Podcasts about fda approval

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. ## Breakthrough in Cancer TreatmentIn a groundbreaking study published in the Journal of Oncology, researchers have discovered a new combination of drugs that has shown promising results in treating pancreatic cancer. The study, which involved over 500 patients, found that the combination of drug A and drug B was able to significantly shrink tumors in over 70% of patients. This discovery has the potential to revolutionize the way we treat pancreatic cancer and could lead to improved outcomes for patients in the future.## FDA Approves New Drug for Alzheimer's DiseaseThe FDA has approved a new drug for the treatment of Alzheimer's disease, marking a major milestone in the fight against this devastating condition. The drug, which works by targeting the underlying causes of Alzheimer's, has shown promising results in clinical trials and is now available to patients across the country. This approval represents a significant step forward in our understanding of Alzheimer's disease and offers hope to the millions of people affected by this condition.## Vaccine Update: Delta VariantWith the rise of the Delta variant, there has been growing concern about the effectiveness of existing vaccines against this strain of the virus. However, recent studies have shown that current vaccines are still highly effective at preventing severe illness and hospitalization caused by the Delta variant. While breakthrough infections may occur, the vaccines are still providing robust protection against the worst outcomes of COVID-19. This is reassuring news as we continue to navigate the ongoing pandemic.## Collaboration Leads to New Drug DevelopmentA collaboration between two pharmaceutical companies has resulted in the development of a new drug for the treatment of rare genetic disorder. By pooling their resources and expertise, the two companies were able to accelerate the drug development process and bring this much-needed treatment to market sooner than would have been possible on their own. This successful collaboration serves as a model for future partnerships in the pharmaceutical industry and highlights the importance of working together to advance medical research.## ConclusionIn conclusion, these recent developments in cancer treatment, Alzheimer's disease, vaccine effectiveness, and collaborative drug development represent significant advances in the field of Pharma and Biotech. With ongoing research and innovation, we can look forward to more breakthroughs that will improve patient outcomes and change the landscape of healthcare. Thank you for listening to Pharma and Biotech daily, where we bring you the latest news and updates from the world of pharmaceuticals and biotechnology.

Welcome to another episode of the Oncology Brothers podcast! In this episode, we dived into the recent FDA approval of Durvalumab combined with chemotherapy for resectable muscle-invasive bladder cancer, based on the NIAGARA trial. Join us as we chat with Dr. Thomas Powles, a GU medical oncologist and the lead author of the NIAGARA trial. We discussed the study design, the significant improvements in overall survival, and the implications of this new treatment approach. Dr. Powles shared insights on the use of immunotherapy in the perioperative setting, the importance of pathological complete response, and the safety of combining Durvalumab with chemotherapy. Key topics covered in this episode: •⁠  ⁠Overview of the NIAGARA trial and its findings •⁠  ⁠Comparison of Durvalumab and cisplatin-based chemotherapy outcomes •⁠  ⁠The significance of event-free survival and overall survival rates •⁠  ⁠Insights on managing side effects and treatment sequencing •⁠  ⁠The evolving role of ctDNA in determining treatment strategies YouTube: https://youtu.be/s_tXoX5yhV8 Follow us on social media: •⁠  ⁠X/Twitter: https://twitter.com/oncbrothers •⁠  ⁠Instagram: https://www.instagram.com/oncbrothers •⁠  Website: https://oncbrothers.com/ Tune in to learn how these advancements are changing the landscape of bladder cancer treatment and improving patient outcomes. Don't forget to like, subscribe, and check out our other episodes for more insights on oncology and FDA approvals! #OncologyBrothers #BladderCancer #Dervalumab #FDAApproval #NiagaraTrial #Immunotherapy #CancerResearch #OncologyPodcast

In this episode of Tickers, Dr. Matthew Preston & Dr. Thaon Simms analyze Indies Pharma (INDIES) and its potential to reach $5 per share!

Roger Seheult, MD of MedCram explains a new FDA approved medication for COPD and the ENHANCE trials. See all Dr. Seheult's videos at: https://www.medcram.com/ (This video was recorded on April 28th, 2025) Roger Seheult, MD is the co-founder and lead professor at https://www.medcram.com He is Board Certified in Internal Medicine, Pulmonary Disease, Critical Care, and Sleep Medicine and an Associate Professor at the University of California, Riverside School of Medicine. MEDCRAM WORKS WITH MEDICAL PROGRAMS AND HOSPITALS: MedCram offers group discounts for students and medical programs, hospitals, and other institutions. Contact us at customers@medcram.com if you are interested. MEDIA CONTACT:  Media Contact: customers@medcram.com Media contact info: https://www.medcram.com/pages/media-c... Video Produced by Kyle Allred FOLLOW US ON SOCIAL MEDIA: https://www.facebook.com/MedCram https://twitter.com/MedCramVideos https://www.instagram.com/medcram DISCLAIMER: MedCram medical videos are for medical education and exam preparation, and NOT intended to replace recommendations from your doctor. #COPD #FDA #Ensifentrine

Video Version Only on HCPLive! In this episode of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, break down new Phase 3 data from the ESSENCE trial examining semaglutide 2.4 mg (Wegovy) for metabolic dysfunction-associated steatohepatitis (MASH) with stage 2 or 3 fibrosis. With results published in The New England Journal of Medicine, hosts are joined by first author Arun J. Sanyal, MD, director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health at Virginia Commonwealth University, to discuss key takeaways from part 1 of the ESSENCE trial, semaglutide's impact on liver outcomes and weight loss, and what the data could mean for the future of MASH treatment. ESSENCE Once-weekly semaglutide 2.4 mg significantly improved liver outcomes in patients with metabolic dysfunction–associated steatohepatitis (MASH) and stage 2 or 3 fibrosis, according to findings from the ESSENCE trial. In part 1 of the ongoing, double-blind, placebo-controlled trial, 800 patients were evaluated at 72 weeks for two primary endpoints: resolution of steatohepatitis without worsening fibrosis, and fibrosis improvement without worsening steatohepatitis. Spanning 253 sites in 37 countries, the full trial enrolled 1197 biopsy-confirmed patients between May 2021 and April 2023. At the interim analysis, semaglutide achieved both primary endpoints. Resolution of steatohepatitis without fibrosis worsening occurred in 62.9% of patients receiving semaglutide compared with 34.3% in the placebo group (difference, 28.7%; 95% CI, 21.1–36.2; P

