Podcasts about fda approval

It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: FDA approves the first fast-acting biosimilar insulin in the US, Tandem issues warning, DOJ stands up for remote monitoring in schools, GLP1 use protects against dementia, and more! Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom   Check out VIVI Cap to protect your insulin from extreme temperatures The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com Episode transcription with links:   Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX We've got the first and only biosimilar FDA approved and moving to market. Kirsty – insulin aspart, which is a biosimilar to Novolog will be available as a single-patient-use prefilled pen for subcutaneous use and a multiple-dose vial for subcutaneous and intravenous use. KIRSTY has been available in Europe and Canada since 2022. This same company makes Semglee, the first biosimilar for long acting? Sales of Insulin Aspart in the United States were approximately $1.9 billion in 2024, according to IQVIA. https://www.globenewswire.com/news-release/2025/07/15/3115973/0/en/Biocon-Biologics-Expands-Diabetes-Portfolio-with-FDA-Approval-of-Kirsty-the-First-and-Only-Interchangeable-Rapid-Acting-Insulin-Aspart-in-the-United-States.html XX Tandem Diabetes Care (Nasdaq:TNDM) has issued an urgent medical device correction for some t:slim X2 automated insulin pumps. In a July 22 notice, the San Diego-based company warned of pumps that may exhibit a higher rate of speaker failure. During normal use, the insulin pump software monitors current flowing through the speaker during use. Measurements that fall within a pre-determined range indicate a functioning speaker. Meanwhile, measurements falling outside the range indicate a speaker failure.   When the measurements land outside the expected range, the system declares a malfunction, referred to as “Malfunction 16.” If the pump declares this malfunction, insulin delivery will stop and the pump will no longer be operational. Malfunction 16 terminates communication between the pump and continuous glucose monitor (CGM), as well as the t:slim mobile app.   If not addressed, the issue can lead to hyperglycemia, which can result in hospitalization or medical intervention. The company reports 700 adverse events and 59 reported injuries to date, with no reports of death.   Tandem identified that certain speaker versions have a higher rate of Malfunction 16 events due to a wiring issue within the speaker. Users can continue using their pump but with added precautions because Malfunction 16 can occur at any time. They should use the t:slim mobile app with push notifications turned on so the app alerts them if the malfunction occurs, the company said.   Additionally, Tandem intends to release a software update aimed at enhancing the early detection of speaker failure. The update also introduces persistent vibration alarms to help reduce potential safety risk. Tandem plans to notify affected pump users when it makes the update available. https://www.drugdeliverybusiness.com/tandem-warns-insulin-pump-speaker-malfunction/ XX BIG WIN! The DOJ protects T1D rights again! The US Attorney's office for the Western District of Washington State reached a settlement with a public school district that once again confirms remotely monitoring students' CGMs is a reasonable accommodation that schools must provide to comply with the Americans with Disabilities Act. If its true for one state its true for all states under federal law! If your local schools still refuse to remotely monitor CGMs of their students, provide them with this letter to compel them to FOLLOWT1Ds and FOLLOW Federal Laws. If they still refuse contact us! https://followt1ds.org/ XX new study finds people taking GLP-1 agonists had a significantly lower cumulative risk of developing dementia, when compared to metformin users. Past studies show that people who have type 2 diabetes — a chronic condition where the body does not use its insulin properly — are at a higher risk of developing dementia. The study found that when comparing the neuroprotective abilities of two diabetes medications — metformin and glucagon-like peptide-1 receptor agonists (GLP-1 agonists) — participants taking GLP-1 agonists had a significantly lower cumulative risk of developing dementia, when compared to metformin.   https://www.medicalnewstoday.com/articles/glp-1s-may-offer-better-dementia-protection-than-metformin XX Front office changes coming to Dexcom.  CEO Kevin Sayer will step down  & give the reins to current Chief Operating Officer Jake Leach. Scheduled for January 1, 2026, Leach will also join Dexcom's board of directors where Sayer will remain  executive chairman. One of our frequent guests here.. Leach has worked at Dexcom for 21 years. He served as chief technology officer from 2018 to 2022 before he was named COO in late 2022. He was given the title of president in May. https://www.medtechdive.com/news/dexcom-ceo-change-kevin-sayer-jake-leach/756382/ XX A major international study has revealed that many children and young adults in Sub-Saharan Africa who are diagnosed with type 1 diabetes (T1D) may actually have a different, non-immune-based form of the condition. Unlike the traditional autoimmune version of T1D, this form appears to develop without the immune system attacking the insulin-producing cells. This finding could significantly reshape how diabetes is diagnosed and treated across the region, potentially leading to more precise care and better health outcomes. The researchers found that many young people in Sub-Saharan Africa diagnosed with T1D often don't have the usual markers in their blood (called islet autoantibodies) typically seen in people with T1D in other parts of the world. Specifically, 65% of participants with T1D in this region did not have islet autoantibodies. When the researchers compared this data to studies in the U.S., they found a smaller but significant proportion (15%) of Black participants diagnosed with T1D had a similar form of diabetes found in Sub-Saharan Africa – characterized by negative autoantibodies and a low T1D genetic risk score.   However, white Americans with T1D showed the typical autoimmune pattern, even if they didn't have detectable autoantibodies, their genetics still pointed to autoimmune diabetes.   “The identification of this T1D diabetes subtype in Sub-Saharan African populations and among individuals of African ancestry in the U.S. suggests a potential ancestral or genetic link,” Dabelea notes. “These findings highlight the need to consider alternative etiologies in this group and a deeper understanding of the underlying mechanisms may provide important insights for future prevention and treatment strategies.”     https://scitechdaily.com/new-diabetes-subtype-discovered-in-africa-challenges-global-assumptions/   XX Formal recognition for the specialty of Diabetology.   Diabetology is the specialty focused on the full continuum of diabetes care — encompassing diagnosis, treatment, prevention, technology integration, education, and cardiometabolic management. While it intersects with endocrinology, primary care, and public health, diabetology is uniquely defined by its depth and focus on diabetes alone.       