Podcasts about regeneron

Plus: Costco and Gap see different impacts of tariffs on their businesses. Shares of Ulta Beauty rally after the cosmetics retailer raises its annual outlook. And an experimental lung-disease treatment by Sanofi and Regeneron delivers mixed results. Victoria Craig hosts. Sign up for the WSJ's free What's News newsletter. Learn more about your ad choices. Visit megaphone.fm/adchoices

052825 2nd HR Susan on Macron; Deep Dive Invitro Fertilization and Regeneron Pharma by Kate Dalley

This week, we kick things off with the return of Space Karen's meltdown tour: Elon Musk got flustered in an interview, sputtered out one-word answers, and called the journalist an “NPC,” which is rich coming from the guy whose only real upgrade since PayPal is yelling “freedom” in meme fonts. Meanwhile, 23andMe sold your DNA to Regeneron at a bankruptcy auction, proving once and for all that your spit is more valuable than most tech startups.IN THE NEWS is a parade of corporate idiocy and dystopian fuckery. Coinbase employees got bribed into leaking user data (because clearly we didn't have enough crypto chaos), Klarna keeps flip-flopping between AI and human workers like it's a bad Tinder date, and OpenAI is out here buying Jony Ive's design firm for $6.5 billion because sure, what's another billion when you're trying to build a surveillance device to stalk 100 million users? Meanwhile, the Chicago Sun-Times is publishing AI-generated trash with imaginary authors, Anthropic's new model attempts blackmail, and researchers dumped two billion Discord messages online just for kicks. And yes, Elon's Tesla robotaxis will now only roam the safest parts of Austin, which is code for “we still can't make this thing turn left.”In MEDIA CANDY, we're watching Murderbot, Godfather of Harlem, and Hotel Cocaine because who doesn't love a little synthetic assassin, crime drama, and coke-fueled nostalgia? Notepad.exe now writes for you (and probably files HR complaints too), and Audible is teaming up with publishers to replace narrators with robot voices. Yay, progress. Over in THE DARK SIDE WITH DAVE, Bittner brings the malware, monsters, and a new theme park review that's somehow less terrifying than the news. Bookworms, don't miss Curepedia and The AI Con — one's about goth gods, the other's about taking down our techno-overlords. And pour one out for George Wendt — Norm from Cheers is now drinking with the angels.Sponsors:DeleteMe - Head over to JoinDeleteMe.com/GOG and use the code "GOG" for 20% off.Private Internet Access - Go to GOG.Show/vpn and sign up today. For a limited time only, you can get OUR favorite VPN for as little as $2.03 a month.SetApp - With a single monthly subscription you get 240+ apps for your Mac. Go to SetApp and get started today!!!1Password - Get a great deal on the only password manager recommended by Grumpy Old Geeks! gog.show/1passwordShow notes at https://gog.show/698FOLLOW UPElon Musk Gets Rattled by Hard Questions He Can't Answer, Calls Interviewer an "NPC" While Giving One-Word NPC-Like Responses Himself23andMe (and Your Genetic Data) Sold to Regeneron in Bankruptcy AuctionIN THE NEWSExtortionists bribed Coinbase employees to give them customer dataOpenAI buys Jony Ive's design startup for $6.5 billionSam Altman Tells Staff Plan to Ship 100 Million Devices That See Everything in Users' LivesKlarna Hiring Back Human Help After Going All-In on AIKlarna CEO and Sutter Hill take victory lap after Jony Ive's OpenAI dealKlarna used an AI avatar of its CEO to deliver earningsKlarna users are buying now, but not paying laterDOGE Used a Meta AI Model to Review Emails From Federal WorkersChicago Sun-Times publishes made-up books and fake experts in AI debacleWe're Focused on the Wrong A.I. Problem in JournalismAnthropic's new AI model turns to blackmail when engineers try to take it offlineMIT Backs Away From Paper Claiming Scientists Make More Discoveries with AIResearchers Dump 2 Billion Scraped Discord Messages OnlineMusk says Tesla's self-driving tests will be geofenced to 'the safest' parts of AustinMEDIA CANDYMurderbotGodfather of HarlemHotel CocaineAPPS & DOODADSThe Grand Encyclopedia of Eponymous LawsApple confirms iOS 19 will end support for legacy Home app systemAudible to Partner With Publishers to Create AI-Voiced AudiobooksIn 3.5 years, Notepad.exe has gone from “barely maintained” to “it writes for you”AT THE LIBRARYCurepedia: An A-Z of the Cure by Simon PriceThe AI Con: How to Fight Big Tech's Hype and Create the Future We Want By: Emily M. Bender, Alex HannaTHE DARK SIDE WITH DAVEDave BittnerThe CyberWireHacking HumansCaveatControl LoopOnly Malware in the BuildingFirst photos from inside Universal Studio's new Orlando theme park Epic Universe revealedA Very Honest Review on Monsters Unchained: The Frankenstein Experiment | Universal's Epic UniverseGadget recommendation - Electric Air Duster with FlashlightCLOSING SHOUT-OUTSGeorge Wendt, Norm From Cheers, Dead at 76See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

Next-generation anti-VEGF agents are designed for durability. But does that actually change the rate at which they're administered? David Miller, MD, joins us to review a pair of ARVO 2025 presentations that examined his clinic's real-world administration patterns for bevacizumab (Avastin, Genentech), faricimab (Vabysmo, Genentech/Roche), and high-dose aflibercept (Eylea HD, Regeneron). What were the differences—and did they really matter?  Also, Robert Wang, MD, helped us understand the state of play in the TKI pipeline as he shared data from the phase 2b ODYSSEY study. What are the latest data on CLX-AX (Clearside Biomedcial)? And where does it stack up against the other TKIs in the pipeline? Stick with us to find out. 

The US may be stepping back from its role as mediator in the war in Ukraine, and US long-term borrowing costs rose to their highest level since late 2023 on Monday. US drugmaker Regeneron has agreed to buy 23andMe out of bankruptcy, and the EU and the UK have announced a deal to “reset” their relationship at a summit in London. Mentioned in this podcast:Trump leaves Russia and Ukraine to settle war in talks US borrowing costs climb after Moody's downgrade 23andMe sold out of bankruptcy to RegeneronUK-EU post-Brexit reset: the key pointsToday's FT News Briefing was produced by Sonja Hutson, Kasia Broussalian, Lulu Smyth, and Marc Filippino. Additional help from Sam Giovinco, Michael Lello, David da Silva and Gavin Kallmann. Topher Forhecz is the FT's acting co-head of audio. The show's theme song is by Metaphor Music. Read a transcript of this episode on FT.com Hosted on Acast. See acast.com/privacy for more information.

Plus: Construction on a big wind project off New York's coast is back on, after an abrupt about-face by the Trump administration. And Biotech firm Regeneron has agreed to buy 23andMe out of bankruptcy for $256 million dollars. Kate Bullivant hosts. Sign up for WSJ's free What's News newsletter.  Learn more about your ad choices. Visit megaphone.fm/adchoices

The company declared bankruptcy in March. Learn more about your ad choices. Visit podcastchoices.com/adchoices

Plus: China's Xiaomi plans $7 billion investment in chip design. And 23andMe will live on after $256 million Regeneron buyout. Victoria Craig hosts. Learn more about your ad choices. Visit megaphone.fm/adchoices

NVIDIA unveils NVLink Fusion, Regeneron acquires genetic testing company 23andMe and its data, China's industrial robot production surges. MP3 Please SUBSCRIBE HERE for free or get DTNS Live ad-free. A special thanks to all our supporters–without you, none of this would be possible. If you enjoy what you see you can support the show onContinue reading "Apple To Let EU iPhone Users Choose 3rd-Party Assistants? – DTH"

Your DNA is now in the hands of biotech giant Regeneron. They say they'll protect it. Plus, Owen Wilson deepfake scams, Meta lets fraud off the hook, and phone-free vacations. Got T-Mobile? Here's how to claim your part of the $350M data breach settlement. Learn more about your ad choices. Visit megaphone.fm/adchoices

Drs. Safa Rahmani, Jesse Sengillo, and Kat Talcott join for a journal club episode. Faricimab Switch Study (https://www.ophthalmologyretina.org/article/S2468-6530(25)00124-1/abstract) Gender Differences in Communication (https://www.ajo.com/article/S0002-9394(25)00133-3/fulltext) PE Acquisitions and Industry Payments (https://jamanetwork.com/journals/jamaophthalmology/article-abstract/2830815) Sustainability and Cataract Surgery (https://www.aaojournal.org/article/S0161-6420(25)00135-6/abstract) Relevant Financial Disclosures: Dr. Sridhar is a consultant for Genentech and Regeneron. You can claim CME credits for prior episodes via the AAO website. Visit https://www.aao.org/browse-multimedia?filter=Audi

Join us for this two-episode mini-series featuring lead study authors, Mario Castro and Njira Lugogo, as they discuss key findings from the VESTIGE trial and their implications on asthma care.  Uncover: ·      The importance of patient phenotyping: How can biomarkers and imaging improve asthma management? ·      Mucus plugging and airflow obstruction: What does the latest research reveal? ·      Biologics and airway remodeling: What did the VESTIGE trial reveal about biologics and airway remodeling? ·      The role of imaging in clinical practice: How can CT scans provide new insights into asthma care? Speakers Mario Castro, University of Kansas School of Medicine, United States Njira Lugogo, University of Michigan, Ann Arbor, Michigan, United States Disclaimers: ·      This program is non-promotional and is sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. ·      The speakers are being compensated and/or receiving an honorarium from Sanofi and Regeneron in connection with this program ·      The content contained in this program was jointly developed by AMJ, the speakers, and Sanofi and Regeneron, and is not eligible for continuing medical education (CME) credits ·      See full US Prescribing Information for dupilumab ·      MAT-US-2412937 v2.0 - Pro1 Expiration Date: 04/21/2026 Speaker disclosures: ·      MC reports research support from the American Lung Association, AstraZeneca, Gala Therapeutics, Genentech, GSK, NIH, Novartis, PCORI, Pulmatrix, sanofi-aventis, Shionogi, and Theravance Biopharma, consultancy fees from Allakos, Amgen, Arrowhead Pharmaceuticals, Blueprint Medicines, Connect BioPharma, Genentech, GSK, Merck, Novartis, OM Pharma, Pfizer, Pioneering Medicines, sanofi-aventis, Teva, Third Rock Ventures, and Verona Pharmaceuticals, speaker fees from Amgen, AstraZeneca, Regeneron Pharmaceuticals Inc., and Sanofi, and royalties from Aer Therapeutics. ·      NLL reports research support paid to institution from Amgen, AstraZeneca, Avillion, Genentech, Gossamer Bio, GSK, Regeneron Pharmaceuticals Inc., Sanofi, and Teva, consultancy fees from and participation on advisory boards with Amgen, AstraZeneca, Genentech, GSK, Novartis, Regeneron Pharmaceuticals Inc., Sanofi, and Teva, travel support from AstraZeneca, and honoraria for non-speaker bureau presentations from AstraZeneca and GSK. References: 1.        Castro M et al. Effect of dupilumab on exhaled nitric oxide, mucus plugs, and functional respiratory imaging in patients with type 2 asthma (VESTIGE): a randomised, double-blind, placebo-controlled, phase 4 trial. Lancet Respir Med. 2025;13:208-20. doi: 10.1016/S2213-2600(24)00362-X.

Join us for this two-episode mini-series featuring lead study authors, Mario Castro and Njira Lugogo, as they discuss key findings from the VESTIGE trial and their implications on asthma care.  Uncover: ·      The importance of patient phenotyping: How can biomarkers and imaging improve asthma management? ·      Mucus plugging and airflow obstruction: What does the latest research reveal? ·      Biologics and airway remodeling: What did the VESTIGE trial reveal about biologics and airway remodeling? ·      The role of imaging in clinical practice: How can CT scans provide new insights into asthma care? Speakers Mario Castro, University of Kansas School of Medicine, United States Njira Lugogo, University of Michigan, Ann Arbor, Michigan, United States Disclaimers: ·      This program is non-promotional and is sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. ·      The speakers are being compensated and/or receiving an honorarium from Sanofi and Regeneron in connection with this program ·      The content contained in this program was jointly developed by AMJ, the speakers, and Sanofi and Regeneron, and is not eligible for continuing medical education (CME) credits ·      See full US Prescribing Information for dupilumab ·      MAT-US-2412937 v2.0 - Pro1 Expiration Date: 04/21/2026 Speaker disclosures: ·      MC reports research support from the American Lung Association, AstraZeneca, Gala Therapeutics, Genentech, GSK, NIH, Novartis, PCORI, Pulmatrix, sanofi-aventis, Shionogi, and Theravance Biopharma, consultancy fees from Allakos, Amgen, Arrowhead Pharmaceuticals, Blueprint Medicines, Connect BioPharma, Genentech, GSK, Merck, Novartis, OM Pharma, Pfizer, Pioneering Medicines, sanofi-aventis, Teva, Third Rock Ventures, and Verona Pharmaceuticals, speaker fees from Amgen, AstraZeneca, Regeneron Pharmaceuticals Inc., and Sanofi, and royalties from Aer Therapeutics. ·      NLL reports research support paid to institution from Amgen, AstraZeneca, Avillion, Genentech, Gossamer Bio, GSK, Regeneron Pharmaceuticals Inc., Sanofi, and Teva, consultancy fees from and participation on advisory boards with Amgen, AstraZeneca, Genentech, GSK, Novartis, Regeneron Pharmaceuticals Inc., Sanofi, and Teva, travel support from AstraZeneca, and honoraria for non-speaker bureau presentations from AstraZeneca and GSK. References: 1.        Castro M et al. Effect of dupilumab on exhaled nitric oxide, mucus plugs, and functional respiratory imaging in patients with type 2 asthma (VESTIGE): a randomised, double-blind, placebo-controlled, phase 4 trial. Lancet Respir Med. 2025;13:208-20. doi: 10.1016/S2213-2600(24)00362-X.