How does crowdfunding fit into a startup's fundraising strategy? In this intriguing episode of The Angel Next Door Podcast, host Marcia Dawood converses with guest Woodie Neiss about how crowdfunding has emerged as a transformative option for entrepreneurs seeking capital. The conversation unveils the ways securities-based crowdfunding is reshaping how new ventures are funded, making investments more accessible to various investors.Woodie Neiss, an experienced entrepreneur and a key advocate for crowdfunding legislation, shares his journey from Wall Street to becoming a pivotal figure in changing securities laws. His efforts have helped launch a thriving crowdfunding industry that offers over $2.8 billion in raised capital to more than 8,000 startups. He is also one of the founders of Crowdfund Capital Advisors (CCA), a crowdfunding advisory, implementation, and education firm.This episode is a must-listen for anyone involved in entrepreneurship, providing insights into significant crowdfunding developments and statistics. Woodie discusses how the industry has evolved, highlighting trends in sectors like healthcare and technology, and explaining how crowdfunding complements traditional fundraising strategies. Whether you're an investor, entrepreneur, or policymaker, this episode offers valuable perspectives on the current and future state of investment crowdfunding. To get the latest from Woodie Neiss, you can follow him below!https://www.linkedin.com/in/sherwoodneiss/https://crowdfundcapitaladvisors.com/https://a.co/d/f9987We - Investomers: How Customers-Turned-Investors are Shaping the Future of Early-Stage Finance Sign up for Marcia's newsletter to receive tips and the latest on Angel Investing!Website: www.marciadawood.comLearn more about the documentary Show Her the Money: www.showherthemoneymovie.comAnd don't forget to follow us wherever you are!Apple Podcasts: https://pod.link/1586445642.appleSpotify: https://pod.link/1586445642.spotifyLinkedIn: https://www.linkedin.com/company/angel-next-door-podcast/Instagram: https://www.instagram.com/theangelnextdoorpodcast/TikTok: https://www.tiktok.com/@marciadawood

This week, Rachel and Liz discuss Liz's conversation with Nada Hanafi on the FDA approval pathway and how training can be used to mitigate risk. They share what they learned from Nada about the process and their insights for developing curriculum that has high standards to ensure patient safety. In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your clinical trial training strategies? Contact us at training@cumbyconsulting.com.Related Resources:Nada's interview Subscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe!Connect with us on LinkedIn:   ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠About Cumby Consulting:   Cumby Consulting's team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

Welcome to another episode of the Oncology Brothers podcast! In this episode, Drs. Rohit and Rahul Gosain are joined by Dr. Aman Chauhan, a medical oncologist specializing in neuroendocrine tumors from Sylvester Comprehensive Cancer Center in Miami. As of April 2025, the oncology landscape has seen 10 new FDA approvals, including the recent approval of cabozantinib for neuroendocrine tumors based on the CABINET study. The discussion dived deep into the implications of this approval, the study design, and how cabozantinib fits into the treatment landscape for both pancreatic and extra-pancreatic neuroendocrine tumors. Key topics covered in this episode include: •⁠  ⁠The evolution of treatment options for neuroendocrine tumors •⁠  ⁠Insights into the CABINET study design and results •⁠  ⁠Sequencing treatment options for patients with neuroendocrine tumors •⁠  ⁠Side effects and management strategies for cabozantinib •⁠  ⁠The importance of personalized treatment approaches in oncology Join us as we explore the exciting advancements in neuroendocrine tumor management and what they mean for patients and oncologists alike. Don't forget to like, subscribe, and check out our other discussions on FDA approvals, toxicity management, and conference highlights! Follow us on social media: •⁠  ⁠X/Twitter: https://twitter.com/oncbrothers •⁠  ⁠Instagram: https://www.instagram.com/oncbrothers •⁠  Website: https://oncbrothers.com/ Don't forget to like, subscribe, and hit the notification bell for more updates on oncology insights!

Orthocell Ltd chairman John van der Wielen talked with Proactive about the company receiving FDA clearance for its nerve repair product, Remplir, paving the way for entry into the multi-billion US healthcare market. The approval marks a significant milestone in Orthocell's international growth strategy and reflects the strength of its regulatory and clinical capabilities. Van der Wielen emphasised the significance of breaking into the US market in a challenging regulatory environment. “Not many people would have thought with the current US turmoil, a company like ours could achieve FDA clearance,” he said. Orthocell has established operations in the US with logistics and distribution already in place. The company is implementing a hybrid sales model using in-house personnel and regional distributors, aiming for rapid initial uptake with an eye on more exclusive arrangements in the future. Remplir's three-year shelf life and no temperature control requirement make it ideal for streamlined deployment. He also highlighted that Orthocell has already performed over 2,000 procedures in Australia and anticipates the US market to be 20 to 30 times larger, creating a strong revenue opportunity. With $32 million in cash reserves, the company expects to become cash flow positive within two years.

Spinocerebellar ataxia includes a group of rare, genetic, neurodegenerative disorders. People with the condition suffer from the loss of balance, coordination, and muscle control. As the condition progresses, people can lose the ability to walk and speak. There is no approved treatment for SCA, but Biohaven has applied to the U.S. Food and Drug Administration to begin marketing its experimental therapy troriluzole, which can normalize levels of glutamate, a key neurotransmitter implicated in the disease. We spoke to Melissa Beiner, senior medical director at Biohaven, about spinocerebellar ataxia, the company's therapy under review at the FDA to treat the condition, and why it may have the potential to benefit a number of other neurological conditions as well.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Sanofi and Alnylam have received FDA approval for the first RNAi treatment for hemophilia, with the drug, Qfitlia, indicated for both hemophilia A and B. This approval is significant as it can be given regardless of the presence of neutralizing antibodies against clotting factors VIII or IX. However, the sudden departure of FDA director Peter Marks has caused uncertainty in the biopharma industry. In other news, Vertex has cut a diabetes asset but analysts remain optimistic about their phase III option. Lilly's RNA silencer has shown promising results in lowering a key cardiovascular biomarker. Trilink is offering custom guide RNAs for CRISPR workflow to accelerate therapy discoveries. Despite market challenges, the cell and gene therapy sector has seen a 30% investment surge. Companies like Amgen, Aldeyra, and Argenx are among those with upcoming FDA actions. Arbutus has announced layoffs, while big pharmas are pushing boundaries in radiopharmaceuticals. Michelle Werner of AltoRNA is focused on making better drugs. Safety questions are looming in Duchenne as Dyne and Wave plan FDA filings. There are job opportunities available in data management and program leadership within the biopharma industry.Moving on to other news, several big pharmaceutical companies such as Novartis, Bayer, AstraZeneca, Bristol Myers Squibb, and Eli Lilly are competing in the radiopharmaceuticals market, which is projected to be worth over $13 billion by 2033. The FDA is expected to announce decisions on therapies for dry eye disease soon. Michelle Werner, CEO of AllTrna, is focused on developing trna-based treatments for various diseases.Safety concerns are emerging in the Duchenne muscular dystrophy space as companies like Dyne and Wave plan FDA filings. The EU rejected Lilly's Alzheimer's drug Kisunla, Biontech's bispecific showed promise in treating SCLC patients, and Wave's duchenne exon-skipper reversed muscle damage in a mid-stage trial. Job opportunities within the biopharma industry were also highlighted for those interested.Thank you for tuning in to Pharma and Biotech daily - keeping you updated on all the latest news in the world of pharmaceuticals and biotechnology.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. The Department of Health and Human Services, led by Secretary Robert F. Kennedy Jr., has revealed intentions to reduce 10,000 positions and restructure departments. The appointment of vaccine critic David Geier to investigate vaccine safety within the CDC has also been announced. Soleno has recently obtained FDA approval for a medication designed to address hyperphagia in Prader-Willi syndrome patients. Meanwhile, Johnson & Johnson's combination therapy for lung cancer has displayed encouraging outcomes. A power struggle at Aurion has resulted in Alcon taking control, amidst allegations of impeding Aurion's IPO plans. Opportunities in the biopharma industry are available at the United States Pharmacopeia, alongside updates on biopharma layoffs and industry advancements. That's all for today's episode. Stay tuned for more essential news from the world of Pharma and Biotech. Thank you for listening.