The American College of Diabetology (ACD) is the national professional organization representing clinicians who specialize in diabetes care. ACD advances clinical excellence and education to improve the lives of those affected by diabetes. https://www.businesswire.com/news/home/20250725766248/en/American-College-of-Diabetology-Announces-Formal-Taxonomy-Classification-for-Diabetology   XX Tidepool announces cloud-to-cloud integration with Abbott's FreeStyle Libre portfolio. From the release: This integration allows people living with diabetes using the FreeStyle Libre portfolio to connect their data to their Tidepool account seamlessly. For healthcare providers, this means more comprehensive insights and streamlined workflows, with FreeStyle Libre systems data flowing continuously into the Tidepool Data Platform. https://www.tidepool.org/blog/abbott-freestyle-libre-integration-launched XX Stelo dexom ai food XX With high drug prices remaining an ongoing concern for U.S. politicians, Roche is considering following in the footsteps of some of its peers with a direct-to-consumer (DTC) model to cut out the middlemen.     About 50% of the money spent on drugs in the U.S. healthcare system goes straight to PBMs instead of the companies that create the medicines, Roche CEO Thomas Schinecker called out in a press conference on Thursday.   Bringing the drugs directly to the consumer could be a solution to positively impact pricing for patients “without destroying innovation,” Schinecker added on a separate Thursday call with investors, noting that the company has discussed the matter with the U.S. government and its Department of Health and Human Services. The pricing talks come after President Donald Trump inked a “Most Favored Nation” executive order in May, aiming to tie U.S. drug prices to lower prices in other developed nations. The plan was quickly called out by industry voices such as the PhRMA trade group, which labeled it a “bad deal” for U.S. patients. https://www.fiercepharma.com/pharma/roche-weighing-direct-consumer-drug-sales-ease-us-drug-pricing-woes-cut-out-pbms-ceo-says XX SAB BIO secures substantial $175M financing to advance T1D therapy with impressive investor lineup and extended cash runway until 2028. Most critically, this financing fully funds the pivotal Phase 2b SAFEGUARD study evaluating SAB-142 for delaying progression of autoimmune Type 1 diabetes in newly diagnosed patients. By extending the cash runway into mid-2028, SAB has effectively eliminated near-term financing risk and provided clear visibility through this crucial clinical trial and potential commercialization preparation. Participation from strategic investor Sanofi, along with new investors RA Capital Management, Commodore Capital, Vivo Capital, Blackstone Multi-Asset Investing, Spruce Street Capital, Forge Life Science Partners and Woodline Partners LP, and existing investors Sessa Capital, the T1D Fund, and ATW Partners         https://www.stocktitan.net/news/SABS/sab-bio-announces-oversubscribed-175-million-private-fwsf2t91ek4z.html   XX In a landmark 14-year study, researchers have found that artificially sweetened drinks raise the risk of developing type 2 diabetes by more than a third, significantly higher than those loaded with sugar. It challenges the long-standing perception of diet drinks being a healthier alternative and suggests they may carry metabolic risks of their own. In the first longitudinal study of its kind, led by Monash University, researchers tracked 36,608 participants over an average period of 13.9 years to assess how both sugar-sweetened beverages (SSBs) and artificially sweetened beverages (ASBs) impacted health outcomes. The self-reported health data, from the Melbourne Collaborative Cohort Study, was drawn from participants aged 40 to 69 years at the time of recruitment.   What they found was that drinking just one can of artificially sweetened soda increased the risk of developing type 2 diabetes by 38%, compared to people who didn't consume these drinks at all. For those consuming the same amount of sugary drinks, the risk was 23% higher. This suggests there's more than obesity at play. The researchers believe this result is due to an independent metabolic effect, possibly gut microbiome disruption or a change in glucose metabolism.   While the study didn't identify which artificial sweeteners were at play,   Evidence suggests that artificial sweeteners can alter the composition and function of gut bacteria, leading to glucose intolerance – a precursor to type 2 diabetes. And that some sweeteners may trigger insulin release, desensitize metabolic responses over time, or confuse the body's glucose regulation system – even without actual sugar in the picture.   Another hypothesis is that regular exposure to the kind of intense sweetness that artificial products deliver may condition the body to anticipate sugar calories that never come, affecting appetite regulation, insulin sensitivity and broader metabolic pathways. However, the authors suggest that how sweeteners affect the gut microbiota and glucose regulation are the most likely drivers of increased diabetes risk.   https://newatlas.com/diet-nutrition/one-drink-diabetes-risk/ XX After months of deliberation, information gathering and public testimony, a state board unanimously agreed Monday that two common medications for type-2 diabetes and other conditions appear to pose an affordability challenge to the state and Marylanders.   The state Prescription Drug Affordability Board approved two resolutions saying that prescription drugs Jardiance and Farxiga likely pose an “an affordability challenge for the state health care system” and the state should look for ways to bring down those costs.   Health care advocates call the long-awaited resolution an “important first step” in the process in bringing down prescription costs for those on the state's health plan.       That milestone has been years in the making. Created in 2019 by the General Assembly, the Prescription Drug Affordability Board was slow to launch due in part to a veto from former Gov. Larry Hogan (R) amid pandemic-induced economic uncertainty in 2020 that delayed the board's formation. The board also cited out-of-pocket costs for consumers and state and local spending on those drugs as indicators that there may be an affordability challenge.   The board will now look at options to address the potential affordability challenge, which could include setting an upper payment limit on those drugs. But it's not clear when the state will see cost savings.   That said, some members of the health care system and the pharmaceutical industry say that policies such as upper payment limits could weaken access to life-saving drugs. Others say that the board has not engaged enough viewpoints from the health care industry. https://marylandmatters.org/2025/07/29/state-board-determines-two-type-2-diabetes-drugs-may-be-unaffordable/   XX One year after it was revealed that Chrissy Teigen and John Legend's son, Miles, was diagnosed with type 1 diabetes, Teigen is revealing how she's making her son feel more included. Teigen first opened up about her 7-year-old son's diagnosis after she and her two oldest kids, Miles and 9-year-old daughter Luna were at the 2024 summer Olympics cheering on Simone Biles. Teigen posted a photo of Miles and Luna holding up a sign. Also visible in the picture was the insulin pump on Miles' arm. Now, Teigen is sharing some insight into how she's making Miles more comfortable with having type 1 diabetes, including giving LeBron James' Barbie doll type 1 diabetes as well. In a video shared on Instagram, Teigen is seen taking the T1D Barbie, removing her insulin pump and gluing the pump onto LeBron James' Barbie. “Turning T1D Barbie into T1D Lebron James for my son,” Teigen captioned the video, revealing James is Miles' hero. 41 million followers https://www.yahoo.com/lifestyle/articles/chrissy-teigen-gives-lebron-james-154608782.html  

