshaping the landscape of healthcare and drug development. Kicking things off, GlaxoSmithKline (GSK) has made headlines with its acquisition of Chimagen Biosciences' trispecific T cell engager technology, targeting multiple myeloma. This move, valued at up to $750 million, highlights GSK's strategic focus on expanding its oncology pipeline through cutting-edge immunotherapeutic approaches. Trispecific T cell engagers are an emerging class of biologics that bind to three different targets simultaneously, effectively arming the immune system to recognize and destroy cancer cells more efficiently. This acquisition not only strengthens GSK's position in the competitive oncology market but also addresses a significant need for more effective multiple myeloma treatments. In parallel, Curium has achieved a notable milestone with the FDA approval of Bexlutry, a radioligand therapy for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This therapy utilizes radioactive isotopes attached to molecules that specifically target cancer cells, delivering radiation directly while minimizing harm to healthy tissue. The approval of Bexlutry is a crucial development in oncologic care, expanding treatment options for patients dealing with complex and heterogeneous tumors. It underscores the growing role of targeted radiotherapies in providing precision medicine solutions. On the financial front, Electra Therapeutics is gearing up for an initial public offering (IPO) to raise $325 million. The proceeds are intended to advance its late-stage clinical trials for severe hemophagocytic lymphohistiocytosis (SHLH), a rare autoimmune condition. This move reflects a broader trend among biotech companies turning to public markets to support niche therapeutic areas with high unmet needs and potential orphan drug status benefits. Turning to clinical advancements, Corbus Pharmaceuticals has reported encouraging Phase 1b data for CRB-913, which employs CB1 inverse agonism in combating obesity. By modulating endocannabinoid activity linked to appetite and energy balance, this approach offers a promising direction for managing metabolic disorders. Simultaneously, CSL Seqirus has shared Phase 3 results showcasing the superior efficacy of its MF59-adjuvanted cell-based quadrivalent influenza vaccine in older adults, highlighting ongoing innovations in vaccine technologies tailored for vulnerable populations. The FDA's regulatory landscape is also evolving with the launch of Operation Trialblazer. This initiative seeks to streamline early-phase U.S. clinical trials through expedited IND application processes, facilitating faster transitions from research to clinical applications and fostering innovation by reducing bureaucratic hurdles. Meanwhile, the FDA is preparing for potential psychedelic medicine approvals, ensuring robust oversight frameworks are in place as these therapies near market availability. Yet, as always in drug development, challenges persist. Novo Nordisk's decision to terminate its GLP-1 obesity drug partnership with Ascendis following unsatisfactory results exemplifies the inherent risks even promising preclinical data can present. Similarly, setbacks faced by Axoltis Pharma and Eli Lilly with their neurological and metabolic candidates reinforce the complexities of translating scientific hypotheses into viable therapies. Sanofi has taken significant strategic steps as well by divesting 20 older medicines and three manufacturing sites to Cheplapharm. This decision aligns with Sanofi's focus on innovation under CEO Paul Hudson's leadership and allows the company to reallocate resources towards groundbreaking therapies. In diagnostic advances, the FDA's approval of Telix's Pixclara marks a breakthrough for brain cancer imaging. Being the first FET-PET imaging drug approved for gliomas, Pixclara could significantly enhance diagnostic accuracy and treatment planning for these challenging tumors. These developments underscore a transformative period where scientific innovation is paired with strategic regulatory adjustments to navigate complex market dynamics. As companies continue adapting to these changes, their ability to innovate while addressing safety and efficacy concerns will be critical in advancing therapeutic frontiers and improving patient outcomes across diverse medical landscapes. As always, we'll be here at Pharma Daily to keep you informed on these pivotal changes shaping our industry's future. Thank you for tuning into today's episode of Pharma Daily. Keep innovating and stay informed!Support the show
Berenberg upgraded Eli Lilly (LLY) to buy from hold and boosted its price target to $1,400 from $1,220 as the healthcare giant extends its lead over Novo (NVO). Rick Ducat stacks the stock against its peers and shows how bulls can regain momentum in the stock following a slowdown in recent sessions. He turns to an example options trade for Eli Lilly. ======== Schwab Network ========Empowering every investor and trader, every market day.Options involve risks and are not suitable for all investors. Before trading, read the Options Disclosure Document. http://bit.ly/2v9tH6DSubscribe to the Market Minute newsletter - https://schwabnetwork.com/subscribeDownload the iOS app - https://apps.apple.com/us/app/schwab-network/id1460719185Download the Amazon Fire Tv App - https://www.amazon.com/TD-Ameritrade-Network/dp/B07KRD76C7Watch on Sling - https://watch.sling.com/1/asset/191928615bd8d47686f94682aefaa007/watchWatch on Vizio - https://www.vizio.com/en/watchfreeplus-exploreWatch on DistroTV - https://www.distro.tv/live/schwab-network/Follow us on X – https://twitter.com/schwabnetworkFollow us on Facebook – https://www.facebook.com/schwabnetworkFollow us on LinkedIn - https://www.linkedin.com/company/schwab-network/About Schwab Network - https://schwabnetwork.com/about
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today's episode delves into some of the latest breakthroughs, regulatory updates, and strategic maneuvers reshaping the landscape of drug development and patient care. Starting with remarkable advancements in drug approvals, Scholar Rock's Isembldy (apitegromab), a monoclonal antibody designed to inhibit myostatin, has secured FDA approval for treating spinal muscular atrophy. This approval came after successful Phase 3 trials and marks a significant milestone in managing neuromuscular diseases. By targeting the myostatin pathway, which regulates muscle growth, Isembldy offers hope for improved motor function in patients suffering from this debilitating condition. Meanwhile, Pharming's Joenja (leniolisib) received an expanded label from the FDA, now approved for pediatric patients aged four and older with activated phosphoinositide 3-kinase delta syndrome, reflecting ongoing efforts to tackle rare autoimmune disorders. Telix Pharmaceuticals has also made strides with the approval of Pixclara (floretyrosine F 18) for PET imaging of glioma, enhancing diagnostic precision for both adult and pediatric brain cancer patients. In clinical trial successes and challenges, GSK and Hansoh Pharmaceutical reported that their antibody-drug conjugate, risvutatug rezetecan, significantly reduced the risk of death in Phase 3 trials for relapsed small-cell lung cancer by 54%. This underscores the potential of targeted therapies in oncology, especially where second-line treatments have been limited. AstraZeneca's Tagrisso (osimertinib), meanwhile, continued to demonstrate its efficacy with a notable reduction in death risk in early-stage EGFR-mutated non-small cell lung cancer at an eight-year follow-up, reinforcing its value as an adjuvant therapy. However, AstraZeneca faced setbacks with camizestrant's Phase 3 trial failing to meet primary endpoints in estrogen receptor-positive breast cancer. A similar challenge arose with Enhertu (trastuzumab deruxtecan) in HER2-mutant non-small cell lung cancer, indicating ongoing difficulties in developing effective combination therapies. Turning to strategic business developments, Johnson & Johnson's decision to divest its orthopedics unit DePuy Synthes to Apollo Equity Management for $20 billion reflects a strategic refocus on core areas like pharmaceuticals and medical devices. Similarly, Novo Nordisk's rebranding as 'Novo' signals an effort to strengthen its competitive stance against Eli Lilly within the GLP-1 agonist market, crucial for managing metabolic disorders such as diabetes. In collaborations and licensing deals aimed at broadening access to healthcare innovations, Bio Usawa's partnership with Axmed is set to enhance access to affordable biologic medicines across Africa, a vital step towards expanding healthcare reach in underserved regions. In oncology research advancements, Owkin has licensed its AI-driven K Pro scientist platform to Servier to accelerate drug discovery through artificial intelligence and machine learning applications. Regulatory challenges continue to shape industry dynamics. The FDA has postponed its decision on Exelixis's Zanzalintinib combined with Roche's Tecentriq for metastatic colorectal cancer until March 2027, reflecting rigorous scrutiny to ensure safety and efficacy. Meanwhile, Cellectis has opted to halt its allogeneic CAR-T programs amid increasing competition from in vivo approaches, showcasing strategic adaptability within the rapidly evolving field of cell therapy. In recent news focusing on mRNA technology and personalized cancer vaccines, Moderna's flu vaccine approval using mRNA technology marks a pivotal moment for this platform after facing skepticism over the years. Furthermore, Moderna and Merck have reported positive Phase 3 results for their personalized mRNA-based cancer vaccine—an advancement positioning them as leaders in personalized cancer immunotherapy following success in melanoma treatment. The sector remains dynamic as companies navigate these complex environments. Breakthroughs such as ivonescimab's success provide optimism for future innovations that could significantly enhance patient care and treatment outcomes across various diseases. The emphasis on mRNA technologies and personalized medicine heralds a new era of targeted therapies poised to redefine standards of care across multiple disease areas. As these initiatives progress, they hold potential not only for improving existing treatment paradigms but also for pioneering new frontiers in healthcare delivery. As these developments unfold, they highlight the industry's dual focus on advancing scientific innovation while navigating complex regulatory landscapes and competitive pressures. The implications are profound: promising enhanced patient outcomes through novel therapies while prompting strategic realignments among key industry players. These initiatives not only aim to improve existing treatment paradigms but also pioneer new frontiers in healthcare delivery.Support the show
On this week's episode, Tess Cameron, Brian Skorney, Paul Matteis, and Yaron Werber open with a look at markets, noting the XBI slipped just over 3% amid concerns about energy prices, inflation, and long-term U.S. fiscal health weighing on the rate-sensitive sector. The conversation then turns to policy, discussing new FDA leadership appointments including Karim Mikhail as CBER director, with hosts noting the industry's hope for a calmer, less chaotic regulatory tone. They highlight the FDA's apparent openness to psychedelics, pointing to stock reactions across the space. On the data front, Novartis's pelacarsen missed expectations reducing Lp(a) relative to rival programs from Amgen and Eli Lilly, while its DM1 program also fell short, shifting attention to Dyne Therapeutics' upcoming expansion cohort data. The hosts debate whether Novartis's setbacks make early-commercial, post-Phase 3 companies more attractive acquisition targets given looming loss-of-exclusivity pressure across large pharma. In other data news, Roivant's mosliciguat hit its Phase 2 primary endpoints in interstitial lung disease, with the company already advancing to Phase 3. The episode closes with Biohaven's epilepsy trial hold pending further metabolite data, and questions over whether the hold could affect its recent SK Pharma deal. This episode aired on September 11, 2026.
Broadcast from KSQD, Santa Cruz on 9-10-2026: The Pennsylvania measles outbreak has reached 540 confirmed cases with 119 new cases in the past week—the highest yearly count in 35 years, with likely three-fold undercount. Dr. Dawn emphasizes measles' R-value of 14 (versus COVID's peak of 3), its four-day pre-rash contagion window, and two-hour airborne persistence. Lancaster County's pediatric vaccination has dropped from the 95% threshold needed for herd immunity to 87%. She discusses the recent infant death (measles at birth with subsequent splenic rupture during vaginal delivery), the impossibility of vaccinating pregnant women against this live-virus disease, and public health workers doing pop-up clinics and home vaccine delivery. Dr. Dawn criticizes federal threats to strip tax-exempt status and terminate federal grants from universities like UCLA and UC Davis over race-conscious admissions. She argues this targets exactly the schools admitting students most likely to serve underserved communities and enter primary care—where the physician shortage is most acute—rather than dermatology or interventional radiology at tertiary centers. UCLA's Eisenberger social pain lab found that social exclusion (via a rigged game with undergraduates) activates the same brain regions as physical pain (dorsal anterior cingulate cortex and anterior insula on fMRI). A follow-up study showed acetaminophen blunted both self-reported social pain and empathy for others' pain, later replicated with EEG changes in DACC. Dr. Dawn suggests strategic use before stressful social events—though not combined with alcohol. Orexins are wakefulness-regulating neurotransmitters discovered in narcoleptic Doberman Pinschers and Labrador Retrievers. Takeda's oveporexton was approved August 5 as the first orexin agonist for narcolepsy, and Eli Lilly recently paid $8 billion for a related biotech, with Morgan Stanley projecting $16 billion in annual sales. Beyond narcolepsy, orexin agonists show promise for ADHD, attention/motivation, and potentially sleep apnea, with lower abuse potential than methylphenidate or Adderall. A caller advocates for free education and mandatory multilingual instruction in elementary school. Dr. Dawn describes France's tuition-and-food-subsidized medical education with post-graduation community service requirements built in, and shares her own experience with 2% National Defense Student Loans established after Sputnik. Researchers identified a distinctive brain-wave signature marking the transition to unconsciousness under propofol anesthesia—the loss of alpha-band coordination between the parietal cortex and thalamus. Delivered via scalp electrodes, this signature could enable individualized anesthesia dosing and provide non-behavioral markers of consciousness for brain-injured patients. A grandmother caller asks about protecting her first-grader during the measles outbreak. Dr. Dawn confirms two-dose MMR vaccination provides 100% protection against severe measles and 98% against mild disease, and reminds her to prompt women of childbearing age to verify their vaccination status before pregnancy, since maternal measles or COVID infection carries much higher mortality. Researchers studying breath and stool volatile compounds in asthmatic children identified four molecular markers that could enable early sepsis detection through breath analysis. This would prove especially valuable in neonates, where blood cultures are technically difficult, and could provide hours-to-days warning before clinical sepsis manifests. Vaginal birth exposes the infant to maternal vaginal and fecal bacteria that serve as the first beneficial inoculation, with some maternal microbes crossing the placenta prenatally. During the first week of life, maternal antibodies in colostrum and breast milk train the neonatal immune system to tolerate friendly bacteria—preventing later asthma, food allergies, and autoimmune disease. Dr. Dawn highlights colostrum as the critical component and suggests it should be sourced for infants who cannot be breastfed. Magnesium L-threonate crosses the blood-brain barrier efficiently, with about a gram at bedtime improving deep and REM sleep, morning alertness, mood, and productivity. It also reduces migraine severity, and one of Dr. Dawn's patients successfully replaced ADD medications with 3g daily. The only meaningful upper limit is diarrhea, which signals malabsorption.