The researchers say that the one-time therapy gives a working copy of that gene to the inner ear during a medical operation. Most of the children were treated in one ear, although one child in the two-person study was treated in both ears.研究人员说，一次性疗法在医疗操作过程中将该基因的工作副本赋予了内耳。 尽管两人的研究中的一个孩子在两个耳朵中都接受了治疗，但大多数孩子都被一只耳朵接受治疗。The study with six children took place at Fudan University in Shanghai. Dr. Yilai Shu helped lead the study and trained in Chen's laboratory. Chen was involved in the research. Chinese science organizations and biotechnology company Shanghai Refreshgene Therapeutics helped provide financial support. 与六个孩子的研究在上海的福丹大学进行。 Yilai Shu博士帮助领导了这项研究，并接受了Chen的实验室的培训。 陈参与了研究。 中国科学组织和生物技术公司上海刷新的治疗学有助于提供财务支持。Researchers observed the children for about six months. They do not know why the treatment did not work in one of them. But the five others, who were completely deaf, can now hear a normal discussion, the researchers said. 研究人员观察到孩子大约六个月。 他们不知道为什么治疗在其中一种中没有起作用。 研究人员说，但是五个完全聋哑的五个人现在可以听到正常的讨论。 Chen estimated they now hear at a level 60 percent to 70 percent of normal. The therapy caused no major side effects. 陈估计他们现在听到的是正常水平的60％至70％。 该疗法没有引起重大副作用。Early results from other research have shown similar results. 其他研究的早期结果显示出相似的结果。Regeneron Pharmaceuticals is a biotech company based in New York state. It announced in October that a child under two years old showed improvements six weeks after gene therapy. The results came from a study Regeneron did with support from Decibel Therapeutics, a company in Boston. Regeneron Pharmaceuticals是一家位于纽约州的生物技术公司。 它在十月份宣布，两岁以下的儿童在基因治疗六周后表现出改善。 结果来自Regeneron在波士顿公司的Decibel Therapeutics的支持下进行的研究。 Columbia University's Dr. Lawrence Lustig is involved in the Regeneron study. He said although the children in these studies do not end up with very good hearing, “even a moderate hearing loss recovery in these kids is pretty astounding.” 哥伦比亚大学的劳伦斯·卢斯蒂格（Lawrence Lustig）博士参与了Regeneron研究。 他说，尽管这些研究中的孩子们并没有听到很好的听力，但“即使这些孩子的听力损失恢复也令人震惊。” He added that many questions remain. They include how long the therapies will last and if hearing will continue to improve in the children. 他补充说，仍然存在许多问题。 它们包括疗法将持续多长时间，以及儿童的听力是否会继续改善。 Some people question if gene therapy for deafness is ethical. 有些人质疑基因疗法是否对耳聋是道德的。 Teresa Blankmeyer Burke is a professor who is deaf and who deals with medical ethics. She teaches at Gallaudet University, a university for deaf people in Washington, D.C. She said that there is no agreement about the need for gene therapy targeting deafness. Teresa Blankmeyer Burke是一位聋哑人，涉及医学道德的教授。 她在华盛顿特区的聋人大学加洛德大学（Gallaudet University）教授。 She also pointed out that deafness does not cause severe or deadly illness. Blankmeyer Burke said that it is important to work with deaf community members about the importance of gene therapy. She added gene therapy is seen by many as a possible threat to “signing Deaf communities.” 她还指出，耳聋不会引起严重或致命的疾病。 布兰克迈尔·伯克（Blankmeyer Burke）说，与聋人社区成员合作有关基因疗法的重要性很重要。 她补充说，许多人认为基因疗法可能是对“签署聋人社区”的可能威胁。 However, Chen said: “This is real proof showing gene therapy is working.” And he added, “It opens up the whole field.” 但是，陈说：“这是表明基因疗法正在起作用的真正证据。” 他补充说：“这打开了整个领域。”

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. AstraZeneca has decided to abandon its neuroscience research and focus on weight loss and immunology, following recent discontinuations in Alzheimer's and migraine research. FDA experts are urging Commissioner Makary to resist politicization of the agency. Novartis CEO dismisses tariffs but warns against Trump's pricing controls. Pfizer announces $1.7 billion in cost savings, including a revamp of its R&D organization. Trilink Biotechnologies introduces custom sets of mRNA for screening studies. Other news includes Steminent showcasing therapy for spinocerebellar ataxia, Regeneron's shares tumbling, and ABEONA receiving FDA approval for a gene therapy for a rare skin disease. In summary, AstraZeneca shifts focus, FDA concerns arise, Novartis CEO speaks out, Pfizer announces cost savings, Trilink Biotechnologies introduces new product, Steminent showcases therapy, Regeneron's shares tumble, and ABEONA receives FDA approval.

Description: Co-hosts Ryan Piansky, a graduate student and patient advocate living with eosinophilic esophagitis (EoE) and eosinophilic asthma, and Holly Knotowicz, a speech-language pathologist living with EoE who serves on APFED's Health Sciences Advisory Council, interview Dr. Melanie Ruffner, an Attending Physician with the Division of Allergy and Immunology and the Center for Pediatric Eosinophilic Disorders at Children's Hospital of Philadelphia. Dr. Ruffner describes her work in clinic and the paper she co-authored about pediatric and adult eosinophilic esophagitis (EoE). She covers the questions they considered in the paper and the conclusions they reached. Disclaimer: The information provided in this podcast is designed to support, not replace the relationship that exists between listeners and their healthcare providers. Opinions, information, and recommendations shared in this podcast are not a substitute for medical advice. Decisions related to medical care should be made with your healthcare provider. Opinions and views of guests and co-hosts are their own.   Key Takeaways: [:49] Co-host Ryan Piansky introduces the episode, brought to you thanks to the support of Education Partners Bristol Myers Squibb, GSK, Sanofi, Regeneron, and Takeda. Ryan introduces co-host Holly Knotowicz.   [1:17] Holly introduces today's topic, pediatric and adult eosinophilic esophagitis (EoE), and introduces today's guest, Dr. Melanie Ruffner.   [1:23] Dr. Melanie Ruffner is an attending physician with the Division of Allergy and Immunology in the Center for Pediatric Eosinophilic Disorders at Children's Hospital of Philadelphia. Holly welcomes Dr. Ruffner to Real Talk.   [1:50] As an attending physician in the Center for Pediatric Eosinophilic Disorders at Children's Hospital of Philadelphia, Dr. Ruffner sees patients who have eosinophilic esophagitis and other eosinophilic disorders, including eosinophilic GI tract disorders.   [2:09] Dr. Ruffner also leads a research group that studies how the immune system causes inflammation in response to certain foods, leading to EoE.   [2:20] Inflammation in the esophagus is tied to other diseases like epithelial barrier dysfunction and fibrosis.   [2:28] Our bodies use many different proteins that allow cells to communicate with one another. One type of signaling protein that causes inflammation is called cytokines.   [2:41] Dr. Ruffner's group is interested in how these signaling proteins called cytokines interact with epithelial cells and how that impacts the oral function of the esophagus in patients with EoE.   [3:02] In training, Dr. Ruffner became interested in eosinophilic esophagitis and other non-IgE-mediated food allergies because we don't have a lot of clear treatments or clear mechanisms that cause them.   [3:21] Dr. Ruffner felt there was a lot of work to be done in that area. It was rewarding to be in clinical encounters with those patients. Often, patients had spent a long time trying to find out what was happening and to find a treatment plan that worked for them.   [4:31] Dr. Ruffner's group sees some patients who have eosinophilic gastroenteritis and patients who are referred for hypereosinophilia with impacts of inflammation in other organ systems.   [5:06] Dr. Ruffner co-authored a paper about pediatric and adult EoE published in the Journal of Allergy and Clinical Immunology. It explored if EoE in pediatric patients and adult patients is a spectrum or distinct diseases.   [5:29] EoE is a chronic allergic condition that affects the esophagus. The esophagus carries food from the mouth to the stomach. In people with EoE, the immune system overreacts to foods and causes inflammation in the esophagus.   [5:47] Eosinophils are a type of white blood cell. Eosinophils infiltrate the tissue in the esophagus of people with EoE. Doctors look for eosinophils in the tissue of the esophagus as a sign that inflammation in the esophagus is EoE.   [6:04] The symptoms of EoE can vary in children and adults. That was one of the things the doctors were interested in when they were thinking about this paper. There are no blood or allergy tests that make it easy to diagnose EoE, which requires an endoscopy.   [6:31] An endoscopy is performed by a gastroenterologist. The gastroenterologists look at the appearance of the esophagus and take biopsies.   [6:49] A pathologist counts the eosinophils in the tissue to determine if there are eosinophils present. If there are more than 15 eosinophils in the high-powered field of the microscope and symptoms and clinical conditions are present, EoE is diagnosed.   [7:25] One of the variables Dr. Ruffner considers is that symptoms can be different in children versus adults. In older adolescents and adults, the classic symptom is difficulty swallowing or dysphagia. That is often caused by fibrosis in the esophagus.   [7:54] In younger children this is often not how EoE presents. They may vomit or refuse food. They may experience more weight loss. Symptoms vary over the lifespan. Pediatric EoE symptoms of nausea and abdominal pain can also show up in adults.   [9:54] Atopy refers to allergic conditions. In the paper, a history of atopy means a history of allergic conditions, like atopic dermatitis, IgE-mediated food allergy, allergic rhinitis, or asthma.   [10:37] These disorders tend to cluster together, over time, because they share many common genetic risks. They cluster in families because some of the genetic risks are the same. Not every family member will have the same atopic or allergic conditions.   [11:07] In families, perhaps one person will have atopic dermatitis and allergic rhinitis while another will have atopic dermatitis, allergic rhinitis, asthma, and EoE. They may have inherited different genetics or had different environmental exposures.   [11:50] Ryan says that describes his family. They each have different atopic conditions. Ryan got them all! Dr. Ruffner says it describes her family, as well.   [12:26] Dr. Ruffner says it's understandable for families to stress about atopic conditions. Unfortunately, right now, there's no way to predict who will develop which atopic conditions. It's on the minds of the medical and research communities.   [13:10] IgE is an antibody that binds to food allergens and mediates anaphylaxis, usually within 30 minutes, with hives, vomiting, and difficulty breathing. Not everyone with a diagnosed food allergy will be given an epinephrine auto-injector.   [13:44] IgE-mediated food allergies are influenced by type 2 cytokines. Cytokines are immune system signaling proteins that have been labeled as groups. The group that is involved in allergy most heavily is under the label type 2.   [14:15] These type 2 cytokines are responsible for influencing B cells to make IgE. In the tissue in EoE, we find that there is a large amount of these type 2 cytokines present.   [14:37] This is quite relevant because dupilumab, the monoclonal antibody that has been approved to treat EoE, targets type 2 inflammation by blocking type 2 cytokines.   [16:04] Dr. Ruffner says one of the biggest challenges in the field of EoE is we don't have a way to stratify who should get which treatment for EoE. Patients have to choose between diet and pharmacologic therapy.   [16:48] We don't know enough about the inflammatory profiles to give any patient the specific guided information that one therapy would be better than another.   [17:11] Pediatric and adult patients are given the same treatment options. Some dosing, such as proton pump inhibitors and dupilumab, is weight-based so different doses are needed.   [17:36] Over time, people's needs change. From early school age to when people leave home, they may have very different needs. They may do well on diet therapy when their diet is controlled by parents, but, on their own, that may not be the best option for them.   [18:20] Therapy may change over time to support each patient's individual goals. It can be challenging because therapies are imperfect. Each therapy has a percentage probability of success. Not every therapy is guaranteed to work for every individual.   [19:01] There is some flexibility and possibility of switching between therapies to support people. Ryan shares one of his experiences in changing treatments.   [20:03] Some patients are stable on a therapy for a time but then see symptoms creep back up. Dr. Ruffner strongly suggests they talk to their care team for an endoscopy and biopsy to see if they need to switch therapy and if their diet has changed.   [21:31] In young children, Dr. Ruffner sees a much higher incidence of feeding refusal. The child may have a preferred food or a preferred texture like puree, long past when that would be appropriate for the age.   [22:41] It can be very difficult to move past this learned behavior even if remission is achieved through therapy. The child may need feeding therapy to help with that. [22:59] Feeding behaviors in older individuals may be much more subtle. Talk about them with your care team. Needing water to eat, cutting food very small, and fearing to eat around people are common eating behaviors to discuss in older patients.   [23:53] These eating behaviors affect people's well-being deeply because they affect how social they feel when they are around people. Ideally, you want to be around people and share in social times.   [24:16] Holly has used these eating behaviors herself and notices them in other people. When adults come to her for therapy, she asks how many times they refill their water when they eat, and if food ever gets stuck. They are surprised that those are symptoms.   [26:01] Dr. Ruffner says it's important to recognize the difference in symptoms in diagnosing EoE. The main risk factor of EoE is fibrosis, over time. The thought is that early in EoE there is an inflammatory phenotype, but later, there is a fibrotic phenotype.   [26:51] The phenotype refers to the presentation or characteristic of disease. What is the appearance at endoscopy? What do we see in the biopsied tissue? Is there fibrosis or not?   [27:15] This is the crux of the paper: Is this on a spectrum, that the inflammation is driving the fibrosis, or are these two different things altogether? There is some evidence to suggest that the inflammation contributes to this fibrosis over time.   [27:40] One thing that is missing is following a group of patients from the start and having that evidence. There is mechanistic evidence from studies to show that inflammation can contribute to fibrosis. That was one of the discussions in the paper.   [28:29] In endoscopies, something that can be seen with fibrosis or fibrostenotic features is more of an appearance of rings and narrowing of the esophagus. A proportion of patients with strictures or narrowing need to have them dilated.   [29:11] For patients who have dilation, it can help with symptoms significantly. When pathologists look at the tissue with fibrosis, they can see changes in the protein structure. There is more collagen and other changes in the tissue, causing fibrosis.   [30:03] Some patients use adaptive eating behaviors to adapt to significant changes in their esophagus and go for many years without being diagnosed until they present with an impaction when food becomes stuck in their esophagus.   [30:46] This makes EoE a challenging disorder for many because it can be very difficult to diagnose. The journey to a diagnosis is very individual. As a group, adults are much more likely to have fibrosis, leading to dysphagia, strictures, or impaction.   [31:25] Statistically, across all patients, you see fibrosis more in adults than in children.   [32:42] In the paper, Th1 cells are mentioned. Th1 is an immune system term referring to a cell that produces interferon-gamma. Studies show there may be differences in interferon signaling in different age groups but it needs to be studied further.   [33:57] Dr. Ruffner's team had looked at a small group and saw that interferon signaling seemed to be relatively similar between children and adults. Both CD4 and CD8 T cells (types of immune system cells) are potentially producing interferon in the esophagus.   [34:32] More study needs to be done around those immune system cells and their potential significance in EoE, if any.   [35:33] The paper suggests that EoE in children and adults is essentially a spectrum of the same disorder rather than distinct diseases.   [35:42] Aspects of immunology, responses to different treatments across children and adults, the similar responses to diet and different medications, and over time in the same individuals, indicate these are changes and complications over time.   [36:41] Dr. Ruffner suggests that medical researchers need to understand which patients are at the highest risk of complications and work to identify the best treatments to prevent those.   [37:14] Dr. Ruffner is thinking about the response to proton pump inhibitor therapy. One of the things she is looking at is whether or not proton pump inhibitors affect how eosinophils migrate into the tissue.   [37:33] They are finding that it seems that PPIs can decrease the degree of migration of eosinophils into the tissue. They are very interested in looking at that. Ryan says when Dr. Ruffner gets that paper published, she'll have to come back on the show!   [38:06] Ryan thanks Dr. Ruffner. For our listeners who would like to learn more about eosinophilic disorders, including EoE, please visit APFED.org and check out the links in the show notes.   [38:15] If you're looking to find a specialist who treats eosinophilic disorders, we encourage you to use APFED's Specialist Finder at APFED.org/specialist.   [38:24] If you'd like to connect with others impacted by eosinophilic diseases, please join APFED's online community on the Inspire Network at APFED.org/connections.   [38:33] Ryan thanks Dr. Ruffner for participating in the podcast episode. Holly also thanks APFED's Education Partners Bristol Myers Squibb, GSK, Sanofi, Regeneron, and Takeda for supporting this episode.   Mentioned in This Episode: Dr. Melanie Ruffner, MD, PhD, Attending Physician with the Division of Allergy and Immunology and the Center for Pediatric Eosinophilic Disorders at Children's Hospital of Philadelphia “Pediatric and adult EoE: A spectrum or distinct diseases?” by Stanislaw J. Gabryszewski, Melanie A. Ruffner, and Jonathan M. Spergel   APFED on YouTube, Twitter, Facebook, Pinterest, Instagram Real Talk: Eosinophilic Diseases Podcast apfed.org/specialist apfed.org/connections   Education Partners: This episode of APFED's podcast is brought to you thanks to the support of Bristol Myers Squibb, GSK, Sanofi, Regeneron, and Takeda.   Tweetables:   “EoE is a chronic allergic condition that affects the esophagus. The esophagus carries food from the mouth to the stomach. In people with EoE, the immune system overreacts to food allergens and causes inflammation in the esophagus.” — Dr. Melanie Ruffner   “In EoE, there are no blood or allergy tests that make it easy to diagnose EoE without an endoscopy.” — Dr. Melanie Ruffner   “Is EoE on a spectrum, that the inflammation is driving the fibrosis, or are these two different things altogether? There is some evidence to suggest that the inflammation contributes to fibrosis over time.” — Dr. Melanie Ruffner   “When pathologists look at the tissue with fibrosis, they can see the changes in the protein structure.” — Dr. Melanie Ruffner   “There are some folks who have adapted their eating behavior quite significantly and may have quite a number of chronic changes in their esophagus that they have adapted around, and they go for many years without being diagnosed.” — Dr. Melanie Ruffner

