Podcasts about recent fda

David Kay shares his experience as the first employee at Upside Foods, offering a deep dive into the cultivated meat industry's challenges, successes, and political landscape. As an animal advocate who entered the alternative protein space, he provides unique insights on depolarising the conversation around cultivated meat and building bipartisan support.›• Difference between focusing on environmental/health versus animal welfare messaging• David's journey from animal advocacy to becoming the first employee at Upside Foods• How cultivated meat differs from plant-based products as "real meat" grown from cells• Where hundreds of millions in investment funding goes in cultivated meat startups• State-level bans on cultivated meat and fighting political polarisation• How industry is organising through trade associations like AMPS Innovation• Importance of elite institutions in normalising animal advocacy• Recent FDA approval for Mission Barns' cultivated pork fatAdd David on LinkedIn to follow his work and learn more about his perspectives on the alternative protein industry.Resources:Animal liberation bookGFI website State of the industry reports AgFunder – Elaine WatsonMission Barns FDA ApprovalDavid Kay LinkedInIf you enjoy the show, please leave a rating and review us - we would really appreciate it! Likewise, feel free to share it with anyone who you think might enjoy it. You can send us feedback and guest recommendations via Twitter or email us at hello@howilearnedtoloveshrimp.com. Enjoy!

Featuring an interview with Dr Stephen V Liu, including the following topics: Management of localized non-small cell lung cancer (NSCLC) (0:00) First-line treatment of advanced NSCLC (10:53) Targeted therapy for patients with NSCLC and actionable genomic alterations (30:24) Recent FDA approvals for NSCLC (37:49) Recent advances in small cell lung cancer (47:14) Lurbinectidin in combination with atezolizumab as front-line maintenance therapy for patients with early-stage SCLC (52:33) CME information and select publications

Send us a textKirk Huntsman, Chairman and CEO of Vivos Therapeutics joins us on this week's WTR Small-Cap Spotlight following the company announcement of its first known FDA clearance for a medical device in pediatric obstructive sleep apnea. He discusses what the FDA approval means for the millions of US children with this serious health condition. Kirk talks about how the pediatric market fits into Vivos' new marketing and distribution strategy, as well as the progress with medical-based affiliations.

  In this groundbreaking episode, we explore the rapidly evolving field of psychedelic-assisted therapy with Dr. Paul Liknaitzky, a leading researcher at the forefront of this innovative approach to mental health treatment. From the original and sometimes controversial studies of the 1960s to cutting-edge clinical trials today, we explore how substances once associated with counterculture are now at the forefront of mental health treatment. Dr. Liknaitzky reveals the fascinating synergy between psychedelics and psychotherapy, explaining why this combination holds such promise for treating depression, PTSD, and other mental health disorders. He discusses the latest findings on psilocybin, DMT, and MDMA, examining their unique properties and the scientific rationale behind their use in clinical settings. Through a blend of scientific evidence, real-world examples, and thoughtful analysis, we navigate the complex landscape of regulatory challenges, brain imaging advancements, and the future directions of psychedelic studies. Dr. Liknaitzky also addresses common misconceptions, emphasising the importance of controlled environments and professional guidance in this field. Whether you're a healthcare professional seeking to understand emerging treatments, someone curious about alternative approaches to mental health, or simply interested in the latest developments in psychology, this episode offers a balanced, informative look at a field that could significantly impact our approach to mental health care in the coming years. Key Topics: Historical context: Psychedelic studies from the 1960s to present The synergy of psychedelics and psychotherapy in treatment Importance of combining psychedelics with therapy for effective treatment Regulatory challenges: Recent FDA decisions on psychedelic treatments Ongoing research: Focus on psilocybin and future studies Exploring DMT: Differences from traditional formulations Promising psychedelics for treating depression Brain imaging in psychedelic research: Using fMRI to track changes Future directions in psychedelic studies Potential impact of psychedelic therapy on relationships and family dynamics Actionable Takeaways: The effect of psychedelics is intensified by psychotherapy through a psychotherapeutic process.  A productive and successful psychotherapy requires deep trust between patient and therapist. Having your own psychedelic experience potentially improves your competency to be a good psychedelic therapist. We should try to remain in conversation with reality. The critical thing to remain in a relationship with is the reality of real people's lives as we treat them after we treat them. Psilocybin is a promising drug for psychedelic treatment of depression. MDMA is an empathogen that massively increases tolerance for distress and allows you to feel incredibly comfortable. Neuroimaging studies with Psilocybin and LSD cause our default mode network to get quiet. Connect with Paul Liknaitzky: Website: https://www.monash.edu/psychedelics LinkedIn: https://www.linkedin.com/in/paul-liknaitzky-phd-6a2681aa/ Support the Podcast:If you found this episode valuable, please consider subscribing, rating, and leaving a review on your preferred podcast platform. Your support helps us reach more people with important conversations like this one. Share this episode with someone who might benefit from hearing it—emotional eating is more common than we think, and this conversation could make a difference in someone's life.See omnystudio.com/listener for privacy information.