In our exclusive interview, Dr Uboha discussed the significance of this approval, key efficacy and safety data from the pivotal phase 3 RATIONALE-306 trial (NCT03783442), and considerations for integrating this agent into the ESCC treatment paradigm. 

More good news about Omega-3s for heart health; Addressing early-stage dementia; When Lyme Disease doesn't respond to antibiotics; Ultra-processed food hijacks brain within days; Exosomes and adaptive deep-brain stimulation offer hope for Parkinson's; Psychologists conclude relentless “pursuit of happiness” may exhaust our brains' control centers; A common over-the-counter drug taken in pregnancy may hike offsprings' risk of ADHD. 

Send us a textWhat if we could skip glass slides altogether and go straight from fresh tissue to digital image? Muse Microscopy's SmartPath device aims to do just that, capturing diagnostic-quality images directly from fresh tissue. In this episode brought to you by Muse Microscopy, I sit down with Dr. Rao and Dr. Edwards to discuss the insights, challenges, and future of this groundbreaking technology. We explore its regulatory ramifications, change management in veterinary and human pathology, and financial feasibility. Tune in to learn why SmartPath could be a game-changer for both pathologists and patients.00:00 Introduction to SmartPath Technology00:54 Meet the Experts: Dr. Rao and Dr. Edwards01:08 FDA Approval and Implementation Plans01:35 Change Management in Pathology01:56 Training Pathologists for SmartPath03:48 Translational Tissue Banking and Clinical Applications04:29 Impact on Breast Pathology05:49 Pathologists' Reception and Adoption14:33 Financial Viability and ROI19:44 Conclusion and Future ProspectsLinks and Resources:This episode on YouTubeMuse Microscopy WebsiteSmartPath Device Demo VideoSupport the showBecome a Digital Pathology Trailblazer get the "Digital Pathology 101" FREE E-book and join us!

The technology was previously funded by the Foundation for the treatment of retinitis pigmentosa and dry age-related macular degeneration.

Welcome to the Oncology Brothers podcast! In this episode, Drs. Rahul and Rohit Gosain are joined by Dr. Anwaar Saeed, Chief of GI Medical Oncology at UPMC, to discuss the recent approval of Tislelizumab, a new checkpoint inhibitor for upper GI malignancies, including esophageal squamous cell cancer, GE junction, and gastric cancer. We dive deep into the studies that led to Tislelizumab's approval, including the Rationale 302, 305, and 306 trials. Dr. Saeed explains the unique mechanism of action of Tislelizumab, its higher binding affinity to PD-1, and how it compares to other PD-1 inhibitors like nivolumab and pembrolizumab. Key topics covered in this episode: •⁠  ⁠Overview of Tislelizumab and its mechanism of action •⁠  ⁠Insights from the Rationale 306 trial and its implications for frontline treatment •⁠  ⁠Discussion on the Rationale 305 trial focusing on adenocarcinoma •⁠  ⁠The importance of PD-L1 testing and biomarker-driven treatment decisions •⁠  ⁠Side effect profiles of Tislelizumab compared to other immunotherapies •⁠  ⁠Future directions in the use of immunotherapy for upper GI malignancies Join us for this informative discussion that highlights the evolving landscape of cancer treatment and the importance of precision oncology. If you find this episode helpful, please share it with your colleagues and leave us a review! YouTube: https://youtu.be/hQeLdpSzGCk Follow us on social media: •⁠  ⁠X/Twitter: https://twitter.com/oncbrothers •⁠  ⁠Instagram: https://www.instagram.com/oncbrothers •⁠  Website: https://oncbrothers.com/ Don't forget to subscribe for more practice-changing discussions in the world of oncology. We are the Oncology Brothers!  

Dr Tap discusses the significance of the FDA approval of vimseltinib for symptomatic TGCT, in which surgical resection may worsen functional limitation or cause severe morbidity. He also discussed key efficacy and safety data from the pivotal phase 3 MOTION trial and the increasingly important role that multidisciplinary collaboration will play as this targeted therapy is further integrated into clinical practice. 

Dr. Hoffman continues his conversation with Dr. Kieran Murphy, author of “The Essence of Invention: Medicine and the Joy of Creativity,”

In this episode of the Intelligent Medicine podcast, Dr. Ronald Hoffman interviews Professor Kieran Murphy, an interventional neuro radiologist and prolific inventor from Toronto Western Hospital. Dr. Murphy has developed numerous innovative medical devices and filed 60 patents. He shares insights from his book, “The Essence of Invention: Medicine and the Joy of Creativity,” discussing his work on medical innovation, his unique background, and personal experiences that have driven his creative solutions. The conversation covers various topics, including the importance of creativity, the impact of bureaucracy on modern medicine, and groundbreaking innovations like ozone therapy for herniated discs and a radio-protective supplement for medical personnel. Dr. Murphy emphasizes mindfulness and paying attention to phenomena as key components for fostering creativity and innovation in medicine.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Pfizer and Eli Lilly are considering reshoring manufacturing in the U.S. in response to President Trump's tariff threats. Biohaven faces setbacks in clinical trials, while Roche gains FDA approval for a stroke drug expansion. Startup Delphia aims to use a precision medicine approach to target cancer cells. Industry leaders will discuss orphan drug development at the World Orphan Drug Congress 2025. Other news includes Beigene's label expansion, AstraZeneca and Daiichi Sankyo's success with Enhertu in stomach cancer, and Atara's restructuring.

Dr Fakih discusses the significance of this approval, key findings from the pivotal CodeBreaK 300 trial (NCT05198934), and how this combination fits into the current KRAS G12C–mutated mCRC treatment paradigm.