September 11, 2026: Your daily rundown of health and wellness news, in under 5 minutes. Today's top stories: Apple Watch adds a readiness score, Health Age feature, and $119 blood-testing panel, using its 100 million users to challenge Oura and Whoop on distribution Salomon signs a five-year global partnership with IRONMAN, becoming title partner of the World Championship in Kona starting in 2027 Eli Lilly uses its GLP-1 windfall to expand into women's health, recruiting scientists across osteoporosis, preeclampsia, and endometriosis Today's episode is brought to you by AIIR — a modern communications and experiential agency for health, wellness, fitness, and performance brands. From earned media to events and creator-led campaigns, AIIR helps companies sharpen their story, earn attention, and build trust that compounds. Visit https://aiir.agency to learn more. 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
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 pivotal advances and industry dynamics that are shaping the future of healthcare. The U.S. Food and Drug Administration has recently granted approval to Ionis Pharmaceuticals' Zanvastro, a breakthrough in treating Alexander disease. This condition, a rare neurodegenerative disorder caused by mutations in the glial fibrillary acidic protein gene, has historically posed significant treatment challenges. Zanvastro, an antisense oligonucleotide therapy, is notable for being the first of its kind to target this protein, marking a monumental step in precision medicine. The success of this therapy not only opens new avenues for treating Alexander disease but also highlights the potential of antisense technologies to address other rare genetic disorders. Ionis Pharmaceuticals is poised to further explore this innovative therapeutic approach in other neurodegenerative conditions like Angelman syndrome, reinforcing their leadership in targeting rare genetic diseases at the molecular level. Meanwhile, strategic partnerships continue to transform the metabolic disease treatment landscape. The Menarini Group's partnership with Gan & Lee Pharmaceuticals aims to bring the GLP-1 receptor agonist Bofanglutide to European markets. This collaboration underscores the growing emphasis on GLP-1 therapies for managing type 2 diabetes and obesity. With an investment of $72 million upfront and potential milestone payments reaching $771 million, this partnership illustrates the strategic importance of cross-border collaborations in accelerating drug availability and leveraging regional expertise. In parallel, Argo Biopharma has announced promising phase 2 results for its small interfering RNA therapy targeting plasma prekallikrein in hereditary angioedema. This innovative approach offers a prophylactic treatment option for a disease characterized by severe swelling attacks. By harnessing RNA interference mechanisms, Argo Biopharma joins a broader movement within biotech towards gene-silencing technologies that tackle previously challenging conditions. Further emphasizing innovation, Superluminal Medicines has raised $60 million to advance its AI-discovered MC4R-targeting drug for rare obesity conditions. This initiative highlights the transformative potential of artificial intelligence in drug discovery, enabling rapid identification of therapeutic candidates by analyzing extensive datasets and predicting molecular interactions. The focus on rare forms of obesity reflects a broader trend toward personalized medicine, where treatments are increasingly tailored to specific genetic profiles. Regulatory developments also feature prominently with Liquidia Corporation receiving FDA fast track designation for Yutrepia, an inhaled small molecule aimed at treating systemic sclerosis-related Raynaud's phenomenon. This designation will expedite the development and review process for Yutrepia, facilitating quicker access to this potentially life-enhancing treatment for those suffering from autoimmune complications. However, challenges persist within the industry. The FDA issued a warning letter to Fresenius Medical Care over deficiencies related to complaint handling and contamination inspections for sterile injectable products. This action underscores ongoing concerns regarding compliance with safety standards and highlights the critical need for rigorous quality control mechanisms to ensure patient safety. In exploring new therapeutic modalities, psilocybin has shown promise in managing neuropathic pain through preclinical studies. These findings add to the growing body of evidence supporting psychedelics' potential benefits beyond mental health applications, opening new avenues for pain management therapies that could revolutionize treatment protocols. The competitive landscape in weight management sees significant movement with Novo Nordisk's Wegovy pill and Eli Lilly's Foundayo vying for dominance in oral GLP-1 receptor agonists. As companies race to develop more patient-friendly formulations, these innovations promise to significantly boost adherence and outcomes in obesity management. Lastly, industry trends reveal an evolving marketing landscape where social media collaborations and strategic partnerships are becoming central to engaging patients and advocating medical conditions. For example, Novartis' partnership with a British Olympian aims to enhance multiple sclerosis advocacy by leveraging influential platforms for patient education and empowerment. These developments paint a picture of a dynamic pharmaceutical and biotech sector characterized by scientific innovation, strategic partnerships, regulatory vigilance, and data-driven approaches. As companies continue to navigate these complexities, their ability to leverage cutting-edge technologies and foster global collaborations will be crucial in delivering transformative health solutions. The industry's focus on precision medicine and novel therapeutic modalities promises significant advancements in patient care and disease management in the years ahead. Thank you for joining us at Pharma Daily—your source for the latest news shaping the world of pharmaceuticals and biotechnology.Support the show
Jordan and Nate are back live this week, kicking off with genuinely useful talk about mobility work, self experimentation, and using AI to plug in your own blood work and genetics for a targeted health plan. From there it is a stacked news day: Trump's fresh executive order cracking down on meat packing monopolies and opening up direct to consumer sales for small ranchers, plus Trump publicly defending unvaccinated Amish communities amid Pennsylvania's ongoing measles controversy. They dig into a genuinely wild story about a researcher behind a major vaccine autism study pleading guilty to fraud, the FDA cracking down on overseas peptide vendors while Eli Lilly quietly sues the same market it helped create, and a hopeful stat on soda sales dropping after SNAP reform. The show wraps with a candid, occasionally hilarious conversation about screen addiction in kids and what actually gets them back outside. Equal parts hard news and honest banter.
Ugens store gæst er Andreas Holm Mattsson, medstifter og Chief AI Officer i danske Evaxion: Hvad betyder Moderna og Mercks fase 3-gennembrud mod modermærkekræft, hvordan skræddersyr AI en vaccine til den enkelte patients tumor – så unik, at selv enæggede tvillinger ville få hver sin – og hvorfor virker det bedst på kræftformer med mange mutationer? Evaxions egen EVX-01 mod melanom viser 92% af patienterne fortsat i respons efter to år, og hos 25% er canceren helt væk. Treårsdata kommer på ESMO i oktober, hvor Evaxion også kan blive det første danske selskab nogensinde, der vinder Prix Galien-prisen – biotech-branchens svar på Nobelprisen.Imens falder markedet på gode nyheder: Jobreporten viste 162.000 nye jobs mod 55.000 ventet, og så røg aktierne ned, fordi en rentestigning i september nu prises højere. Mads' pointe: Økonomien er skiftet fra forbrugsdreven til produktionsdreven, og det har markedet ikke lært at læse endnu. Hans melding er klar – Nvidia til P/E under 20 med 70% vækst er "fuldstændig godnat", og vi står måske i en historisk købsmulighed.Tesla ruller Cybercab ud i Austin uden rat og pedaler – uden at spørge om lov først – og aktien falder 6%, mens Mads akkumulerer. OpenAI lancerer GPT-6 Astra, og Sam Altman erklærer AGI for ankommet; Chamaths tørre kommentar: AGI har eksisteret et halvt år, bare kun hos modeludviklerne. Dertil Nvidias køb af Hugging Face, SpaceX der nu selv producerer gasturbineblade med raketteknologi, myten om datacentrenes vandforbrug (mandelfarme i Californien bruger 4-7 gange mere end alle USA's datacentre tilsammen) og NASA's nye teleskop, der kom op ni måneder før tid.Regnskaber: Broadcom vokser 86%, guider 100% vækst to år frem og bygger chips med både Google, OpenAI og Meta – og alligevel står aktien stille. Dell vokser med 58% med indtjening op på 203% frem mod 2030.Plus Pluto-data – IREN er både mest handlet og mest solgt, Eli Lilly mest købt – og porteføljen er oppe 1,7%, klar til endelig at handle igen, når erhvervskontoen åbner i næste uge. Denne episode er sponsoreret af AIOSS. Et komplet kosttilskud i pulverform med probiotika, fibre og vitaminer - udviklet til en velfungerende tarm og en sundere hverdag. Brug koden “aktieuniverset" på aioss.dk. Denne episode er sponsoreret af FlowNordics. Få automatiseret jeres manuelle workflows – fra gentagne opgaver til skræddersyede databaseløsninger med AI. Læs mere på flownordics.com. Denne episode er sponsoreret af Ansnei. Sikre din virksomhed eller hjem med et højteknologisk alarmsystem. Klik ind på Ansnei.com/aktie og få et ekslusivt tilbud på en sikkerhedsløsning og alarmpakke. Denne episode er sponsoreret af Finobo. 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Markedsføringen er betalt af NDIIR ApS, CVR-nr. 43934090, FT-nr. 34183, der er investeringsrådgiver for afdelingen. Mads Christiansen er medejer af NDIIR ApS. Podcasten kan ligeledes referere til andre fonde.Indholdet i podcasten udtrykker alene værternes og gæsters egne holdninger, refleksioner og analyser, og skal ikke opfattes som en personlig anbefaling af bestemte værdipapirer eller strategier. Podcasten skal ikke anses som investeringsrådgivning, da den enkelte lytters finansielle situation, nuværende aktiver eller passiver, investeringskendskab og erfaring, investeringsformål, investeringshorisont, risikoprofil eller præferencer ikke kan inddrages. Det afhænger af den enkelte investors personlige forhold og målsætning, om en bestemt investering eller investeringsstrategi er hensigtsmæssig, og vi anbefaler, at man rådfører sig med sin investeringsrådgiver, inden en eventuel beslutning om investering tages.PMINDI kan findes via Nordnet (nordnet.dk/markedet/investeringsforeninger-liste/18148998-portfolio-manager-new-deal-invest) eller ved at søge på ISIN DK0062499810 hos din egen bank eller handelsplatform, herunder Saxo Bank.PMINDI er kun egnet for investorer med høj risikovillighed og en investeringshorisont på mindst 5 år. Al investering medfører risiko, herunder potentielt tab af kapital. Historiske resultater er ikke en pålidelig indikator for fremtidige resultater, der kan afvige meget eller være negative.Læs central investorinformation (PRIIP-KID) og prospekt for PMINDI med de fulde risikoscenarier på fundmarket.dk/newdeal-invest-kl-n. 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Carolina Football is back in Chapel Hill after the win over TCU in Dublin (8:05)Tar Heel Basketball officially announced its roster and coaching staff...plus Michael Malone met with the media in Chapel Hill (17:47)Former Carolina baseball player and former President/CEO of Eli Lilly, Vaughn Bryson joinsPlus: postcards (1:10:37), Montross Day of Service (1:24:59) and Adam lays down an attendance challenge (1:25:32)See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
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Sanjiv Lal is a self-made healthcare entrepreneur who started his career as a pharmacist at CVS and went on to build businesses across diagnostics, wellness and regenerative medicine.Raised middle class in Ohio as the son of Indian immigrants, Sanjiv went to state college before beginning his career at CVS and later Eli Lilly. Working inside healthcare exposed him to a problem hecouldn't ignore: advances in medicine were helping people live longer, but not necessarily healthier. He decided to build differently.Over the next two decades, Sanjiv founded three laboratory companies, helped build diagnostic organizations responsible for more than one million patient test results, and today owns Beverly HillsRejuvenation Center, a 22-location wellness and regenerative medicine business, while building his newest company, Cell Factors.At 40, his work became deeply personal. After surviving COVID, Sanjiv developed Stage 3 kidney disease that his physicians attributed to remdesivir. Becoming the patient inside the industry where he'dbuilt his career changed both his definition of success and what he wanted to build next.