Roche and Regeneron, two of the world's largest pharmaceutical companies, have announced a combined $56 billion investment that's set to transform U.S. real estate and manufacturing. Billions of dollars will go into expanding research and manufacturing facilities across key states like California, Indiana, New York, and North Carolina, creating thousands of new jobs. These investments signal long-term confidence in the U.S. market and could spark a boom in life sciences real estate. As the pharmaceutical industry navigates potential new tariffs, this expansion is reshaping global supply chains and strengthening biotech hubs in the U.S. Learn how these developments could impact investors and the future of American manufacturing. Topics Discussed: 00:00 Big Pharma Announcements 00:22 Roche's US Plan 01:01 Regeneron's US Plan 01:55 President Trump's Tariffs  02:15 Other Expansions 02:33 Real Estate Investors LINKS Download Your Free Top 5 Cities to Invest in 2025 PDF!https://www.realwealth.com/1500 JOIN RealWealth® FOR FREE https://realwealth.com/join-step-1 FOLLOW OUR PODCASTS Real Wealth Show: Real Estate Investing Podcast https://link.chtbl.com/RWS Real Estate News: Real Estate Investing Podcast: https://link.chtbl.com/REN    

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Lilly is currently involved in a legal battle with compounders over knockoff versions of tirzepatide, marketed as Zepbound for weight loss. The FDA has prohibited compounders from producing these knockoffs after confirming the end of the tirzepatide shortage in December 2024. On the other hand, BMS is facing disappointment with Cobenfy's late-stage failure in treating schizophrenia, marking their second high-profile setback in recent weeks. RFK is contemplating removing COVID-19 from the CDC's vaccine guidelines for children to align with other countries and the WHO. Biotech investors are navigating a turbulent period due to new tariffs and economic uncertainty, causing additional upheaval in an already fragile market. Trump is looking to reinstate international drug pricing policies, while Swiss ADC Biotech is opting for the SPAC route to Nasdaq.Summit's bispecific has outperformed another cancer medication, putting pressure on Keytruda's dominance. In the midst of this biotech downturn, Wacker Biotech is offering advanced therapy process development and production services. Moving on to the next news, executives in the pharmaceutical industry often receive substantial golden parachutes upon leaving a company. Pfizer is defending its cardiac blockbuster drug against competition from Alnylam and BridgeBio. The biotech sector was showing signs of a rebound until new tariffs and economic uncertainty introduced further instability.Lilly is pursuing legal action against compounders for producing counterfeit drugs, while Roche and Regeneron are committing billions to US manufacturing amidst tariff challenges. The industry is undergoing significant changes under the current administration, with opportunities to learn from global markets. Challenges such as investor pullback and market volatility are impacting the biotech sector.Janssen's departure from Galapagos and the promising future of all-American biotech companies are also discussed. Stay tuned for more updates on upcoming events and job opportunities in the field.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Roche and Regeneron are both investing heavily in US manufacturing, with Roche committing $50 billion and Regeneron signing a $3 billion deal with Fujifilm. This move comes as Trump's tariffs threaten the industry. Meanwhile, Pfizer, Alnylam, and BridgeBio are competing in the market for ATTR-CM treatment, with Alnylam and BridgeBio vying for patients switching from Pfizer's tafamidis drug and all three companies seeking new patients.Novo Nordisk has filed for FDA approval of an oral weight loss pill, AstraZeneca and Daiichi Sankyo are pushing their drug Enhertu for frontline breast cancer treatment, and Gilead's Trodelvy in combination with Keytruda has shown promise in slowing disease progression in triple-negative breast cancer. Wacker Biotech is offering services for advanced therapies, while Tempest has recently laid off 80% of its workforce.The industry is facing regulatory challenges and economic uncertainty, with Trump's tariffs potentially impacting pharma companies. Lilly has promised to manufacture a weight-loss pill in the US following a phase III win, and Makary discusses rare disease approvals and public distrust in a new interview. Biotech's future may be more focused on American companies according to PitchBook.

While much of the country was off celebrating Easter and Passover this weekend, the FDA—and its new leader Marty Makary—were busy making news. Makary, who was confirmed as FDA commissioner last month, gave his first major interview, where he unveiled a new regulatory pathway for rare disease therapies and addressed the “epidemic of distrust” he feels is imperiling the agency. Makary also shared his thoughts on the conflicts of interest he sees between the FDA and pharma industry, highlighting a new directive to ban industry representatives from serving on the agency's advisory committees—a move experts believe will have minimal impact in reducing COIs.Makary also touched on vaccines and what he believes to be the cause of autism. On this, he was more restrained than his boss, HHS Secretary Robert F. Kennedy Jr., who continues to insist on re-investigating what he believes is a link between autism and vaccines. The interview comes as more former FDA officials sound the alarm about the changes happening within the agency.Elsewhere on the policy front, President Donald Trump continues to threaten tariffs on pharma products. In response, two more companies, Roche and Regeneron, are committing billions of dollars to enhance their U.S. footprints. They join Novartis, J&J and Eli Lilly in this regard, with the latter additionally promising to manufacture its investigational oral obesity drug orforglipron in the U.S.That announcement followed the news that orforglipron generated “injectable-like efficacy” in a Phase III diabetes trial. Lilly intends to submit for approval of the pill for weight management by the end of this year and diabetes in 2026. Not to be outdone, chief rival Novo Nordisk revealed Saturday that it has already filed for FDA approval of an oral formulation of its own blockbuster, semaglutide, for overweight and obesity.Finally, make sure to check out this week's edition of BioPharm Executive where we take a deep dive into another sizzling space—transthyretin amyloid cardiomyopathy (ATTR-CM)—and find out which pharma CEO has the biggest golden parachute.

Comment on the Show by Sending Mark a Text Message.This episode is part of my initiative to provide access to important court decisions  impacting employees in an easy to understand conversational format using AI.  The speakers in the episode are AI generated and frankly sound great to listen to.  Enjoy!The battlefield of workplace accommodations and family caregiving responsibilities takes center stage in our detailed examination of Kemp v. Regeneron Pharmaceuticals. This landmark case illuminates the critical distinction between denying leave and subtly discouraging employees from exercising their rights under the Family and Medical Leave Act.We trace the journey of Denise Kemp, a decade-long employee with a history of promotions and positive performance, whose relationship with her employer deteriorated after seeking flexibility to care for her disabled daughter. The tension between remote work policies and leave rights creates a fascinating legal puzzle that ultimately hinged on technicalities rather than merits.The Second Circuit's ruling provides crucial clarity on what constitutes FMLA interference, establishing that employers can violate the law without ever formally denying leave requests. Yet despite this employee-friendly interpretation, procedural rules—particularly the unforgiving statute of limitations—proved decisive. We explore how timing can make or break employment claims regardless of their underlying validity.Beyond the technical legal analysis, we extract practical lessons for both sides of the employment relationship. For workers, understanding deadlines and documenting problematic interactions becomes paramount. For companies, the case serves as a warning that compliance means more than simply processing paperwork—it requires creating an environment where employees feel genuinely free to exercise their rights without subtle punishment.Have you encountered challenges balancing family care responsibilities with workplace expectations? The evolving legal landscape around remote work accommodations continues to shape both employee rights and employer obligations. Share your experiences or questions about navigating these complex waters. If you enjoyed this episode of the Employee Survival Guide please like us on Facebook, Twitter and LinkedIn. We would really appreciate if you could leave a review of this podcast on your favorite podcast player such as Apple Podcasts. Leaving a review will inform other listeners you found the content on this podcast is important in the area of employment law in the United States. For more information, please contact our employment attorneys at Carey & Associates, P.C. at 203-255-4150, www.capclaw.com.Disclaimer: For educational use only, not intended to be legal advice.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Pfizer has dropped its lead obesity molecule, danuglipron, due to safety concerns regarding liver issues, leaving the company with only one molecule in its obesity pipeline. This decision has raised questions about the future direction of Pfizer's obesity research. Additionally, there are fears about the impact of recent firings at the Department of Health and Human Services on the FDA, with concerns about delays in drug approvals and increased political influence on regulatory decisions.In other news, Verve's base editor showed promise in lowering bad cholesterol levels in a phase Ib trial, and there are ongoing legal battles between Vanda and the FDA over off-label use of a drug for jet lag. Overall, the biotech industry is facing challenges and uncertainties in light of recent developments.The FDA is facing an uncertain future following a major overhaul by Kennedy, which included staff cuts that could threaten user fees, nearly half of the FDA's budget. Drug review delays and increased executive oversight are expected, with fears mounting about the agency's future direction. AI is enabling the development of smart antibodies that can more precisely target cancer cells while sparing healthy tissues.Upcoming FDA actions include a cell-based gene therapy for a rare skin disease and product expansions for Regeneron and Sanofi. Experts are concerned that FDA layoffs could trigger a mechanism that may set the industry back 35 years. Other news includes the FDA replacing some animal testing with AI and human 'organoid' lab models, changing attitudes towards the MMR vaccine, recent approvals in colorectal cancer, and more.Readers are encouraged to provide feedback on what topics they would like to see covered next.