In today's episode, we had the pleasure of speaking with Aditya Bardia, MD, MPH, FASCO, about the FDA approval of fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) for the treatment of adult patients with unresectable or metastatic, hormone receptor–positive, HER2-low or -ultralow breast cancer, as determined by an FDA-approved test, that has progressed on at least 1 endocrine therapy in the metastatic setting. Dr Bardia serves as a professor in the Department of Medicine in the Division of Hematology/Oncology and is the director of Translational Research Integration at the UCLA Health Jonsson Comprehensive Cancer Center. In our exclusive interview, Dr Bardia discussed the significance of this approval, findings from the pivotal DESTINY-Breast06 trial (NCT04494425), and what this new indication for T-DXd means for the future of HER2 testing in breast cancer.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.The Epic Act has been reintroduced in Congress to remove the IRA's 'pill penalty', with hopes for positive changes. However, budgetary constraints may make it challenging for the current administration to make significant amendments to the IRA. As money continues to flow into weight loss drugs, physicians are prioritizing efficacy and access. Emalex is moving towards FDA approval after a successful Phase III trial for Tourette Syndrome. AstraZeneca also received positive Phase III results for an oral breast cancer drug. SpringWorks Therapeutics successfully turned a Pfizer 'ghost drug' into a victory by keeping a rare disease program alive with the help of advocacy groups. This success story has led experts to believe that this method could be applied to other rare diseases as well. The company serves as a case study for how to mine biopharma's IP storeroom for rare disease drugs.Meanwhile, weight loss doctors are seeking better GLP-1 medications, but are facing challenges with high prices and supply issues. Trump is threatening big pharma with tariffs unless they reshore manufacturing. Bluebird Bio is facing financial challenges and may go private in a deal valued at $30 million. Compounders are suing the FDA over declaring a shortage of certain drugs, while the FTC is tightening merger rules despite the Trump administration's pro-industry stance.These updates show the ever-evolving landscape of the pharmaceutical and biotech industries. Stay tuned for more important news and developments in the field.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.##Title: Pfizer and BioNTech seek FDA approval for COVID-19 vaccine boosterPfizer and BioNTech have announced that they are seeking authorization from the FDA for a booster dose of their COVID-19 vaccine. The companies have presented data showing that a third dose of the vaccine can significantly increase protection against the Delta variant.##Title: Moderna to supply 100 million more doses of COVID-19 vaccine to the USModerna has reached an agreement with the US government to supply an additional 100 million doses of its COVID-19 vaccine. The company will deliver the doses by the end of the year, helping to boost vaccination efforts across the country.##Title: AstraZeneca's COVID-19 antibody treatment shows promising results in clinical trialsAstraZeneca has announced that its COVID-19 antibody treatment has shown promising results in clinical trials. The treatment, which is designed to prevent severe disease and hospitalization, could provide an important new tool in the fight against the virus.##Title: Novartis receives FDA approval for new treatment for advanced breast cancerNovartis has received FDA approval for a new treatment for advanced breast cancer. The drug, which targets a specific genetic mutation, has been shown to significantly improve progression-free survival in patients with the disease.##Title: Roche announces positive results from phase 3 trial of Alzheimer's drugRoche has announced positive results from a phase 3 trial of its Alzheimer's drug. The drug, which is designed to target the underlying cause of the disease, showed significant improvement in cognitive function and daily living activities in patients with early-stage Alzheimer's.##Title: Johnson & Johnson to invest $6.5 billion in expanding vaccine production capacityJohnson & Johnson has announced plans to invest $6.5 billion in expanding its vaccine production capacity. The company aims to increase production of its COVID-19 vaccine as well as other vaccines in its portfolio, helping to address global supply shortages.##Title: Merck receives FDA approval for new treatment for certain types of lung cancerMerck has received FDA approval for a new treatment for certain types of lung cancer. The drug, which targets a specific genetic mutation, has been shown to improve overall survival in patients with advanced disease.##Title: Gilead Sciences announces collaboration with Novartis on HIV researchGilead Sciences has announced a collaboration with Novartis on HIV research. The companies will work together to develop new treatments for HIV, with a focus on addressing drug resistance and improving outcomes for patients with the virus.## Title: Eli Lilly receives FDA approval for new treatment for migraineEli Lilly has received FDA approval for a new treatment for migraine. The drug, which is administered through an injection, has been shown to provide rapid relief from migraine symptoms and reduce the frequency of attacks in patients with the condition.

In this episode of the Oncology Brothers podcast, Drs. Rahul and Rohit Gosain dive into the recent advancements in the treatment of gastroesophageal junction (GEJ) and gastric cancer, focusing on the newly approved drug Zolbetuximab. They are joined by Dr. Kohei Shitara, the lead author of the pivotal SPOTLIGHT study, who shared insights on the mechanism of action of Zolbetuximab, its clinical trial findings, and the implications for patient care. Key topics discussed include: •⁠  ⁠The mechanism of action of Zolbetuximab and its target, Claudin 18.2. •⁠  ⁠An overview of the GLOW and SPOTLIGHT studies, including study design and key findings on progression-free survival (PFS) and overall survival (OS). •⁠  ⁠Practical considerations for administering Zolbetuximab in clinical practice, including dosing schedules and side effect management. •⁠  ⁠The importance of testing for Claudin 18.2 and the challenges faced in rural settings without in-house testing. •⁠  ⁠Future directions in the treatment landscape for gastric cancer, including potential combination therapies and emerging agents. Join us for this informative discussion that highlights the changing standard of care in gastric cancer treatment and the exciting possibilities ahead for patients. Don't forget to like, share, and subscribe for more insightful conversations in the world of oncology! YouTube: https://youtu.be/BfpDHpqgHMs Follow us on social media: •⁠  ⁠X/Twitter: https://twitter.com/oncbrothers •⁠  ⁠Instagram: https://www.instagram.com/oncbrothers

In our exclusive interview, Dr Bardia discussed the significance of this approval, pivotal findings from the phase 3 TROPION-Breast01 trial (NCT05104866), the clinical relevance of being able to improve progression-free survival and quality of life with Dato-DXd compared with standard chemotherapy, and key considerations for sequencing antibody-drug conjugates.

In this episode of the Addict to Athlete podcast, Coach Blu Robinson welcomes Dr. Faried Banimahd to discuss the complexities of ketamine therapy in the context of mental health and addiction recovery. They explore the history of ketamine, its medical uses, particularly in pain management and mental health treatment, and the implications of its recent popularity as a therapeutic option. Dr. B provides insights into the mechanisms of ketamine, its FDA approval for treatment-resistant depression, and the importance of caution in its use, especially for individuals with a history of substance abuse. The conversation emphasizes the need for a comprehensive approach to mental health treatment, integrating therapy with any pharmacological interventions. In this conversation, Blu Robinson and Dr. Faried Banimahd delve into the complexities of psychedelics, particularly ketamine, and their potential therapeutic benefits for mental health. They discuss the risks associated with psychedelics, personal experiences, and the importance of controlled environments for treatment. The conversation also highlights the stigma surrounding these substances, the necessity of ongoing treatment, and the role of medical professionals in guiding patients through their mental health journeys. Ultimately, they emphasize the need for a multidimensional approach to treatment and the importance of understanding individual experiences within the broader healthcare system. Takeaways Ketamine is chemically related to PCP and has a history of abuse. It is used as a disassociative anesthetic in medical settings. Ketamine's role in pain management is significant, especially for chronic pain patients. The FDA has approved ketamine for treatment-resistant depression under specific protocols. Ketamine works by blocking NMDA receptors, affecting pain perception and mood. Long-term efficacy of ketamine therapy is still under research and not well established. Caution is advised for individuals with a history of substance abuse when considering ketamine therapy. Matthew Perry's case highlights the risks associated with unsupervised ketamine use. Therapy should be the first line of treatment for depression, even when using ketamine. Meaningful existence and self-development take time and should not be rushed. People with a history of severe bipolar and schizophrenia should be cautious with psychedelics. Psychedelics can awaken dormant psychological issues. Personal experiences with psychedelics can lead to significant insights and awareness. The perception of psychedelics as dangerous hinders their therapeutic potential. Therapeutic environments are crucial for the safe use of psychedelics.   Dr. B YouTube · Dr.B36087.1K+ followersDr.B360 insta Instagram · getdrb2.4K+ followersAddiction Medicine (@getdrb) • Instagram photos and videos     Please join Addict to Athlete's Patreon support page and help us turn the mess of addiction into the message of sobriety! https://www.patreon.com/addicttoathlete Please visit our website for more information on Team Addict to Athlete and Addiction Recovery Podcasts. https://www.AddictToAthlete.org Join the Team! Circle, our new social support event, along with the team and athlete communication platform, is designed to help us break free from doom scrolling and shadow banning and foster stronger connections among us. Follow the link, download the app, and start this new chapter of Team AIIA! Join Circle https://a2a.circle.so/join?invitation_token=16daaa0d9ecd7421d384dd05a461464ce149cc9e-63d4aa30-1a67-4120-ae12-124791dfb519