Dr. Caroline Piatek describes the purpose and use of this new drug approval for some patients with PNH, or Paroxysmal Nocturnal Hemoglobinuria

We need copper to prevent the body from literally RUSTING! Yes, we tell you why copper is so important to creating energy which is the core for balancing our hormones, enzymes, stress and our overall health. This information will change YOUR life and those who you share this with!Pet Health Cafe' is broadcast live at Thursdays 8PM ET.Pet Health Cafe' TV Show is viewed on Talk 4 TV (www.talk4tv.com).Pet Health Café Radio Show is broadcast on W4HC Radio - Health Café Live (www.w4hc.com) part of Talk 4 Radio (www.talk4radio.com) on the Talk 4 Media Network (www.talk4media.com). Pet Health Café Podcast is also available on Talk 4 Podcasting (www.talk4podcasting.com), iHeartRadio, Amazon Music, Pandora, Spotify, Audible, and over 100 other podcast outlets.

12-5-23 AJ Daily2024 Angus Herdsman of the Year Candidates AnnouncedAdapted from a release by Katelyn Engel, Angus Communications See What You Need for Recent FDA Prescription Rules Adapted from a release by Zoetis Services LLC Don't Let Cold Weather Freeze Cattle Performance This Winter Adapted from a release by Wyatt Bechtel, Filament, for Purina Animal Nutrition Compiled by Paige Nelson, field editor, Angus Journal.  For more Angus news, visit angusjournal.net. 

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The FDA Group's CEO, Nick Capman, sits down with George Toscano, President & CEO of Toscano Consulting Group, to explore recent FDA enforcement trends and the nuances of the FDA inspection process, especially in light of the COVID-19 pandemic's impact on the industry. Discussion points include: » George's extensive background in the pharmaceutical, biologics, and medical device industries, highlighting his transition from an analytical development chemist to a consultant specializing in quality and regulatory work. » The emergence of new companies in the pharmaceutical space during the COVID-19 pandemic, particularly those producing hand sanitizers, and the challenges they faced with Good Manufacturing Practices (GMP). » The FDA's increased scrutiny on the presence of diethylene glycol and ethylene glycol in components, reflecting on historical issues and the importance of stringent testing for these contaminants. » The problem of inadequate authority within quality units, especially in Over-The-Counter (OTC) manufacturers, leading to compliance issues and insufficient testing for harmful impurities. » A shift in the FDA's focus towards ophthalmic products due to recent contamination issues, and the anticipation of this becoming a new wave of enforcement. » The significant reduction in on-site FDA inspections during the pandemic, the transition to remote evaluations and document requests, and the gradual return to on-site inspections with continued use of remote tools. » The concept of FDA "waves" of focus, with a recent pre-COVID wave on OTC manufacturers, and the potential for new waves targeting different areas such as ophthalmic products. » The perennial issues cited by the FDA, such as the failure to conduct adequate investigations and the lack of or failure to follow written procedures, which are expected to continue being focal points in FDA observations. Mr. Toscano is an experienced consultant with over 25 years in the industry, specializing in international compliance, Data Integrity, and quality systems. He has successfully managed projects addressing FDA enforcement actions, such as 483 responses, Warning Letters, and Consent Decrees. His expertise extends to laboratory and manufacturing investigations, CAPA, change control, and stability programs. He has also led analytical R&D labs, overseeing product development and regulatory submissions, including ANDA, NDA, and 505(b)2 applications. Recently, he spearheaded a multi-year expansion and remediation for a biologics manufacturer under a consent decree. His comprehensive knowledge in quality assurance, data integrity, validation, and cGMP training has been pivotal in helping clients develop and fix quality systems to meet FDA standards. Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

On this episode, we're reviewing two recent U.S. Food and Drug Administration (FDA) approvals for patients with breast cancer: the February 3 approval of sacituzumab govitecan-hziy, and the January 27 approval of elacestrant.To listen to more podcasts from ASCO, visit asco.org/podcasts.