Gene therapy is rapidly emerging as a transformative approach for treating genetic hearing loss, with Regeneron advancing one of the field's most promising candidates: DB-OTO. In this conversation, Regeneron's Auditory Global Program Head Dr. Jonathon Whitton provides an in-depth look at the company's work developing a gene therapy targeting otoferlin-related hearing loss, a rare but significant condition causing congenital deafness in children. Whitton explains the scientific rationale behind targeting the OTOF gene, the challenges of delivering gene therapy to the inner ear, and why this therapy holds particular promise for pediatric patients. He also discusses how Regeneron is designing clinical trials with long-term outcomes in mind, as well as the broader implications for treating other forms of genetic hearing loss. This discussion offers valuable insights into the future of hearing therapeutics and the role large biotech companies may play in making genetic treatments more accessible. The following Regeneron pages highlight the company's research on gene therapies for hearing loss and provide information on genetic testing and navigating a hearing loss diagnosis:https://aboutgenetichearingloss.comhttps://www.regeneron.com/stories/auditory-gene-therapyBe sure to subscribe to our channel for the latest episodes each week and follow This Week in Hearing on LinkedIn and X (formerly Twitter).- https://twitter.com/WeekinHearing- https://www.linkedin.com/company/this-week-in-hearing- https://hearinghealthmatters.org/thisweek/

LIVE from Transform 2025 in Las Vegas! Amira Barger is an award-winning Executive Vice President of Communications and Head of DEI Advisory at Edelman, providing senior reputation management and polycultural counsel to clients across the globe. Recently named Woman of the Year by Women Health Care Executives, Top 100 Executives by Involve People, Top CMOs of 2024 by the CMO Alliance, Top 50 Global DEI Professionals by OnConferences, Top 100 People Leaders by Mogul, Fearlessly Authentic Leader by Leaderology, and 30 under 40 in Healthcare Innovation by Business Insider – Amira is a scholar, practitioner and thought leader who brings more than 20 years of experience in strategic communications that reach stakeholders, mobilize the community and inspire action. Amira has global experience in pharma/healthcare communications, corporate branding, web and social media, M&A experience, media relations, team management, sustainability/social impact, reputation management, and DEI. Throughout her career, Amira has utilized these competency areas for clients such as: CVS Health, Eli Lilly, Walgreens, Hologic, Genentech, Pfizer, GSK/Haleon, BMS, Zoetis, Alkermes, Regeneron, Amgen, Medtronic, Children's Miracle Network, Kaiser Permanente, First 5 Los Angeles, Covered California, Centers for Disease Control and Prevention, FEMA, and California Community Colleges. Adam and Amira discuss: - How does “niceness” in workplace culture hold back real DEI progress, and what should leaders do instead? - Challenging Workplace Norms to Advance DEI and Justice - Empowering Women in Leadership - Valuing the Whole Human - "How can leaders move beyond surface-level well-being initiatives to truly create workplaces that honor employees as whole humans, not just workers? Connect with Amira: https://www.linkedin.com/in/amirabarger/ Live from Transform 2025, we're bringing you an exclusive podcast series packed with insights from some of the brightest minds in hiring, talent strategy, and workforce transformation! In this series, we've got incredible guests from Okta, Tubi, Edelman, Greenhouse, Findem, and more, sharing how top organizations are rethinking hiring, culture, and talent acquisition in today's fast-changing world. Greenhouse combines a structured, data-driven hiring approach with AI-embedded workflows that empower recruiters to focus on strategic, high-impact work. From sourcing top talent to personalizing the candidate experience, Greenhouse streamlines and optimizes the entire hiring process. This ensures that every hire is the right hire—eliminating bias, creating fairness, and helping teams make smarter, faster decisions. Over 7,500 companies, including HubSpot, Duolingo, and J.D. Power, trust Greenhouse to build better teams and turn talent into a strategic advantage. Want to learn how today's top companies are winning the talent game? Tune in now and visit Greenhouse.com to transform the way you hire. Thanks for listening. Please follow us on Instagram @NHPTalent and X @AdamJPosner. Visit www.thePOZcast.com for all episodes

Drs. Akshay Thomas and Priya Vakharia join to preview the April 2025 edition of Retinal Physician, focusing on current and future therapies for neovascular AMD.Relevant Financial Disclosures: Dr. Sridhar has consulted for Genentech, Regeneron, and Eyepoint. Dr. Vakharia has consulted for Regeneron, Ocular Therapeutix, and Eyepoint.You can claim CME credits for prior episodes via the AAO website. Visit https://www.aao.org/browse-multimedia?filter=Audi

Sabrina Traskos, VP of global procurement for Regeneron, explains how marketing procurement is trying to coexist with AI by developing new compensation models that aim to ease tension in the relationship between agencies and in-house marketers.And for our Trends segment, we talk about the massive, ongoing layoffs roiling HHS, and one very high-profile resignation at the FDA. 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.

Have you ever wondered if steroids are the best choice for managing your eczema?  While both topical and oral steroids offer quick relief from severe eczema flares, understanding their long-term risks and safer alternatives can dramatically improve your quality of life. In this episode, Dr. Mondana Ghias joins Kortney and Dr. Gupta to discuss the complex role of systemic corticosteroids in eczema management. They dive deep into the short-term relief that steroids provide for severe eczema symptoms and emphasize why steroids must be approached cautiously due to potential side effects and dependency risks. Dr. Ghias also highlights the unique challenges of eczema care for individuals with skin of color, addressing differences in treatment response and the common issue of hypopigmentation caused by topical steroids. What we cover in our episode about steroid use in eczema treatment: Role of Systemic Steroids: When steroids are necessary and how they quickly manage severe eczema flares. Risks and Side Effects: Understanding the serious long-term effects of systemic and topical steroids. Steroid Withdrawal: Recognizing the signs of steroid withdrawal and strategies to manage rebound effects. Challenges of Topical Steroids for Skin of Color: The unique risks of steroid use and managing hypopigmentation. Alternatives to Steroids and Innovative Treatments: The rise of biologics and targeted therapies offering safer, long-term solutions. The Importance of Specialist Care: Working with a dermatologist or allergist will help you find a sustainable long-term management plan. Made in partnership with The Allergy & Asthma Network. Thanks to Sanofi and Regeneron for sponsoring today's episode. This podcast is for informational purposes only and does not substitute professional medical advice. Always consult with your healthcare provider for any medical concerns.

This episode covers: Cardiology This Week: A concise summary of recent studies Relevance and management of ventricular ectopic beats  Lp(a) in cardiovascular risk management Mythbusters: A vegetarian diet lowers cardiovascular risk Host: Susanna Price Guests: Carlos Aguiar, Thomas Deneke, Kausik Ray Want to watch that episode? Go to: https://esc365.escardio.org/event/1802 Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsor. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. Declarations of interests: Stephan Achenbach, Thomas Deneke, Nicolle Kraenkel and Susanna Price have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Novo Nordisk, Pfizer, Sanofi, Servier, Takeda, Tecnimede. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Kausik Ray declared to have potential conflicts of interest to report: research grants from Amarin, Amgen, Daiichi Sankyo, Merck Sharp & Dohme, Pfizer, Regeneron, and Sanofi, consultant for Abbott, Amarin, Amgen, AstraZeneca, Bayer, Biologix, Boehringer Ingelheim, Cargene Therapeutics, CRISPR, CSL Behring, Eli Lilly and Company, Esperion, Kowa Pharmaceuticals, NewAmsterdam Pharma, Novartis, Novo Nordisk, Pfizer, Regeneron, Resverlogix, Sanofi, Scribe Therapeutics, Silence Therapeutics, Vaxxinity, and Viatris, honoraria for lectures from Novartis, BI, AZ, Novo Nordisk, Viatris, Amarin, Biologix Pharma, Sanofi, Amgen, Esperion, Daiichi Sankyo, Macleod and stock options New Amsterdam Pharma, Pemi 31, SCRIBE Therapeutics. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.President Trump has nominated Susan Monarez as the new head of the CDC, facing challenges such as a measles outbreak that has already resulted in two deaths. Merck commits nearly $2 billion for an oral lipid-lowering drug, joining other companies targeting lipoprotein(a). GSK is studying the impact of their shingles vaccine, Shingrix, on reducing dementia risk. Cassava has ended their Alzheimer's program for Simufilam after years of controversy. The average life sciences salaries have increased by 9% in 2024, but bonuses and equity values have dropped. Trump has doubled down on the threat of tariffs on pharmaceuticals. In other news, Opthea and Unity have failed to unseat Regeneron's Eylea in vision disorders, while Alector will be laying off 13% of its workforce. AstraZeneca is making a potential $10 billion commitment to China despite political pressure. Opportunities in the life sciences industry are available at companies like Oncothera, Dyne Therapeutics, Amgen, and Novo Nordisk.