Patrik Jonsson, vicepresidente ejecutivo de Eli Lilly and Company y presidente de Lilly International by Diario La república
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into groundbreaking scientific advancements, crucial regulatory updates, and strategic industry movements that are shaping the future of patient care and drug development. AstraZeneca, in collaboration with Daiichi Sankyo, has achieved a significant milestone with their antibody-drug conjugate, Enhertu, combined with Roche's Perjeta. This combination therapy has recently secured European Union approval for first-line treatment of HER2-positive metastatic breast cancer. The approval highlights the transformative potential of antibody-drug conjugates in treating aggressive breast cancer subtypes. Enhertu targets HER2-positive tumors by delivering cytotoxic agents directly to the cancer cells, thereby minimizing off-target effects and enhancing efficacy. Such innovations underscore the industry's commitment to improving therapeutic outcomes for patients facing complex medical challenges. In another notable development, Novartis has entered into a substantial $3.2 billion licensing agreement with Alteogen, focusing on ALT-B4 hyaluronidase technology. This collaboration emphasizes the growing interest in subcutaneous drug formulations that offer improved patient compliance and convenience compared to traditional intravenous routes. Hyaluronidase helps disperse and absorb subcutaneously injected drugs more efficiently by degrading hyaluronic acid in tissues, thereby enhancing bioavailability and reducing injection volumes. Shifting gears to clinical trial advancements, Hutchmed's combination therapy featuring Tagrisso (osimertinib) and Orpathys (savolitinib) has achieved a Phase 3 success in first-line treatment for MET-overexpressing non-small cell lung cancer. This marks an important stride towards personalized medicine approaches that target specific genetic mutations driving tumor growth. The success of this combination therapy points to a future where targeted treatments become more prevalent in addressing complex oncogenic drivers. In the realm of strategic partnerships, Novacyt and Illumina have embarked on a five-year collaboration focusing on diagnostics and DNA sequencing technologies. This partnership aims to leverage Illumina's genomic sequencing expertise to advance precision medicine efforts in diagnostics, further highlighting the importance of collaborations in overcoming technological hurdles. Meanwhile, in gene therapy developments, NewBiologix and Synastra Biotechnology have joined forces to develop stable recombinant adeno-associated viral cell lines for Duchenne muscular dystrophy therapies. Their partnership aims to address manufacturing challenges associated with gene therapies for rare diseases, potentially accelerating treatment availability for patients in need. Despite these promising advancements, the industry is not without its challenges. Cellares recently announced significant job cuts following the loss of a contract with Bristol Myers Squibb for cell therapy production. Additionally, regulatory scrutiny remains high as evidenced by the UK Medicines and Healthcare products Regulatory Agency's suspension of Amgen's Tavneos amid concerns over trial data integrity. Such developments underscore the critical importance of maintaining rigorous data standards in drug development. Turning our attention to regulatory dynamics, the Trump administration has introduced a new drug pricing model under Medicare, providing weight loss medications at reduced prices for eligible seniors. This initiative involves major players like Eli Lilly and Novo Nordisk and aims to enhance access to obesity treatments for seniors—a move that could signify a shift towards preventive healthcare. On the clinical front, Alnylam Pharmaceuticals' next-generation gene-silencing technology shows promise for treating transthyretin amyloidosis with cardiomyopathy (ATTR-CM). Despite setbacks faced by AstraZeneca and Ionis Pharmaceuticals in similar trials, Alnylam's approach holds potential when used alongside standard treatments. The pharmaceutical sector also sees evolving market dynamics with reverse mergers rising sharply by 1,600% in Q3. This trend rivals traditional IPOs as companies seek alternative routes to liquidity amid fluctuating investor sentiments. Such strategic adaptations reflect the industry's resilience amidst economic uncertainties. In conclusion, these developments paint a picture of an industry dynamically adapting to technological advancements, regulatory changes, and market demands. From innovative drug delivery technologies to strategic partnerships and robust regulatory frameworks, the sector remains committed to advancing precision medicine and improving patient care globally. As these trends continue to unfold, they promise significant implications for drug development processes and therapeutic paradigms across various disease landscapes.Support the show
Eli Lilly is testing a new GLP-1 called brenipatide in phase three trials, and weight loss isn't even the main focus, researchers are watching it for alcohol use disorder, opioid addiction, bipolar disorder, and IBS. Chalene Johnson also breaks down a new Yale University study on why the hunger hormones ghrelin and leptin roar back the moment someone stops taking a GLP-1. Then Chalene calls out an Instagram account called Baddie Bethany (also posting as Baddie Betty on Facebook), nearly a million followers and Instagram is rolling out a brand new AI content label. She also flags an AI "Dr. Chen" wellness account blending real health facts with false ones to earn trust. Plus, five new health devices she's watching, including a toilet sensor called Throne, an AI skin scanner called SkinBit, and a caregiving wearable from the founders of Fitbit. Topics discussed: Eli Lilly, brenipatide, Zepbound, Yale University, ghrelin, leptin, berberine, Baddie Bethany, Baddie Betty, Dr. Chen, Chen Family Wellness, Carrie Sisson, Instagram, Throne, SkinBit, Prenuvo, 3D Radiology, Eight Sleep, Apple, Fitbit, Lufu, Lindsey Clancy trial. Join Chalene on Patreon her private podcast to hear all the latest on the Penthouse Drama and the Session with a Renowned Pet Psychic
Scott Wapner and the Investment Committee discuss the outlook for stocks as bond yields ease. The experts weigh in on the data center debate. Calls of the Day are on Vertex, Eli Lilly, and Wynn Resorts. Oliver Renick reports on Options Action. Jim Lebenthal details his latest portfolio move. Investment Committee Disclosures 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 of Lab Rats to Unicorns, John Flavin sits down with Dr. Kiran Musunuru, a cardiologist, geneticist, professor at the University of Pennsylvania, and leading expert in gene editing. Kiran's research spans cardiovascular, metabolic, and rare genetic diseases, with a focus on turning advances in human genetics and CRISPR into therapies that address the underlying causes of disease. He is also a co-founder of Verve Therapeutics and helped lead the development of a personalized gene-editing treatment for infant KJ Muldoon. Kiran traces the path that brought him to gene editing, from growing up with a cardiologist father and pursuing combined medical and scientific training to recognizing the potential of human genetics, stem cells, and eventually CRISPR. He explains how his willingness to adopt new technologies led his lab from early tools like zinc finger nucleases and TALENs to CRISPR, base editing, and prime editing. That progression ultimately opened the possibility of not simply treating symptoms, but making precise changes to DNA that could turn off disease-causing genes or repair genetic mutations at their source. Throughout the conversation, Kiran shares how experiments targeting the cholesterol gene PCSK9 led to the idea of a one-time treatment for cardiovascular disease and ultimately to the creation of Verve Therapeutics. He discusses his unexpected journey into entrepreneurship, Verve's progression into human trials and acquisition by Eli Lilly, and his return to academia to apply the same gene-editing platform to rare diseases. The episode culminates with the remarkable story of KJ, whose personalized base-editing therapy was designed and produced in roughly six months, as well as Kiran's larger vision for transforming one-off treatments into a scalable platform capable of reaching patients around the world.
In der heutigen Folge sprechen die Finanzjournalisten Lea Oetjen und Holger Zschäpitz über den gruseligen September-Auftakt, Kracherzahlen von Dell und eine Enzym-Aktie, die fremde Blockbuster in eigene Erlöse verwandelt. Außerdem geht es um SAP, CrowdStrike, Cloudflare, RWE, Merck, Apple, Credo Technology, MongoDB, GitLab, Palo Alto Networks, Nvidia, Broadcom, Shein, H&M, Fast Retailing, Next, Inditex, Associated British Foods (ABF), Gap, Roche, Johnson & Johnson, Merck & Co., Halozyme Therapeutics, Bristol-Myers Squibb, Pfizer, Eli Lilly, Alteogen, Schott Pharma, Gerresheimer, Ypsomed, West Pharmaceutical Services, Husqvarna, Toro, KraneShares Global Humanoid and Embodied Intelligence ETF (WKN: A41PZ8) und iShares Automation & Robotics ETF (WKN: A2ANH0). Am 2. Oktober findet unser „Alles auf Aktien“-Summit in Berlin statt. Mit dem Code „AAAFRIENDS“ sparst du 50 Prozent auf dein Ticket – aber nur unter folgendem Link: https://veranstaltung.businessinsider.de/event/financesummit26/summary?rp=c6dc55d6-6f4f-4fb4-b75f-3… Wir freuen uns an Feedback über aaa@welt.de. Noch mehr "Alles auf Aktien" findet Ihr bei WELTplus und Apple Podcasts – inklusive aller Artikel der Hosts. Hier bei WELT: https://www.welt.de/podcasts/alles-auf-aktien/plus247399208/Boersen-Podcast-AAA-Bonus-Folgen-Jede-Woche-noch-mehr-Antworten-auf-Eure-Boersen-Fragen.html. Hier könnt ihr den AAA-Newsletter abonnieren: https://www.welt.de/newsletter/article232797673/Alles-auf-Aktien-Der-taegliche-Boersen-Newsletter-fuer-WELTplus-Abonnenten.html Und – ganz neu: AAA gibt es jetzt auch auf Instagram: https://www.instagram.com/alles_auf_aktien/ Disclaimer: Die im Podcast besprochenen Aktien und Fonds stellen keine spezifischen Kauf- oder Anlage-Empfehlungen dar. Die Moderatoren und der Verlag haften nicht für etwaige Verluste, die aufgrund der Umsetzung der Gedanken oder Ideen entstehen. Hörtipps: Für alle, die noch mehr wissen wollen: Holger Zschäpitz können Sie jede Woche im Finanz- und Wirtschaftspodcast "Deffner&Zschäpitz" hören. +++ Werbung +++ Du möchtest mehr über unsere Werbepartner erfahren? Hier findest du alle Infos & Rabatte! https://linktr.ee/alles_auf_aktien Anzeige: Eight Sleep: Der Pod 5 reguliert die Temperatur im Bett automatisch, trackt Schlaf- und Gesundheitswerte ohne Wearable und kann so zu besserem Schlaf beitragen. Mit dem Code ALLESAUFAKTIEN erhaltet ihr auf https://www.eightsleep.com/allesaufaktien bis zu 350 Euro Rabatt. Impressum: https://www.welt.de/services/article7893735/Impressum.html Datenschutz: https://www.welt.de/services/article157550705/Datenschutzerklaerung-WELT-DIGITAL.html
In der heutigen Folge sprechen die Finanzjournalisten Lea Oetjen und Holger Zschäpitz über historische Abschiede, SpaceX-Druck für Siemens Energy und die Zinsgewinner des Anleihenschocks. Außerdem geht es um DHL Group, Apple, Shein, Inditex, Microsoft, Halliburton, Valero Energy, PG&E, Edison International, Nvidia, MediaTek, Aon, KKR, Eli Lilly, Hyperliquid Treasury, Siemens Energy, Nordex, Sto, OHB, Vonovia, Aroundtown, TAG Immobilien, LEG Immobilien, Amazon, BMW, UBTECH Robotics, Zeekr (Geely Automobile Holdings Limited), Unitree Robotics, Renesas Electronics, NXP Semiconductors, Analog Devices, MinebeaMitsumi, Regal Rexnord, TE Connectivity, Amphenol, Walmart, Daifuku, Jabil, Toyota, BYD, Xiaomi, Xpeng, Tesla, Siemens, Schneider Electric, JPMorgan Chase, Crédit Agricole, Grenke und Volkswagen. Am 2. Oktober findet unser „Alles auf Aktien“-Summit in Berlin statt. Ihr wollt dabei sein? Wir verlosen Tickets: Schreibt uns eine Mail an AAA@WELT.de und begründet, warum ihr unbedingt gewinnen solltet. Falls ihr euer Glück nicht dem Zufall überlassen wollt, bekommt ihr mit dem Code „AAAFRIENDS“ satte 50 Prozent Rabatt aufs Ticket – aber nur über diesen Link: https://veranstaltung.businessinsider.de/event/financesummit26/summary?rp=c6dc55d6-6f4f-4fb4-b75f-3f3501d84859 Wir freuen uns an Feedback über aaa@welt.de. Noch mehr "Alles auf Aktien" findet Ihr bei WELTplus und Apple Podcasts – inklusive aller Artikel der Hosts. Hier bei WELT: https://www.welt.de/podcasts/alles-auf-aktien/plus247399208/Boersen-Podcast-AAA-Bonus-Folgen-Jede-Woche-noch-mehr-Antworten-auf-Eure-Boersen-Fragen.html. Hier könnt ihr den AAA-Newsletter abonnieren: https://www.welt.de/newsletter/article232797673/Alles-auf-Aktien-Der-taegliche-Boersen-Newsletter-fuer-WELTplus-Abonnenten.html Und – ganz neu: AAA gibt es jetzt auch auf Instagram: https://www.instagram.com/alles_auf_aktien/ Disclaimer: Die im Podcast besprochenen Aktien und Fonds stellen keine spezifischen Kauf- oder Anlage-Empfehlungen dar. Die Moderatoren und der Verlag haften nicht für etwaige Verluste, die aufgrund der Umsetzung der Gedanken oder Ideen entstehen. Hörtipps: Für alle, die noch mehr wissen wollen: Holger Zschäpitz können Sie jede Woche im Finanz- und Wirtschaftspodcast "Deffner&Zschäpitz" hören. +++ Werbung +++ Du möchtest mehr über unsere Werbepartner erfahren? Hier findest du alle Infos & Rabatte! https://linktr.ee/alles_auf_aktien Anzeige: Eight Sleep: Der Pod 5 reguliert die Temperatur im Bett automatisch, trackt Schlaf- und Gesundheitswerte ohne Wearable und kann so zu besserem Schlaf beitragen. Mit dem Code ALLESAUFAKTIEN erhaltet ihr auf https://www.eightsleep.com/allesaufaktien bis zu 350 Euro Rabatt. Impressum: https://www.welt.de/services/article7893735/Impressum.html Datenschutz: https://www.welt.de/services/article157550705/Datenschutzerklaerung-WELT-DIGITAL.html