This is an emergency episode so I'll pop in later to update the show notes as it's already midnight! Eugenie x   Visit www.homeopathychoice.org to sign up or donate Visit www.homeopathychoice.org/HAT to join the Homeopathy Action Team 

This episode of Ropes & Gray's podcast series Non-binding Guidance explores recent FDA guidance on recall readiness and other recall-related hot topics. In recent months, we have seen a trend of increased FDA inspection and enforcement activity as the impact from COVID-19 starts to lessen. Earlier this year, FDA also finalized guidance on the Initiation of Voluntary Recalls under 21 CFR Part 7, Subpart C, which explores FDA expectations regarding the process companies should already have in place ahead of a potential recall situation. Join Ropes & Gray FDA regulatory attorneys Josh Oyster and Beth Weinman as they provide a quick refresher on recalls and discuss the latest recall readiness suggestions from the Agency to help companies make decisions about how and when to recall their FDA-regulated products and how to involve FDA in that process. They also discuss FDA's recent recall-related actions that invoked rarely-used legal authorities applicable to medical devices.

After the FDA advisory committee decided to not approve the third booster shot for the general public except for 65+ and at-risk groups, Israel's Prime Minister and Health Minister spun the news for the Israeli public to fit their agenda. This is not something new and it is very worrying, and this is not just an issue that plagues Israel. Especially when we are dealing with issues of life, death and health, we want to know we can trust the information we receive. And yet, something is very wrong.

This week, we'll be reviewing two recent FDA approvals in the oncology space, for patients with mismatch repair–deficient, or dMMR, recurrent or advanced solid tumors, and for adult patients with cancers associated with von Hippel-Lindau (VHL) disease.Coverage of stories discussed this week on ascopost.com:FDA Grants Accelerated Approval to Dostarlimab-gxly for dMMR Advanced Solid TumorsFDA Approves Belzutifan for Cancers Associated With von Hippel-Lindau DiseaseTo listen to more podcasts from ASCO, visit asco.org/podcasts.

This week, we'll focus on two recent approvals from the U.S. Food and Drug Administration in patients with leukemia and lymphoma, respectively.Coverage of stories discussed this week on ascopost.com:FDA Approves Venetoclax Combination Regimen for Certain Adult Patients With AMLFDA Extends the Approval of Pembrolizumab for Patients With Classical Hodgkin LymphomaTo listen to more podcasts from ASCO, visit asco.org/podcasts.

Featuring a roundtable discussion with Drs Andrew J Armstrong, Celestia S Higano, David F Penson and Neal D Shore on the following topics: Optimizing the Choice of Therapy for Patients with Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Selection of chemotherapy or secondary hormonal therapy (enzalutamide, abiraterone, apalutamide) to administer with androgen deprivation therapy (ADT) (0:00) Management of HSPC in patients with de novo asymptomatic metastases (9:04) Use of secondary hormonal therapy or chemotherapy in addition to ADT for patients with mHSPC in community-based practices (15:53) Effect of patient age and comorbidities on choice of therapy for mHSPC (21:15) Clinical outcomes with the addition of chemotherapy or secondary hormonal therapy to ADT for patients with mHSPC (29:42) Tolerability and side-effect profiles of abiraterone/prednisone and enzalutamide (33:32) Paradigm shift in the management of mHSPC — Neal D Shore, MD (37:36) Case: A man in his late 60s with mHSPC achieves a good clinical response to ADT and apalutamide (53:51) Case: A man in his early 50s with HSPC and extensive bone metastases (55:11) Overall survival outcomes with the addition of secondary hormonal therapy or chemotherapy to ADT; management of the primary tumor in patients with mHSPC (57:35) Practical factors influencing the selection of therapy for patients with mHSPC — David F Penson, MD, MPH, MMHC (1:02:39) Case: A man in his late 50s with mHSPC and a BRCA2 mutation receives abiraterone and prednisone after treatment with docetaxel and ADT (1:21:49) Balancing the risks and benefits of secondary hormonal therapy (1:25:47) Selection and Sequencing of Therapies for Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Choice of therapy based on symptoms and site of metastases for patients with mCRPC (1:27:28) Management of mCRPC after disease progression on secondary hormonal therapy; testing for AR-V7 to predict resistance (1:32:29) Clinical experience with the PARP inhibitors olaparib and rucaparib; activity of cabazitaxel in patients with mCRPC (1:36:54) Recent FDA approval of rucaparib and olaparib for mCRPC; implications for genetic testing and routine practice (1:39:40) Sequencing of therapies for men with mCRPC — Celestia S Higano, MD (1:46:36) Promising agents and strategies for men with metastatic prostate cancer — Andrew J Armstrong, MD, ScM (2:04:40) CME information and select publications