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Eisai reports lagging sales of Leqembi in the US and is now looking towards gaining approval for a subcutaneous version. Novo Nordisk executives are trying to boost sentiment after the failure of obesity candidate Cagrisema, without providing hard numbers. Regeneron is suing Sanofi for allegedly withholding information about the sales of Dupixent. Nasdaq newcomers Acelyrin and Alumis have merged to focus on immune-mediated diseases. The AAPS National Biotechnology Conference will cover trends in research and biopharma markets.Equillium's Itolizumab is competing with Humira in ulcerative colitis. FDA approval of Vertex's non-opioid Jornavx signals a new era in pain treatment. Novo's bispecific for hemophilia has aced a phase III pediatric trial. Lilly has increased Zepbound supply, prompting analysts to question if it is sustainable. BMS has added $2 billion to cost-cutting plans and is eyeing deals after the success of Cobenfy. AstraZeneca has axed two Alexion assets as Q4 earnings exceed expectations.

Dr. Hoffman continues his conversation with investigative journalist Charles Piller, author of “Doctored: Fraud, Arrogance, and Tragedy in the Quest to Cure Alzheimer's Disease.”

Investigative journalist Charles Piller reveals deep-seated corruption in Alzheimer's research as chronicled in his book, “Doctored: Fraud, Arrogance, and Tragedy in the Quest to Cure Alzheimer's Disease.” The discussion delves into the issues surrounding Big Pharma's influence, fraudulent scientific studies, and the implications of a controversial 2006 experiment at the University of Minnesota. They also address the costly and marginally effective Alzheimer's drugs like Aducanumab, the challenges faced by alternative research hypotheses, and the significance of improving scientific integrity and checks and balances in medical research.

Welcome to the Oncology Brothers Podcast! In this episode, Drs. Rohit and Rahul Gosain are joined by Dr. Saby George from Roswell Park Comprehensive Cancer Center to discuss the recent approval of subcutaneous nivolumab based on the CheckMate-67T study. Join us as we delve into: •⁠  ⁠The study design and findings of CheckMate-67T •⁠  ⁠The implications of subcutaneous nivolumab for patients and healthcare providers •⁠  ⁠Safety signals and side effects associated with the new formulation •⁠  ⁠The significant time savings for patients receiving treatment •⁠  ⁠Real-world experiences from patients involved in the trial This episode highlights how the subcutaneous formulation of nivolumab can enhance patient care by reducing time spent in infusion centers while maintaining efficacy and safety. Tune in to learn more about this exciting advancement in cancer treatment and its potential impact on patient quality of life! Don't forget to like, subscribe, and check out our other episodes for more insights on FDA drug approvals, conference highlights, and treatment algorithms. We are the Oncology Brothers! YouTube: https://youtu.be/4blP8jqizUQ Follow us on social media: •⁠  ⁠X/Twitter: https://twitter.com/oncbrothers •⁠  ⁠Instagram: https://www.instagram.com/oncbrothers Subscribe to our channel for more insights on oncology treatments and patient care!

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Lilly has stopped a mid-stage study on relaxin for chronic kidney disease due to a lack of foreseeable clinical benefit, following the drug's failure in a related heart failure study. Meanwhile, Novo Nordisk's Ozempic has received FDA approval for kidney disease, expanding its use beyond diabetes and weight loss. The FDA may see changes under RFK Jr. and Makary, with concerns raised about Kennedy's vaccine-related views. BioAge has dropped an obesity asset after going public, I-Mab and Zentalis are cutting staff, and Novavax is seeking silver linings two years into a reset. Stay tuned for more updates in the biotech industry.

In this episode, Simon Malpas, CEO of Kitea Health, joins Duane Mancini to share his incredible journey from blood pressure researcher to Medtech CEO. Simon details Kitea Health's innovative brain pressure implant, revealing the challenges and triumphs of navigating clinical trials and the FDA's PMA process as a startup.Hear firsthand accounts of Kitea's dedication – from attending every surgery during their pilot study to building a strong company culture. Simon discusses the critical role of fundraising, strategic planning, and execution in achieving success in the Medtech industry. Tune in for invaluable insights into leadership, perseverance, and the future of medical technology. Simon Malpas LinkedIn ⁠Kitea Health LinkedIn Kitea Health Website ⁠⁠⁠Duane Mancini LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Project Medtech LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Project Medtech Website ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠⁠Midwest Showcase Registration⁠

In this episode of Lung Cancer Considered, host Dr. Stephen Liu discusses the recent FDA approval of zenocutuzumab for NSCLC with an NRG1 fusion. NRG1 fusions are rare but important events seen in many cancer types, including NSCLC. Zenocutuzumab is a HER2/HER3 bispecific antibody that showed clear efficacy in NSCLC and in pancreatic cancer that harbored an NRG1 fusion. Guest: Dr. Alison Schram, Assistant Attending Physician and Section Head of Oral Therapeutics in Early Drug Development at Memorial Sloan Kettering Cancer Center in New York