Description: Co-hosts Ryan Piansky, a graduate student and patient advocate living with eosinophilic esophagitis (EoE) and eosinophilic asthma, and Holly Knotowicz, a speech-language pathologist living with EoE who serves on APFED's Health Sciences Advisory Council, interview Dr. John Accarino, an allergist and immunologist at Massachusetts General Hospital and Mass General for Children, on the topic of immunology support for eosinophilic esophagitis (EoE). Dr. Accarino shares his experiences as a person living with food allergies, allergic asthma, peanut allergy, and eosinophilic esophagitis. He tells how his experiences help him in his work with patients. Dr. Accarino shares some education on a variety of allergy mechanisms and the treatments that mitigate them. Disclaimer: The information provided in this podcast is designed to support, not replace the relationship that exists between listeners and their healthcare providers. Opinions, information, and recommendations shared in this podcast are not a substitute for medical advice. Decisions related to medical care should be made with your healthcare provider. Opinions and views of guests and co-hosts are their own.   Key Takeaways: [:49] Co-host Ryan Piansky introduces the episode, brought to you thanks to the support of Education Partners Bristol Myers Squibb, GSK, Sanofi, and Regeneron. Ryan introduces co-host Holly Knotowicz.   [1:14] Holly introduces today's topic, immunology support for eosinophilic esophagitis (EoE), and introduces today's guest, Dr. John Accarino, an allergist and immunologist at Massachusetts General Hospital. Holly welcomes Dr. Accarino to Real Talk.   [1:49] Holly notes that Dr. Accarino is her allergist and immunologist.   [2:03] Dr. Accarino works at Massachusetts General Hospital and Mass General for Children. Allergy and Immunology is a field where he can see pediatrics and adults. Originally trained in pediatrics, now Dr. Accarino sees patients of all ages.   [2:23] Dr. Accarino grew up with allergies. He has experienced food allergies since he was young, along with allergic asthma, and some eczema, which he grew out of. Later in life, he was diagnosed with eosinophilic esophagitis. He talks with his patients about his experiences.   [2:47] Dr. Accarino also does research on drug allergies in the context of certain drug interactions that involve eosinophils.    [3:06] When Holly was referred to Dr. Accarino, it was for multiple sclerosis (MS). He told her, “It looks like you have EoE. I have EoE.” It was a huge relief to Holly not to have to explain EoE to her doctor.   [3:41] Some patients start to explain their EoE to Dr. Accarino, and he assures them he understands where they're coming from. Sometimes, he has to be careful not to think everyone has his symptoms, as there is a large spectrum of presentations.   [4:26] Dr. Accarino wasn't diagnosed with EoE until he was in his allergy fellowship, after he suspected it when he had a food impaction at a steakhouse at a graduation party from his pediatric residency. He tried to manage the EoE with lifestyle changes.   [5:39] Dr. Accarino didn't often go to see a doctor during residency, but he realized it was probably a good time to get an endoscopy.   [5:52] Holly shares how she was also diagnosed as a clinical fellow. She was subbing for someone on the GEDP team at Children's Hospital in Colorado. Listening to all the patients, she realized, “This sounds a little bit like me … What is going on?”   [6:23] Even with his medical background, it took Dr. Accarino some time to decide to get the endoscopy and biopsies. You or your doctor have to have a high level of suspicion to realize this isn't just reflux. Food doesn't get stuck in every person's throat.   [7:01] Thinking back, Dr. Accarino remembers an instance as a child when a dry muffin got stuck in his throat. He stayed calm and waited for it to pass. He thought it was normal.   [7:39] He drank a lot of water and chewed his food a lot. Those are markers of potential esophageal inflammation.   [8:20] Different groups have different management strategies for EoE. Dietary management, topical steroids, biologics. A subgroup of people with EoE are responsive to proton pump inhibitors (PPIs). Finding the best management strategy is a work in progress.   [8:53] With pediatric patients, the parents control the diet, and the children eat what is prepared. He notes that with adult patients, sometimes they let foods slip through.   [9:10] If you want to do a single-food elimination diet with dairy, there's a lot of dairy in the American diet. Dr. Accarino tried eliminating dairy and wheat, but he still had persistent eosinophils with dietary elimination.   [9:24] Dr. Accarino then tried PPIs. To know if you have PPI-responsive EoE, you might do twice-daily omeprazole at a significant dose. Have the endoscopy after a few weeks pass and see if the eosinophils are still present in the biopsy.   [9:59] Dr. Accarino did that recently and still has the eosinophils. He plans to talk to his gastroenterologist about considering dupilumab, but he feels that he can mitigate his subjective day-to-day experience of symptoms with dietary elimination and PPIs.    [10:24] If you still have the presence of eosinophils on biopsy, there's still inflammation happening. In the long term, you still have to worry about fibrosis and narrowing.    [10:34] The last treatment Dr. Accarino tried was as a research participant in a study for dissolvable fluticasone. He received either the medication or a placebo; he doesn't know which.   [11:01] To stay in the study, he had to journal and report his symptoms regularly. He didn't have enough symptoms to stay in the study. They were looking for a baseline to see how it changed with either the placebo or the medication.   [11:20] In research, you have to have a baseline to start, and then you want to see improvement, plus or minus. With EoE, it's difficult. You have the biopsy and eosinophils, but there's a large spectrum of symptoms that people may experience.   [12:40] Holly appreciates Dr. Accarino's unique perspective as a doctor with EoE who has experienced various treatments and diets. He understands the concerns of his patients.   [12:43] Dr. Accarino says even taking a twice-daily PPI or other medication is difficult for a lot of people, and that's the most simple of these therapies.   [13:06] Dr. Accarino wants to validate everyone's experience in terms of how difficult it is to treat this disorder, how it may present in different ways, and how there may be a delay in diagnosis.   [13:16] This isn't IgE-mediated immediate food allergy, where you eat a food and may have swelling within minutes; you may have flushing or hives. That's very clear. With EoE, it's a different mechanism; in many cases, there is a delay.   [14:37] Allergy, in general, is under the purview of clinical immunology. Dr. Accarino is allergic to peanuts and has an  IgE-mediated immediate reaction to them. If he eats a peanut, he has symptoms within minutes. He could have anaphylaxis. As a result, he carries an epinephrine auto-injector.   [15:01] If Dr. Accarino has a skin test, it will be positive for peanut. He has IgE antibodies to peanuts. He also has oral allergy syndrome where the body mistakes certain fruits, vegetables, or nuts with certain tree pollens or grass pollens.   [15:23] Oral allergy syndrome is usually a lower-risk condition where it's a less-stable protein that once cooked might not produce any symptoms. If it's raw when you consume it, you may have oral itching, a bit of throat discomfort, or tongue itching. [15:54] Your stomach acid breaks it down so it doesn't get into your bloodstream and you shouldn't have a systemic reaction.   [16:01] If Dr. Accarino eats a peanut, his stomach acid doesn't break down the high-risk, stable peanut protein, it gets into his bloodstream, and he can have a systemic anaphylactic reaction.   [16:20] Chronic EoE symptoms can present with something like a food impaction, or bad reflux or belly pain, and nausea. The reaction may not be immediate. It may be progressive over days or weeks.   [16:38] FIRE is an interesting condition that takes some time to narrow down. It's an immediate response of the esophagus, but we don't think it's histamine-mediated.   [16:56] We don't know, exactly, the mechanism but it's in people with eosinophilic esophagitis. They feel differently, and there would be different specific food triggers.   [17:11]  It took some time to figure out what was going on. Dr. Accarino felt like he had a lump in his throat, then a lump in his chest, nausea, and belly pain. It felt like a slow progression of EoE symptoms, and it was from specific food triggers, in his case.   [17:30] In some of the FIRE literature, they looked at banana and avocado. For Dr. Accarino, it took a couple of exposures to protein bars and milk protein whey isolate, specific to protein bars he had multiple times, until he figured out that was the trigger.   [17:50] Another protein whey isolate that Dr. Accarino scooped as a powder and made into a shake also led to FIRE.   [17:55] It took that event for Dr. Accarino to figure out it wasn't just a flareup of EoE or reflux but some trigger that caused this response that wasn't anaphylaxis but may be due to the recruitment of eosinophils or some immediate process not well understood.   [18:18] FIRE is going to be very hard to research. How would we figure this out? Would we bring someone in and do an endoscopy immediately and see what happens? There's a lot of descriptive data and case series.   [18:32] Dr. Accarino has had experiences when he knew it wasn't an immediate anaphylactic reaction, oral allergy, or reflux. He asked what else it could be in the context of EoE. When he looked at different case series, that's the presentation he had.   [19:17] Dr. Accarino acknowledges that having personal experience with FIRE, oral allergies, and IgE-mediated allergies, on top of EoE, has influenced his work as a medical professional. He can share anecdotes with patients as he explains the available testing.   [19:39] Dr. Accarino says a lot of immunology and allergy is explaining the diagnostic tools and management strategies we have and what we think is going on.   [19:50] The immune system is infinitely complex, and a lot of the practice is making a digestible analogy, not just in the context of allergic conditions but also everything with the immune system. There are so many cells doing so many different things.   [20:04] Dr. Accarino explains false positives in testing. He has positive scratch tests for peanuts, cashews, and almonds, which shows he has IgE for each of them. He is allergic to peanuts, but he can eat cashews and almonds. Those are false positives.    [20:56] When a scratch test is negative for immediate food allergy, it's a powerful predictive tool. But you may get false positives. How positive is it? There might be room for more discussion.   [21:10] There may be more hesitation for people who do large panels of food testing without any history of reacting to any foods.   [21:31] Some people have EoE triggered by milk or wheat but have negative skin tests. That doesn't mean they aren't triggered by these foods. The skin test is an IgE histamine mast cell mechanism, not for eosinophils, which are other immune cells.   [21:58] We go down these steps of thinking about diagnostic triggers and eventually treatment for those immediate symptoms mentioned for EoE.   [22:09] Dr. Accarino doesn't expect FIRE to be responsive to epinephrine. He doesn't have to stabilize the mast cells. It's a chronic disease that's flaring up. You treat it with a chronic type of treatment.   [24:10] Dr. Accarino says that for a doctor, immunology is rewarding, interesting, and complex, but it's intimidating until you get your foothold and see patients and clinical experiences.   [25:14] A lot of medical students and residents are a little fearful of immunology. They might not think about it too much. Dr. Accarino loves to talk about it and think about it. He can't think of anything more complex in terms of systems within our body.   [25:37] Ryan comments on his experiences with IgE-mediated food allergies, some environmental allergies that he has no idea how they work, and EoE, which he believes he has a good grasp on.   [25:55] Ryan imagines that having a physician with a good understanding of the immune system and also personal experience would be helpful for a patient with multiple allergic conditions.   [26:13] Dr. Accarino sees a large overlap of seasonal or year-round environmental allergies and EoE. There are some studies that show that endoscopies on patients with EoE may change at different times of the year if they have underlying seasonal allergies.   [26:33] Some people who have food allergies also have EoE or other eosinophilic disorders. Some discussions with them may be about blood tests that detect eosinophils in the bloodstream versus biopsies of the esophagus, stomach, or colon.   [27:15] It's thinking about what tests are available, what they tell us, and how to use them to predict the next steps, things like dietary changes or for immediate food allergy, considering challenges versus full avoidance. Each test has its pluses and minuses.   [27:35] People like a clear test, and they like an easy fix, but sometimes there's a lot of nuanced conversation of shared decision-making and trying things in a supervised setting.   [27:57] Holly speaks as a patient of the investigative testing Dr. Acarino is doing with her immune system trying to figure it out along with her MS and EoE.   [28:14] Dr. Accarino says the words immune system, immunity, and inflammation are used a lot in talking about foods. Dr. Accarino uses the framework of the immune system trying to help you.   [28:42] Sometimes, instead of making helpful antibodies to things like vaccines or viruses, that give you protection, the immune system makes antibodies that attack a certain organ or your joints.   [29:02] Dr. Accarino thinks of treatments that suppress the immune system in certain ways. Some treatments cool down the populations of many different immune cells. Oral steroids and prednisone are used for many conditions for autoimmune flares.    [29:29] Oral steroids, in the long term, may lead to weight gain, bone density changes, and diabetes. The big push for many diseases is toward non-steroidal biologics to target specific cells that cause disease.   [29:59] For Crohn's disease, a specific monoclonal antibody is used to target TNF-alpha molecules and blocks that inflammation pathway.   [30:14] For EoE, dupilumab, a specifically designed antibody, blocks a specific receptor in a specific pathway so the immune system doesn't have to be shut down and the patient doesn't have the side effects of steroids. It's a targeted therapy.   [30:32] What you see in commercials for injectable medications are large, designed antibodies that, if you took them in a pill form, your stomach acid would break down and digest. So they are injections and infusions that go directly into the bloodstream.   [31:22] Medications that end in -mab are monoclonal antibodies. They are very large molecules that would not be stable in stomach acid.   [32:09] Dr. Accarino talks of eosinophil normal function and aberrant function. IgE-mediated reactions are usually related to mast cells, a type of immune cell that shouldn't be in the bloodstream.   [32:54] Dr. Accarino can do a CBC with differential to see the number of white blood cells and the number of red blood cells. The differential of white blood cells will include neutrophils, lymphocytes, and eosinophils. It shouldn't show mast cells.   [33:19] If you have mast cells in your bloodstream, that's mastocytosis, a different problem. Mast cells live in your skin, in your gut, and around your blood vessels. They're full of granules like histamine and tryptase.   [33:38] Dr. Accarino explains how mast cells release their contents and how he would treat the resulting swelling or itch with an antihistamine or epinephrine. Epinephrine treats systemic reactions and stabilizes the mast cells.   [34:16] Mast cells have many receptors and may be triggered by many things other than IgE. This is a conversation Dr. Accarino has with patients who have chronic hives unrelated to any foods.   [34:29] Some people get hives from non-steroidal anti-inflammatory drugs NSAIDs. Some get hives from vancomycin. Some get hives when the temperature changes, from tight clothing, or from IV contrast. It's not an IgE-mediated mechanism, but it's still mast cells being degranulated.   [35:45] Dr. Accarino says people see hives and they think allergy. But, like EoE, it doesn't involve histamine. There can be hives that aren't related to allergies. This can be idiopathic urticaria or spontaneous urticaria.   [36:04] Sometimes, when switching from a day shift to a night shift, hormonal changes will trigger hives. Sometimes, the stress of having a family member in the hospital will cause hives. An accumulation of triggers can lead to mast cell degranulation.   [36:38] There are many ways that allergy can have different mechanisms and treatments, with different cells involved. There are different molecules that cause symptoms and manifestations.   [36:50] Navigating that and understanding what might be going on can give people a sense of reassurance. The biggest fear is a life-threatening allergic reaction. People will read about fatal anaphylaxis and wonder if it will happen to them with their condition.   [37:16] Sometimes, thinking of the cells involved and the pathways may give a level of reassurance that this may not be the same thing that they read about.   [37:28] Ryan thanks Dr. Accarino for joining us today.   [37:37] Dr. Accarino says it was nice to reflect on things and to go through different scenarios and experiences he has gone through. It was nice to have the opportunity to share them with Ryan, Holly, and all the listeners.   [37:57] For our listeners who would like to learn more about eosinophilic disorders, including EoE, please visit APFED.org and check out the links in the show notes.   [38:06] If you're looking to find a specialist who treats eosinophilic disorders, we encourage you to use APFED's Specialist Finder at APFED.org/specialist.   [38:15] If you'd like to connect with others impacted by eosinophilic diseases, please join APFED's online community on the Inspire Network at APFED.org/connections.   [38:25] Ryan thanks Dr. Accarino for joining us today for this fun conversation. Holly also thanks APFED's Education Partners Bristol Myers Squibb, GSK, Sanofi, and Regeneron for supporting this episode.   Mentioned in This Episode: Dr. John Accarino, MD, Allergist and Immunologist at Massachusetts General Hospital and Mass General for Children Episode 034: Food-Induced Response and Eosinophilic Esophagitis   APFED on YouTube, Twitter, Facebook, Pinterest, Instagram Real Talk: Eosinophilic Diseases Podcast apfed.org/specialist apfed.org/connections   Education Partners: This episode of APFED's podcast is brought to you thanks to the support of Bristol Myers Squibb, GSK, Sanofi, and Regeneron.   Tweetables:   “Allergy and immunology is a field where I can see pediatrics and adults. I was originally trained in pediatrics, but now I see all ages, from infants up until older adults.” — Dr. John Accarino   “Part of the conversation sometimes is trying not to overly bias myself, where I say, ‘Oh, this is my experience.' … Like many diseases, there's a large spectrum of presentations, … different symptoms that people have.” — Dr. John Accarino   “We don't think [Food-Induced Response in Eosinophilic Esophagitis is] histamine-mediated. We don't know exactly the mechanism, but it's in people with eosinophilic esophagitis. They feel differently, and there would be different specific food triggers. It took some time to figure out that was going on.” — Dr. John Accarino   “When a scratch test is negative for immediate food allergy, it's a very powerful predictive tool. But there are times that you may get false positives. How positive is it? There might be room for more discussion.” — Dr. John Accarino   “There are a lot of ways that allergy can have different mechanisms and different treatments, with different cells involved.” — Dr. John Accarino

Ever wonder if the “asthma shot” from the ER, or those go-to steroid pills for your asthma flares, might be doing more harm than good? Dr. Dipa Sheth joins us to discuss the common pitfalls of relying too heavily on oral corticosteroids (OCS), also known as oral steroids. We unpack why these systemic medications should generally be reserved for short-term use. She also shares how improving asthma control can help you avoid frequent steroid use in the first place. Although oral steroids can effectively treat asthma flare-ups in emergency settings, overuse poses significant risks, from adrenal insufficiency to osteoporosis. We dig into ways patients can proactively manage their asthma, reduce ER visits, and talk to healthcare providers about preventive treatments (like inhalers or biologics for asthma) that keep inflammation in check without the side effects of frequent steroid use. Note: Although we discuss oral corticoid steroids, they can also be given as injections or via IV drip for asthma. We would also like to refer to them as systemic steroids as they impact the entire body, unlike inhaled steroids, which target the airways and lungs.  What we cover in our episode about oral steroid overuse Understanding Oral Corticosteroids (OCS): Learn what these steroids (often called the “asthma shot” in the ER) are and how they can help with severe flare-ups. Why Overusing Steroids Can Be Risky: Discover the potential long-term side effects of relying on systemic steroids (pills, injections, or IV), from adrenal insufficiency and osteoporosis to more frequent infections. Short-Term Fix vs. Lasting Relief for Asthma Care: Learn how urgent care or ER visits may mask an under-managed condition and why seeing a specialist can improve asthma control. Safer Alternatives to OCS: Explore inhaled corticosteroids, biologics, and other preventive treatments that target asthma at its source, reducing the need for frequent steroids. Taking Control and Reducing ER Visits: Get practical strategies for working with your healthcare provider to minimize steroid use, prevent flare-ups, and break free from the cycle of repeated steroid courses. This podcast is made in partnership with The Allergy & Asthma Network. Thanks to Sanofi and Regeneron for sponsoring today's episode. This podcast is for informational purposes only and does not substitute for professional medical advice. If you have any medical concerns, always consult with your healthcare provider.