The U.S. Food and Drug Administration (FDA) had a very busy 10 or so days, so this week, we'll go over five recent oncology and hematology approvals the Agency issued, in bladder cancer, breast cancer, bile duct cancer, and leukemia.Coverage of stories discussed this week on ascopost.com:FDA Approves Mitomycin for Low-Grade Upper Tract Urothelial CancerFDA Approves Tucatinib in Combination With Trastuzumab/Capecitabine for Advanced Unresectable or Metastatic HER2-Positive Breast CancerFDA Approves Pemigatinib for Patients With Cholangiocarcinoma and an FGFR2 Rearrangement or FusionFDA Approves Ibrutinib/Rituximab for CLL/SLLFDA Approves Sacituzumab Govitecan-hziy for Patients With Previously Treated Metastatic Triple-Negative Breast Cancer

Something that you might find surprising is the number of medical device companies that are simply not prepared for an FDA inspection. The bottom line is that you should expect to be inspected. Today we're going to be talking to Mike Drues, the president of Vascular Sciences, about the lessons that companies have learned from their not-so-successful FDA inspections. You can learn from them, too! Some of the highlights of the show include: ● Jon's story of a situation where a company was completely unprepared for an FDA inspection years after their product went to market. ● The difference between not having the required information and having the required information in a format that's unacceptable to the FDA. ● What companies can do to prevent problems with FDA inspections. ● The importance of knowing what you know and knowing what you don't know and knowing the difference between the two. ● Why it's so important to consider the root cause of troubles with FDA inspections. Many times, the root cause is a tick-the-box mentality. ● Best practices for being prepared for an inspection. ● Why an independent audit might not be an effective way to know that you're prepared for an inspection, as well as tips on knowing whether your auditor is beneficial. ● Why it's good to purposely inject a problem into your process to be sure that your quality control system will detect it. ● The importance of taking a holistic approach rather than only looking at issues one at a time.