Key Steps to FDA Approval for a Therapeutic Drug Hello, this is Hall T. Martin with the Startup Funding Espresso -- your daily shot of startup funding and investing. FDA approval is a lengthy and involved process with therapeutic drugs that startups must go through. Here's a list of the key steps to achieve FDA approval: After basic research, the founder applies for an Investigational New Drug Application called an IND. The founder takes the proposed therapeutic or drug through four phases of clinical trials. Phase 1 is for safety testing.  Phase 2 is for effectiveness. Phase 3 focuses on additional safety testing to determine side effects. Phase 4 focuses on additional efficacy tests. After testing comes the New Drug Application or NDA. The FDA reviews the NDA, including the clinical data and research, to determine approval. There are fast-track paths for drugs that treat serious medical conditions that have no current solution. There is also a breakthrough therapy path for drugs that show substantial improvement over the current solution. For investing in therapeutic startups, consider the FDA pathway for the drug and where it currently resides on that pathway.   Thank you for joining us for the Startup Funding Espresso where we help startups and investors connect for funding. Let's go startup something today. _________________________________________________________ For more episodes from Investor Connect, please visit the site at:   Check out our other podcasts here:   For Investors check out:   For Startups check out:   For eGuides check out:   For upcoming Events, check out    For Feedback please contact info@tencapital.group    Please , share, and leave a review. Music courtesy of .

In this episode, host Ben Plumley, along with co-host Yvette Raphael, reports from the International AIDS Society Scientific Conference in Kigali, Rwanda. They discuss significant advancements in HIV prevention, particularly the recent FDA approval of Lenacapavir, with Dr. Alex Kintu from Gilead Sciences. The conversation covers the clinical journey and delivery mechanisms of Lenacapavir, its impact on young people and pregnant women, and the urgency of making this innovation widely accessible amidst funding challenges. The episode also highlights the critical role of community engagement and accountability boards in informing and driving HIV prevention strategies. Tune in for an in-depth look at the latest scientific and policy developments in the fight against HIV/AIDS. 00:00 Introduction and Welcome 00:37 Yvette's Stage Takeover Experience 01:33 Discussion on Gilead Sciences and HIV Prevention 02:15 Dr. Alex Kintu's Background and Role 03:33 FDA Approval and Next Steps for Lenacapavir 04:08 Global Access and Regulatory Processes 11:04 Understanding Lena Kavir and Its Importance 17:36 Challenges and Future of HIV Prevention 27:23 Community Engagement and Youth Involvement 34:33 Closing Remarks and Call to Action

FDA Approval: Datopotamab Deruxtecan for EGFR NSCLC by IASLC

This podcast highlights three updates: Moderna's Spikevax COVID-19 vaccine is now fully FDA-approved for high-risk children 6 months to 11 years, though rare myocarditis remains a concern. A large study found first-trimester TMP-SMX antibiotics increase congenital malformation risks compared to β-lactams, reinforcing β-lactams as safer. Finally, a trial showed no cardiovascular benefit from taking blood pressure medication at bedtime versus morning dosing.

