Podcasts about fda approval

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into some of the most significant shifts and strategies shaping our industry.Novartis's acquisition of Avidity Biosciences for a staggering $12 billion marks a pivotal moment in the pharmaceutical landscape this year. With this acquisition, Novartis underscores its commitment to bolstering its neuromuscular disease pipeline. Avidity Biosciences has made a name for itself with its cutting-edge RNA therapeutic technologies, particularly its Antibody Oligonucleotide Conjugates (AOCs). This platform uniquely combines monoclonal antibodies with oligonucleotides, enhancing precision in targeting specific cell types. The integration of Avidity's technology into Novartis's research efforts could accelerate the development of new therapies, potentially transforming patient care with more effective and targeted treatment options. This move not only highlights the industry's focus on specialized therapeutic areas but also anticipates future advances in RNA therapeutics, extending beyond neuromuscular disorders to areas like oncology.In a similar vein, the FDA has shown its willingness to reconsider drugs that previously faced setbacks. GSK's Blenrep has made a return to the U.S. market after receiving approval for treating certain myeloma patients. This approval is particularly noteworthy given the drug's earlier negative advisory committee vote and postponed decision. It marks a significant rebound for GSK's oncology portfolio and reflects the FDA's dynamic approach towards drugs that show potential in specific therapeutic combinations.Meanwhile, Sanofi continues to make waves with Dupixent, achieving over €4 billion in quarterly sales due to its expanded indications. This success contrasts with a decline in Sanofi's vaccine sales, demonstrating shifting dynamics within pharmaceutical portfolios where biologics and specialty drugs are increasingly pivotal. Sanofi's recent financial report highlighted a notable 17% drop in vaccine sales due to reduced demand and pricing challenges in Europe. In response, companies must navigate fluctuating public health demands and economic pressures effectively.On the global stage, efforts to make transformative therapies like Vertex's Trikafta more accessible are gaining momentum through innovative trade-policy workarounds. A buyers club aims to introduce a lower-cost alternative produced by Bangladesh's Beximco, highlighting ongoing challenges and creative strategies in global drug accessibility.Roche's expansion through Chugai's $200 million M&A deal for an IgA nephropathy asset underscores the strategic importance of regional markets in driving growth. Similarly, Lonza's acquisition of a California biologics site aligns with its goals to meet increasing biomanufacturing demands.The industry is also adapting to technological advancements, with AI integration into life sciences commercialization being touted as a frontier for growth. Despite this potential, many organizations remain unprepared to harness AI fully. Leading companies embedding AI solutions aim for measurable outcomes that could significantly drive strategic decision-making and operational efficiencies.Eli Lilly's acquisition of Adverum Biotechnologies aligns with its strategic interests in gene therapy, focusing on promising therapeutic programs that address unmet medical needs. This acquisition centers around Ixo-vec for wet age-related macular degeneration (AMD), highlighting broader industry trends towards investing heavily in innovative therapies that address unmet needs.Conversely, Sanofi's halt on an RSV vaccine development highlights the inherent risks in vaccine development pipelines. Meanwhile, Regeneron's decision to discontinue a CAR T candidate acquired from 2seventy bio showcases ongoing reassessment witSupport the show

This week in review covers 5 episodes from October 20 to October 24, featuring major developments in pharmaceutical and biotech industries including strategic acquisitions, regulatory updates, and clinical trial results.Episodes included:1. Pharma Innovations: AI's Impact and Strategic Shifts2. Strategic Acquisitions and AI Revolutionize Pharma Landscape3. Industry Shifts: Novo Nordisk's Revamp & ADC Breakthroughs4. Transformative Advances in Precision Oncology and ADCs5. Transformative Oncology Breakthroughs and Regulatory ShiftsKey topics covered:- Strategic acquisitions and partnerships- Regulatory updates and FDA approvals- Clinical trial results and breakthroughs- Industry trends and market developmentsStay informed with Pharma Daily's comprehensive coverage of the pharmaceutical and biotech world.Support the show