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we dive into the dynamic landscape of the industry, highlighting significant scientific breakthroughs, strategic partnerships, and regulatory updates that are reshaping healthcare as we know it. Novartis recently announced a major milestone with its BTK inhibitor, Rhapsido, which met its Phase 3 clinical trial goals for treating relapsing multiple sclerosis. This success is particularly noteworthy as it comes without any liver safety concerns, a common challenge for this class of drugs. The development of Rhapsido marks a promising advancement in managing neurological disorders, offering new hope for patients dealing with the debilitating effects of multiple sclerosis. However, not all developments are without challenges. Novartis and Bristol Myers Squibb have halted their CAR-T trials due to safety concerns linked to autoimmune conditions like lupus and multiple sclerosis. These pauses highlight the complexities involved in developing CAR-T therapies for non-oncological applications. At the same time, Roche and Simcere Zaiming have joined forces to develop SIM0660, a T-cell engager targeting B-cell diseases. This partnership, involving an initial payment of $75 million and potential milestones up to $1.53 billion, underscores the increasing interest in antibody-based therapies. These treatments leverage the body's immune system, moving towards more targeted modalities for oncology and autoimmune diseases. Meanwhile, drug pricing reforms continue to take center stage as the White House negotiates Most Favored Nation pricing agreements with pharmaceutical giants like Alcon and Astellas Pharma. These agreements aim to make medications more affordable by aligning US drug prices with those in other developed countries. Such policy initiatives reflect growing governmental efforts to address rising healthcare costs and improve access to essential medications. Shifting focus to vaccines, GSK has embarked on a Phase 3 trial for its mRNA-based flu vaccine. This initiative highlights the broader trend of extending mRNA technology beyond COVID-19 vaccines to tackle other infectious diseases. The adaptability and rapid production capabilities of mRNA platforms could revolutionize vaccine development and enhance our response to seasonal influenza. In cardiovascular health, Amgen's Repatha has shown a 20% reduction in mortality risk during a Phase 3 trial focused on primary cardiovascular prevention. This finding reinforces the critical role of PCSK9 inhibitors in lowering cholesterol levels and preventing cardiovascular events for high-risk patients. Similarly, Alumis faced setbacks when its TYK2 inhibitor failed to meet primary endpoints in a Phase 2 study for systemic lupus erythematosus. Despite this, promising subgroup signals suggest potential paths forward. On the regulatory front, the FDA has issued warnings to Alar Pharmaceuticals regarding unapproved promotional claims for its ketamine-based product ALA-3000. Additionally, Boston Scientific has suspended sales of its Imager II angiographic catheters due to manufacturing defects causing serious injuries. Medtronic is recalling its esophageal reflux monitoring capsule over safety issues tied to numerous injuries. These regulatory actions emphasize the critical importance of compliance with safety standards in protecting patient well-being. Industry innovation is further propelled by ongoing fundraising activities supporting cutting-edge research. Companies such as PMV Pharmaceuticals are advancing precision oncology therapies targeting p53 mutations, while Rakovina Therapeutics utilizes AI-powered platforms for cancer drug discovery. These efforts underscore the sector's commitment to addressing complex diseases through technological innovation. The exploration of novel therapeutic modalities continues with Eli Lilly's acquisition of Merida Biosciences for $2.88 billion to target autoimmune diseases by selectively degrading pathogenic autoantibodies. This acquisition aligns with broader trends toward precision medicine solutions aimed at modulating immune responses. In oncology news, Akeso's success with ivonescimab in biliary tract cancer exemplifies the potential of bispecific antibodies beyond initial indications. Meanwhile, Genentech's collaboration with DualityBio aims at overcoming resistance mechanisms in antibody-drug conjugates, promising expanded treatment options for patients resistant to existing therapies. Lastly, Labcorp's introduction of a new hepatitis D test represents a proactive step toward addressing diagnostic gaps in viral infections. Early detection remains crucial for effective disease management and improved patient outcomes. These developments collectively illustrate an industry at the forefront of innovation and strategic adaptation. As companies navigate these evolving landscapes, their focus remains steadfast on improving patient care through groundbreaking therapies while overcoming regulatory hurdles—a testament to their resilience and dedication in pursuing new healthcare frontiers.Support the show
Mid-sized biopharma companies are under growing pressure to accept most-favored nation drug pricing deals with the White House. On the latest BioCentury This Week podcast, BioCentury's analysts assess the trade-offs companies face, the litigation risks around mandatory Medicare MFN pricing demonstrations, and what happens to companies that don't sign on.The analysts also discuss Eli Lilly's acquisition of Merida, its thirteenth takeout of the year, Heidi Overton's nomination as FDA commissioner and what it signals about FDA independence, and Revolution Medicines' 35-day filing-to-approval timeline under FDA's national priority review voucher pilot.View full story: https://www.biocentury.com/article/660655#DrugPricing #FDA #BiotechMA #Oncology #BiopharmaPolicy0:00 - Introduction2:14 - MFN Drug Pricing Deals10:09 - Lilly Acquires Merida22:22 - FDA Commissioner Pick30:11 - RevMed's Rapid ApprovalTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. The current landscape in the pharmaceutical and biotech industries is a tapestry of dynamic mergers, clinical trial advancements, regulatory approvals, and strategic partnerships. A major highlight is Eli Lilly's acquisition of Merida Biosciences for up to $2.9 billion. This move exemplifies the industry's strategic focus on expanding portfolios specifically in autoimmune and allergic diseases. Merida's precision degradation platform is set to significantly enhance Eli Lilly's capabilities, offering potential novel therapies that could address unmet needs in these therapeutic areas. Regulatory developments continue to shape the trajectory of this industry. The FDA's approval of Protagonist Therapeutics' Mimrylo (rusfertide) for polycythemia vera marks a significant advancement in peptide therapy. This hepcidin mimetic offers a novel approach to regulate hematocrit levels, addressing a critical need in managing this blood disorder. Additionally, the FDA has expanded PharmaEssentia's Besremi (ropeginterferon alfa-2b) label to include essential thrombocythemia regardless of genotype, broadening its applicability in myeloproliferative neoplasms. The approval of Stelara (ustekinumab) for pediatric patients with ulcerative colitis underscores an ongoing commitment to developing therapies for autoimmune conditions by utilizing monoclonal antibodies targeting IL-12/IL-23 pathways. Clinical trial outcomes continue to underscore the potential transformative impact of advanced therapeutics on patient care. Jazz Pharmaceuticals' Ziihera (zanidatamab) achieved a second overall survival win in a Phase 3 trial for HER2-positive gastroesophageal adenocarcinoma, reinforcing the promise of bispecific antibodies in oncology. In cardiovascular health, AstraZeneca's AZD5462, an oral relaxin agonist, demonstrated promise in a Phase 2 trial for chronic heart failure, showcasing the potential of small molecule therapeutics in this field. Additionally, Arrowhead Pharmaceuticals' Redemplo (plozasiran) Phase 3 data supports label expansion efforts for severe hypertriglyceridemia through RNA interference technology targeting the ApoC3 gene. The industry also continues to witness promising partnerships aimed at leveraging cutting-edge technologies. Mission Therapeutics and Neurolight are collaborating to deploy brain function biomarkers in Parkinson's disease trials, linking diagnostics and digital health innovations. Meanwhile, Create Medicines and Westgene Biopharma are advancing in vivo CAR therapies using targeted lipid nanoparticle delivery technology—a significant step forward in cell and gene therapy. Despite these positive developments, challenges persist. BioNTech's halt of its Phase 2 trial of an mRNA vaccine for colorectal cancer due to futility highlights the inherent uncertainties in drug development, particularly within innovative domains like personalized neoantigen therapies. Financial strategies remain pivotal as companies like Electra Therapeutics file IPOs to advance their immunology and cancer pipeline assets, indicating robust investor interest in these high-potential areas. Quoin Pharmaceuticals' planned $50 million private placement signifies strategic capital infusion towards rare and orphan disease development. In terms of sustainability, efforts within healthcare are gaining momentum as organizations like UCI Health and Kaiser Permanente explore electrification as part of their environmental agendas. These initiatives reflect a broader trend towards reducing healthcare's carbon footprint, highlighting the sector's role in addressing climate change. Finally, regulatory landscapes continue to evolve with legal challenges as Florida's Attorney General sues Express Scripts and Prime Therapeutics over alleged price-fixing. This lawsuit underscores ongoing scrutiny over pharmacy benefit managers' practices, potentially prompting regulatory reforms to ensure fair pricing mechanisms within the pharmaceutical supply chain. Overall, these developments illustrate a dynamic landscape where scientific innovation and regulatory maneuvers intersect to shape future pharmaceutical and biotech trajectories. The implications for patient care are profound as new treatments offer hope while industry players navigate complex regulatory and market environments. As these trends continue to unfold, they hold significant implications for future drug development processes and healthcare solutions worldwide. Thank you for tuning into Pharma Daily; we'll continue to bring you critical insights into this ever-evolving industry.Support the show
Primary care physicians play an essential role in screening for and identifying cognitive health changes in patients. Thomas W. Bishop, PsyD, shares the importance of training residents to practice with cognitive health in mind. He shares his go-to screening tools and highlights how lifestyle factors such as physical activity and social connection are key to brain health. Dr Bishop also makes the case for an integrated team approach to navigating the complex diagnostic differences between dementia, delirium, and depression. This episode is brought to you in partnership with Eli Lilly and Company, and has been produced independently of STFM partners. Hosted by Omari A. Hodge, MD, and Jay-Sheree Allen Akambase, MDCopyright © Society of Teachers of Family Medicine, 2026Resources:A Large Health System Quality Improvement Intervention Providing Training and Tools to Improve Detection of Cognitive Impairment in Primary Care - J Am Geriatr SocKAER Framework - Gerontological Society of America (GSA)Mini-Cog - Quick Screening for Early Dementia Detection MoCA CognitionOutliers: The Story of Success by Malcolm GladwellLifeStyle Medicine and Nutritional Healing with Joseph E. Scherger, MD, MPH - STFM PodcastGuest Bio:Dr Thomas W. Bishop is a clinical psychologist and Professor of Family Medicine at the University of Tennessee Health Science Center College of Medicine, Chattanooga, where he serves as an Associate Program Director and Director of Behavioral Medicine. He is also Adjunct Associate Professor of Family Medicine at the University of Michigan. Across his career, Dr Bishop has focused on preparing family medicine learners and care teams to deliver integrated, whole-person care within primary care settings.His background includes longstanding work in behavioral medicine, psychology training within medical education, and scholarship related to cognition, learning, memory, and neurobehavioral functioning. His early academic work and professional interests included neuropsychology, and his career has continued to center on helping frontline clinicians recognize how cognitive, emotional, behavioral, and medical factors intersect in everyday patient care. Through years of practice in integrated primary care, he has helped train residents to identify concerns that may signal brain health problems, use practical screening approaches, promote prevention, engage patients and families, and connect patients with appropriate specialty evaluation and treatment when needed.Dr Bishop has taught and presented nationally on behavioral health in family medicine, communication skills, interprofessional education, physician development, and innovative approaches to residency training. In this conversation, he brings that experience to the important topic of equipping family medicine residents to address brain health through prevention, screening, and referral for appropriate specialty care.Link:https://www.stfm.org/stfmpodcast092026
One Big Question Podcast
Goldman Sachs CEO David Solomon joins exclusively from the G20 to discuss his outlook for the economy, AI, the bond market and much more. Then, Eli Lilly CEO David Ricks also joins from the G20 to discuss the company's new acquisition and the weight loss drug space at large. We also speak to Former CEA Chair Jason Furman about his expectations for the economy and the Fed. Squawk on the Street Disclaimer Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.