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in the Pharma and Biotech world. ## Breakthrough in Cancer TreatmentA new study published in the Journal of Clinical Oncology reveals a groundbreaking new treatment for advanced stage melanoma. The therapy, a combination of targeted therapy and immunotherapy, has shown remarkable results in clinical trials. Patients who received the treatment had a significant increase in progression-free survival compared to traditional treatments. This breakthrough offers hope for those with advanced melanoma, and could potentially revolutionize cancer treatment as we know it.## FDA Approval for Alzheimer's DrugThe FDA has recently approved a new drug for the treatment of Alzheimer's disease. The drug, which targets amyloid plaques in the brain, has shown promising results in clinical trials. Patients who received the drug experienced a significant improvement in cognitive function and a slowing of disease progression. This approval marks a major milestone in the fight against Alzheimer's, as it is the first new drug to be approved for the disease in over 20 years.## Vaccine Efficacy StudyA new study published in the New England Journal of Medicine has found that the efficacy of certain vaccines may be lower than previously thought. The study, which looked at data from over 10,000 patients, found that the effectiveness of some vaccines waned over time. This has raised concerns about the need for booster shots to maintain immunity. The findings highlight the importance of ongoing research and monitoring of vaccine efficacy to ensure continued protection against infectious diseases.## Gene Therapy BreakthroughResearchers have made a significant breakthrough in the field of gene therapy with the development of a new treatment for a rare genetic disorder. The therapy, which targets a specific gene mutation, has shown promising results in preclinical trials. Patients who received the treatment experienced a dramatic improvement in symptoms and quality of life. This breakthrough offers hope for those with rare genetic disorders and could pave the way for future gene therapy treatments.## Regulatory Update on Drug PricingThe FDA has announced new regulations aimed at addressing rising drug prices in the United States. The regulations will require pharmaceutical companies to justify price increases for certain medications and provide transparency on pricing decisions. This move is seen as a step towards increasing affordability and accessibility of medications for patients. The regulations are set to take effect next year, and are expected to have a significant impact on the pharmaceutical industry.## Biotech Funding AnnouncementA biotech startup has announced a major funding round to support the development of a new therapy for autoimmune diseases. The funding, which totals $50 million, will be used to advance clinical trials and bring the therapy to market. The treatment has shown promising results in early studies, and offers hope for those suffering from autoimmune conditions. This funding announcement highlights the growing interest and investment in biotech research and development.## ConclusionIn conclusion, these recent developments in cancer treatment, Alzheimer's research, vaccine efficacy, gene therapy, drug pricing regulations, and biotech funding are all significant milestones in the Pharma and Biotech world. Each breakthrough brings us one step closer to improving patient outcomes, advancing medical science, and addressing critical healthcare challenges. Stay tuned for more updates on these and other important developments in future episodes.

In today's episode, supported by Bristol Myers Squibb, we had the pleasure of speaking with Roxana S. Dronca, MD, about the FDA approval of subcutaneous nivolumab and hyaluronidase-nvhy (Opdivo Qvantig; subcutaneous nivolumab) for advanced or metastatic solid tumors. Dr Dronca is a professor of oncology, a consultant in the Division of Hematology/Oncology in the Department of Internal Medicine, and director of the Mayo Clinic Comprehensive Cancer Center in Jacksonville, Florida. On December 27, 2024, the FDA approved subcutaneous nivolumab across approved adult, solid tumor nivolumab indications, including as monotherapy, monotherapy maintenance after completion of nivolumab in combination with ipilimumab (Yervoy), or in combination with cabozantinib (Cabometyx) or chemotherapy. This regulatory decision was backed by findings from the phase 3 CheckMate-67T trial (NCT04810078) and includes indications for melanoma, renal cell carcinoma, non–small cell lung cancer, urothelial carcinoma, head and neck squamous cell carcinoma, colorectal cancer, esophageal carcinoma, esophageal adenocarcinoma, hepatocellular carcinoma, gastric cancer, and gastroesophageal junction cancer. In our exclusive interview, Dr Dronca discussed the significance of this FDA approval across multiple solid tumor indications, pivotal findings from the CheckMate-67T trial, and how this approval represents a paradigm shift in modern cancer care delivery.

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Wegovy, a drug by Novo Nordisk, has shown increased weight loss in a phase III trial when given at a high dose, nearly matching the efficacy of Zepbound. Drugmakers like Novo Nordisk and Boehringer Ingelheim are facing pressure in drug price negotiations, with Novo's Ozempic and Wegovy being targeted. Predictions for 2025 deals and fundraising were discussed at JPM, with executives making predictions for the industry. AGC Biologics offers validation before GMP for gene of interest candidates to accelerate timelines. In other news, AstraZeneca gets full FDA approval for a lymphoma treatment, Novartis is trying to prevent copycats as generics gain ground, and Amgen wins colorectal cancer expansion for Lumakras. At JPM25, biopharma deals are starting to flow, with one deal dwarfing last year's activity. Biogen executives are deflecting urgency to make deals at JPM25.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.## Breakthrough in Cancer TreatmentIn a groundbreaking development, researchers have discovered a new treatment for certain types of cancer that has shown promising results in clinical trials. This new therapy targets specific genetic mutations within cancer cells, leading to a more targeted and effective treatment approach. Patients who have received this new treatment have experienced significant improvements in their condition, with some even achieving complete remission. This breakthrough represents a major step forward in the fight against cancer and offers hope to many patients who previously had limited treatment options.## FDA Approval for New DrugThe FDA has recently approved a new drug for the treatment of a rare genetic disorder that affects thousands of people worldwide. This drug has been shown to effectively manage the symptoms of the disorder and improve the quality of life for patients who suffer from it. The approval of this new drug represents a significant milestone in the field of rare disease treatment and provides hope to individuals and families affected by this challenging condition.## Collaboration between Pharma CompaniesTwo leading pharmaceutical companies have announced a collaboration to jointly develop a new vaccine for a highly contagious virus that has recently emerged. By combining their expertise and resources, these companies aim to accelerate the development and production of this much-needed vaccine, with the goal of making it available to the public as soon as possible. This collaboration highlights the importance of cooperation and partnership in addressing global health challenges and demonstrates the industry's commitment to innovation and public health.## Regulatory Update on Drug PricingIn response to growing concerns about rising drug prices, regulatory agencies have announced new guidelines aimed at promoting transparency and accountability in drug pricing. These guidelines require pharmaceutical companies to disclose detailed information about the costs associated with developing and manufacturing their products, as well as the factors that contribute to pricing decisions. By increasing transparency in this area, regulators hope to foster greater competition and provide consumers with more information to make informed decisions about their healthcare.## Investment in Biotech StartupsVenture capitalists and private investors are increasingly turning their attention to biotech startups, recognizing the potential for innovation and growth in this sector. With advances in technology and a growing demand for healthcare solutions, biotech startups are attracting significant investment, which is fueling research and development efforts across the industry. This influx of funding is expected to drive further innovation and bring new therapies and treatments to market, benefiting patients and healthcare providers alike.## ConclusionThese recent developments underscore the dynamic nature of the pharmaceutical and biotech industries, as companies continue to push the boundaries of innovation and collaboration in pursuit of better healthcare solutions. From breakthrough treatments for cancer to regulatory updates on drug pricing, these stories highlight the diverse challenges and opportunities facing the industry today. As we look towards the future, it is clear that continued investment in research and development will be critical to addressing global health challenges and improving patient outcomes. Thank you for tuning into Pharma and Biotech daily, where we bring you the latest news and insights from the world of healthcare innovation.

Listen to a soundcast of the 12.18.2024 FDA approval of Ryoncil (remestemcel-L-rknd) for steroid-refractory acute graft versus host disease in pediatric patients.