In today's episode, we had the pleasure of speaking with Vishal A. Patel, MD, FAAD, FACMS, about the FDA approval of adjuvant cemiplimab-rwlc (Libtayo) for the treatment of patients with high-risk cutaneous squamous cell carcinoma (CSCC). Dr Patel is an associate professor of dermatology at the GW School of Medicine & Health Sciences, as well as the director of the Cutaneous Oncology Program at the GW Cancer Center in Washington, DC. In our exclusive interview, Dr Patel discussed the clinical relevance of this approval, key details about the pivotal phase 3 C-POST trial (NCT03969004), and the safety profile of cemiplimab in patients with CSCC.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into some of the most significant shifts occurring in these industries, touching on strategic restructuring, regulatory milestones, and groundbreaking scientific advancements that are shaping the future of drug development and patient care.Let's begin with a major corporate shakeup at Novo Nordisk. The company has announced a significant leadership transition as former CEO Lars Rebien Sorensen is set to become the new chairman of the board. This change follows the resignation of seven board members and indicates a strategic realignment within the company. The Novo Foundation's involvement suggests a deeper strategic shift, potentially aligning with new organizational objectives and innovations. Such moves are pivotal as they could influence Novo Nordisk's market position and future product development.Turning to scientific breakthroughs, Merck's collaboration with Kelun-Biotech has yielded promising results with their Trop2 antibody-drug conjugate, sacituzumab-tmt. This ADC has shown success in two Phase 3 trials targeting lung and breast cancers, underscoring the therapeutic potential of ADCs in oncology. By selectively targeting cancer cells while minimizing damage to healthy tissues, ADCs could significantly improve patient outcomes and represent a powerful modality in cancer treatment.In regulatory affairs, Kenvue is challenging the FDA over proposed safety warnings for Tylenol linked to autism during pregnancy. This dispute highlights the ongoing debates surrounding drug safety and regulatory oversight. The outcome could have significant implications for labeling practices and consumer trust in over-the-counter medications. Meanwhile, Summit Therapeutics plans to file for FDA approval of ivonescimab, highlighting ongoing innovation in drug development pipelines. Similarly, Novo Nordisk's semaglutide pill Rybelsus has received FDA expansion approval to reduce major adverse cardiovascular events. This sets a new benchmark for oral metabolism drugs by demonstrating their potential beyond glycemic control to positively impact cardiovascular health.As we explore industry trends, there's growing interest in direct-to-consumer drug sales. While this approach offers patients access to medications at reduced costs, it raises concerns about privacy and the quality of care without traditional healthcare provider interactions. Additionally, a notable decline in pharmaceutical TV ad spending by 19% in Q3 suggests a shift towards digital engagement strategies. Amidst these narratives, the Biotechnology Innovation Organization (BIO) has launched an awareness campaign to combat misinformation about vaccines. This effort underscores the importance of immunizations in public health and aims to reinforce trust amid rising disinformation.In another scientific advancement, GSK has released positive Phase 3 data for Spero Therapeutics' oral antibiotic candidate. The oral formulation's efficacy comparable to intravenous options could lead to broader use and improved patient adherence—critical advancements as antibiotic resistance remains a global health challenge.Investment activities reflect strategic shifts within the industry as well. Curewell Capital's investment in Wilmington PharmaTech aims to enhance U.S. active pharmaceutical ingredient production capacity—a crucial step given recent global supply chain disruptions. Similarly, India's ACG is making a $200 million investment in its first U.S. empty-capsule production facility, highlighting the strategic importance of manufacturing capabilities on American soil.Galapagos' decision to wind down its cell therapy unit marks a significant strategic pivot from its previous focus on this modality. This shift reflects broader industry trends where companies reassess priorSupport the show

John Gerardi asks the tough questions about the Trump administration's slow action on restricting the abortion pill, including the FDA's approval of a new generic version. With Jonathan Keller, he explores the legal, political, and moral stakes of Mifepristone regulation, why it matters for abortion numbers nationwide, and the challenge of holding pro-life leaders accountable.  

In today's episode, we had the pleasure of speaking with J. Thaddeus Beck, MD, FACP, about the FDA approval of pembrolizumab and berahyaluronidase alfa-pmph (subcutaneous pembrolizumab; Keytruda Qlex) for subcutaneous injection in adult and pediatric patients at least 12 years of age with solid tumors for which the intravenous formulation of pembrolizumab (Keytruda) is indicated.

John and Jonathan unpack the FDA's surprise approval of a generic abortion pill, the political and legal fallout, and why pro-lifers are demanding a real fight over Mifepristone.

Israelis celebrate reports of a ceasefire; on Culture Friday, John Stonestreet covers the FDA approval of generic mifepristone and Bari Weiss at CBS; and Collin Garbarino reviews Tron: Ares. Plus, the Friday morning newsSupport The World and Everything in It today at wng.org/donateAdditional support comes from Cedarville University—a Christ-centered, academically rigorous university located in southwest Ohio, equipping students for Gospel impact across every career and calling. Cedarville integrates a biblical worldview into every course in the more than 175 undergraduate and graduate programs students choose from. New online undergraduate degrees through Cedarville Online offer flexible and affordable education grounded in a strong Christian community that fosters both faith and learning. Learn more at cedarville.edu, and explore online programs at cedarville.edu/onlineFrom Covenant College, where Christian faculty equip students for their callings through hard ideas, deep questions, and meaningful work. covenant.edu/worldAnd from Ambassadors Impact Network, helping entrepreneurs who are looking for more than just funding. Discover a community of Christian faith-led investors. More at ambassadorsimpact.com

In today's episode, we had the pleasure of speaking with Joseph Jacob, MD, MCR, about the FDA approval of the gemcitabine intravesical system (formerly TAR-200; Inlexzo)​ for the treatment of patients with BCG-unresponsive non–muscle-invasive bladder cancer. Dr Jacob is an associate professor of urology and the director of Urologic Oncology in the Department of Urology at State University of New York Upstate Medical University in Syracuse. In our exclusive interview, Dr Jacob discussed the significance of this approval, key efficacy findings from the pivotal phase 2b SunRISe-1 trial (NCT04640623), and the TAR-200 administration procedure, which he describes as straightforward for practitioners and convenient for patients.