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 significant advancements and regulatory milestones that underscore the industry's commitment to addressing complex health challenges with innovative therapeutics and strategic investments. Eli Lilly has achieved a major breakthrough with the FDA approval of Mounjaro (tirzepatide), a dual GLP-1/GIP agonist designed to reduce cardiovascular risks in individuals with type 2 diabetes. This marks a pivotal step forward in diabetes management, as it not only improves glycemic control but also offers cardiovascular protection. The approval of tirzepatide highlights the therapeutic potential of dual agonists in metabolic disorders, setting a new standard for diabetes care. This development places Eli Lilly at the forefront of incretin-based therapies, a crucial advancement given the high cardiovascular risk associated with diabetes. Priovant Therapeutics has secured its first FDA approval for Lisraya (brepocitinib), a novel TYK2/JAK1 inhibitor tablet aimed at treating dermatomyositis, an autoimmune condition characterized by muscle inflammation and skin rash. As a first-in-class therapeutic option, brepocitinib underscores the growing focus on targeted therapies that modulate specific pathways involved in autoimmune diseases. Priovant's success, following its acquisition from Pfizer, signals its emergence as a significant player in rare disease treatment. Bristol Myers Squibb is making waves with a $173 million investment to construct a second radiopharmaceutical manufacturing facility in Indiana. This strategic move aligns with the increasing demand for precision oncology treatments that utilize radiolabeled compounds for targeted cancer therapy. BMS's investment demonstrates a strong commitment to advancing personalized medicine and meeting future demands in this rapidly evolving field. Gilead Sciences has received FDA approval for Bixlenvo (bictegravir/lenacapavir), an integrase/capsid inhibitor combination pill for virologically suppressed HIV patients. This small molecule therapy offers a potent antiviral strategy by combining two mechanisms of action—integrase inhibition and capsid disruption—enhancing long-term viral suppression for HIV patients. This represents an evolution in HIV treatment, promising improved adherence and patient outcomes. In China, Hutchmed's Atled (fanregratinib) has been approved by the NMPA for treating FGFR2-fusion intrahepatic cholangiocarcinoma after successful Phase 2 trials. Fanregratinib exemplifies precision medicine's approach by targeting specific genetic alterations driving cancer progression, offering new hope for patients with this challenging condition. Cytokinetics has reported promising Phase 3 results for Myqorzo (aficamten) in non-obstructive hypertrophic cardiomyopathy. Aficamten acts as a cardiac myosin inhibitor, representing a novel therapeutic avenue that directly targets the underlying pathophysiology of this rare heart disorder. The positive outcomes from these trials support its bid for FDA approval and could expand treatment options significantly. In respiratory disease research, Generate Bio's GB-0895 has shown encouraging Phase 1 biomarker reductions in chronic obstructive pulmonary disease (COPD). This monoclonal antibody approach targets TSLP and marks progress in developing new therapies for respiratory diseases with high unmet needs. Teva Pharmaceuticals has positioned itself as the stalking horse bidder for BioXcel Therapeutics' neuroscience portfolio amid bankruptcy proceedings. Teva's bid highlights ongoing consolidation trends within the pharmaceutical industry as companies seek to bolster their portfolios through strategic acquisitions. Roche's Genentech announced a substantial deal with DualityBio worth over $1 billion for antibody-drug conjugates (ADCs), focusing on developing treatments for cancers resistant to existing ADC therapies. This partnership showcases Roche's commitment to addressing complex oncology challenges through innovative modalities. Furthermore, AusperBio has secured $120 million in series C funding to advance its oligonucleotide therapy for chronic hepatitis B through Phase 3 trials. Such funding milestones demonstrate robust investor confidence and highlight promising advancements in oligonucleotide therapeutics for chronic infections like hepatitis B. These scientific advancements highlight the dynamic landscape of the biotech and pharmaceutical industries, characterized by innovation-driven solutions across various therapeutic areas. The emphasis on targeted therapies, precision medicine, and strategic investments underscores the sector's dedication to enhancing patient care through cutting-edge science and technology. As these developments unfold, they hold significant potential to impact treatment paradigms, offering hope for improved outcomes across various diseases with high unmet needs. The industry's focus on cutting-edge research and strategic collaborations continues to drive innovations that could redefine therapeutic landscapes globally. Thank you for tuning into Pharma Daily—your source for reliable updates on the evolving world of pharmaceuticals and biotechnology. Join us next time as we continue to explore groundbreaking advancements shaping patient care worldwide.Support the show
Broadcom, OpenAI, SK Hynix, Gamestop y Eli Lilly, bajo la lupa de Ignacio Vacchiano, responsable de distribución en España de Leverage Shares.
Når man snakker om Novo, så snakker man også ofte om krigen med hovedkonkurrenten Eli Lilly, som igen og igen har trukket den danske medicinalgigants aktier i rødt. Men faktisk ligger i der i den nære fremtid en endnu større udfordring, der tårner sig op i horisonten. Hør hvad det er, som potentielt kan true 70 pct. af Novos omsætning, i denne Lyn-analyse, og hvad analytikerne mener, Novo Nordisk skal gøre. Gæst: Nick Sturm, journalist, Finans. Vært: Mads Ring. Foto: Novo/presse.See omnystudio.com/listener for privacy information.
Watch Here : https://www.youtube.com/watch?v=qhGSBWOgJtk Website: https://vigoroussteve.com/ Consultations: https://vigoroussteve.com/consultations/ eBooks: https://vigoroussteve.com/shop/ YouTube Channel: http://www.youtube.com/user/VigorousSteve/ Workout Clips Channel: https://www.youtube.com/channel/UCWi2zZJwmQ6Mqg92FW2JbiA Instagram: https://instagram.com/vigoroussteve/ TikTok: https://www.tiktok.com/@vigoroussteve Reddit: https://www.reddit.com/r/VigorousSteve/ PodBean: https://vigoroussteve.podbean.com/ Spotify: https://open.spotify.com/show/2wR0XWY00qLq9K7tlvJ000 Patreon: https://www.patreon.com/vigoroussteve
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Let's dive right into today's top stories, where pioneering advancements and strategic shifts are reshaping how we understand and treat complex diseases. In recent developments, Akeso's PD-1xVEGF bispecific antibody ivonescimab is making waves beyond its initial use in non-small cell lung cancer. The successful completion of a Phase 3 trial for biliary tract cancer marks a pivotal moment, suggesting broader applications of this dual-targeting therapy. Ivonescimab's mechanism—enhancing immune response while inhibiting tumor angiogenesis—could significantly improve patient outcomes across various cancers. However, questions about its efficacy continue to prompt careful scrutiny as it challenges existing treatment paradigms. Regulatory dynamics are equally compelling, with the FDA undergoing potential restructuring under President Trump's nominee for commissioner. The creation of two new deputy commissioner roles is speculated to enhance oversight and accelerate drug approval processes. Such changes are crucial as the FDA navigates increasing demands for rapid evaluations amidst complex pharmaceutical landscapes. Meanwhile, Teva Pharmaceutical Industries finds itself under a competition probe in Turkey, highlighting global antitrust challenges within the industry. As Teva juggles its dual role as a generics leader and an innovator, this scrutiny underscores the delicate balance of maintaining market dominance while adhering to fair competition laws. On the safety front, Baxter International has initiated recalls of two medical products due to particulate contamination concerns. This action underscores the critical importance of rigorous quality control in safeguarding patient trust and safety. Similarly, Vitruvias Therapeutics has recalled thyroid tablets labeled "superpotent," emphasizing precision's vital role in pharmaceutical manufacturing. Eli Lilly is expanding its focus on obesity treatment through Medicare access campaigns for GLP-1 receptor agonists. By targeting older adults, Lilly aims to address obesity as a chronic condition requiring sustained intervention, potentially enhancing health outcomes for millions. Public health remains a pressing concern as Pennsylvania reports its first measles-associated deaths in decades amid rising nationwide cases. This situation highlights the ongoing need for robust vaccination campaigns and public health strategies to combat vaccine-preventable diseases effectively. Cybersecurity is also at the forefront, with Boston Scientific experiencing disruptions from a cyberattack. This incident reflects a broader trend affecting medtech firms globally, underscoring the necessity for robust cybersecurity measures to protect sensitive data and ensure uninterrupted healthcare services. Strategic collaborations continue to drive innovation. SK Biopharmaceuticals' $795 million deal with Biohaven Pharmaceuticals aims to accelerate epilepsy therapy development targeting KV7 ion channels. Such partnerships exemplify how strategic investments can expedite drug development timelines and bring promising therapies to market faster. LabCorp's launch of a new hepatitis D test represents an advancement in diagnostic capabilities, aiming to identify patients with severe viral infections earlier, potentially leading to more timely interventions and better management of complications. Shifting our focus back to oncology, Revolution Medicines has achieved FDA approval for daraxonrasib, a RAS inhibitor targeting metastatic pancreatic cancer. With compelling data presented at ASCO, this approval signifies a breakthrough in treating RAS mutations—a challenging target implicated in many cancers. The drug's direct inhibition of mutated KRAS proteins disrupts cancer cell proliferation pathways considered "undruggable" until now. The implications are profound: daraxonrasib not only offers hope to patients with limited options but also sets new benchmarks for future RAS-targeted therapy development. It highlights precision medicine's growing trend—tailoring treatments based on genetic profiles to enhance effectiveness while minimizing side effects. In another significant advancement, Jazz Pharmaceuticals' Ziihera (zanidatamab) has been approved by the FDA as a first-line HER2-targeted therapy for gastroesophageal adenocarcinoma. This bispecific antibody represents a promising new class of treatment, enhancing options for patients with this aggressive cancer type and underscoring personalized medicine's importance in oncology. As we conclude today's update, these developments showcase how scientific breakthroughs, regulatory adaptations, and strategic collaborations collectively shape the future landscape of drug development and patient care globally. The industry remains dynamic as it navigates complexities while striving for innovative solutions that promise better health outcomes across diverse medical conditions. Stay tuned for more updates on Pharma Daily as we continue bringing you insights into the ever-evolving world of pharmaceuticals and biotechnology.Support the show
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into the latest happenings in these dynamic sectors, where scientific advancements, regulatory decisions, and strategic business initiatives are continuously reshaping the landscape of healthcare. Starting with a significant regulatory update, the FDA has granted Capricor Therapeutics a three-month extension to review Phase 3 data for Deramiocel, a promising treatment targeting upper limb functionality in Duchenne Muscular Dystrophy (DMD). This decision underscores not only the complexity of analyzing data in neuromuscular diseases but also highlights the stringent requirements for treatments that aim to improve quality of life for patients with conditions like DMD. In other regulatory news, Johnson & Johnson has expanded the label for its monoclonal antibody IMAAvy (nipocalimab) to treat warm autoimmune hemolytic anemia. This approval is based on compelling Phase 2/3 clinical data and emphasizes the growing role of monoclonal antibodies in targeting autoimmune disorders. These developments offer promising new therapeutic avenues and signify a shift towards more precise treatment options. Moving to infection control, GSK's Hibsago (bepirovirsen) has received approval in Japan for chronic hepatitis B. This antisense oligonucleotide aims for a functional cure by targeting the hepatitis B surface antigen, representing a significant leap forward in infectious disease management. Similarly, Biocon Biologics' biosimilar pegfilgrastim has been approved in Japan for supportive care in neutropenia, crucial for cancer patients undergoing chemotherapy. These approvals highlight the global acceptance of biosimilars as effective and cost-efficient alternatives. The business landscape is also evolving with noteworthy partnerships and acquisitions. Lundbeck and Eversana are expanding their AI-driven commercialization efforts across the U.S., reflecting how advanced technologies are becoming integral to marketing strategies. Meanwhile, McKesson's $2.25 billion acquisition of Precision Medicine Group underscores the strategic focus on oncology and personalized medicine—an area poised for substantial growth. Innovation continues with AC Immune's positive Phase 1 data for ACI-19764, an oral NLRP3 inhibitor targeting chronic inflammatory disorders. This advancement could potentially revolutionize treatments for