Welcome back to Ditch the Lab Coat, the podcast where we break down the fascinating world of medicine with a blend of scientific skepticism and real-world insight. In today's episode, we dive deep into the mysteries of the vagus nerve—a nerve so ancient and essential, it's been called the “conductor” in the symphony of human physiology.Join host Dr. Mark Bonta as he sits down with Dr. Kevin Tracey, neurosurgeon, president and CEO of the Feinstein Institutes for Medical Research, and a pioneer in the world of bioelectronic medicine. Dr. Tracey's breakthrough research has shown us that the vagus nerve is far more than just a conduit for signals—it's a key player in managing inflammation, regulating our immune system, and maybe even shaping the future of medicine.In this conversation, you'll explore the mind-bending complexity of the nervous system, discover how cutting-edge science is redefining how we treat diseases like rheumatoid arthritis and long Covid, and learn how a tiny chip implanted in the neck might one day replace whole classes of immune-suppressing drugs. Dr. Tracey shares metaphors, straight talk about medical myths, and a vision for a future where reprogramming the body's reflexes could offer relief to millions.Get ready for a journey that's equal parts awe-inspiring and practical, as we unpack the true potential (and real-world considerations) of harnessing the vagus nerve's power. Whether you're a healthcare professional, a science nerd, or just someone searching for new answers, this episode invites you to see medicine in a whole new way. Resources : ( https://feinstein.northwell.edu/ )Episode HighlightsVagus Nerve Complexity Unveiled — We're only scratching the surface of understanding the vagus nerve's vast, intricate network and its essential bodily roles.Inflammation: Friend and Foe — Inflammation is vital short-term, but when uncontrolled, it's destructive and underlies many autoimmune and chronic diseases.Nervous-Immune System Interplay — The nervous and immune systems communicate reflexively, with nerves directly capable of controlling immune and inflammatory responses.Bioelectronic Treatments Emerge — Vagus nerve stimulation—via implanted chips—shows promise for conditions like rheumatoid arthritis without full-body immunosuppression risks.Individualized Nerve Fiber Functions — Each of the 200,000 vagus fibers controls specific functions, forming a body-wide symphony of precision responses.Not All Self-Help Fits — Lifestyle hacks can support vagus health, but serious disease often requires targeted nerve stimulation, not general wellness.Caution Against Online Misinformation — Vagus nerve advice online is often oversimplified or inaccurate; nuance and scientific backing are essential.Lifestyle Still Matters — Balanced diet, sleep, exercise, and community all help regulate vagus nerve tone and reduce chronic stress.Future Disease Applications Possible — Vagus stimulation may treat IBD, MS, and neurodegenerative or psychiatric conditions as research evolves.Episode Timestamps6:25 — Exploring Nervous System Complexity9:08 — Vagus Nerve Controls Inflammation11:05 — Vagus Nerve: Brain Signals Control Inflammation15:45 — Nervous System's Role in Immunity20:43 — Understanding Your Vagus Nerves23:25 — Vagus Nerve Health and Research25:12 — Vagus Nerve Stimulation Insights29:36 — Vagus Nerve Stimulator: Inflammation Therapy32:13 — Neurotransmitter Effects on Cytokine Production38:22 — Minimizing Nerve Damage in Surgery39:30 — Vagus Nerve Stimulation Benefits43:42 — Exploring Vagus Nerve Mysteries46:42 — Vagus Nerve Stimulation for Autoimmune Diseases50:52 — Cold Plunges & Bioelectrical Future DISCLAMER >>>>>>    The Ditch Lab Coat podcast serves solely for general informational purposes and does not serve as a substitute for professional medical services such as medicine or nursing. It does not establish a doctor/patient relationship, and the use of information from the podcast or linked materials is at the user's own risk. The content does not aim to replace professional medical advice, diagnosis, or treatment, and users should promptly seek guidance from healthcare professionals for any medical conditions.   >>>>>> The expressed opinions belong solely to the hosts and guests, and they do not necessarily reflect the views or opinions of the Hospitals, Clinics, Universities, or any other organization associated with the host or guests.    Disclosures: Ditch The Lab Coat podcast is produced by (Podkind.co) and is independent of Dr. Bonta's teaching and research roles at McMaster University, Temerty Faculty of Medicine and Queens University. 

FDA Approval: Sunvozertinib for EGFR Exon 20 by IASLC

In today's episode, supported by Thermo Fisher Scientific, we had the pleasure of speaking with Apar Kishor Ganti, MD; and Allison Cushman-Vokoun, MD, PhD, FCAP, about the FDA approval of the Oncomine DX Express Test for use as a companion diagnostic for sunvozertinib (Zegfrovy) in EGFR exon 20 insertion mutation–positive non–small cell lung cancer and for use in tumor profiling. Dr Ganti is a professor in the University of Nebraska Medical Center (UNMC) Division of Oncology & Hematology, the Dr. and Mrs. D. Leon UMNC Research Fund Chair in Internal Medicine, and the associate director for Clinical Research at the Fred & Pamela Buffett Cancer Center in Omaha. Dr Cushman is the Henry F. Krous Professor of Pathology, a professor in the UNMC Department of Pathology, Microbiology and Immunology, director of the Division of Diagnostic Molecular Pathology and Human Genetics, medical director of the Molecular Diagnostics and Personalized Medicine Laboratory at Nebraska Medicine, director of the Molecular Genetic Pathology Fellowship Program, and associate director of the UMNC MD-PhD Scholars Program.  In our exclusive interview, Drs Ganti and Cushman discussed the significance of the launch of the Oncomine DX Express Test, the benefits and limitations of rapid next-generation sequencing, and features that set Oncomine DX apart from other available tests. 