In this episode of Disruption/Interruption, host KJ sits down with Jim Foote, CEO and founder of First Ascent Biomedical. Jim shares his personal journey from technology executive to cancer care innovator, after his son’s diagnosis changed his life. Discover how he’s disrupting the status quo in oncology with AI-driven, personalized medicine that’s giving new hope to patients and families. Key Takeaways: The Problem with Standard Cancer Care [3:53]The standard of care treats patients as if they are the same, but everyone is unique. This approach works two-thirds of the time, but leaves one-third of patients with few options. Functional Precision Medicine [13:04]Jim’s company tests up to 152 FDA-approved drugs on a patient’s biopsy to find the most effective treatment, providing doctors with data-driven options tailored to each individual. AI and Technology are Transforming Oncology [28:05]Advances in AI, robotics, and cloud computing have converged, making personalized cancer treatment faster, more affordable, and more effective than ever before. Impact and Future Vision [26:51]Jim’s goal is for every cancer patient to receive individualized treatment from the moment of diagnosis, improving outcomes and reducing unnecessary side effects. Quote of the Show (14:40):“I literally have gone from trying and hoping to testing and choosing.” — Jim Foote Join our Anti-PR newsletter where we’re keeping a watchful and clever eye on PR trends, PR fails, and interesting news in tech so you don't have to. You're welcome. Want PR that actually matters? Get 30 minutes of expert advice in a fast-paced, zero-nonsense session from Karla Jo Helms, a veteran Crisis PR and Anti-PR Strategist who knows how to tell your story in the best possible light and get the exposure you need to disrupt your industry. Click here to book your call: https://info.jotopr.com/free-anti-pr-eval Ways to connect with Jim Foote: LinkedIn: http://www.linkedin.com/in/jim-foote Company Website: https://firstascentbiomedical.com/ How to get more Disruption/Interruption: Amazon Music - https://music.amazon.com/podcasts/eccda84d-4d5b-4c52-ba54-7fd8af3cbe87/disruption-interruption Apple Podcast - https://podcasts.apple.com/us/podcast/disruption-interruption/id1581985755 Spotify - https://open.spotify.com/show/6yGSwcSp8J354awJkCmJlDSee omnystudio.com/listener for privacy information.

In today's episode, we had the pleasure of speaking with Lyudmila Bazhenova, MD, about the FDA approval of sunvozertinib (Zegfrovy) for patients with EGFR-mutated metastatic non–small cell lung cancer (NSCLC). Dr Bazhenova is a clinical professor of medicine at the University of California San Diego (UCSD); as well as a medical oncologist at the UCSD Moores Cancer Center. In our exclusive interview, Dr Bazhenova discussed the significance of this approval, key efficacy and safety data from the pivotal the phase 1/2 WU-KONG1B trial (NCT03974022), and how the use of sunvozertinib in the NSCLC treatment paradigm may propel future possibilities for the use of EGFR-directed agents in this disease.

Guest: Robyn ChambersMinistry: Focus on the FamilyPosition: Vice President of Advocacy for ChildrenTopics: significance of March for Life + analysis of pro-life developmentsWebsites: focusonthefamily.com/pro-life; thedailycitizen.org

Guest: Robyn ChambersMinistry: Focus on the FamilyPosition: Vice President of Advocacy for ChildrenTopics: significance of March for Life + analysis of pro-life developmentsWebsites: focusonthefamily.com/pro-life; thedailycitizen.org

In this episode of Lung Cancer Considered, host Dr. Stephen Liu discusses the recent FDA approval of maintenance lurbinectedin plus atezolizumab for extensive stage small cell lung cancer, based on the phase III IMforte trial. Dr. Hossein Borghaei joins the podcast to explain the results and offer perspective on the impact of maintenance therapy for SCLC. Guest: Dr. Hossein Borghaei, DO, MS Chief, Division of Thoracic Medical Oncology Professor, Department of Hematology/Oncology Fox Chase Cancer Center

In this episode of the Oncology Brothers podcast, we dive deep into the latest advancements in treating extensive stage small cell lung cancer (SCLC), focusing on the IMforte data and its clinical implications. We welcomed esteemed thoracic medical oncologists Drs. Isabel Preeshagul, Ticiana Leal, and Dr. Stephen Liu to discuss the findings presented at ASCO 2025 and World Lung 2025. Key topics included: • Overview of the IMforte study design and patient population • The role of lurbinectedin and atezolizumab as maintenance therapy • Significant improvements in progression-free survival (PFS) and overall survival (OS) • Management of side effects and the importance of prophylactic growth factors • Patient selection criteria for this new standard of care With a focus on bridging the gap between community and academia, this episode provides valuable insights for medical oncologists and patients alike. Tune in to learn how these advancements are changing the landscape of SCLC treatment and improving patient outcomes.  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 check out our other discussions on recent approvals, treatment algorithms, and challenging cases. We are the Oncology Brothers! #IMforte #SCLC #Lurbinectedin #MaintenanceTherapy #ASCO2025 #OncologyBrothers #ES-SCLC

In today's episode, we had the pleasure of speaking with Anne Chiang, MD, PhD, and Stephen Liu, MD, about the FDA approval of lurbinectedin (Zepzelca) plus atezolizumab (Tecentriq) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) as maintenance treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after frontline induction therapy with atezolizumab or atezolizumab and hyaluronidase, carboplatin, and etoposide. Chiang is an associate professor of medicine in the Section of Medical Oncology and the associate cancer center director of Clinical Initiatives at the Yale School of Medicine in New Haven, Connecticut. Dr Liu is an associate professor of medicine at Georgetown University, as well as the director of Thoracic Oncology and head of Developmental Therapeutics at the Georgetown Lombardi Comprehensive Cancer Center in Washington, DC. In our exclusive interview, Drs Chiang and Liu discussed the significance of this approval, key efficacy and safety data from the pivotal phase 3 IMforte trial (NCT05091567), and how the addition of this regimen in the ES-SCLC treatment paradigm may affect clinical practice.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.President Trump has announced a 100% tariff deadline for pharmaceutical companies starting on October 1. However, companies that have already begun construction on manufacturing facilities in the U.S. are exempt from these tariffs. This move is part of the administration's efforts to lower drug prices and improve access to treatments for patients.In other news, Crinetics Pharmaceuticals has received FDA approval for their once-daily treatment for acromegaly, a rare pituitary condition. This approval marks a significant milestone for Crinetics and is expected to have a positive impact on patients' lives.Additionally, Lilly's oral SERD has been approved by the FDA for the treatment of breast cancer. This treatment has shown improved progression-free survival compared to standard therapy, offering new hope for patients battling this disease.The Trump administration is also preparing a proposed rule to further lower drug prices in the U.S., as part of an ongoing effort to align drug prices with other economically similar countries. These developments in the pharmaceutical industry are aimed at improving access to treatments and lowering costs for patients.