Johnson & Johnson’s Stelara, Regeneron’s Eylea and Amgen’s Prolia are just some of the drugs facing off against new biosimilars or generics in 2025, as featured in the latest edition of Fierce Pharma’s annual special report documenting the 10 biggest losses of U.S. exclusivity expected throughout the year. In this week’s episode of The Top Line, we dig into the report, which details the stories behind 10 key medicines that are set to face off against new generic or biosimilar competitors this year as their patents expire. Fierce’s Eric Sagonowsky and Angus Liu recap the report, sharing their perspectives on several of the drugs and discussing the industry effects of 2025’s sizable patent cliff. To learn more about the topics in this episode: The top 10 drugs losing US exclusivity in 2025 After patent settlement, Amgen scores FDA nod for its biosimilar version of J&J's Stelara Amgen grabs FDA thumbs-up for Soliris biosim, eyes 2025 launch Novartis wins 11th-hour bid to block generic version of blockbuster heart med Entresto Amgen settles Prolia patent suit with Celltrion, teeing up potential biosimilar launch in June See omnystudio.com/listener for privacy information.

What does "control" mean when managing allergic conditions, and how can you achieve it? When you have asthma, eczema, nasal polyps, or other conditions caused by type 2 inflammation, reaching a state of control can dramatically improve your quality of life. But what does "control" really mean? Is it the same as a cure? And what steps should you take if your current treatment isn't working? In this episode, Dr. Payel Gupta and Kortney dive deep into the idea of control in the context of Type 2 inflammation. They explain that control doesn't mean you'll never experience symptoms again. Rather, it's about having fewer, milder flare-ups and the freedom to live your life more comfortably. Dr. Gupta explains what control means for various conditions, why it matters, and how recognizing signs of poor control can protect against long-term complications. Kortney shares her own experience managing asthma and eczema with biologics, highlighting why symptom tracking and regular check-ins with your doctor are essential, even when you're feeling good. What we cover in our episode about achieving control over Type 2 inflammation: Defining Control in Type 2 Inflammation: Learn what control actually looks like. Discover the difference between controlling symptoms and curing the condition entirely. Why Achieving Control Matters: Find out why uncontrolled Type 2 inflammation can lead to worsening symptoms, frequent hospital visits, increased medication needs, and significantly impact your day-to-day life. Managing Multiple Conditions and the Role of Specialists: Understand why having more than one Type 2 inflammatory condition can lead to a "domino effect," worsening overall health. Learn how specialists like allergists can help you manage multiple conditions effectively. Treatment Options for Controlling Type 2 Inflammation: Get an overview of available treatments, including biologic therapies specifically designed to target underlying inflammation pathways. Understand the role these medications play in improving quality of life. Practical Tips for Managing Symptoms at Home: Learn ways to reduce inflammation by identifying and minimizing triggers, allergy-proofing your environment, and adopting healthier lifestyle practices. More episodes that will help you:  Ep. 101 What is Type 2 Inflammation Ep. 98 Food Allergy Treatment and Management Ep. 87 What biologic therapies are available for allergic conditions? Ep. 85 Navigating Biologic Therapy – What You Need to Know Ep. 78 Chronic Spontaneous Urticaria Treatments Ep. 56 Biologic Therapies for Asthma Made in partnership with The Allergy & Asthma Network. Thanks to Sanofi and Regeneron for sponsoring today's episode. This podcast is for informational purposes only and does not substitute professional medical advice. Always consult with your healthcare provider for any medical concerns.

Can you slow down the atopic march and prevent kids from developing more allergic diseases? Type 2 inflammation plays a central role in allergic diseases, which impact children from infancy through adulthood. From eczema and asthma to food allergies and allergic rhinitis, these conditions are all connected through an underlying immune response: Type 2 inflammation. But is there a way to prevent the progression of these diseases? In this episode, Dr. Payel Gupta and Kortney are joined by Dr. Priya Bansal to explore how Type 2 inflammation manifests in children, the concept of the atopic march, and whether treatments like immunotherapy or biologics can alter the course of the diseases. Many parents aren't aware of the atopic march until their child starts developing multiple allergic conditions. Understanding how Type 2 inflammation progresses and when to intervene can be crucial in managing these diseases early. Dr. Bansal shares her expert insights on the best time to seek treatment and how biologics may help some children break the cycle of inflammation. What we cover in our episode about type 2 inflammation in children Understanding Type 2 Inflammation in Children: Understand type 2 inflammation's role in conditions like eczema, asthma, allergic rhinitis, and food allergies. Learn why children with one allergic condition often develop others over time. The Atopic March: Discover why some children with eczema go on to develop asthma and food allergies. Learn why early intervention can make a difference. Immunotherapy and Biologics: Can They Change the Course of Disease? Understand how allergy shots, OIT, SLIT and biologics work, when they are recommended, and whether they can stop or slow down the atopic march in children. When to See an Allergist & Parental Concerns About Treatment: Learn the signs that indicate your child may need an allergist evaluation. Plus, we address common concerns about aggressive treatment options, including steroids and biologics. Managing Type 2 Conditions at Home & School: Practical tips for parents navigating food allergic diseases. Made in partnership with The Allergy & Asthma Network. Thanks to Sanofi and Regeneron for sponsoring today's episode. This podcast is for informational purposes only and does not substitute professional medical advice. Always consult with your healthcare provider for any medical concerns.  

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in the Pharma and Biotech world. The FDA's vaccine planning meeting was canceled due to disruptions caused by Robert F. Kennedy Jr. GSK's CEO Emma Walmsley received a pay increase to align with industry standards. Lilly invested $27 billion in US manufacturing after Trump's tariff threats. Regeneron scaled back approval goals for a lymphoma bispecific drug. Kallyope released disappointing data for an oral obesity candidate. Trilink offers mRNA designs for reliable performance. Congress reintroduced the EPIC Act to remove IRA's 'pill penalty'. Layoffs were announced at Lava and Ryvu, with new job opportunities in the life sciences industry available.

Join Prof. Lisa Beck as she explores the chronic and persistent burden of AD as well as the concept of early intervention.   ADVENT is a medical education non-promotional resource for healthcare professionals organized by Sanofi and Regeneron. Learn more at ADVENTprogram.com.   This podcast is intended for healthcare professionals only.   Disclaimer: This program is non-promotional and is sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. The speakers are being compensated and/or receiving an honorarium from Sanofi and Regeneron in connection with this program. The content contained in this program was jointly developed by the speakers and Sanofi and Regeneron and is not eligible for continuing medical education (CME) credits.   Speaker disclosures: Lisa Beck MD, consults for Abbvie, Allakos, Arcutis Biotherapeutics, Arena Pharmaceuticals, Aslan Pharma, Astria Therapeutics, Celldex, Dermavent, DermTech, Escient Pharma, Eli Lilly Company, Evelo Biosciences, Galderma, Incyte, Janssen, LEO Pharma, Merck, Nektar Therapeutics, Numab Therapeutics, Pfizer, Proteologix, Rapt Therapeutics, Regeneron, Ribon Therapeutics, Sanofi/Genzyme, Sanofi-Aventis, Sitryx Therapeutics, Stealth BioTherapeutics, Trevi Therapeutics, Union Therapeutics, Xencor and Yuhan and has been an Investigator for Abbvie, Astra-Zeneca, DermTech, Kiniksa, Pfizer, Regeneron, Ribon Therapeutics and Sanofi.    © 2025 Sanofi and Regeneron Pharmaceuticals, Inc. All Rights Reserved. MAT-GLB-2407353  – 1.0 – 02/2025 MAT-US-2501683 v1.0 - P Expiration Date: 02/24/2027