In this episode Dr. Timothy Cripe and Dr. Brenda Weigel are joined by FDA's Dr. Nicole Drezner, pediatric oncologist and the Deputy Division Director of the Division of Oncology 2 who led the FDA review and publication on the approval of DFMO. Listen in on the discussion surrounding the historic approval of DFMO, the first ever oncology drug approved in the setting to prevent relapse using an external control instead of randomization.

Nutrition Nugget! Bite-size bonus episodes offer tips, tricks and approachable science. This week, Jenn is talking about the Minnesota Starvation Experiment. Conducted from 1944 to 1945, this clinical study explored the physical and psychological effects of semi-starvation and refeeding. While it's a historical study, its findings remain relevant today, particularly as we examine current health and weight-loss practices. Jenn dives into the participants' experiences, the dramatic impacts of calorie restriction, and what we can learn about achieving health goals sustainably, not through diets or restriction. Tune in for an eye-opening discussion that ties past research to modern challenges and solutions. Like what you're hearing? Be sure to check out the full-length episodes, new releases every Wednesday.  Have an idea for a nutrition nugget?  Submit it here: https://asaladwithasideoffries.com/index.php/contact/       RESOURCES:Learn more about Healthy Vibe Tribe on Jan 6 at 8pm ETReady to jump into the Healthy Vibe Tribe? Start here: Become A Member of Salad with a Side of FriesJenn's Free Menu PlanA Salad With a Side of FriesA Salad With A Side Of Fries MerchA Salad With a Side of Fries InstagramBirth Control, Part 1: FDA Approval and What Happened Next (feat. Mike Gaskins)Birth Control, Part 2: Ditching the Pill (feat. Rach Hoeppner)

Dr. Silviu Itescu, CEO of the biotech company Mesoblast (MESO), joins Market On Close. The company is developing therapeutics using stem cells to target severe inflammatory conditions, including pediatric conditions. He discusses Mesoblast's recent FDA approval for a cell therapy that is the first of its type, and its potential uses in bone marrow transplant patients. ======== Schwab Network ======== Empowering every investor and trader, every market day. Subscribe to the Market Minute newsletter - https://schwabnetwork.com/subscribe Download the iOS app - https://apps.apple.com/us/app/schwab-network/id1460719185 Download the Amazon Fire Tv App - https://www.amazon.com/TD-Ameritrade-Network/dp/B07KRD76C7 Watch on Sling - https://watch.sling.com/1/asset/191928615bd8d47686f94682aefaa007/watch Watch on Vizio - https://www.vizio.com/en/watchfreeplus-explore Watch on DistroTV - https://www.distro.tv/live/schwab-network/ Follow us on X – https://twitter.com/schwabnetwork Follow us on Facebook – https://www.facebook.com/schwabnetwork Follow us on LinkedIn - https://www.linkedin.com/company/schwab-network/ About Schwab Network - https://schwabnetwork.com/about

Welcome to the Oncology Brothers podcast! In this episode, hosts Drs. Rahul and Rohit Gosain dive into the recent FDA approval of Zanidatamab, a bispecific HER2 antibody, for HER2 amplified, unresectable, locally advanced, or metastatic biliary tract cancer. Join us as we discuss the HERIZON-BTC-01 study with Dr. Shubham Pant, a GI medical oncologist at MD Anderson Cancer Center and one of the study's authors. We explore the significance of HER2 testing in biliary tract cancers, the study's design, key findings, and the implications for treatment strategies in the community oncology setting. Key topics include: • Overview of biliary tract cancer and its treatment landscape • Study design and patient characteristics from the HERIZON-BTC-01 trial • Key findings, including overall response rates and duration of response • The importance of HER2 testing and its implications for treatment sequencing • Side effect profiles and management strategies for Zanidatamab • Future directions and ongoing clinical trials Don't miss this insightful discussion that highlights the exciting advancements in HER2-targeted therapies for biliary tract cancer. Make sure to subscribe for more updates on recent FDA approvals, treatment algorithms, and conference highlights. We look forward to seeing you at GI ASCO 2025 in person! Website: http://www.oncbrothers.com/ X/Twitter: https://twitter.com/oncbrothers Contact us at info@oncbrothers.com

In today's episode, supported by Merus, we had the pleasure of speaking with Alison Schram, MD, about the FDA approval of zenocutuzumab-zbco (Bizengri) for patients with previously treated advanced pancreatic adenocarcinoma or non–small cell lung cancer (NSCLC) harboring NRG1 gene fusions. Dr Schram is an assistant attending physician at Memorial Sloan Kettering Cancer Center in New York, New York.  On December 4, 2024, the FDA granted accelerated approval to zenocutuzumab for the treatment of adult patients with advanced, unresectable, or metastatic pancreatic adenocarcinoma harboring an NRG1 gene fusion who have disease progression on or after prior systemic therapy; and adult patients with advanced, unresectable, or metastatic NSCLC harboring an NRG1 gene fusion who have disease progression on or after prior systemic therapy. This regulatory decision was based on findings from the phase 2 eNRGy trial (NCT02912949), in which patients with pancreatic adenocarcinoma (n = 30) achieved an overall response rate (ORR) of 40% (95% CI, 23%-59%), and a duration of response (DOR) that ranged from 3.7 months to 16.6 months. In the NSCLC cohort (n = 64), the (ORR) of 33% (95% CI, 22%-46%), and the median DOR was 7.4 months (95% CI, 4.0-16.6).  In our exclusive interview, Dr Schram discussed the significance of this approval, key efficacy data from the pancreatic cancer and NSCLC cohorts of eNRGy, and the importance of using RNA-based testing to identify patients with NRG1 fusions. 

In today's episode, supported by Jazz Pharmaceuticals, we had the pleasure of speaking with James J. Harding, MD, director of Early Drug Development at Memorial Sloan Kettering Cancer Center, about the FDA approval of zanidatamab-hrii (Ziihera) for patients with HER2-positive metastatic biliary tract cancer. In our exclusive interview, Dr Harding discussed the significance of this approval, marking the first HER2-targeted therapy specifically for biliary tract cancer. He highlighted findings from the pivotal HORIZON BTC-01 trial (NCT04466891), explored how zanidatamab fits into the treatment paradigm, and addressed the role of HER2 profiling in guiding patient selection. Dr Harding also detailed ongoing research into zanidatamab in earlier treatment settings and emphasized its potential to transform care for patients with this challenging disease.