Send us a textDr. Michael Koren joins Kevin Geddings to introduce the concept of "scienceploitation." He explains that many marketing tactics in the health and supplement industry are disguised as scientific claims. For example, phrases like "supports immune health" often sound convincing but are meaningless without specific, evidence-based backing from rigorous clinical trials. Dr. Koren also highlights the benefits of participating in clinical trials, noting that involvement gives a behind-the-scenes look into how the healthcare industry works.Be a part of advancing science by participating in clinical research.Have a question for Dr. Koren? Email him at askDrKoren@MedEvidence.comListen on SpotifyListen on Apple PodcastsWatch on YouTubeShare with a friend. Rate, Review, and Subscribe to the MedEvidence! podcast to be notified when new episodes are released.Follow us on Social Media:FacebookInstagramX (Formerly Twitter)LinkedInWant to learn more? Checkout our entire library of podcasts, videos, articles and presentations at www.MedEvidence.comMusic: Storyblocks - Corporate InspiredThank you for listening!

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 TreatmentExciting news in the world of oncology as a new breakthrough in cancer treatment has been announced. Researchers have discovered a novel therapy that targets specific mutations in cancer cells, leading to significantly improved outcomes for patients. This groundbreaking treatment is set to revolutionize the way we approach cancer care and could potentially save countless lives in the future.## FDA Approval for New DrugIn other news, the FDA has granted approval for a new drug that shows promising results in the treatment of a rare genetic disorder. This drug has undergone rigorous testing and has been shown to be both safe and effective in clinical trials. The approval of this medication represents a major milestone in the field of rare disease treatment and offers hope to patients who previously had limited options for managing their condition.## Collaboration between Pharmaceutical CompaniesA collaboration between two leading pharmaceutical companies has been announced, with the goal of developing innovative therapies for a range of diseases. This partnership brings together the unique expertise and resources of both companies, potentially leading to the discovery of new treatments that could benefit patients worldwide. This collaboration highlights the importance of working together to address unmet medical needs and advance the field of medicine.## Advancements in Gene TherapyExciting advancements have been made in the field of gene therapy, with researchers reporting promising results in early clinical trials. Gene therapy has the potential to treat a wide range of genetic disorders by replacing or modifying faulty genes. These latest developments represent a significant step forward in the field of genetic medicine and offer hope to patients who previously had limited treatment options.## ConclusionIn conclusion, these recent developments in the world of Pharma and Biotech are not only groundbreaking but also offer hope for patients facing serious medical conditions. From breakthroughs in cancer treatment to advancements in gene therapy, the future of medicine is looking brighter than ever. Stay tuned for more updates on these exciting developments as we continue to follow the latest news in Pharma and Biotech.

In today's episode, supported by Bayer, we had the pleasure of speaking with Alicia Morgans, MD, MPH, and Neal Shore, MD, FACS, about the FDA approval of darolutamide (Nubeqa) plus androgen deprivation therapy for patients with metastatic castration-sensitive prostate cancer (mCSPC). Morgans is the medical director of the survivorship program at Dana-Farber Cancer Institute; as well as an associate professor of medicine at Harvard Medical School, both in Boston, Massachusetts. Shore is the medical director of the Carolina Urologic Research Center. In our exclusive interview, Drs Morgans and Shore discussed the significance of this approval; key efficacy, safety, and quality of life data from the pivotal phase 3 ARANOTE trial (NCT04736199); and how this regulatory decision both opens doors for the treatment of more patients and raises questions about the optimal role of darolutamide in the management of mCSPC. 

Welcome to another episode of the Oncology Brothers podcast! In this episode, Drs. Rahul and Rohit Gosain are joined by Dr. Ross Camidge, a leading thoracic medical oncologist from the University of Colorado, to discuss the recent approval of telisotuzumab-vedotin (Teliso-V) for metastatic non-small cell lung cancer (NSCLC) with C-met overexpression, based on the LUMINOSITY trial. Join us as we explore: • The mechanism of action of telisotuzumab and its role as an antibody-drug conjugate. • The prevalence of C-met overexpression in NSCLC and its implications for testing and treatment. • Key findings from the Luminosity trial, including response rates and study design. • The importance of C-met testing in clinical practice. • Management of side effects associated with telisotuzumab, particularly peripheral neuropathy. Follow us on social media: •⁠  ⁠X/Twitter: https://twitter.com/oncbrothers •⁠  ⁠Instagram: https://www.instagram.com/oncbrothers •⁠  Website: https://oncbrothers.com/ This episode is packed with valuable insights for oncologists and healthcare professionals navigating the evolving landscape of lung cancer treatment. Don't miss out on this informative discussion!