Description: Co-hosts Ryan Piansky, a graduate student and patient advocate living with eosinophilic esophagitis (EoE) and eosinophilic asthma, and Holly Knotowicz, a speech-language pathologist living with EoE who serves on APFED's Health Sciences Advisory Council, interview Dr. Wayne Shreffler, Chief of Pediatric Allergy and Immunology and Co-Director of The Food Allergy Center at Massachusetts General Hospital. Dr. Shreffler is also an investigator at The Center for Immunology and Inflammatory Disease and The Food Allergy Science Initiative. His research is focused on understanding how adaptive immunity to dietary antigens is both naturally regulated and modulated by therapy in the context of food allergy. This interview covers the results of a research paper on The Intersection of Food Allergy and Eosinophilic Esophagitis, co-authored by Dr. Shreffler. Disclaimer: The information provided in this podcast is designed to support, not replace the relationship that exists between listeners and their healthcare providers. Opinions, information, and recommendations shared in this podcast are not a substitute for medical advice. Decisions related to medical care should be made with your healthcare provider. Opinions and views of guests and co-hosts are their own.   Key Takeaways: [:50] Co-host Ryan Piansky introduces the episode, brought to you thanks to the support of Education Partners Bristol Myers Squibb, GSK, Sanofi, and Regeneron. Ryan introduces co-host, Holly Knotowicz.   [1:15] Holly introduces today's topic, the intersection of food allergy and eosinophilic esophagitis.   [1:26] Holly introduces today's guest, Dr. Wayne Shreffler, Chief of Pediatric Allergy and Immunology and Co-Director of The Food Allergy Center at Massachusetts General Hospital and an investigator at The Center for Immunology and Inflammatory Disease and The Food Allergy Science Initiative.   [1:43] Dr. Shreffler's research is focused on understanding how adaptive immunity to dietary antigens is both naturally regulated and modulated by therapy in the context of food allergy.   [1:54] Holly welcomes Dr. Shreffler to Real Talk. When Holly moved to Maine, she sent her patients to Dr. Shreffler at Mass General.   [2:25] Dr. Shreffler trained in New York on a Ph.D. track. He was interested in parasitic diseases and the Th2 immune response. Jane Curtis, a program director at Albert Einstein College of Medicine, encouraged him to consider MD/PhD programs. He did.   [3:31] Jane Curtis connected him to Hugh Sampson, who was working with others to help understand the clinical prevalence of food allergy and allergens.   [3:51] As a pediatric resident, Dr. Shreffler had seen the burden of allergic disease, caring for kids in the Bronx with asthma. His interest in Th2 immunity, the clear and compelling unmet clinical need, and the problem of food allergy guided his career.   [4:31] Dr. Shreffler's wife has food allergies and they were concerned for their children. Fortunately, neither of them developed food allergies.   [5:21] Dr. Shreffler thinks the food allergy field has a lot of people who gravitate toward it for personal reasons.   [5:53] Food allergy is an adverse response to food that is immune-mediated. There is still uncertainty about this but Dr. Shreffler believes that a large percentage of patients with EoE have some triggers that are food antigens.   [6:27] The broad definition of food allergy would include things like food protein-induced enterocolitis syndrome (FPIES).   [6:47] The way we use the term food allergy in the clinic, there are two forms: IgE-mediated allergies and non-IgE-mediated allergies, including EoE.   [7:40] Some patients have food-triggered eczema, some have FPIES.   [8:04] In 2024, Dr. Shreffler and Dr. Caitlin Burk released a paper that looked at the triggers of EoE, particularly the intersection of IgE-mediated food allergy and EoE.   [8:41] Dr. Caitlin Burk joined the group as they were publishing papers on IG food allergy and EoE. It was a moment where things unexpectedly came together.   [9:17] Adaptive immunity to food proteins comes from antibodies that cause milk allergy, egg allergy, peanut allergy, or multiple allergies. The IgE has specificity.   [9:40] T cells also are specific to proteins. They express a host of receptors that recognize almost anything the immune system might encounter. They have a long memory like B-cells.   [10:09] The overlap in these two threads of research was regarding a population of T cells that are important for mediating chronic inflammation at epithelial sites, including the gut.   [10:36] These T cells have been described in the airways in asthma, in the skin in eczema, and the GI tract. Researchers years ago had also described them as being associated with IgE food allergy. People with IgE food allergies avoid allergens.   [11:13] T cells, being associated with chronic allergic inflammation, now being associated with food allergies which are not having chronic exposures to the allergen, was interesting and surprising.   [11:30] Dr. Shreffler and his group found the T cell subset in patients who don't do well with Oral Immunotherapy (OIT) and patients who have EoE with immediate symptoms.   [12:01] Dr. Shreffler notes differences. There are immediate symptoms of IgE food allergy. There is a subset of patients with EoE who have immediate symptoms that are not fully understood. Maybe IgE plays a role there.   [12:28] There are different mechanisms for how symptoms are caused and so different ways of making a diagnosis. A food allergy with an IgE antibody can be measured through skin tests and blood tests. This can help identify which foods are the trigger.   [12:57] This common T cell subset that we see in EoE and food allergy, helps to explain why IgE alone is not always a very specific marker for identifying people who will have immediate reactions when they're exposed to the food.   [13:17] For patients who react at low levels, it's not just that they have more or better IgE but they also have an expansion of these T cells that are common between EoE and other chronic forms of allergy and IgE food allergy.   [13:41] There's a lot to learn that might be relevant for patients about this T cell subset.   [14:23] These T cells are a specific subset of the group of Th2 T cells, which are a subset of all CD4 T cells. Some CD4 T cells are important for responding to viruses and tumors. Others are important for responding to outside allergens.   [15:01] In an allergy or a parasite infection, Th2 T cells are important. There is a subset of T cells that is driven by repetitive and chronic exposure to the triggering protein, antigen, or allergen.   [15:47] Most antigens are proteins that trigger an immune response. An antigen that elicits an allergic response is an allergen. [16:30] A food trigger is a protein antigen that is an allergen. In IgE, food allergies, milk, and eggs are prevalent triggers early in life. For reasons not well understood, a lot of people outgrow them. In older patients, peanut and tree nut allergies are prevalent.   [17:01] In EoE, milk is one of the most common dietary triggers into adulthood. Some patients with IgE allergy to milk can tolerate it if it's well cooked. Patients with EoE are less likely to be able to get away with regular and ongoing exposure to milk protein.   [17:54] Milk, eggs, and nuts are common triggers in both conditions. There can also be rare food allergy triggers. That's part of the early evidence that the adaptive immune response was likely to be involved. It can be so specific for some people to rare things.   [18:20] Hallmarks of something being immune-mediated are that it is reproducibly demonstrable as a trigger. It's going to be long-lived. It's going to be generally relatively small amounts. The immune system is good at detecting small exposures.   [19:07] EoE is tricky because there's not that clear and easy temporal association between an offending allergen exposure for most people and their symptoms. People don't associate the symptoms with the triggers.   [20:14] A history of having blood in the stools can be milk-allergen-driven and was associated with a diagnosis of EoE in those kids when they're older.   [20:26] There are a lot of commonalities in the allergens but it's not always obvious clinically.   [22:40] A challenge in diagnosing EoE is that providers have to be on guard against their biases. They have to give a patient good advice. In EoE there is no test to identify triggers, except rigorous introduction, elimination, reintroduction, and endoscopies.   [24:18] For some of Dr, Shreffler's patients, it becomes less important to know their dietary triggers. They gravitate toward an approved form of treatment that may, if successful, allow them to have a more normal diet because of effective medication.   [24:50] Dr. Shreffler thinks there are other triggers, including pollens. There is evidence of seasonality of active EoE in patients shown to have allergic sensitization to pollens. That's indirect evidence. If the body is making IgE, it's likely making other responses.   [25:32] There are questions about how large the population of patients is who have EoE that may be more intrinsically than extrinsically driven because of genetic variations.   [25:54] Dr. Shreffler believes that EoE in some patients is allergen-driven and in some patients EoE is food-driven. Food is a trigger for the majority of pediatric patients and a large percentage of adult patients but not necessarily the exclusive trigger.   [27:04] If a patient is motivated to learn what dietary triggers may be at play, Dr. Shreffler often makes assessments outside of pollen season for allergens to which the patient has demonstrated positivity.   [28:09] Looking at the epidemiology, both EoE and food allergy are atopic disorders. You see an increased prevalence of asthma, hay fever, eczema, and even allergic proctocolitis in infancy. You see an enrichment of one disorder to another.   [28:29] The overlap of food allergy to EoE is stronger than you might expect. About 30 to 40% of patients with EoE will also have IgE food allergy. A higher rate will have IgE positivity, whether or not that food is a trigger of immediate symptoms.   [28:48] Patients with food allergies are about four times more likely to have EoE than the general population. That's a stronger association than the risk of eczema or other atopic conditions to EoE.   [30:09] There are differences between IgE food allergy and EoE. The presence of IgE gives a useful tool for identifying the food trigger in food allergy, but not in EoE. Identifying rare triggers in EoE patients is done by clinical observation.   [31:46] Epinephrine and antihistamines are not useful in treating EoE. Blocking IgE with Omalizumab has not been effective in trials in treating EoE. PPIs, topical steroids, and dupilumab are helpful for many EoE patients.   [32:38] Dupilumab has been evaluated a bit in food allergy in combination with OIT, and there was no statistically significant benefit from dupilumab in food allergy.   [33:25] A group in Pennsylvania has been evaluating epicutaneous immunotherapy as a modality to treat EoE. It's also being evaluated for IgE food allergy. Dr. Shreffler thinks it's something to keep an eye on.   [33:40] The oral route for immunotherapy can drive EoE for patients. As they become less sensitive from an immediate reactivity viewpoint, a significant percentage of patients develop GI symptoms. This has also been observed with sublingual therapy.   [34:14] Iatrogenic EoE, caused by the treatment, may resolve on the cessation of the immunotherapy treatment.   [36:25] Dr. Shreffler says in some cases, the shared decision is a decision where he has a strong evidence-based opinion. In some cases, there's a lot more room for a range of clinical decisions that could be equally supported by what we know right now.   [36:57] We've said that EoE is a contraindication for OIT. There is a shift happening. Dr. Shreffler sits with families and has a conversation about restricting diet or trying chronic therapy and keeping an ad-lib diet.   [37:38] What about doing the same thing by treating the immediate-type food allergy with chronic allergen exposure and then ameliorating the effects of EoE if it emerges, with another therapy? A hundred providers would have a diversity of responses.   [38:19] When there is a history of EoE in a family, Dr. Shreffler advocates for getting a baseline scope. It becomes an important “ground zero.”   [38:28] The goal is to have less invasive ways to monitor these conditions.   [39:32] Chronic inflammation, which is the hallmark of EoE, is well-targeted by therapies like PPIs and steroids. Steroids don't help with IgE-related food allergies. They're not effective at blocking the IgE-driven immediate response.   [41:13] Until recently, IgE food allergy has only been managed with avoidance. We have some other tools now. Xolair is not effective in EoE but is effective in two-thirds to three-quarters of patients with immediate-type food allergies for preventing anaphylaxis.   [41:45] Dr. Shreffler refers to an upcoming study on the effectiveness of Xolair in treating people with food allergies. Those who were able to tolerate a minimum amount were allowed to begin consuming allergen. We'll get insight into how those patients did.   [43:08] Food-induced immediate response of the esophagus (FIRE) is immediate discomfort with exposure to some allergens. Dr. Shreffler explains it. Data supports that these patients are experiencing an IgE-mediated but local response to those triggers.   [44:59] If FIRE is IgE-mediated, it may be that Xolair would help suppress it in these patients. It's worth looking at Xolair for this subset of EoE patients.   [45:20] Ryan invites any listeners who want to learn more about FIRE to check out episode #34 with Dr. Nirmala Gonsalvez.   [45:37] In the paper, Dr. Shreffler wrote about what he hopes will be the practical usefulness of the finding, the intersection between IgE food allergy and EoE.   [45:56] A subset of Th2 T cells express a protein called GPR15. It appears to be a marker for the subset of cells that are playing a role in the EoE.   [46:36] Caitlin Burk's work now is looking at their activation status in active disease and post-diet elimination and remission. She is developing a data set that is leading us toward the possibility of focusing on that cell subset and techniques to adopt in clinics.   [47:12] She is also working out more advanced techniques to look at the receptors. Dr. David Hill at CHOP is working on similar research. This research has the potential to lead to the development of better tests for EoE.   [47:44] Holly tells Dr. Shreffler this has been such an informative episode with so many tidbits of things to help patients advocate for themselves. Holly thanks him for sharing all of that.   [48:12] Dr. Shreffler is trying to see what can be utilized from their research to make non-invasive tests to identify food allergen triggers for patients so they don't have to go through so many endoscopies. He sees it as a huge unmet need.   [48:31] Ryan thanks Dr. Shreffler for joining us. For our listeners who would like to learn more about eosinophilic disorders, including EoE, please visit APFED.org and check out the links in the show notes.   [48:41] If you're looking to find a specialist who treats eosinophilic disorders, we encourage you to use APFED's Specialist Finder at APFED.org/specialist.   [48:50] If you'd like to connect with others impacted by eosinophilic diseases, please join APFED's online community on the Inspire Network at APFED.org/connections.   [49:00] Ryan thanks Dr. Shreffler for joining us today for this interesting conversation. Holly also thanks APFED's Education Partners Bristol Myers Squibb, GSK, Sanofi, and Regeneron for supporting this episode.   Mentioned in This Episode: Dr. Wayne Shreffler, MD, Ph.D., Chief of Pediatric Allergy and Immunology and Co-Director of The Food Allergy Center at Massachusetts General Hospital “Triggers for eosinophilic esophagitis (EoE): The intersection of food allergy and EoE” Dr. Caitlin Burk Dr. David A. Hill   APFED on YouTube, Twitter, Facebook, Pinterest, Instagram Real Talk: Eosinophilic Diseases Podcast apfed.org/specialist apfed.org/connections   Education Partners: This episode of APFED's podcast is brought to you thanks to the support of Bristol Myers Squibb, GSK, Sanofi, and Regeneron.   Tweetables:   “This fascinating problem of food allergy: why does the immune system do that for some people — recognize what should be nutritive and innocuous sources of energy as an immunological trigger? ” — Dr. Wayne Shreffler   “A food allergy; because there is this IgE antibody, we can do skin tests. We can measure that in the blood. It's a useful marker for helping to identify which foods are the trigger.” — Dr. Wayne Shreffler   “EoE is tricky because there's not that clear and easy temporal association between an offending allergen exposure for most people and their symptoms. People don't associate the symptoms with the triggers.” — Dr. Wayne Shreffler   “Everything is shared decision-making. In some cases, it's a shared decision where I have a strong evidence-based opinion. In some cases, there's a lot more room for a range of clinical decisions that could be equally justified.” — Dr. Wayne Shreffler   “Steroids don't help with IgE-related food allergy. They're not effective at blocking that IgE-driven immediate response.” — Dr. Wayne Shreffler   “I'm trying to see what we can utilize from our research to make non-invasive tests to identify food allergen triggers for patients so they don't have to go through so many endoscopies. I think that's a huge unmet need.” — Dr. Wayne Shreffler  

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. J&J is currently involved in a legal battle with Samsung Bioepis, alleging unlawful sublicensing of a Stelara biosimilar. Meanwhile, Takeda has made a significant investment in a new BridGene partnership aimed at targeting undruggable targets. In other news, Regeneron has made strides in developing a gene therapy that can restore hearing in patients with rare genetic deafness. However, Deerfield Management claims that Alcon is hindering Aurion Biotech's IPO progress. Additionally, Trilink is offering mRNA designs that ensure reliable performance across various applications. There have also been reports of compounders suing the FDA, Reperio Therapeutics downsizing their staff, and discussions on how to support small molecule innovations in the industry. And if you missed it, recent developments include Trump threatening big pharma with tariffs, the FDA rehiring scientists, and advancements in pain treatment, RNA editing, and gene therapies being highlighted. Opportunities in neuroscience sales, regulatory affairs, and marketing are currently available for those interested. Thank you for tuning in to Pharma and Biotech Daily for the latest updates in the industry.

There was a high point this week for employees riding the rollercoaster that is currently the FDA, as 300 recently fired employees are reportedly being asked to return. This could serve to boost spirits at the agency, which is reeling from unpredictable and seemingly ‘indiscriminate' layoffs—and low morale as a result.   Trump made additional waves over the weekend, threatening to enact tariffs on the largest pharmaceutical companies—unless they relocate their manufacturing operations to the U.S. And the early impacts of the new administration continue to be felt, as the CDC's vaccine advisory board postponed its first meeting of 2025—just a week after RFK Jr.'s confirmation as HHS secretary.   In weight loss news, the Outsourcing Facilities Association (OFA), which represents compounders, is suing the FDA after the agency declared an end to the shortage of semaglutide, marketed by Novo Nordisk as Ozempic and Wegovy. This followed a similar OFA lawsuit last fall, filed after the FDA removed Eli Lilly's tirzepatide— Zepbound and Mounjaro—from its shortage list. In a possible attempt to protect Zepbound from compounder competition, Lilly announced Tuesday that it will expand single dose vials options of the blockbuster weight loss drug at a reduced price. This all comes as a new study compares physician wishlists with investment in the obesity space—and reveals key indicators for drug developers.  And it's been a good news/bad news kind of week in gene therapy, as Pfizer discontinued hemophilia B drug Beqvez worldwide, Regeneron reported more positive data from its gene therapy for genetic deafness and, facing a cash crunch, bluebird bio elected to go private in an acquisition by global investment firms Carlyle and SK Capital Partners.   Finally, let us leave you with a ghost story—the story of so-called “ghost assets” that have found a new home, and a new purpose.  

Why do conditions like asthma, nasal polyps, or eczema become more severe when they coexist? Kortney and Dr. Payel Gupta are joined by Dr. Michael Blaiss to explore the common thread linking multiple allergic and inflammatory diseases: Type 2 Inflammation. If you've ever wondered why certain conditions often appear together, this deep dive will help you connect the dots. Type 2 Inflammation is a hot topic in immunology because it's the engine that drives many allergic and inflammatory diseases. It's also the key to modern treatment strategies, including targeted biologic therapies. Dr. Blaiss explains how clinicians recognize multiple Type 2-driven conditions in the same patient, why it is important to know the connection between multiple conditions and Type 2 inflammation, and the big-picture benefits of treating inflammation aggressively to prevent complications. What We Cover in our Episode about The Diseases Related to Type 2 Inflammation Conditions Related to Type 2 Inflammation: Explore how chronic rhinosinusitis with nasal polyps (CRSwNP), rhinitis, asthma, atopic dermatitis (eczema), prurigo nodularis, eosinophilic esophagitis (EoE), and food allergies can all share a common inflammatory pathway. The Likelihood of Having Multiple Type 2 Conditions: How often do patients have more than one condition related to Type 2 Inflammation, and why is recognizing overlap a potential game-changer for diagnosis and treatment? Treating the Root Inflammation vs. Individual Symptoms: Discover how clinicians decide whether to address each condition separately or tackle the underlying Type 2 inflammatory process affecting them all. Markers & Personalized Medicine: Dr. Blaiss discusses whether potential tests, such as eosinophil counts or IgE levels, can confirm Type 2 inflammation. He also explains how knowing you have Type 2 Inflammation can help guide targeted therapy. Prevention & Aggressive Intervention: Understand why it's crucial to treat inflammation early to reduce the risk of developing multiple Type 2 conditions and how this proactive approach benefits long-term health. Want to know more? Type 2 Inflammation Overview – Explains the role of Type 2 inflammation in conditions like asthma and nasal polyps. This podcast is for informational purposes only and does not substitute for professional medical advice. If you have any medical concerns, always consult with your healthcare provider. Produced in partnership with The Allergy & Asthma Network. Thanks to Sanofi and Regeneron for sponsoring today's episode. While they support the show, all opinions are our own, and sponsorship doesn't influence our content or editorial decisions. Any mention of brands is for informational purposes and not an endorsement.

