Podcasts about fda approval

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

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.

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

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.

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