Lucy Mailing is an MD/PhD student at the University of Illinois. She recently completed her PhD in Nutritional Sciences and continues to perform research on the impact of diet and exercise on the gut microbiome in states of health and disease. She has authored several peer-reviewed journal articles related to the microbiome and health and was recently named an Emerging Leader in Nutritional Sciences by the American Society for Nutrition. Lucy has also been a staff research associate for the Kresser Institute for four years and writes about evidence-based gut health on her blog. She plans to begin medical school at the University of Illinois in 2020 after a year dedicated to writing and the launch of a gut-related startup. In this podcast, Lucy discusses the most promising trends and research in gut health. She talks about the best and worst ways to test for GI problems and the effects of exercise intensity and diet change on the gut microbiota. She also challenges the notion that ketogenic and high-fat diets are bad for the gut, and explains why your SIBO breath test results might be inaccurate.  Lucy is a fine example of one of the many wonderful experts who have shaped NBT into what it is today—an online clinic helping athletes and likeminded people overcome chronic health complaints and improve performance. If you’re an athlete and you’ve been listening to the podcast for a while and you’re still struggling with your gut health, feel free to come to the front page where you’ll find a button to book a free starter session. During the session, we’ll take a look at your history and share how we’d work with you. We now have a variety of billing options, one of which will make sense for you. Here’s the outline of this interview with Lucy Mailing: [00:00:21] Ancestral Health Symposium; Lucy’s presentation slides; Look for the video from Lucy’s 2019 presentations to be posted on the AHS YouTube channel in the upcoming months.  [00:01:17] Becoming interested in the microbiome. [00:03:01] Working with Chris Kresser; ADAPT Health Coach Training. [00:07:49] Why the focus on the microbiome? [00:08:25] Transplanted human microbiome into sterile mice, mice take on phenotype of donor; Study: Zheng, P., et al. "Gut microbiome remodeling induces depressive-like behaviors through a pathway mediated by the host’s metabolism." Molecular psychiatry 21.6 (2016): 786. [00:09:30] What does a healthy microbiome look like? [00:13:09] Viome; metatranscriptomics. [00:14:37] 16S testing; uBiome. [00:15:06] Proteobacteria as a red flag that colonic epithelial cells are starving for energy. Study: Hughes, Elizabeth R., et al. "Microbial respiration and formate oxidation as metabolic signatures of inflammation-associated dysbiosis." Cell host & microbe 21.2 (2017): 208-219. [00:16:24] Jason Hawrelak; Podcast: How to Use Probiotics to Improve Your Health. [00:17:29] Butyrate; Is supplementing a good idea? Tesseract, ProButyrate. [00:21:17] Dietary recommendations: Microbiota accessible carbohydrates (term from Justin Sonnenberg). [00:22:37] Preliminary evidence that reduced carbohydrate diet may be beneficial for people with inflammatory bowel disease; Study: Suskind, David L., et al. "Clinical and fecal microbial changes with diet therapy in active inflammatory bowel disease." Journal of clinical gastroenterology 52.2 (2018): 155. 00:23:42] Carnivore diet. [00:25:01] Dr. Michael Mosley; Robb Wolf. [00:27:59] Fecal microbiota transplant (FMT) from ketogenic mice; Study: Olson, Christine A., et al. "The gut microbiota mediates the anti-seizure effects of the ketogenic diet." Cell 173.7 (2018): 1728-1741. [00:29:54] Autologous FMT restores the ecosystem after antibiotics: Study: Taur, Ying, et al. "Reconstitution of the gut microbiota of antibiotic-treated patients by autologous fecal microbiota transplant." Science translational medicine 10.460 (2018): eaap9489. [00:31:17] Mike T Nelson; Podcasts: 1. High Ketones and Carbs at the Same Time? Great Performance Tip or Horrible Idea…, 2. The Importance of Strength Training for Endurance Athletes, 3. How to Assess an Athlete: The Best Principles, Methods, and Devices to Use. [00:33:35] Taymount Clinic for FMT. [00:34:11] Recent FDA report on risks of infection related to FMT. [00:34:49] Doctor's Data stool testing; PCR sequence-based testing. [00:35:40] Culture vs PCR. [00:39:27] Diagnostic Solutions GI-MAP as a PCR DNA stool test. [00:41:04] Metagenomics; Onegevity, Sun Genomics, DayTwo. [00:42:37] Small Intestinal Bowel Overgrowth (SIBO) breath testing; Mark Pimentel, MD. [00:42:57] Dr. Bryan Walsh. [00:43:33] Lucy's blog posts on SIBO breath testing: All about SIBO: Small Intestinal Bacterial Overgrowth, and What the latest research reveals about SIBO. [00:43:41] A positive breath test may not be due to SIBO; Study: Connolly, Lynn, and Lin Chang. "Combined orocecal scintigraphy and lactulose hydrogen breath testing demonstrate that breath testing detects orocecal transit, not small intestinal bacterial overgrowth in patients with irritable bowel syndrome." Gastroenterology 141.3 (2011): 1118-1121. [00:46:11] Individuals with SIBO may in fact have small intestinal dysbiosis; Study: Saffouri, George B., et al. "Small intestinal microbial dysbiosis underlies symptoms associated with functional gastrointestinal disorders." Nature communications 10.1 (2019): 2012. [00:48:00] What you can learn from a uBiome Explorer 16S test. [00:54:17] Probiotics, prebiotics; Pomegranate husk powder. [00:58:02] Response to prebiotics is highly individualized; Study: Venkataraman, A., et al. "Variable responses of human microbiomes to dietary supplementation with resistant starch." Microbiome 4.1 (2016): 33. [00:59:50] Effects of exercise on the microbiome; Studies: 1. Allen, Jacob M., et al. "Exercise alters gut microbiota composition and function in lean and obese humans." Med Sci Sports Exerc 50.4 (2018): 747-757; 2. Allen, Jacob M., et al. "Voluntary and forced exercise differentially alters the gut microbiome in C57BL/6J mice." Journal of applied physiology118.8 (2015): 1059-1066; 3. Allen, J. M., et al. "Exercise training-induced modification of the gut microbiota persists after microbiota colonization and attenuates the response to chemically-induced colitis in gnotobiotic mice." Gut Microbes 9.2 (2018): 115-130. [01:02:26] Research on the microbiome of marathoners; Study: 1. Zhao, Xia, et al. "Response of gut microbiota to metabolite changes induced by endurance exercise." Frontiers in microbiology 9 (2018): 765; 2. Scheiman, Jonathan, et al. "Meta-omics analysis of elite athletes identifies a performance-enhancing microbe that functions via lactate metabolism." Nature Medicine (2019): 1. [01:02:39] Lauren Petersen; Study: Petersen, Lauren M., et al. "Community characteristics of the gut microbiomes of competitive cyclists." Microbiome 5.1 (2017): 98. Our 2016 podcast with Lauren: The Athlete Microbiome Project: The Search for the Golden Microbiome. [01:05:51] Find Lucy: NextGen Medicine. [01:07:04] Dr. Josh Turknett’s Migraine Miracle. Our podcast with Josh: The Migraine Miracle.