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.The CDC's new vaccine advisors are meeting with an unexpected agenda today, including discussions on topics such as Sanofi and Gilead's protein degrader deals, the FDA's review of Sarepta's gene therapy, and a contentious hearing with RFK Jr. over vaccines. The meeting marks the beginning of a new era for the influential vaccine committee. The FDA has named a psychedelic proponent as CDER deputy director, while Nektar has declared a Phase IIb win for eczema treatment. Experts say conflicts of interest among axed ACIP members are a "red herring," and the pharma industry is facing turmoil in failed immuno-oncology projects. Prescription drug sales are projected to hit $1.75 trillion by 2030, thanks to GLP-1s. Transitioning to the next news, a major pharmaceutical company has announced a breakthrough in cancer research, potentially changing the landscape of treatment options for patients worldwide. This development comes at a time when the industry is seeing significant advancements in personalized medicine and targeted therapies. Moving on to regulatory updates, the FDA has recently approved a new drug for a rare disease, providing hope for patients who previously had limited treatment options. This decision showcases the agency's commitment to expediting the approval process for innovative therapies that address unmet medical needs. In other news, a biotech startup has secured funding for its groundbreaking technology that aims to revolutionize drug delivery methods. This investment highlights the growing interest in novel approaches to drug development and underscores the importance of innovation in the industry.Wrapping up today's episode, we take a look at the latest trends in digital health, with companies leveraging artificial intelligence and big data analytics to improve patient outcomes and streamline healthcare delivery. These technological advancements have the potential to transform the way healthcare is delivered and pave the way for a more efficient and patient-centric system. That's all for today's episode of Pharma and Biotech daily. Stay tuned for more updates on the latest developments in the pharmaceutical and biotechnology sectors.

In this episode of Lung Cancer Considered, host Dr. Stephen Liu discusses the recent FDA approval of taletrectinib, a next-generation ROS1 kinase inhibitor, for NSCLC with a ROS1 gene fusion. Dr. Enriqueta Felip and Dr. Jorge Nieva join the conversation to help review the data and offer help place this new agent in the proper perspective.

In his weekly clinical update, Dr. Griffin and Vincent Racaniello discuss in shock how RFK is breaking his promise of not altering vaccine policies by appointing new members of the ACIP, next ACIP meeting on guidelines for the COVID and RSV vaccines, circulation of “human insect viruses” including West Nile virus, and an outbreak of mpox on a cruise ship, and the ongoing measles outbreak before Dr. Griffin reviews recent statistics on RSV, influenza and SARS-CoV-2 infections the Wasterwater Scan dashboard, how to reduce the use of antibiotics for RSV and influenza infections in children, approval of the moderna RSV mRNA vaccine, whether or not the NB.1.8.1 should be included in the fall 2025 vaccines, immunization recommendations for COVID-19 vaccines, where to find PEMGARDA, provides information for Columbia University Irving Medical Center's long COVID treatment center, where to go for answers to your long COVID questions, contacting your federal government representative to stop the assault on science and biomedical research, and a shout out for the special episode of TWiV with David Tuller on long COVID and ME/CFS. Subscribe (free): Apple Podcasts, RSS, email Become a patron of TWiV! Links for this episode RFK Jr. is sabotaging the vaccine program. Here's how to stop him (Washington Post) Innovaciones Alumbra (Alumbra Innovaciones) John T Walton (Wikiepedia) Walmart (Wikipedia) Sam Walton (Wikipedia) Condé Nast (Wikipedia) Christy Walton (Wikipedia) Vaccine Integrity Project ( CIDRAP) CIDRAP launches Vaccine Integrity Project (Twin Cities: University of Minnesota) Next ACIP meeting (CDC: ACIP) June meeting: MEETING OF THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP)(CDC: ACIP agenda) West Nile Virus and Other Nationally Notifiable Arboviral Diseases — United States, 2023 (CDC: MMWR) Clade II Mpox Infections Among Cruise Ship Passengers and Crew Members — United States, 2024 (CDC: MMWR) H5 bird flu: current situation (CDC: Avian Influenza) Wastewater for measles (WasterWater Scan) Measles cases and outbreaks (CDC Rubeola) Weekly measles and rubella monitoring (Government of Canada) Measles (WHO) Get the FACTS about measles (NY State Department of Health) Measles (CDC Measles (Rubeola)) Measles vaccine (CDC Measles (Rubeola)) Presumptive evidence of measles immunity (CDC) Contraindications and precautions to measles vaccination (CDC) Measles (CDC Measles (Rubeola) Measles vaccine recommendations from NYP (jpg) Adverse events associated with childhood vaccines: evidence bearing on causality (NLM) Measles Vaccination: Know the Facts (ISDA: Infectious Diseases Society of America) Deaths following vaccination: what does the evidence show (Vaccine) Influenza: Waste water scan for 11 pathogens (WastewaterSCan) US respiratory virus activity (CDC Respiratory Illnesses) Weekly surveillance report: clift notes (CDC FluView) Respiratory virus activity levels (CDC Respiratory Illnesses) Weekly surveillance report: clift notes (CDC FluView) Pediatric antibiotic use associated with respiratory syncytial virus and influenza in the United States, 2008-2018 (JID) FDA-CDC-DOD: 2025-2046 influenza vaccine composition (FDA) RSV: Waste water scan for 11 pathogens (WastewaterSCan) US respiratory virus activity (CDC Respiratory Illnesses) RSV-Network (CDC Respiratory Syncytial virus Infection) Novel Drug Approvals for 2025 (FDA) Effectiveness and impact of nirsevimab in Chile during the first season of a national immunisation strategy against RSV (NIRSE-CL) (LANCET: Infectious Diseases) Safety, Tolerability, and Immunogenicity ofmRNA-1345 in Adults at Increased Risk for RSV Disease Aged 18 to 59 Years (CID) Moderna Receives U.S. FDA Approval for RSV Vaccine, mRESVIA, in Adults Aged 18–59 at Increased Risk for RSV Disease (moderna) Waste water scan for 11 pathogens (WastewaterSCan) COVID-19 deaths (CDC) COVID-19 national and regional trends (CDC) Spatiotemporal Association of Coronavirus Disease 2019 Cases and Deaths With Exposure to Wildfire Particulate Matter in 2020 (OFID) COVID-19 variant tracker (CDC) SARS-CoV-2 genomes galore (Nextstrain) Next ACIP meeting (CDC: ACIP) Antigenic and Virological Characteristics of SARS-CoV-2 Variant BA.3.2, XFG, and NB.1.8.1 (biRxiV) Where to get pemgarda (Pemgarda) EUA for the pre-exposure prophylaxis of COVID-19 (INVIYD) Infusion center (Prime Fusions) CDC Quarantine guidelines (CDC) NIH COVID-19 treatment guidelines (NIH) Implementation of an online drug-drug interaction screener for the STRIVE ensitrelvir trial for COVID-19 (OFID) Drug interaction checker (University of Liverpool) Infectious Disease Society guidelines for treatment and management (ID Society) Molnupiravir safety and efficacy (JMV) Convalescent plasma recommendation for immunocompromised (ID Society) What to do when sick with a respiratory virus (CDC) Managing healthcare staffing shortages (CDC) Steroids,dexamethasone at the right time (OFID) Anticoagulation guidelines (hematology.org) Daniel Griffin's evidence based medical practices for long COVID (OFID) Long COVID hotline (Columbia : Columbia University Irving Medical Center) The answers: Long COVID Long COVID and ME/CFS with David Tuller (microbeTV) Reaching out to US house representative Letters read on TWiV 1228 Dr. Griffin's COVID treatment summary (pdf) Timestamps by Jolene Ramsey. Thanks! Intro music is by Ronald Jenkees Send your questions for Dr. Griffin to daniel@microbe.tv Content in this podcast should not be construed as medical advice.