inflammation-related conditions affecting cardiovascular and neurological health. In ophthalmology, Bausch + Lomb is pushing forward with its combination eye drop therapy into Phase 3 trials for dry eye disease, demonstrating resilience and commitment despite earlier challenges. Shifting focus to obesity treatment, Eli Lilly's launch of Foundayo in the UK presents formidable competition to Novo Nordisk's Wegovy. This move signifies an intensifying race in obesity management, with potential implications for market dynamics and revenue streams. On the financial front, Hansa Biopharma is gearing up for a potential Nasdaq IPO as it awaits FDA decisions on its kidney transplant drug candidates. Amidst this backdrop, Massachusetts has seen a 25% surge in biotech venture funding this year despite challenges faced by startups. Turning to scientific breakthroughs, Jazz Pharmaceuticals has secured FDA approval for its HER2 bispecific antibody Ziihera as a first-line treatment for HER2-positive stomach cancer. This represents not only a new treatment paradigm but also positions Jazz Pharmaceuticals favorably within an estimated $2 billion market potential. In judicial updates, Merck and AstraZeneca's legal challenges against Medicare's drug price negotiation authority have been dismissed. This outcome supports efforts to reduce healthcare costs through negotiated pricing—a move that could reshape pharmaceutical pricing strategies significantly. Meanwhile, Sentivera's licensing deal focused on inflammatory diseases illustrates the financial potential and therapeutic promise of targeting inflammation—a pathway implicated in numerous serious health conditions. Geopolitical dynamics also play a role as concerns arise about China potentially outpacing U.S. companies in biotech innovation. Such developments may influence future policy decisions regarding international collaborations and domestic investments. Finally, scientific exploration continues to push boundaries with advancements such as human brain organoids providing new insights into neurological disorders and potential therapies. Eli Lilly's collaboration on trans-amplifying RNA vaccines further highlights RNA technology's expanding role post-mRNA vaccine success during COVID-19. As these stories unfold, they paint a picture of an industry marked by relentless innovation and strategic foresight aimed at improving patient outcomes globally. From regulatory hurdles to cutting-edge science, each development contributes to a healthcare environment that is increasingly dynamic and poised for future breakthroughs. Stay tuned as we continue to track these important stories impacting the world of pharmaceuticals and biotechnology.Support the show
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. In the rapidly evolving landscape of pharmaceutical and biotechnology sectors, several significant developments have marked recent progress in drug development, clinical trials, regulatory approvals, and industry partnerships. A landmark partnership between Roche and Hanmi Pharm has been established to develop HM17321, a promising weight loss drug. This collaboration involves a substantial $190 million upfront payment and could reach up to $2.3 billion based on milestone achievements. The high stakes underscore the potential value of addressing obesity through innovative pharmacological interventions, highlighting industry focus on metabolic disorders. Roche's recent $2.5 billion agreement with Hanmi Pharmaceutical emphasizes addressing metabolic disorders through less-explored mechanisms, indicating confidence in its potential to target obesity through novel pathways. Further illustrating industry dynamism, Lundbeck has reported impressive financial performance with a 16% sales growth in the first half of 2026. This growth is driven by the success of Vyepti and Rexulti. Vyepti, an antibody-based therapy for migraine prevention, continues to capture market share due to its efficacy and safety profile. Meanwhile, Rexulti extends Lundbeck's influence in treating major depressive disorder and schizophrenia, solidifying its position in neurological therapies. Significant advancements on the regulatory front have been made for drugs targeting rare diseases and neurological disorders. Spruce Biosciences is advancing toward a fourth-quarter FDA filing for its Sanfilippo syndrome drug following successful manufacturing discussions. This enzyme replacement therapy targets an ultra-rare lysosomal storage disorder with profound neurological impacts on affected children—a vital step forward in addressing unmet medical needs in rare diseases. Moreover, multiple drug approvals across various regions underline regulatory successes. The European Commission has approved Acadia Pharmaceuticals' Daybue (trofinetide) for treating neurobehavioral symptoms in Rett syndrome patients. This approval follows successful Phase 3 trial results and marks an important milestone in managing this severe neurodevelopmental disorder. Similarly, Takeda's Orzeyful (oveporexton), a first-in-class orexin receptor agonist for narcolepsy type 1, has been approved in Japan, emphasizing advancements in targeting orexin deficiency—a key driver of narcolepsy. In oncology developments, Bayer's Hyrnuo (sevabertinib) received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for HER2-mutant non-small cell lung cancer based on promising Phase 1/2 data. This tyrosine kinase inhibitor represents a novel approach to targeting genetic mutations within cancer cells. Additionally, GC Biopharma's Hunterase has gained approval in India and Taiwan for treating Hunter syndrome (mucopolysaccharidosis type II), utilizing enzyme replacement therapy to address this lysosomal storage disorder affecting multiple organs including the central nervous system. Notably, this therapy demonstrates an ability to cross the blood-brain barrier—a significant technical achievement enhancing treatment efficacy. The regulatory landscape is also evolving with new guidelines such as the UK's MHRA clarifying pathways for microbiome-based medicinal products. These developments underscore the growing interest in microbiome therapies as promising approaches to treating infectious diseases. Amidst these advancements, challenges persist as seen with Regenxbio facing a 22% share drop following an FDA clinical hold on its Hunter syndrome gene therapy RGX-121 due to spine MRI findings. This situation highlights inherent risks associated with cutting-edge gene therapies despite their groundbreaking potential. Overall, these scientific developments and regulatory updates illustrate a vibrant pharmaceutical and biotech industry focused on innovative treatments addressing complex diseases. This momentum promises enhanced patient care while signifying a robust pipeline of therapeutic options poised to transform disease management paradigms across multiple domains. The industry continues to witness significant scientific advancements and regulatory shifts. GlaxoSmithKline's (GSK) achievement of securing the world's first regulatory approval for a hepatitis B vaccine in Japan underscores GSK's leadership in infectious disease prevention—a critical advancement in global public health efforts. Moreover, collaboration between Roche and Eli Lilly culminated in FDA approval for an innovative Alzheimer's biomarker blood test. This diagnostic tool offers a groundbreaking development in Alzheimer's disease management by providing a less invasive method for early detection and monitoring—crucial for improving patient outcomes and tailoring therapeutic interventions. On strategic corporate fronts, Daiichi Sankyo is enhancing its oncology portfolio by promoting Ken Keller to head a new commercialization unit aimed at becoming a top-five oncology player by 2035. This reflects broader industry trends toward specialized therapies offering substantial clinical benefits. Cell therapy sector dynamics are also evident as Cellares' CEO plans operational resizing after losing a significant manufacturing client—a reflection of broader industry dynamics where scaling innovative therapies like automated cell therapy requires balancing operational capabilities with market demands. Berry Street's merger with Healthify aims to expand AI-driven metabolic care by integrating Healthify's AI technology with Berry Street's clinical network—aligning trends toward personalized medicine and digital health integration. On the regulatory front, Spruce Biosciences progresses towards filing for FDA approval of its ultra-rare disease drug candidate emphasizes commitment to developing treatments despite complex pathways promising significant impact for underserved populations. Lastly, TME Pharma remains optimistic about its brain cancer drug nearing partnership conclusions reflecting confidence despite competitive pressures—highlighting key scientific advancements shaping pharmaceutical landscapes emphasizing innovative therapies' focus on improving patient care outcomes through enhanced diagnostics novel therapeutics comprehensive healthcare solutions. Recent developments highlight significant scientific advancements poised to influence patient care trajectories as Capricor Therapeutics received a three-month extension from FDA reviewing additional data refined indication Duchenne muscular dystrophy therapy candidate deramiocel set November 22 action date underscoring FDA commitment thorough evaluation processes providing potential new treatment option pending approval. In contrast, Regenxbio faces FDA hold RGX-121 gene therapy candidate aimed at Hunter syndrome due to small nodules cystic masses spines patients registrational trial highlighting ongoing challenges gene therapy rigorous safety assessments complexities developing advanced genetic treatments. With Roche entering substantial agreement Hanmi Pharmaceutical access investigational obesity drug HM17321 next-generation asset aims induce weight loss enhance lean mass positioning potentially transformative therapy burgeoning weight management market reflecting growing interest competition obesity treatments strategic focus expanding metabolic disorder portfolio. Regulatory business maneuvers paralleled broader industry trends including shifts manufacturing strategies essential advanced therapies innovative approaches underscored recent discussions vivo delivery systems reshaping viral vector production improving efficiency scalability potentially lowering costs accelerating time-to-market further highlighting rigorous safety standards governing clinical research drug development processes landscape therapeutic development continues evolve companies like Novo Nordisk trialing lower maintenance doses oral Wegovy obesity treatment gained significant market traction initiatives reflect ongoing efforts optimize dosing regimens enhance patient compliance outcomes collectively underscore dynamic period pharmaceutical biotech sectors characterized scientific innovation strategic investments regulatory scrutiny implications profound patient care new therapies promise address unmet medical needs navigating complex environments adapt changes influence future drug development strategies therapeutic landscapes significantly events signal not only challenges opportunities companies strive bring novel treatments market safely effectively ultimately aiming improve patient outcomes various disease areas poised intersection technological innovation oversight driving advancements hold potential enhance care expand possibilities.Support the show
Eli Lilly is escalating its fight against companies selling unapproved retatrutide — and this time, the lawsuits could have implications far beyond GLP-1s. Dave Crosland and Scott McNally break down what makes these lawsuits different and what they could mean for research chemical and peptide companies serving the bodybuilding world. Then we get into your questions on Dianabol and estrogen testing, Raloxifene vs. Tamoxifen, cycling with an enlarged prostate, insulin protocols, long-term low-dose Anavar, micro dosing Tren, Masteron and vision issues, and more. 0:00 Will Lilly & Retatrutide Change the Research Chem Market? 0:45 Support the Show 1:25 What the Eli Lilly Lawsuits Could Mean for Bodybuilding 7:45 Lilly Targets Shipping, Social Media & Payment Processing 10:00 Social Media Crackdowns on Steroid & Gear Talk 13:00 Craziest Pre-Workouts Ever 16:50 Does Dianabol Estrogen Show Up on a Standard E2 Test? 18:30 Raloxifene vs. Tamoxifen 20:00 Steroid Cycles With an Enlarged Prostate 24:00 Insulin Protocols: Dave vs. Scott 44:20 Vigorous Steve's Long-Term 5 mg Anavar Experiment 47:40 British Slang 52:00 Can 15–25 mg of Tren Per Week Do Anything? 53:45 Masteron & Vision Issues UK Blood Work Get your Labs done by Dave in the UK : https://evalbloodanalysis.com/home/ Support the Podcast Patreon — Help keep the show growing. Even $5/month makes a difference. https://www.patreon.com/thinkbigbodybuilding Sponsors TRUE NUTRITION — Custom supplements for serious lifters Use code THINK to save https://www.truenutrition.com/THINK STROM SPORTS — Performance supplements trusted by athletes UK: https://tinyurl.com/ydmbfa54 US: https://stromsportsus.com Supplement Source Canada — Top brand supplements with fast shipping http://www.supplementsource.ca Merch Official THINK BIG Merch — Train, represent, support the brand https://think-big.printify.me/products
Wil Bain hears from a business rates expert and a hotel owner about what needs to happen to support pubs and hotels facing high business rates costs. This comes as the government announces an independent review of the way pubs and hotels are valued for business rates in England and Wales.Elsewhere, we'll hear from Canada after trade talks with the United States broke down, with Prime Minister Mark Carney promising to match US tariffs dollar for dollar.And there's a new weight-loss treatment on the market. Eli Lilly's Foundayo, a tablet treatment, becomes available by private prescription today. We'll hear from Eli Lilly and a pharmacist about what makes this new option different.