A virtual roundtable discussion with noted investigators Dr Toni K Choueiri and Prof Thomas Powles for a review of recent innovations in the treatment of renal cell carcinoma. Risk stratification and selection of first-line therapy for metastatic renal cell carcinoma (mRCC) (00:00) Role of cytoreductive nephrectomy in RCC (1:50) Overall survival and complete response (CR) improvements with the FDA-approved nivolumab/ipilimumab combination versus sunitinib for intermediate- or poor-risk previously untreated advanced RCC on the Phase III CheckMate 214 trial (4:18) Activity of nivolumab alone or in combination with ipilimumab for patients with mRCC and brain metastases (9:25) Tolerability of nivolumab/ipilimumab; risk of immune-related adverse events (AEs) (11:21) Recent FDA approvals of avelumab with axitinib (JAVELIN Renal 101) and pembrolizumab with axitinib (KEYNOTE-426) as first-line treatment for advanced RCC (13:24) Comparison of cellular distribution, activity and tolerability of anti-PD-1 versus PD-L1 antibodies (14:14) Similarities and differences in clinical outcomes among the JAVELIN Renal 101 (avelumab/axitinib) and KEYNOTE-426 (pembrolizumab/axitinib) trials (19:01) Indirect comparison of the efficacy and tolerability of nivolumab/ipilimumab versus avelumab/axitinib and pembrolizumab/axitinib (26:35) Importance of educating patients and community practitioners on the distinction between immune checkpoint inhibitor- and chemotherapy-related side effects (30:55) Choosing among newly approved first-line therapeutic options for mRCC (ie, avelumab/axitinib, pembrolizumab/axitinib, nivolumab/ipilimumab); factors influencing whether to use a VEGF tyrosine kinase inhibitor (32:45) Perspective on the results of the Phase III IMmotion151 trial: Atezolizumab with bevacizumab versus sunitinib in patients with previously untreated mRCC (37:16) Ongoing investigation of anti-PD-1/PD-L1 antibody-based therapy in the (neo)adjuvant settings (41:17) Toward increasing cure rates for patients with RCC (46:09) Approach for patients with no evidence of disease after nephrectomy (50:36) Predictors of benefit with immune checkpoint inhibitors and anti-angiogenic agents (53:16) Case (Dr Choueiri): A man in his mid-60s with clear cell mRCC who receives nivolumab/ipilimumab and for whom nivolumab is held briefly because of a number of rare immune-related AEs ultimately attains a durable near CR (57:50) Clinical experience with and management of rare immune-related AEs in patients receiving checkpoint inhibitors (1:01:11) Case (Prof Powles): A woman in her early 30s with newly diagnosed intermediate-risk mRCC receives nivolumab/ipilimumab (1:09:02) Case (Prof Powles): A man in his late 60s with intermediate-risk, clear cell mRCC experiences low-grade immune checkpoint inhibitor-associated side effects with nivolumab/ipilimumab (1:15:06) Case (Dr Choueiri): A man in his mid-50s with clear cell mRCC receives avelumab/axitinib on a clinical trial (1:18:11) Choosing between pembrolizumab/axitinib and avelumab/axitinib (1:23:18) CME information and select publications  