What does it look like to take a neuroscience degree far beyond the lab? In this episode, we explore a career path that crosses scientific research, government regulation, and biotech entrepreneurship with Dr. Amanda Wiggins, CEO of The cGP Lab. Amanda began her career investigating neurodegeneration and cortical spreading depression. Over time, her passion for real-world impact led her into public policy—where she helped shape New Zealand's Human Tissue Act and advised on regulations for stem cell research and genetic technologies. Today, she leads a company advancing neuroprotective health supplements based on cyclic Glycine-Proline (cGP), a molecule with growing potential in aging and cognitive health. We talk about: How to navigate transitions between academia, government, and business The challenges of working across disciplines—and how to build confidence in new spaces Lessons learned from leading regulatory change and scaling innovation Amanda's work at The cGP Lab and the science behind cGP's potential in brain health Advice for scientists who want to move into leadership, entrepreneurship, or public engagement This conversation is for anyone considering a non-linear career in neuroscience or wondering how to apply scientific training in new and meaningful ways. Chapters: 00:00:02 - Bridging Neuroscience and Biotech Innovation 00:04:06 - FDA Approval of Trofinetide for Rett Syndrome 00:07:27 - My Journey in Science and Identity 00:09:22 - Pursuing a PhD in Melbourne 00:11:55 - Choosing a PhD Topic 00:17:26 - Challenges and Motivation in PhD Journey 00:20:54 - Transition from Academia to Regulatory Work 00:22:52 - Transitioning from Academia to Policy 00:25:51 - Advising on the Human Tissue Act 00:29:18 - Advocating Biotechnology in New Zealand 00:33:51 - Regulations and Challenges in Biotechnology 00:37:49 - Newborn Blood Screening and Research Ethics 00:41:22 - Transitioning from Science to Biotech 00:46:04 - Challenges of Startup Success 00:48:34 - Journey to Neuroactive Innovation 00:55:23 - Mentorship and Startup Advice 00:58:49 - Dementia Prevention and Early Detection 01:02:03 - Exploring Alzheimer's Research Frontiers 01:06:45 - Advancing Your Neurocareer About the Podcast Guest:

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Roche and Jazz Pharmaceuticals presented data at ASCO showing that their drug combination improved survival in a phase III lung cancer trial, with analysts noting a strong treatment effect. Jazz has filed for FDA approval for the combination, which could provide an alternative to monotherapy treatments from Roche and AstraZeneca. Trump's tariffs could potentially endanger the rare disease space, according to industry experts. Other news includes Kymera's success with a protein degrader candidate, Amgen's IMDelltra boosting survival in small cell lung cancer, and concerns about the impact of FDA guidelines on nitrosamine testing. BioAgilytix will be at BIO International to discuss their drug production capabilities. Other news includes Kura's new data in acute myeloid leukemia, Keros' layoffs, Regeneron's investment in a Chinese obesity drug, and Sanofi's acquisition of Blueprint to expand their rare disease portfolio. Upcoming events include webinars on AI in life science R&D and the crisis facing the pharma industry. Job opportunities in clinical data management, regulatory affairs, and scientific roles are also highlighted.

In this episode, Dr. Kimberly Brown from The University of Texas at Austin Dell Medical School moderates a discussion with Dr. Thuy Tran from the University of California Irvine about the FDA approval of Lifileucel.