IASLC Lung Cancer Considered: FDA Approval: Subcutaneous Immunotherapy by IASLC

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Pfizer has made a comeback in the obesity market with the acquisition of Metsera for $4.9 billion, rejuvenating its portfolio after facing challenges with three discontinued assets. Meanwhile, Stealth BioTherapeutics has received expedited FDA approval for the first-ever treatment for Barth syndrome, and Sanofi's decision on their oral multiple sclerosis drug has been postponed to December. The ACIP committee has expressed concerns about a lack of knowledge and experience within the reconstituted committee. Biotility offers industry-recognized credentials to advance bioscience careers, Novartis is exploring ways to reduce drug costs in the US, and Merck has received approval for a subcutaneous formulation of Keytruda. Stay tuned for more updates on the psychedelics space, rare disease treatments, and other developments in the biopharmaceutical industry.

Martha Carlin, CEO and founder of the Bio Collective, details the significant influence of the microbiome on overall health. Martha discusses her unconventional path from accounting to microbiome research, sparked by her husband's Parkinson's diagnosis. Together, they explore the complex connections between gut health and diseases like Parkinson's, autism, and even Alzheimer's. Martha sheds light on groundbreaking research funded by NIH grants, the potential of machine learning and AI in understanding microbiome patterns, and the future prospects of personalized probiotics. Practical advice on maintaining a healthy microbiome, the impact of diet and exercise, and the intriguing intersections between gut health, neurochemistry, and systemic diseases are highlighted. The discussion also covers challenges in integrating microbiome research into clinical practice and potential future therapies.

Dr. Hoffman continues his conversation with Martha Carlin, CEO and founder of the Bio Collective.

The FDA just approved the cyclobenzaprine (Tonmya, Flexeril) for fibromyalgia. We look at three risks that medication raises in psychiatry.CME: Take the CME Post-Test for this EpisodePublished On: 09/01/2025Duration: 16 minutes, 42 secondsChris Aiken, MD and Kellie Newsome, PMHNP have disclosed no relevant financial or other interests in any commercial companies pertaining to this educational activity.

In today's episode, supported by Chimerix, we spoke with Patrick Y. Wen, MD, about the FDA approval of dordaviprone (Modeyso) for the treatment of adult and pediatric patients at least 1 year of age with H3K27M-mutated diffuse midline glioma who have progressive disease following prior therapy. Dr Wen is the director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute; as well as a professor of neurology at Harvard Medical School in Boston, Massachusetts. In our conversation, Dr Wen discussed the significance of this accelerated approval across patient age groups, key efficacy and safety data that supported this approval, and the importance of biomarker testing in patients with glioma. He also highlighted potential next steps for expanding the investigation of dordaviprone in patients with glioma and emphasized the ways that multidisciplinary collaboration can provide patients with personalized, optimized care. 