How to Reinvent Your Career in Medical Sales (Nurses, Trainers & Teachers) | Medical Sales UIn this episode of Medical Sales U, host Dave Sterrett breaks down how former nurses, physical trainers, firefighters, and teachers are breaking into top medical device and biotech companies like Exact Sciences, Pfizer, Canon Surgical, and Eli Lilly. Whether you are looking to break into the industry for the first time or want to reinvent yourself to get better pay, better work-life balance, and more purpose, this panel breakdown gives you the exact blueprint to make it happen. TIMESTAMPS:00:00 - Precision Medicine & Early Detection Impact10:00 - Why Precision Medicine & Oncology 12:25 - Researching Target Companies 13:30 - Real Career Change Stories 17:23 - Why Most Applicants Fail 20:45 - How Narrow Should Your Search Be? 23:30 - What Hiring Managers Look For 25:20 - Interview Prep While Working Full-TimeReady to jumpstart your career in medical device or pharmaceutical sales?
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into the latest strategic moves, regulatory updates, and scientific breakthroughs shaping these dynamic industries. Roche is making headlines with its substantial $750 million investment to expand its Genentech facility in Oregon. This expansion is set to double the plant's capacity by 2031, focusing particularly on enhancing its fill-finish manufacturing capabilities. The fill-finish process is integral to drug production, involving the sterilization and filling of drug products into containers for distribution. This move not only underscores Roche's commitment to strengthening its manufacturing infrastructure but also highlights its strategic foresight in bolstering supply chain resilience. By increasing the production of biologics—key players in oncology, immunology, and neurology—Roche is positioning itself to meet growing global demand and potentially accelerate the delivery of critical medications. In other strategic developments, Ambros Therapeutics and Werewolf Therapeutics have decided to join forces in a $150 million merger. This move focuses on developing treatments for Complex Regional Pain Syndrome Type 1 (CRPS-1), a rare pain disorder. The merger signifies a concerted effort to address niche therapeutic areas by pooling resources and expertise in small molecule development. Such alliances are crucial for innovating treatments for conditions that have historically faced unmet medical needs, paving the way for more targeted therapeutic interventions. Aurinia Pharmaceuticals has reached a significant milestone by settling a patent litigation case with Teva Pharmaceuticals. This settlement secures market exclusivity for Aurinia's drug Lupkynis until December 2036. Lupkynis is used in treating autoimmune conditions, and maintaining this exclusivity gives Aurinia a competitive edge by delaying generic competition. It highlights the importance of robust patent protection strategies in sustaining market share and fostering continued investment in drug innovation. On the regulatory front, the FDA has published 55 product-specific guidances aimed at streamlining generic drug development and accelerating ANDA approvals. These guidances play a pivotal role in enhancing the regulatory framework surrounding generic drug manufacturing, especially within oncology. By providing clearer pathways for approval, the FDA facilitates increased competition and potentially reduces drug costs, impacting patient accessibility and healthcare expenditure positively. However, not all news is favorable. Boehringer Ingelheim has voluntarily put on hold its Phase 1 trial of BI 3031185 due to a safety event involving a small molecule oral drug targeting neurological disorders such as borderline personality disorder and ADHD. Safety holds like this one underline the inherent challenges and risks involved in drug development, emphasizing the critical nature of rigorous safety assessments. Furthermore, political pressures are mounting on the FDA as lawmakers urge caution regarding clinical data from China following deaths in gene therapy trials. This situation underscores ongoing concerns about patient safety and data integrity in global clinical trials, which could have significant implications for international collaborations and regulatory policies. In a regulatory setback, Xspray Pharma received a complete response letter from the FDA for Dasynoc (dasatinib), intended for treating chronic myeloid leukemia and acute lymphoblastic leukemia. Such challenges highlight the complexities of securing approvals for oncology drugs where manufacturing issues can impede progress. Xspray Pharma faced another setback as its approval bid for Dasynoc was rejected again due to ongoing manufacturing concerns—underscoring regulatory scrutiny aimed at ensuring drug safety and efficacy standards are met. Turning our attention to neuroscience innovation, Lundbeck is actively evolving its focus under CEO Charl van Zyl's leadership. Nearly three years into his tenure, van Zyl is steering Lundbeck towards becoming a formidable "neuroscience challenger." This strategy underscores the company's commitment to innovation within the field of neuroscience, potentially leading to new therapeutic discoveries and treatments for neurological disorders. Meanwhile, Novo Nordisk's oral GLP-1 receptor agonist Wegovy is regaining traction as Eli Lilly's rival product experiences delays. This resurgence highlights Wegovy's potential impact within the competitive landscape of oral weight-loss solutions aimed at tackling obesity—a condition affecting millions globally. In Europe, Johnson & Johnson secured EU approval for Tecvayli-Darzalex Combo—a milestone that expands treatment options for multiple myeloma patients through combination therapies. In summary, these developments reflect a landscape marked by significant investments in manufacturing capabilities, strategic mergers targeting rare diseases, robust patent strategies protecting market exclusivity, and regulatory efforts to expedite generic drug approvals. Ongoing challenges within clinical trials emphasize safety and efficacy as central concerns. The implications for patient care include enhanced access to innovative treatments through strategic industry collaborations and regulatory facilitation of generics while maintaining stringent safety standards across drug development processes—all contributing towards advancing patient outcomes worldwide.Support the show
This is the second week of our four-part series on the 7th-leading cause of death in the United States. In this episode, we talk about:—The difference between the Disease Care model that focuses on symptoms and Structure-Function Care which focuses on the root cause of the problem. And how those approaches should work together for best patient results. —How Eli Lilly was put on the map by developing insulin, which was a "game-changer at extending life" for those with Diabetes. And the surprising story of the natural health practitioners that were behind the development of Eli Lilly's insulin. —The important role of pharmaceuticals for treating Diabetes, as well as their side-effects. And why it is always better to treat something naturally in a Structure-Function manner if you can reduce or eliminate the body's need for medication. —The shocking percentage of the adult population who have already tried GLP-1 drugs. And how the GLP-1 drugs are causing serious side-effects, including muscle-wasting (often called "Ozempic butt" and "Ozempic face"). —How Type 1 Diabetes CAN be reversed if diagnosed early enough through regular bloodwork. And how Structure-Function Care can help patients to lessen the amount of insulin they need, which helps to extend their longevity and overall health. —Why it is so important to get your kids checked regularly to help prevent diseases like Diabetes from developing. —The Enteroviruses that are involved in the development of Diabetes. And the importance of proper Zinc and Vitamin D levels in the prevention of Diabetes.—Why Dr. Prather says that food allergies, specifically for milk and gluten, contribute to Type 1 Diabetes in children. —The vitamins, minerals, and herbals that are most helpful for Diabetes. And how Holistic Integration can test to see which supplements will work best for each patient. —Why Dr. Prather calls Homeopathy "the secret weapon" at Holistic Integration. And how it helps Diabetes in multiple ways.http://www.TheVoiceOfHealthRadio.com*Receive exclusive bonus content as a member of our Voice Of Health Patreon Community:https://www.patreon.com/cw/VoiceofHealthPodcast
Earnings calls are a chance to catch up with the latest developments across Big Pharma and beyond, and last quarter was no different. From the rollout of AI to the oral GLP-1 battle between Novo Nordisk and Eli Lilly and new leadership at Sarepta and Sanofi, it feels like the opportunities and challenges for biopharma have never been greater. In this week’s episode of "The Top Line," Fierce Pharma Senior Editor Fraiser Kansteiner and Fierce Biotech Senior Editor James Waldron share their takeaways from another whirlwind season of earnings calls. Alongside a Q2 scorecard breakdown, the Fierce editors discuss how several new CEOs are finding their footing, which drugs appear poised to cross the $1 billion sales threshold in 2026 and more. To learn more about the topics in this episode: Biopharma saw a Q2 sales boom led by Lilly, Sanofi, Regeneron and Astellas Sanofi’s new CEO ‘looking deeply’ at late-stage pipeline as clinical clearout continues Novo CEO has 'no doubt' on eventual share price recovery as Wegovy pill continues to wow Sarepta’s new CEO Michael Severino faces critical milestones to prove growth See omnystudio.com/listener for privacy information.
In der heutigen Folge sprechen die Finanzjournalisten Nando Sommerfeldt und Holger Zschäpitz über Broadcoms Schuldenplan, Georgs geniale Gas-Idee und die historischen Auswüchse am Anleihemarkt. Außerdem geht es um Walmart, Advance Auto Parts, AutoZone, O'Reilly Automotive, Home Depot, Lowe's, TJX Companies, Coty, JD Sports Fashion, Adidas, Puma, Fresenius, Fresenius Medical Care, Sartorius, UBS, Tonies, Korea Gas Corporation, Vontobel, Alibaba, Deere, Broadcom, Apollo Global Management, Blackstone, Goldman Sachs, Bank of America, Nvidia, Apple, Microsoft, Amazon, Alphabet, TSMC, Meta Platforms, Samsung Electronics, ASML, SK Hynix, Deutsche Börse, Moderna, BioNTech, Eli Lilly, Novo Nordisk, Mini Future Long auf den TTF-Gaspreis von Vontobel, (WKN: VY80G4), Vanguard FTSE Global All-Cap ETF thesaurierend (WKN: A42B1M), Vanguard FTSE Global All-Cap ETF ausschüttend (WKN: A42B1N), Vanguard FTSE Global Small-Cap ETF thesaurierend (WKN: A42B1P), Vanguard FTSE Global Small-Cap ETF ausschüttend (WKN: A42B1Q), Vanguard FTSE All-World ex-U.S. UCITS ETF thesaurierend (WKN: A42B1R), Vanguard FTSE All-World ex-U.S. ETF ausschüttend (WKN: A42B1S), SPDR MSCI ACWI IMI ETF (WKN: A1JJTD), Vanguard ESG Global All Cap ETF thesaurierend (WKN: A2QL8U), Vanguard FTSE All-World ETF thesaurierend (WKN: A2PKXG), Vanguard FTSE All-World ETF ausschüttend (WKN: A1JX52). Am 2. Oktober findet unser „Alles auf Aktien“-Summit in Berlin statt. Mit dem Code „AAAFRIENDS“ sparst du 50 Prozent auf dein Ticket – aber nur unter folgendem Link: https://veranstaltung.businessinsider.de/event/financesummit26/summary?rp=c6dc55d6-6f4f-4fb4-b75f-3f3501d84859 Wir freuen uns an Feedback über aaa@welt.de. Holt euch jetzt den exklusiven NordVPN-Deal inkl. 4 Bonusmonaten mit dem Code Allesaufaktien oder unter https://nordvpn.com/allesaufaktien Noch mehr "Alles auf Aktien" findet Ihr bei WELTplus und Apple Podcasts – inklusive aller Artikel der Hosts. Hier bei WELT: https://www.welt.de/podcasts/alles-auf-aktien/plus247399208/Boersen-Podcast-AAA-Bonus-Folgen-Jede-Woche-noch-mehr-Antworten-auf-Eure-Boersen-Fragen.html. Hier könnt ihr den AAA-Newsletter abonnieren: https://www.welt.de/newsletter/article232797673/Alles-auf-Aktien-Der-taegliche-Boersen-Newsletter-fuer-WELTplus-Abonnenten.html Und – ganz neu: AAA gibt es jetzt auch auf Instagram: https://www.instagram.com/alles_auf_aktien/ Disclaimer: Die im Podcast besprochenen Aktien und Fonds stellen keine spezifischen Kauf- oder Anlage-Empfehlungen dar. Die Moderatoren und der Verlag haften nicht für etwaige Verluste, die aufgrund der Umsetzung der Gedanken oder Ideen entstehen. Hörtipps: Für alle, die noch mehr wissen wollen: Holger Zschäpitz können Sie jede Woche im Finanz- und Wirtschaftspodcast "Deffner&Zschäpitz" hören. +++ Werbung +++ Du möchtest mehr über unsere Werbepartner erfahren? Hier findest du alle Infos & Rabatte! https://linktr.ee/alles_auf_aktien Anzeige: Eight Sleep: Der Pod 5 reguliert die Temperatur im Bett automatisch, trackt Schlaf- und Gesundheitswerte ohne Wearable und kann so zu besserem Schlaf beitragen. Mit dem Code ALLESAUFAKTIEN erhaltet ihr auf https://www.eightsleep.com/allesaufaktien bis zu 350 Euro Rabatt. Impressum: https://www.welt.de/services/article7893735/Impressum.html Datenschutz: https://www.welt.de/services/article157550705/Datenschutzerklaerung-WELT-DIGITAL.html
Decentralized clinical Trials (DCTs) bring some or all elements of a clinical trial closer to patients. Consent, screening, treatment administration, and more can be administered through digital technologies and local health care providers, expanding accessibility for patients who face barriers to participation in traditional single site trials. In this episode, CANCER BUZZ speaks with Erin Pierce, MSN, APRN, FNP-C, Associate Clinical Investigator and Nurse Practitioner at HonorHealth Research Institute, and Kristen Kipping-Johnsson, MPH, Director of Network Research Operations at the University of Chicago, about how each of their cancer programs are approaching DCT implementation. Their discussion explores how decentralized components, such as community-based treatment delivery, centralized research infrastructure, and hybrid trial designs, can increase participation opportunities for patients in both community and academic settings. Guests: Erin Pierce, MSN, APRN, FNP-C Associate Clinical Investigator Nurse Practitioner HonorHealth Research Institute Scottsdale, AZ Kristen Kipping-Johnson, MPH Director of Network Research Operations University of Chicago Chicago, IL "APPs are really poised to step into that role [of investigator] and help, not take the place of physicians, but work alongside our physician colleagues and enable us to expand the abilities of research." —Erin Pierce, MSN, APRN, FNP-C "Quality of life, being able to keep patients treated closer to home, allow them to stay with the physician that diagnosed them...Those are the things that are really important to me when it comes to decentralization." —Kristen Kipping-Johnson, MPH Resources HonorHealth Research Institute's First Steps to Approaching Decentralized Clinical Trials (DCTs) University of Chicago's Path to Operationalizing Decentralized Phase 1 Trials Across a Regional Network ACCC's Community Oncology Research Institute White Paper: Bringing Cancer Research to the Community: Strategic Approaches to Representative Oncology Clinical Trial Design This podcast was created in partnership with the Decentralized Trials & Research Alliance, with support from Eli Lilly and Company, Gilead Sciences, and Merck.