In today's episode, we spoke with Matthew Galsky, MD, about the FDA approval of neoadjuvant durvalumab (Imfinzi) plus gemcitabine and cisplatin followed by adjuvant durvalumab monotherapy after radical cystectomy for the treatment of adult patients with muscle-invasive bladder cancer (MIBC). Dr Galsky is a professor of medicine (hematology and medical oncology), a professor of urology, director of Genitourinary Medical Oncology, co-director of the Center of Excellence for Bladder Cancer, and director for Translational Research at The Tisch Cancer Institute in New York, New York. In our exclusive interview, Dr Galsky discussed the significance of this approval, key efficacy and safety data from the pivotal phase 3 NIAGARA trial (NCT03732677), and the role of this regimen in the MIBC treatment paradigm, including for cisplatin-eligible patients with mild renal impairment.

In this episode, we will discuss the FDA approval of telisotuzumab vedotin, an antibody drug conjugate, for NSCLC with high c-MET expression. To help review the data and offer perspective on this new agent, I am joined by two expert thoracic oncologists. I want to welcome Dr. Mor Moskovitz, Head of the Thoracic Medical Oncology Service at Davidoff Cancer Center at the Rabin Medical Center in Petah Tikva, Israel.

Dr. Doug Thamm discusses the development and use of Tanovea, a drug for treating lymphoma in dogs. He explains the drug's origins, initially researched as a human cancer therapeutic in collaboration with Gilead Sciences, and its transition to veterinary use.   Dr. Thamm provides insights into Tanovea's application, dosage, and effectiveness compared to the CHOP protocol, as well as its potential side effects and other possible uses in different cancer types like multiple myeloma. The episode also delves into related immunotherapy research and personal reflections from Dr. Thamm, a double cancer survivor, on his career choice in veterinary oncology. Your Voice Matters!   If you have a question for our team, or if you want to share your own hopeful dog cancer story, we want to hear from you! Go to https://www.dogcancer.com/ask to submit your question or story, or call our Listener Line at +1 808-868-3200 to leave a question. Related Videos:  https://www.youtube.com/watch?v=G0iRyKshzq8  Related Links:  Our article on lymphoma: https://www.dogcancer.com/articles/types-of-dog-cancer/lymphoma-in-dogs/  Our article on Tanovea: https://www.dogcancer.com/articles/drugs/tanovea-rabacfosadine-chemotherapy/  Get the facts on dog cancer remission: https://www.dogcancer.com/articles/stats-and-facts/dog-cancer-remission/  Chapters:  00:00 Introduction  00:13 Interview with Dr. Doug Thamm  00:26 The Early Involvement with Tanovea  00:41 Challenges and Discoveries in Drug Development  02:16 Transition from Human to Veterinary Use  02:48 Clinical Trials and Dosage Experiments  06:45 FDA Approval and Practical Use  08:05 Comparing Tanovea and CHOP Protocol  15:23 Exploring Alternative Treatments: Laverdia  18:43 Off-Label Uses and Future Research  23:46 Exploring Tanovea's Effectiveness in Blood Cancers  25:14 Cost Comparison: Tanovea vs. CHOP  26:15 Side Effects of Tanovea  28:47 Pulmonary Fibrosis and Breed-Specific Risks  32:52 Personal Cancer Journeys: Dr. Doug and His Wife  38:23 Debunking Myths About Dog Cancer Treatment  42:24 The Future of Cancer Treatment: Immunotherapy  45:23 Conclusion and Resources    Get to know Dr. Doug Thamm: https://www.dogcancer.com/people/doug-Thammm-v-m-d-diplomate-acvim-oncology/   For more details, articles, podcast episodes, and quality education, go to the episode page: https://www.dogcancer.com/podcast/   Learn more about your ad choices. Visit megaphone.fm/adchoices

Send us a textThe FDA has granted full approval to Novavax's COVID-19 vaccine, providing an alternative to mRNA vaccines that works through a different mechanism using proteins and adjuvants. Despite being four years into the pandemic, COVID-19 remains a significant health concern, causing approximately 1 in 200 deaths in the US in 2025.• Novavax uses bioengineered spike proteins combined with an adjuvant rather than mRNA technology• FDA approved Novavax for all Americans over 65 and those 12-64 with at least one risk factor• Risk factors include conditions like asthma, diabetes, and obesity• Northeast Florida contributed 500 patients to the original Novavax clinical trials• Encore Research Group is currently enrolling participants for an oral COVID vaccine clinical trial• Participants in the oral vaccine trial will receive compensation for their timeFor more information about participating in the oral COVID vaccine study, visit EncoreDocs.com or call 904-730-0101.Be a part of advancing science by participating in clinical research.Have a question for Dr. Koren? Email him at askDrKoren@MedEvidence.comListen on SpotifyListen on Apple PodcastsWatch on YouTubeShare with a friend. Rate, Review, and Subscribe to the MedEvidence! podcast to be notified when new episodes are released.Follow us on Social Media:FacebookInstagramX (Formerly Twitter)LinkedInWant to learn more? Checkout our entire library of podcasts, videos, articles and presentations at www.MedEvidence.comMusic: Storyblocks - Corporate InspiredThank you for listening!

The FDA has granted approval to Teal Health's at-home cervical cancer screening wand, the first self-collection tool for HPV screening in the U.S. Kara Egan, the cofounder and CEO of Teal Health, joined ForbesWomen editor Maggie McGrath talk about this milestone and what happens next.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 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

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!

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. 

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.

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.

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

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!

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