In his weekly clinical update, Dr. Griffin with Vincent Racaniello are dismayed about the recent attack on public health the firing of the director of the CDC as well as resignation of 3 others members of the agency's leadership, the continued Legionnaire's outbreak in Harlem, suspension of Ixchiq the Chikungunya virus attenuated infectious vaccine, the first US case of New World screwworm before Dr. Griffin deep dives into recent statistics on the measles epidemic, RSV, influenza and SARS-CoV-2 infections, the Wasterwater Scan dashboard, Johns Hopkins measles tracker, association Guillian-Barré syndrome with RSV vaccination, guidelines for using RSV vaccines, whether or not the NB.1.8.1 should be included in the fall 2025 vaccines, the American College Obstetricians and Gynecologists recommendations for the COVID, RSV and influenza vaccines, FDA approval letters for Pfizer, moderna and Novagax COVID vaccines including label changes for use in those between 5 through 64 years, where to find PEMGARDA, long COVID treatment center, where to go for answers to your long COVID questions, and contacting your federal government representative to stop the assault on science and biomedical research. Subscribe (free): Apple Podcasts, RSS, email Become a patron of TWiV! Links for this episode White House Says New C.D.C. Director Is Fired, but She Refuses to Leave (NY Times) CDC director refuses to leave after White House order (BBC) Legionnaires' Disease: In Harlem(NYC Health) New York City Health Department Provides Update on Community Cluster of Legionnaires' Disease in Central Harlem(NYC Health: Promoting and protecting the City's health) FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live) (FDA) Vimkunya (Bavarian Nordiac) U.S. and Panama for the control of the Screwworm pest (COPEG) Rare human case of flesh-eating parasite New World screwworm identified in US(CNN) USDA Announces Sweeping Plans to Protect the United States from New World Screwworm (USDA) HHS details New World screwworm response after human case(CIDRAP) Wastewater for measles (WasterWater Scan) Measles cases and outbreaks (CDC Rubeola) Tracking Measles Cases in the U.S. (Johns Hopkins) 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) Respiratory virus activity levels (CDC Respiratory Illnesses) Weekly surveillance report: clift notes (CDC FluView) Relative effectiveness of high-dose versus standard-dose influenza vaccine against hospitalizations and mortality according to frailty score (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) ENFLONSIA: novel drug approvals 2025 (FDA) RSV-Network (CDC Respiratory Syncytial virus Infection) Vaccines for Adults (CDC: Respiratory Syncytial Virus Infection (RSV)) Evaluation of Guillain-Barré Syndrome (GBS) following Respiratory Syncytial Virus (RSV) Vaccination Among Adults 65 Years and Older (FDA) Economic Analysis of Protein Subunit and mRNA RSV Vaccination in Adults aged 50-59 Years (CDC: ACIP) Evidence to Recommendations Framework (EtR): RSV Vaccination in Adults Aged 50–59 years (CDC: National Center for Immunization and Respiratory Diseases) Waste water scan for 11 pathogens (WastewaterSCan) COVID-19 deaths (CDC) Respiratory Illnesses Data Channel (CDC: Respiratory Illnesses) COVID-19 national and regional trends (CDC) COVID-19 variant tracker (CDC) SARS-CoV-2 genomes galore (Nextstrain) Antigenic and Virological Characteristics of SARS-CoV-2 Variant BA.3.2, XFG, and NB.1.8.1 (bioRxiV) Veering from CDC, ACOG recommends maternal vaccination against COVID-19 (CIDRAP) ACOG Releases Updated Maternal Immunization Guidance for COVID-19, Influenza, and RSV (American College of Obstericians and Gynecologists) COVID-19 Vaccination Considerations for Obstetric–Gynecologic Care (American College of Obstericians and Gynecologists) Pfizer and BioNTech's COMIRNATY® Receives U.S. FDA Approval for Adults 65 and Older and Individuals Ages 5 through 64 at Increased Risk for Severe COVID-19 (Pfizer)  COMIRNATY approval letter (FDA) Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccines Targeting LP.8.1 Variant of SARS-CoV-2 (FEEDS) SPIKEVAX approval letter (FDA) Novavax's Nuvaxovid 2025-2026 Formula COVID-19 Vaccine Approved in the U.S (Novavax) NUVAXOVID approval letter (FDA) 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) Drug interaction checker (University of Liverpool) Paxlovid (Pfizer) 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 Reaching out to US house representative Letters read on TWiV 1248 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.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. CDC Director Monarez was fired after less than a month due to internal unrest over new COVID-19 vaccine policies. Novo Nordisk is investing over $500 million in RNA obesity treatments. The FDA has approved updated COVID-19 shots from Pfizer, Moderna, and Novavax with restrictions, causing concern among some groups. Prothena's Alzheimer's drug, PRX012, has shown high rates of brain swelling in Phase I testing. Novo Nordisk is collaborating with other companies on cardiometabolic treatments. The pharma industry is facing challenges and changes, with layoffs and restructurings occurring at various companies. Massachusetts has seen a decline in R&D and biomanufacturing jobs in 2024. Various webinars and events are being held to discuss topics such as pharma manufacturing and data accessibility. Job opportunities in the pharmaceutical industry include positions in business analysis, quality engineering, and project engineering.

In today's episode, supported by Nuvation Bio, we spoke with Joel Neal, MD, PhD, and Christian Rolfo, MD, PhD, about the FDA approval of taletrectinib (Ibtrozi) for the treatment of patients with locally advanced or metastatic, ROS1-positive non–small cell lung cancer (NSCLC). Dr Neal is a professor of medicine in the Division of Oncology at the Stanford Cancer Institute at Stanford University in Palo Alto, California. Dr Rolfo is the director of the Division of Medical Oncology at The Ohio State University Comprehensive Cancer Center—James and a professor in the College of Medicine at The Ohio State University in Columbus. In our conversation, Drs Neal and Rolfo discussed the significance of this approval, key data from the pivotal phase 2 TRUST-I (NCT04395677) and TRUST-II (NCT04919811) trials, and taletrectinib's current role in the NSCLC treatment paradigm.

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

In today's episode, supported by Boehringer Ingelheim, we spoke with Ticiana Leal, MD, and Misako Nagasaka, MD, PhD, about the FDA approval of zongertinib (Hernexeos) for previously treated patients with HER2 TKD–mutant advanced non–small cell lung cancer (NSCLC). Dr Leal is an associate professor and director of the Thoracic Medical Oncology Program in the Department of Hematology and Medical Oncology at Emory University School of Medicine in Atlanta, Georgia; as well as medical director of the Clinical Trials Office and leader of the Lung Cancer Disease Team at the Winship Cancer Institute of Emory University. Dr Nagasaka is an associate professor of medicine in the Division of Hematology and Oncology at the University of California, Irvine (UCI) School of Medicine; as well as a medical oncologist at UCI Health. In our conversation, Drs Leal and Nagasaka discussed the significance of this approval, key efficacy and safety findings from the pivotal phase 1 Beamion LUNG-1 trial (NCT04886804), and where zongertinib currently fits into the NSCLC treatment paradigm.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Lilly's new oral obesity drug is progressing towards FDA approval in 2025 after positive results from the second phase III trial for Orfoglipron. Analysts are optimistic about the potential for a "double-digit billion dollar opportunity" due to a manufacturing advantage.Arginex is looking to expand the label for Vyvgart in myasthenia gravis, while drugmakers are seeing success in AI-driven manufacturing. The White House has denied rumors of a potential ban on COVID-19 vaccines, as the pharmaceutical industry continues to innovate and adapt to challenges.With ongoing developments in scientific research and drug development, the industry remains at the forefront of innovation.