The Stock Day Podcast welcomed BioElectronics Corporation (BIEL)(“the Company”), a leader in non-invasive electroceuticals and the maker of an industry leading family of disposable, drug-free, pain therapy devices. Vice President of Sales, Keith Nalepka, joined Stock Day host Everett Jolly. 

  You can contact Blood & Cancer at podcasts@mdedge.com and you can follow MDedge Hematology Oncology on Twitter @MDedgeHemOnc. Episode 11: Blood & Cancer host David Henry, MD, welcomes John Glaspy, MD, to talk about anemia in cancer. And in today's Clinical Correlation, Ilana Yurkiewicz, MD, talks apathy. Dr. Yurkiewicz has a column at MDedge, which you can find by clicking here. Show notes   By Emily Bryer, DO, resident in the department of internal medicine, University of Pennsylvania Hemoglobin is associated with quality of life and functional status, and quality of life improves continuously as hemoglobin rises from low (8 g/dL) to normal (12 g/dL) levels. The complete workup of anemia involves reticulocyte count, iron studies, folate, B12, peripheral smear, and creatinine. Anemia is a consequence of 1) cancer and 2) chemotherapy In patients with malignancy, the inflammatory state results in iron-restricted erythropoiesis, so patients may be functionally iron deficient even if their iron stores are replete. How do we treat anemia in cancer? Blood transfusion to rapidly improve hemoglobin Intravenous iron, if iron deficient Erythrocyte stimulating agents (ESA), if iron stores are replete. (Although IV iron augments ESA response in all cancer studies reported so far.) Risks associated with blood transfusion: Infection, transfusion-related-lung-injury, reactions to mismatched or well-matched blood, and iron overload (specifically in myelodysplastic syndrome). Recent FDA-mandated studies in anemic metastatic breast and non-small-cell lung cancer patients have demonstrated that there is no difference in survival among patients who receive ESA or placebo to treat their cancer/chemotherapy-associated anemia. HIF-1-alpha (hypoxia-inducible-factor) is a transcription factor produced in response to hypoxia. New class of drugs stabilizing HIF can result in both an increase in erythropoiesis and a decrease in hepcidin. References   2010 Dec 2;116(23):4754-61. Cancer Metastasis Rev.2007 Jun;26(2):341-52. Support Care Cancer.2006 Dec;14(12):1184-94. Cochrane Database Syst Rev.2016 Feb 4;2:CD009624. International Journal of Clinical Transfusion Medicine. 2018;6:21-31.    