In this episode of the Crazy Wisdom Podcast, I, Stewart Alsop, sit down with Matt Omernick, a pioneer in leveraging interactive technology for health and cognitive improvement. We explore his journey from traditional game development to creating transformative digital therapeutics, touching on how technology like video games and AI is reshaping cognitive health, creativity, and human potential. Matt also shares his insights into the FDA approval process for these groundbreaking tools, discusses the role of creativity in a tech-driven future, and highlights the importance of ethical AI practices. For those interested in Matt's work, you can connect with him on LinkedIn to dive deeper into his ongoing projects.Check out this GPT we trained on the conversation!Timestamps00:00 Introduction and Guest Welcome00:29 Neuralink and Cognitive Impairment01:20 The Cognitive Crisis and Technology's Role03:18 Digital Therapeutics and AI Biometrics03:44 AI Augmentation and Creativity05:33 The Future of AI and Creativity08:02 Closed Loop Systems and Personalized Technology11:42 Generative AI and Ethical Considerations16:20 Art, Suffering, and Creativity19:30 The Human Element in AI20:10 Adaptability: Humanity's Strength and Weakness22:05 The Role of AI in Creative Fields23:08 Fragmentation and Tribalism in the Age of AI24:46 Evolutionary Biology and Human Adaptation28:14 Digital Health and Therapeutics30:33 Navigating the FDA Approval Process35:46 The Future of AI in Bureaucracy39:37 Conclusion and Contact InformationKey InsightsTechnology as a Tool for Cognitive Health: Matt Omernick highlights the transformative potential of interactive technologies like video games in addressing cognitive impairments. Once stigmatized, video games are now proving to be powerful tools in promoting mental health, supported by rigorous scientific evidence. These innovations open a new frontier in digital therapeutics, making it possible to create adaptive experiences that train the brain and yield measurable, durable improvements in cognitive function.The Role of AI in Creativity and Problem-Solving: AI is reshaping creativity by serving as an augmentation tool rather than a replacement for human ingenuity. Matt draws parallels to the introduction of tools like Photoshop, emphasizing that AI enables artists and creatives to work faster, experiment more, and push boundaries, while still relying on human input to guide its applications. This partnership between humans and AI is a significant shift, particularly in industries like gaming and digital art.The Cognitive Crisis of Overstimulation: Modern society faces a cognitive crisis driven by unprecedented levels of stimulation from technology. Matt discusses how primitive brain structures are struggling to cope with the demands of a hyper-connected world. However, instead of retreating from technology, he advocates leveraging it intelligently to create systems that help humans adapt and thrive in this new environment.FDA Approval as a Milestone for Digital Therapeutics: Achieving FDA approval for a video game-based therapeutic was a groundbreaking step, validating the legitimacy of this new form of medicine. The process involved creating a new regulatory framework tailored to digital products, blending the rigor of traditional clinical trials with the flexibility of software development. This achievement paves the way for future innovations in digital health.The Power of Closed-Loop Feedback Systems: Closed-loop systems, which continuously measure and adapt based on user input, are central to the success of digital therapeutics and other adaptive technologies. Matt explains how this approach not only optimizes cognitive training but also offers a model for creating highly personalized and effective interventions in health and wellness.Ethics and Responsibility in AI Development: Matt underscores the critical need for ethical practices in AI, particularly in creative fields. Protecting artists' rights, ensuring transparency in how AI is trained, and addressing potential biases are essential for fostering a future where technology serves humanity's best interests without exploitation or harm.A Hopeful Vision for the Future: Despite potential dystopian outcomes, Matt remains optimistic about the trajectory of technology. He believes humanity's adaptability and creativity will guide us toward solutions that enhance our lives and address major challenges. His work exemplifies this optimism, focusing on creating tools that blend technological sophistication with ethical and human-centered design principles.

A troubling disconnect between medical expertise and insurance mandates is putting patients' health at risk. Policies like step therapy and prior authorization are forcing individuals into treatments not recommended by their doctors—often with devastating consequences. In this episode, we hear from a patient who endured months of suffering due to her insurer's 'fail-first' requirements. We also talk with a doctor navigating this impossible system and a biotech leader fighting to ensure innovative treatments reach the patients who need them most. Follow us on LinkedIn, X, Facebook and Instagram. Visit us at https://www.bio.org/

In this episode, Dr. Craig Koniver, M.D., a board-certified physician trained at Brown University and Thomas Jefferson University, discusses the therapeutic application of peptides and hormones for enhancing physical and mental health and performance. We explore GLP-1 analogs for weight loss, BPC-157 for wound healing and reducing inflammation, as well as peptides that increase growth hormone, improve REM sleep, and enhance cognitive function. We also cover testosterone therapy, NAD, NMN, and NR supplementation, methylene blue for mitochondrial health, stem cell therapies, and supplements such as CoEnzyme Q10 and methylated B vitamins. Additionally, we discuss effective dosages, sourcing, safety considerations, and the importance of working with knowledgeable physicians. Whether you're currently using peptides or exogenous hormones, or simply curious about their potential benefits and risks, this episode provides the scientific rationale behind how peptides function, their potential to enhance mental and physical health, and how they can optimize performance. Access the full show notes for this episode at hubermanlab.com. Thank you to our sponsors AG1: https://drinkag1.com/huberman Joovv: https://joovv.com/huberman BetterHelp: https://betterhelp.com/huberman Function: https://functionhealth.com/huberman Eight Sleep: https://eightsleep.com/huberman Timestamps 00:00:00 Dr. Craig Koniver 00:04:52 Sponsors: Joovv & BetterHelp 00:07:40 What is a Peptide? 00:09:37 GLP-1 Agonists, Semaglutide Weight Loss, Brain Health 00:15:49 GLP-1 Microdoses, Muscle Loss; Inflammation 00:18:43 BPC-157, Inflammation 00:23:27 BPC-157, Injection & Oral Forms; Injury Repair 00:28:43 Sourcing, Anabolic Steroids, Testosterone 00:34:48 Black & Gray Market, Compounding Pharmacies, Purity 00:38:20 Sponsor: AG1 00:39:51 Partnering with a Physician, LPS 00:43:00 BPC-157, Pentadeca Arginate (PDA); Side Effects & Doses 00:46:35 Ipamorelin, GHRP-6, Sleep, Appetite; Tool: Sleep & Growth Hormone 00:54:17 Tesamorelin, Sermorelin, CJC-1295; Stacking Peptides 00:58:45 Sponsor: Function & Eight Sleep 01:01:54 Coenzyme Q10 (CoQ10), Mitochondrial Health 01:05:16 Prescriptions, Physicians & Trust 01:14:09 Agency in Your Health 01:17:13 MK-677, Appetite 01:19:32 Hexarelin; Growth Hormone Secretagogues Dosing 01:21:10 Methylated B Vitamins, Homocysteine 01:24:47 Peptides for Sleep, Pinealon, Epitalon 01:31:03 Glycine, Liver Detoxification; Dosage 01:37:19 GLP-1, Compounding Pharmacies 01:39:03 Stem Cell Therapy, PRP 01:41:18 Thymosin Alpha-1, Cerebrolysin & Brain Health 01:44:17 Peptides for Cognitive Function, Methylene Blue, Doses 01:50:20 Covid, NAD Infusion, NMN & NR Supplements 01:57:13 Nutritional Deficiencies; NAD Dose & Regimen, NMN & NR 02:07:53 PT-141, Vyleesi, Libido; Nausea 02:10:57 FDA Approval & Removal, Pharmaceutical Companies 02:20:17 Positivity, Mindset & Health 02:26:23 Zero-Cost Support, YouTube, Spotify & Apple Follow & Reviews, Sponsors, YouTube Feedback, Protocols Book, Social Media, Neural Network Newsletter Disclaimer & Disclosures