After a five-year hiatus, Dan Go returns to break down a sustainable approach to fat loss for busy people who do not have hours to spend in the gym. He explains why identifying the main physiological or psychological bottleneck—such as late-night eating, stress, grazing, or weekend overeating—can matter more than simply handing someone a meal plan. The conversation covers calorie tracking for awareness, protein and fiber for satiety, meal timing, restaurant strategies, preserving muscle with low-volume strength training, FFMI as an alternative to BMI, and a balanced view of GLP-1 medications that considers both their benefits and trade-offs. Dan Go is a fitness coach and entrepreneur whose work focuses on helping busy professionals, founders, and entrepreneurs improve their body composition, health, and performance through sustainable nutrition, behavior change, and efficient training. His coaching approach emphasizes identifying the specific habits, beliefs, and environmental factors that make fat loss difficult, then building practical systems and guardrails that clients can maintain long term. Rather than relying on extreme diets or high-volume workouts, he focuses on awareness, consistency, adequate protein, structured eating, and time-efficient strength training to help clients lose fat while preserving muscle. [Dan Go Official Website] — Dan Go (Dan Go) https://www.dango.co/ [The High Performance Journal] — Dan Go (Dan Go) https://www.dango.co/newsletter [Dan Go on X] — Dan Go (X (formerly Twitter)) https://x.com/CoachDanGo [Dan Go on Instagram] — Dan Go (Instagram) https://www.instagram.com/coachdango/ [Dan Go Private Coaching] — High Performance Founder / Dan Go (High Performance Founder) https://highperformancefounder.com/private-coaching [Why I Quit Drinking Alcohol] — Mark Manson (Mark Manson) https://markmanson.net/why-i-quit-drinking-alcohol [A Satiety Index of Common Foods] — S. H. Holt, J. C. Miller, P. Petocz & E. Farmakalidis (PubMed) https://pubmed.ncbi.nlm.nih.gov/7498104/ [Fat-Free Mass Index (FFMI) Research] — Loenneke et al. (PubMed Central (PMC)) https://pmc.ncbi.nlm.nih.gov/articles/PMC3445648/ [ChatGPT] — OpenAI (ChatGPT) https://chatgpt.com/ [Claude] — Anthropic (Claude) https://claude.com/ [Mounjaro (tirzepatide)] — Eli Lilly and Company (Mounjaro) https://mounjaro.lilly.com/ [Ozempic (semaglutide)] — Novo Nordisk (Ozempic) https://www.ozempic.com/ Show Notes 00:00 Welcome to the Hart2Heart Podcast 00:49 Rapid Fat Loss Setup 01:11 Find The Bottleneck 02:38 Late Night Eating Roots 04:21 Mark Manson Case Study 05:55 Metabolic Reset Phase 06:38 After Weight Loss Plan 09:29 Remove Obstacles First 10:59 Sustainable Diet Rules 13:03 No Cheat Meals 13:15 90 10 Ratio Diet 15:27 Tracking For Awareness 18:12 Calorie Blind Spots 19:45 Guardrails Not Counting 21:43 Satiety And Fiber 24:24 GLOP Protein Breakfast 28:36 Why Eat Breakfast 30:14 Breakfast Beats Stress 31:22 Night Eating Guardrails 32:53 Sleep and Late Meals 34:15 Restaurant Ordering Hacks 38:49 Keep Muscle While Cutting 45:30 FFMI Over BMI 47:31 GLP-1s Balanced Take 54:25 Dosing and Nutrition Guardrails 57:50 Men vs Women Fat Loss 59:58 Where to Find Dan Go The Hart2Heart podcast is hosted by family physician Dr. Michael Hart, who is dedicated to cutting through the noise and uncovering the most effective strategies for optimizing health, longevity, and peak performance. This podcast dives deep into evidence-based approaches to hormone balance, peptides, sleep optimization, nutrition, psychedelics, supplements, exercise protocols, leveraging sunlight, and de-prescribing pharmaceuticals — using medications only when absolutely necessary. Beyond health science, we explore the intersection of public health and politics, exposing how policy decisions shape our health landscape and what actionable steps people can take to reclaim control over their well-being. Guests range from out-of-the-box thinking physicians such as Dr. Casey Means (author of "Good Energy") and Dr. Roger Sehult (Medcram lectures) to public health experts such as Dr. Jay Bhattacharya (Director of the National Institutes of Health (NIH) and Dr. Marty Mckary (Commissioner of the Food and Drug Administration (FDA) and high-profile names such as Zuby and Mark Sisson (Primal Blueprint and Primal Kitchen). If you're ready to take control of your health and performance, this podcast is for you.We cut through the jargon and deliver practical, no-BS advice that you can implement in your daily life, empowering you to make positive changes for your well-being. Connect with Dr. Mike Hart Instagram: @drmikehart Twitter: @drmikehart Facebook: @drmikehart
August 14, 2026: Your daily rundown of health and wellness news, in under 5 minutes. Today's top stories: JG Wentworth survey finds 92% of US adults have delayed or abandoned medical care due to cost, creating an opening for lower-cost consumer health models Regenerative farming products hit $2B in annual US retail sales as 40 global food companies sign onto an initiative tying sourcing to soil health Eli Lilly files six lawsuits against sellers of unapproved retatrutide as CBP intercepts nearly 90,000 illicit GLP-1 vials in July alone Today's episode is brought to you by AIIR — a modern communications and experiential agency for health, wellness, fitness, and performance brands. From earned media to events and creator-led campaigns, AIIR helps companies sharpen their story, earn attention, and build trust that compounds. Visit https://aiir.agency to learn more. 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
P.M. Edition for Aug. 5. Seven-year-old Whatnot is gaining popularity among people drawn to its high-energy live auction sales on everything from fashion to trading cards. But as WSJ retail reporter Hanna Krueger discusses, some users say they're hooked even when they feel like they should walk away. Plus, progressive candidate Abdul El-Sayed clinched the Democratic senate nomination in a closely-watched race in Michigan. We hear from Journal reporter Terell Wright about what this means for the Democratic party's future. And Google shakes up the leadership of its AI operations as it struggles to keep pace with competitors' top models. Alex Ossola hosts. Whatnot, the Live Shopping App Where Some People Bid Until They're Broke Sign up for the WSJ's free What's News newsletter. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.
SpaceX on the move in after-hours trading on the back of its first earnings report since going public. Can investors expect SpaceX to blast off, or will the aerospace giant sink even further below its IPO price?Then, major Pharma earnings from giants like Pfizer and Merck beating Wall Street estimates with Amgen and Eli Lilly on deck. Founder and CEO of Portal Innovations John Flavin lays out the best trades in the Pharma market, and his reaction to Novo Nordisk's slide after disappointing guidance. Plus, why Morgan Stanley is bearish on AMD, digging into Caterpillar earnings, and can McDonald's make a comeback? Fast Money Disclaimer Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.
This week, we're bringing you an episode of WSJ's Take On the Week. Host Telis Demos and guest host Spencer Jakab, investing columnist and writer of the Markets A.M. newsletter, are joined by Kaitlin Hendrix, asset allocation research director at Dimensional Fund Advisors, to decode investors' surging interest in private markets. They break down how investors may already have exposure in their investment portfolios to private companies like Anthropic, Stripe and Flipkart, through holdings in companies like Alphabet's Google, Amazon and Nvidia. Hendrix explains why your public index fund might already provide the diversification you're looking for, without the high fees. Plus, Jakab explains the way that big tech's private company investments are boosting earnings to near-unprecedented levels. To watch the video version of this episode, visit our WSJ Podcasts YouTube channel or the video page of WSJ.com Sign up for the WSJ's free What's News newsletter. Further Reading: Earnings Forecasts Are on Steroids For more coverage of the markets and your investments, head to WSJ.com, WSJ's Heard on The Street Column, and WSJ's Live Markets blog. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.
As cyclosporiasis cases continue to rise, HHS Sec. Robert F. Kennedy Jr. insists the federal government has outbreaks “under control.” New Jersey Gov. Mikie Sherrill reveals that thousands of non-citizens were added to the voter rolls after a DMV glitch. And Novo Nordisk sues fellow obesity drugmaker Eli Lilly over a critical ad. Learn more about your ad choices. Visit podcastchoices.com/adchoices
The Ukrainian President Volodymyr Zelensky has fired his army commander-in-chief, Oleksandr Syrskyi, in one of the biggest shake-ups of the country's military leadership since the start of Russia's full-scale invasion. General Syrskyi had clashed with the popular defence minister, Mykhailo Fedorov, whose own removal from office last week triggered rare mass protests in Ukraine. Also: France becomes the first country in the EU to ban children under the age of 15 from using social media. A special report from the school in Iran where 156 people, mostly children, were killed at the start of the US-Israeli war. As Venezuela's ousted leader Nicolás Maduro is due back in court in New York, Venezuelans tell the BBC they are too focused on trying to rebuild their lives after the earthquakes to give much thought to the criminal proceedings. The maker of Wegovy and Ozempic, Novo Nordisk, has launched legal action against its rival Eli Lilly, accusing it of false advertising in suggesting its weight-loss drugs perform better. Animal welfare experts in Britain are looking after a marmoset monkey that was found abandoned in a laundry bag on a London bus. And we look at the new developments in sleep health technology focusing on disease prediction.The Global News Podcast brings you the breaking news you need to hear, as it happens. Listen for the latest headlines and current affairs from around the world. Politics, economics, climate, business, technology, health – we cover it all with expert analysis and insight. Get the news that matters, delivered twice a day on weekdays and daily at weekends, plus special bonus episodes reacting to urgent breaking stories. Follow or subscribe now and never miss a moment. Get in touch: globalpodcast@bbc.co.ukPhoto: Ukraine's President Zelensky and now former Commander in Chief of the Ukrainian Armed Forces, Colonel General Oleksandr Syrskyi, visit an exhibition of new Ukrainian made drone-missiles Peklo in Kyiv. Credit: REUTERS/Valentyn Ogirenko