Dr. Thomas Forbes is a professor of surgery and RJ Elliot Chair and Division Head of Vascular Surgery at the University of Toronto (@UofTVascular), and the program director of the Advanced Aortic Surgery Fellowship at the University of Toronto. He is also an associate editor of the Journal of Vascular Surgery and the chair of the Document Oversight Committee of the Society for Vascular Surgery. He joins us to discuss the application of new technologies in vascularsurgery, insight into Canadian vascular surgery, vascular surgical training, subspecialization and regionalization, personalized medicine, and the personality of the vascular surgeon.(0:20) Full biography: https://surgery.utoronto.ca/content/thomas-forbes (5:57) Dr. Wayne Johnson - Founding Chair in the Division of Vascular Surgery at the University of Toronto Division, founder of the Canadian Society for Vascular Surgery: https://www.uhn.ca/PMCC/media/Globe_Mail/Pages/forefather_vascular_surgery_Canada_globe-2016.aspx (7:28) Dr. Jim May of the Royal Prince Alfred Hospital, Australia, one of the early pioneers of endovascular surgery: http://sydney.edu.au/medicine/people/academics/profiles/james.may.php (8:27) “Iliac on a stick”; terminology for removing devices of the time: https://bit.ly/2SvtXaW (10:08) A model approach that allows Canadian surgeons to implement new technologies in practice: The PMCC Innovation Committee, co-founded by a vascular surgeon, Dr. Barry Rubin: https://www.uhn.ca/PMCC/media/Globe_Mail/Pages/Peter-Munk-Cardiac-Centre-Innovation-Committee-2017.aspx (11:28) Recent FDA proposed changes to device approval process spark fears of dangers of rapid device adoption: https://vascularnews.com/us-fda-plan-shakeup-of-its-510k-clearance-programme/ (13:44) Regionalization of fenestrated endovascular device practice patterns: https://www.ncbi.nlm.nih.gov/pubmed/29843567 (19:08) Advanced Aortic Surgery fellowship at the University of Toronto: https://surgery.utoronto.ca/fellowships-division-vascular-surgery (29:55) Centers of Excellence: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5516836/pdf/12913_2017_Article_2340.pdf (31:26) SVS Clinical Practice Guideline: https://vascular.org/research-quality/guidelines-and-reporting-standards/clinical-practice-guidelines (33:18) Leapfrog initiative: http://www.leapfroggroup.org/about (33:23) The Volume Pledge: https://www.healthleadersmedia.com/clinical-care/surgical-specialization-may-trump-volume-measure-quality (35:31) “Personalized vascular surgery”: https://www.mdedge.com/vascularspecialistonline/article/106142/vascular-surgery-its-personal (38:43) Dr. Forbes on heart health: “Let’s be more active”: https://www.youtube.com/watch?v=KhhW_E9cAr4 (40:28) Vascular surgeons are the firefighters of the surgery world: https://bit.ly/2G7UFF5 (42:51) MEGS: The Montefiore endovascular grafting system: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1421179/figure/f1-2/?report=objectonly

Recent FDA updates are discussed including combined use of BRAF & MEK inhibitors, frontline daratumumab (10:20), and your next P & T monograph drug to review.

Recent FDA & #oncopharm updates are discussed, including irinotecan in sweat, fostamatinib's FDA-approval for ITP. Then, immunotherapy updates from AACR are reviewed (6:00). Finally (34:00 , osimertinib's updated approval for frontline use in mEGFR NSCLC.

Recent FDA updates & a brief discussion about adjuvant TKI use in solid tumors.

Something that you might find surprising is the number of medical device companies that are simply not prepared for an FDA inspection. The bottom line is that you should expect to be inspected. Today we’re going to be talking to Mike Drues, the president of Vascular Sciences, about the lessons that companies have learned from their not-so-successful FDA inspections. You can learn from them, too! Some of the highlights of the show include: ● Jon’s story of a situation where a company was completely unprepared for an FDA inspection years after their product went to market. ● The difference between not having the required information and having the required information in a format that’s unacceptable to the FDA. ● What companies can do to prevent problems with FDA inspections. ● The importance of knowing what you know and knowing what you don’t know and knowing the difference between the two. ● Why it’s so important to consider the root cause of troubles with FDA inspections. Many times, the root cause is a tick-the-box mentality. ● Best practices for being prepared for an inspection. ● Why an independent audit might not be an effective way to know that you’re prepared for an inspection, as well as tips on knowing whether your auditor is beneficial. ● Why it’s good to purposely inject a problem into your process to be sure that your quality control system will detect it. ● The importance of taking a holistic approach rather than only looking at issues one at a time.

Dr. Michael Greene is an obstetrician-gynecologist at Massachusetts General Hospital, a professor of obstetrics and gynecology at Harvard Medical School, and an Associate Editor of the Journal. Stephen Morrissey, the interviewer, is the Managing Editor of the Journal. D.B. Andropoulos and M.F. Greene. Anesthesia and Developing Brains - Implications of the FDA Warning. N Engl J Med 2017;376:905-7.