Send us an inquiry through a text message here!Welcome to a very special episode of The Veterinary Roundtable! In this episode, the ladies welcome Dr. Linda Black, CEO of Gallant, to discuss how stem cells work, the efficacy of stem cell therapy in dogs and cats, the company's goals for the future, and so much more.Do you have a question, story, or inquiry for The Veterinary Roundtable? Send us a text from the link above, ask us on any social media platform, or email theveterinaryroundtable@gmail.com!Episodes of The Veterinary Roundtable are on all podcast services along with video form on YouTube!Connect with Linda on LinkedIn: https://www.linkedin.com/in/lindablackdvmphd/ Gallant Website: https://www.gallant.com/ TIMESTAMPS00:00 Intro02:15 Dr. Linda Black03:49 Maintaining Mental Health07:02 An Overview of Gallant11:04 Gallant's Use of a Uterus14:00 What Gallant Does When They Need More Pets17:00 How Stem Cells Work21:00 The Potential Candidates For Stem Cell Therapy24:09 FDA Approval and Side Effects27:33 Using With Multiple Therapeutics37:41 The Option of Equine Medicine39:07 Timeline of Expectations43:58 Replacing Treatments That Exist Now45:13 Vaccinations46:35 Gallant's Biggest Hurdle50:40 Dr. Linda Black's Journey57:41 Books We're Reading01:02:37 The Goal of the Podcast01:05:53 One Thing Listeners Should Take Away01:06:50 Outro

Welcome back to the Oncology Brothers podcast! In this episode, Drs. Rohit & Rahul Gosain are joined by Dr. Joshua Sabari from the NYU Langone Cancer Center to discuss the exciting recent approval of Zongertinib, the first oral TKI for HER2-positive lung cancer. We dived deep into the prevalence of HER2 mutations in non-small cell lung cancer, the study design and findings from the Beamion LUNG-1 trial, and the implications of this new therapy in clinical practice. Dr. Sabari shared insights on the efficacy of Zongertinib, including impressive response rates and progression-free survival data, as well as its side effect profile compared to other treatments like trastuzumab deruxtecan (T-DXd). Key topics covered in this episode: •⁠  ⁠Overview of HER2 mutations in lung cancer •⁠  ⁠Study design and results of the Beamion LUNG-1 •⁠  ⁠Comparison of Zongertinib and T-DXd in treatment settings •⁠  ⁠Management of common side effects associated with Zongertinib •⁠  ⁠Future directions for HER2-targeted therapies Join us for this informative discussion as we explore the latest advancements in lung cancer treatment and what they mean for patients and clinicians alike. Don't forget to subscribe for more episodes on new approvals, side effect management, and practice-changing data in oncology! Follow us on social media: •⁠  ⁠X/Twitter: https://twitter.com/oncbrothers •⁠  ⁠Instagram: https://www.instagram.com/oncbrothers •⁠  Website: https://oncbrothers.com/

Did you know that nearly one in three people with obesity may have fatty liver disease without even knowing it? In this episode, I talk about groundbreaking news in obesity and liver health, focusing on the FDA's recent approval of WeGovy to treat metabolic dysfunction associated steatohepatitis (MASH) with moderate to advanced fibrosis. I share a personal story about a friend who once struggled with fatigue, abnormal liver tests, and fatty liver disease, highlighting how limited treatment options used to be. I explain what MASH is, why it's so serious, and how common it is, especially among people with obesity and metabolic syndrome.  Furthermore, I dive into the ESSENCE trial, which showed that WeGovy not only improved liver inflammation and scarring but in some cases even reversed the disease, all while emphasizing that it works best when combined with lifestyle changes like healthy eating and regular activity.  Don't miss this episode where I break down the latest breakthrough in liver and weight loss care that could change your health journey!   Episode Highlights: FDA approval of WeGovy for treating MASH with fibrosis The ESSENCE trial results showing improvements in liver health Understanding what MASH is and why it's so common Importance of combining medication with lifestyle changes Connect with Dr. Alicia Shelly: Website | drshellymd.com Facebook | www.facebook.com/drshellymd Instagram | @drshellymd Linked In | www.linkedin.com/in/drshellymd Twitter | @drshellymd About Dr. Alicia Shelly Dr. Alicia Shelly was raised in Atlanta, GA. She received her Doctorate of Medicine from Case Western Reserve University School of Medicine in Cleveland, OH.  Dr. Shelly has been practicing Primary Care and Obesity medicine since 2014.  In 2017, she became a Diplomat of the American Board of Obesity Medicine. She is the lead physician at the Wellstar Medical Center Douglasville. She started a weekly podcast & Youtube channel entitled Back on Track: Achieving Healthy Weight loss,  where she discusses how to get on track and stay on track with your weight loss journey. She has spoken for numerous local and national organizations, including the Obesity Medicine Association, and the Georgia Chapter of the American Society of Metabolic and Bariatric Surgeons. She has been featured on CNN, Fox 5 News, Bruce St. James Radio show, Upscale magazine, and Shape.com. She was named an honoree of the 2021 Atlanta Business Chronicle's 40 under 40 award. She also is a collaborating author for the, “Made for More: Physician Entrepreneurs who Live Life and Practice Medicine on their own terms''.   Resources: FREE! Discover the 5 Reasons Your Weight-Loss Journey Has Gotten Derailed (And How To Get Back On Track!)

If injectable weight loss drugs like Zepbound can help people lose 20% of their weight, what about a once-a-day pill that achieves 12% weight loss, without the needles and sky-high cost? In this episode, Lisa Oldson, MD shares Andrea's journey through the maze of weight loss medications and introduces the promising new drug orforglipron. You'll hear how this oral GLP-1 agonist compares to popular injectables, why it could be a game-changer for millions, and the top five reasons to consider medication as part of a comprehensive weight loss plan. Whether you're curious about new treatments, concerned about side effects, or looking for affordable options, this episode breaks down what you need to know about orforglipron and the future of weight loss medicine.Thanks for listening! If you'd like more support during your SMART weight loss & health focused journey, sign up for our FREE newsletter by emailing us at Team@SmartWeightLossCoaching.com, or check out our program at: www.SmartWeightLossCoaching.com. We would love to help you reach your happy weight, and transform the way you talk to yourself about your body and the number on the scale. Negative thoughts about yourself don't have to take up so much brain space, and we'd be honored to help you reframe those thoughts. Also…We'd be grateful if you'd follow us and share our podcast with your friends & family. We're here to help you improve your health, live longer, healthier, and lose weight the SMART way! This episode was produced by The Podcast Teacher: www.ThePodcastTeacher.com.

An update on natural thyroid availability and the FDAA correction on disseminated sarcoidosis and stressI'm a former smoker. Should I be concerned about beta carotene in the Alpha Base multivitamin?A comment from a user of lithium orotate for the last eleven yearsDoes long-term use of Horse Chestnut cause a thiamin deficiency?

Just over two years ago, the FDA issued its first draft guidance on clinical trials with psychedelic drugs. Now, HHS has hired a dedicated psychedelics advisor. This week, Reunion Neuroscience reported a mid-stage success with its short-acting psychedelic drug in postpartum depression.At a moment of increasing momentum – both in terms of research, funding and commercial promise – behind psychedelics, it's worth checking in with one of the leaders in the space: Cybin, a clinical-stage biopharma.In November, Cybin reported positive Phase 2 data for its major depressive disorder drug and has its sights set on next steps in the regulatory approval process.Pharma Editor Lecia Bushak brings us a conversation with Cybin CEO Doug Drysdale about "second-generation" psychedelics and how they are impacting the mental health treatment space.For our Trends segment, we're talking about recent updates to health data sharing on the federal level. Step into the future of health media at the MM+M Media Summit on October 30th, 2025 live in NYC! Join top voices in pharma marketing for a full day of forward-thinking discussions on AI, streaming, retail media, and more. Explore the latest in omnichannel strategy, personalization, media trust, and data privacy—all under one roof. Don't wait—use promo code PODCAST for $100 off your individual ticket. Click here to register! AI Deciphered is back—live in New York City this November 13th.Join leaders from brands, agencies, and platforms for a future-focused conversation on how AI is transforming media, marketing, and the retail experience. Ready to future-proof your strategy? Secure your spot now at aidecipheredsummit.com. Use code POD at check out for $100 your ticket! Check us out at: mmm-online.com Follow us: YouTube: @MMM-onlineTikTok: @MMMnewsInstagram: @MMMnewsonlineTwitter/X: @MMMnewsLinkedIn: MM+M To read more of the most timely, balanced and original reporting in medical marketing, subscribe here.Music: “Deep Reflection” by DP and Triple Scoop Music.

In this episode of the Oncology Brothers podcast, Drs. Rohit & Rahul Gosain welcome Dr. Jacob Sands, a thoracic medical oncologist from the Dana-Farber Cancer Institute, to discuss the recent FDA approval of Dato-DXD (datopotamab deruxtecan) for previously treated EGFR-mutated non-small cell lung cancer (NSCLC). Key Topics: •⁠  ⁠Overview of Dato-DXd and its FDA approval •⁠  ⁠Mechanism of action and study design of the TROPION Lung trials •⁠  ⁠Efficacy and safety profile of Dato-DXd •⁠  ⁠Management of side effects and clinical pearls •⁠  ⁠Treatment sequencing for EGFR-mutated NSCLC Join us as we dive into the details of the TROPION Lung trials that led to this significant approval, the mechanism of action of Dato-DXd, and the implications for patients with various EGFR mutations.  Dr. Sands shared insights on the study design, efficacy, and tolerability of this new antibody-drug conjugate, as well as important clinical pearls for managing side effects such as stomatitis, dry eyes, and interstitial lung disease (ILD). We also explored the current treatment landscape for EGFR-mutated NSCLC, including the sequencing of therapies and the potential role of Dato-DXd in clinical practice. Tune in for an informative discussion that highlights the exciting advancements in oncology and the hope they bring to patients. 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 check out our other episodes for more insights into the world of oncology!

In today's episode, we spoke with Nisha Joseph, MD, and Hans Lee, MD, about the FDA's accelerated approval of linvoseltamab-gcpt (Lynozyfic) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 4 or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Joseph is an associate professor in the Department of Hematology and Medical Oncology at Emory University School of Medicine in Atlanta, Georgia. Lee is the director of Myeloma Research at the Sarah Cannon Research Institute in Nashville, Tennessee.  In our conversation, Drs Lee and Joseph discussed the significance of this approval, key data from the pivotal phase 1/2 LINKER-MM1 trial (NCT03761108), and where linvoseltamab fits into the relapsed/refractory myeloma treatment paradigm alongside other approved agents. 

Novo Nordisk (NVO) jumped higher after the FDA approved the company's Wegovy drug as a liver disease treatment. Dayforce (DAY) rallied more than 25% off reports that Thoma Bravo is looking to acquire the company. Nvidia (NVDA) has more bullish momentum heading into next week's earnings thanks to price target hikes from Morgan Stanley and Cantor Fitzgerald. Sam Vadas explains the biggest market movers starting the trading week.======== Schwab Network ========Empowering every investor and trader, every market day. Subscribe to the Market Minute newsletter - https://schwabnetwork.com/subscribeDownload the iOS app - https://apps.apple.com/us/app/schwab-network/id1460719185Download the Amazon Fire Tv App - https://www.amazon.com/TD-Ameritrade-Network/dp/B07KRD76C7Watch on Sling - https://watch.sling.com/1/asset/191928615bd8d47686f94682aefaa007/watchWatch on Vizio - https://www.vizio.com/en/watchfreeplus-exploreWatch on DistroTV - https://www.distro.tv/live/schwab-network/Follow us on X – https://twitter.com/schwabnetworkFollow us on Facebook – https://www.facebook.com/schwabnetworkFollow us on LinkedIn - https://www.linkedin.com/company/schwab-network/ About Schwab Network - https://schwabnetwork.com/about

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Eli Lilly plans to raise drug prices in Europe in response to Trump's Most Favored Nation policy. RFK Jr. has expressed support for mRNA cancer vaccines after cutting mRNA BARDA contracts. Precigen wins FDA approval for an immunotherapy for recurrent respiratory papillomatosis, while Kennedy revives a childhood vaccine safety group and suggests mRNA vaccines could be effective for cancer. Genscript announces a new era of innovation, Bausch Health closes a California site, and Eli Lilly partners with Superluminal for obesity treatments. Trump delays tariffs, and upcoming webinars focus on AI in research, integrated supply chain strategies, and data lakes. Job opportunities include positions at Utro Biopharma, BioMarin Pharmaceutical, and AbbVie.

We love to hear from our listeners. Send us a message.Episode 2 of FDA Fridays, the special series from Cell & Gene: The Podcast, features Host Erin Harris' discussion with regulatory expert Monika Swietlicka, Principal, Regulatory Strategy, Halloran Consulting Group about the key strategies and challenges in navigating FDA regulation for cell and gene therapies. Their conversation covers the importance of defining a therapy's intended role (curative, chronic, or adjunctive) early in development, the different regulatory expectations based on disease context and patient population, and the crucial impact of unmet medical need on regulatory flexibility. Swietlicka emphasizes the necessity of a clear, scientifically sound regulatory narrative, especially when precedent is lacking, and advocates for early, robust investment in CMC to minimize risks. They also explore the complexities of using surrogate endpoints, planning for long-term patient follow-up under uncertainty, and the value of integrating commercial considerations from the outset. Swietlicka calls for cell and gene therapy developers to adopt a commercial mindset and proactive regulatory engagement to achieve clinical and commercial success.Subscribe to the podcast!Apple | Spotify | YouTube Visit my website: Cell & Gene Connect with me on LinkedIn

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Sarepta has released new safety data for their gene therapy Elevidys, showing zero ambulatory deaths in patients with Duchenne muscular dystrophy. This data confirms the therapy's positive risk/benefit profile. Meanwhile, Novo Nordisk's rapid rise and fall was driven by GLP-1s like Ozempic and Wegovy, leading to a plummet in stock value. Insmed has received FDA approval for the first bronchiectasis drug and DPP1 blocker, Brinsupri. Texas has accused Eli Lilly of "bribing" prescribers to push their drugs Mounjaro and Zepbound, leading to a new lawsuit. Genscript is entering a new era of innovation and trust, offering exclusive promos and events. Additionally, Tang Capital is on a buyout binge in the biotech industry, while a top ARPA-H official has departed in protest of cuts to mRNA funding. The biotech industry continues to see contractions with companies like AbSci, Fate, and Oric downsizing. In career advice, loyalty is seen as a flawed strategy that can cost individuals opportunities.Arrowhead, a biotech company, has emerged as a savior in the RNA interference (RNAi) pipeline after Sarepta faced troubles unrelated to Arrowhead's assets. Concentra Biosciences, a biotech shell company, has been on a buying spree, acquiring four biotechs in the past month and seven so far this year. President Trump's most favored nation drug pricing policy is seen as unfavorable for all parties involved. Novo Nordisk experienced a rapid rise and fall due to the success of ozempic and wegovy. Lilly is facing drug pricing pressure while defending its injectable GLP-1 empire. Novartis is rumored to be considering acquiring RNA specialist Avidity. Despite safety concerns, Sarepta beat Q2 estimates, but not due to sales of its product Elevidys. Various biotech companies are downsizing while others are receiving significant investments.

FDA Approval: Zongertinib for HER2 Mutant NSCLC by IASLC

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

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.

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. 

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. 

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.