JCO PO author Dr. Hatim Husain at University of California San Diego, shares insights into his JCO PO article, “Adagrasib Treatment After Sotorasib-Related Hepatotoxicity in Patients With KRASG12C-Mutated Non–Small Cell Lung Cancer: A Case Series and Literature Review”, one of the top downloaded articles of 2024. Host Dr. Rafeh Naqash and Dr. Husain discuss how to utilize real-world and clinical trial data to discern the safety of adagrasib (another KRASG12C inhibitor), following sotorasib discontinuation due to hepatotoxicity. TRANSCRIPT Dr. Rafeh Naqash: Hello and welcome to JCO Precision Oncology Conversations where we bring you engaging conversations with authors of clinically relevant and highly significant JCOPO articles. I'm your host, Dr. Rafeh Naqash, Podcast Editor for JCO Precision Oncology and Assistant Professor at the OU Stephenson Cancer Center.  Today, I'm very excited to be joined by Dr. Hatim Hussain, Professor of Medicine at the University of California, San Diego, and author of the JCO Precision Oncology article, “Adagrasib Treatment After Sotorasib-Related Hepatotoxicity in Patients With KRAS-G12C-Mutated Non-Small Cell Lung Cancer: A Case Series and Literature Review.” This was one of the top downloaded articles of 2024. And the other interesting thing is we generally don't do podcasts for case reports or case series, so this is one of the very few that we have selected for the podcast.  And at the time of the recording, our guest disclosures will be linked in the transcript.  Dr. Hussain, welcome to our podcast and thank you for joining us today. Dr. Hatim Husain: Thank you Dr. Naqash. Such a pleasure to be here and to speak with you all. Dr. Rafeh Naqash: And for the sake of this podcast, we'll refer to each other using our first names. So again, as I mentioned earlier that this is one of the very few case reports that we have selected for podcasts in JCOPO and the intention was very deliberate because it caters to something that is emerging where we are trying to treat more KRAS mutant patients with different KRAS inhibitors. And you tried to address one very unique aspect of it in this article which pertains to toxicity, especially hepatotoxicity. So for the sake of our listeners who tend to be community oncologists, trainees, academic faculty, can you tell us what are KRAS inhibitors? What is KRAS-G12C? And how do some of these approved KRAS inhibitors try to inhibit KRAS-G12C? Dr. Hatim Husain: Sure. For a long time actually we've not had a selective way to inhibit mutant KRAS. And over the last several years actually now, we've seen some dramatic advances here, particularly with the FDA approval of some of the selective inhibitors against the G12C variant. So KRAS-G12C is an isoform of KRAS that is most common in lung cancer and in fact actually is a transversion mutation in the KRAS gene that is a product of the carcinogen of tobacco. And in fact, the incidence of KRAS-G12C in lung cancer, it's quite astounding where as many KRAS-G12C patients there are, there can be, as you know, more than EGFR patients in certain populations and cohorts. The medicines sotorasib and adagrasib were rationally designed to be selective KRAS-G12C inhibitors. And the way that they do this is that they lock the KRAS protein in the OFF state. KRAS is a protein that oscillates between an ON and an OFF state and by virtue of locking the protein in an OFF state, it has shown inhibition of downstream signaling and mitigation of tumor growth and, in fact, tumor cell death. Dr. Rafeh Naqash: I absolutely love the way you describe the ON and OFF state, the oscillation where the ON is bound to the GTP and the OFF is bound to the GDP. The two KRAS inhibitors as currently FDA approved, as you mentioned, are RAS OFF inhibitors and they're emerging KRAS inhibitors that are RAS ON. So now, as we have known from previous data related to immunotherapy and EGFR TKIs such as osimirtinib where toxicity tends to be a compounded effect when you have osimertinib given within a certain timeline of previous checkpoint therapy, we've seen that in the clinic as the data for these KRAS inhibitors is emerging, you talk about some very interesting aspects and data about what has been published so far with regards to prior use of immunotherapy or chemo immunotherapy and the subsequent use of KRAS inhibitors. Could you elaborate upon that? Dr. Hatim Husain: Sure. So for this population of patients, the first line approved strategy is a strategy that most cases will incorporate immune therapy and chemotherapy. Immune therapy can have some important responses for patients with KRAS-G12C. This may be due to the fact that KRAS-G12C patients may have a higher incidence of prior smoking, perhaps higher mutation burdens in some patients, and perhaps immunogenicity is defined in that context. So the standard of care in the first line currently includes immune therapy or immune therapy and chemotherapy. Where the current FDA approvals for selective G12C inhibitors are are after the first line of therapy. There are a number of trials exploring these medicines in the first line to see if they may be incorporated into a future treatment paradigm. Dr. Rafeh Naqash: Thank you for that explanation. Now, going to what you published in this manuscript, can you help us understand the context of why you looked at this? Even though the data just comprises a case series of a handful of patients, but the observations are very interesting and these are real world scenarios where we often tend to be in situations where an individual has had toxicity on a certain drug and may have some response to that drug, but at the same time, the toxicity is challenging. And then you try to debate whether another drug in the same class might be beneficial without those toxicities. So you've tried to address that to some extent using this data set. So can you elaborate upon the question, the methodology, what you tried to look at, and important observations that you have? Dr. Hatim Husain: Yes, our paper was actually inspired by one of my patients. My patient was a patient who had received chemotherapy and immune therapy and actually in the past, even, you know, additional lines of immune therapies, it was really coming to the edge of where standard treatments would exist. It was right at the same time that these selective inhibitors had been approved and the patient had received sotorasib. And what was remarkable was, when given sotorasib, patient had a very high peak and spike in the transaminases. And we would do different trials of strategies around dose, around interruptions. And it was becoming quite difficult, actually, for the patient to proceed with additional therapy. It was around similar times, actually, and I do want to make a note that the patient was progressing, driven in large fact by the fact that we've had to interrupt the medicine. So we feel and believe that the patient had had inadequate dosing because of the level of toxicity that the patient was having with transaminase increase. So it was around the same time that adagrasib was first commercially available that we were at that point, and we did a trial of adagrasib post-sotorasib, largely driven by necessity, without having additional options to provide this patient in our environment. What was remarkable was when the patient received the adagrasib, there were no spikes in transaminases similar to what we had seen before. And that really led us thinking and to say, “Is this adverse event of transaminase increase or hepatotoxicity, is this a class effect with KRAS-G12C inhibitors, or is it more nuanced than that? Are there different, perhaps, mechanisms by which the medicines may work that may more or less differentially contribute to this adverse event?” And so that inspired us to kind of do a larger analysis, kind of really reach out to a larger network of physicians to gather insights and to gather responses in patients who had had a serial approach of sotorasib and then adagrasib.  What we found in this process was, in fact, actually there were many more cases of patients who resembled my patient, where the sequence of sotorasib going to adagrasib may have demonstrated differential contribution of hepatotoxicity in that context. And that really motivated us to put the publication together to due diligence, and in the publication spend a lot of time to kind of outline each patient case in detail around metrics surrounding time from last immune therapy, the number of days on sotorasib, the best response to sotorasib, the interval between sotorasib and adagrasib, the duration of adagrasib and then the grade of hepatotoxicity seen in each of the contexts, and particularly kind of the adagrasib and patient disease status as well. We were quite inspired by the effort to try to, if we do not have randomized data in comparison of one medicine to another, which we do not at this juncture, we do not have a randomized analysis to really diligently and rigorously compare the rates of AEs across each medicine, and even in sequence, we do not have that with immune therapy. But what we felt was trying to get more analysis of this sequential approach of, if patients had received a medicine, had to be taken off because of toxicity and then actually tried on a new medicine, what were those rates? We felt like that was at least some information to try to get at this question. Dr. Rafeh Naqash: And you bring forward a very important point, which is, a lot of times in the real world setting we don't have cross trial comparisons that can be fully applicable, or we don't have trials that compare two drugs of the same class with respect to the AE profile or efficacy. And observations like the one that you described that led to this study are extremely critical in trying to help answer these questions.  From a data standpoint, and you allude to it to some extent in your manuscript, the trials that are trying to address combination of KRAS-G12C with immunotherapy, especially sotorasib or adagrasib, can you elaborate on that data, what has been published so far and summarize it for our listeners? Dr. Hatim Husain: So there is data from clinical trials looking at patients actually who have received concomitant immune therapy and sotorasib. What was seen in this, in a real world analysis, was that some patients actually who had received sotorasib within a close proximity of immune therapy, as well as a larger study actually which showed in combination there were higher rates of hepatotoxicity in that context. In fact, there were rates of grade 3 hepatotoxicity. And I think built upon that data there's a recognition in the field that we have to be very diligent in terms of even the clinical trial designs in how to understand the pairing between immune therapy and selective G12C inhibitors. There are many trials that are ongoing, one of the studies that is ongoing is known as the KRYSTAL-7 study, which is evaluating adagrasib in combination with pembrolizumab in the first line. And we await more information on that strategy as well. In the context of sotorasib, because of some of the trials that have shown higher rates of hepatotoxicity, there are some additional trials now looking at sotorasib in combination with chemotherapy, and those also have some information that have been reported as well. Dr. Rafeh Naqash: From a drug development standpoint, as you mentioned, there's always a tendency to combine something with something else. And in my practice, and I'm sure in your practice too, when we do early phase trials, many trials are still focused on choosing the maximum tolerated dose, which may be something that we need to gradually move away from as we try to implement these combinations of multiple antibodies plus some of these target agents from maybe the biological optimal dose rather than the maximal tolerant dose is a better way to look at the drugs, the pharmacokinetic profile, and then see what is likely the safest combination with the most appropriate target engagement. Do you have any thoughts on that or insights on that from a drug development perspective? Dr. Hatim Husain: It's a wonderful question and I think it is a very insightful question and understanding of where we are in space right now. And I agree with you that historically, cancer drug development was really hinged upon medicines that perhaps required higher doses to see a benefit or to inch out kind of marginal increases upon where we were at. Now, in combination with medicines that have non-overlapping mechanisms of action, the concept is: Can there actually be more synergy across an approach using combinatorial strategies rather than just additive effects? And I think that in some cases this is being studied with immune therapy, in some cases actually even in the context of other novel mechanisms for cancer therapy. I think that in my practice, I will really try to see how a patient at an approved dose will respond. But definitely I'm open to the concept that there may be a dose that doesn't have to be the maximally tolerated dose, but rather the dose that responses can be seen and perhaps actually at a lower dose than what drives many toxicities. Dr. Rafeh Naqash: I often describe this to my patients as individual patient dose optimization outside of a clinical trial, where I'm sure you've probably done this, where in older adults maybe a lower dose of osimertinib is tolerated better, or a lower dose of sotorasib or adagrasib for that matter, tolerated better with perhaps a similar level of efficacy, since we don't have comparisons between doses and efficacy so far.  So I think in the bigger picture, as we discussed in a nutshell, what I would really like the listeners to understand is as we try to move towards this field of precision medicine targeting more and more of the undruggable genes, there's bound to be a certain level of toxicity patterns that we'll start observing. So I think these real world scenarios which may not be addressed using clinical trials because it is in the real world setting where you cycle one treatment after another after another, which may or may not be allowed in most trials and the real world setting can inform, in certain cases, subsequent trial designs. So I think the most important message, at least that I took from your manuscript, was that these real world observations can make a huge difference and inform practice, even though the data sets may be small. Of course, you want to validate some of these findings in a bigger, broader setting, but proof of concept is there. And I think next time I see an individual in my clinic where I see better toxicity, I'll definitely try to talk to them about subsequent treatment with another KRAS inhibitor, maybe adagrasib or something else, if and when appropriate.  Do you have any closing thoughts on some of these things that we discussed? Dr. Hatim Husain: I just want to leave the audience actually with this concept that sometimes we group targeted therapy side effects as being class effects unanimously. And I do think actually that each inhibitor may have different off target effects on where medicine may act. We don't truly understand the mechanism of hepatotoxicity in the context of selective KRAS-G12C inhibitors. One of the hypotheses may be due to off target cysteine reactivity in the numerous off target binding sites that certain medicines may have over others. And just even qualitatively which off target binding sites there may be, and how that may lead to either immunogenic responses and other organs or such. So I do think that we do need more research to understand the mechanism. But I think where we are at right now in this space is not assuming that all medicines are going to have the exact same toxicity. I think especially when patients may not have other options, this is something to consider as well. Dr. Rafeh Naqash: Thank you so much. Now, outside of the scientific insights, Hatim, I know you a little bit from before. And knowing the kind of work that you've done in precision medicine, I'm really interested to know about where you started, how you started, how things have been, and what kind of advice you have for junior faculty fellows who are interested in this field of precision medicine that is becoming more and more exciting as we progress in the oncology space. Dr. Hatim Husain: Thank you, Rafeh. I will say, actually as a medical student, I was actually very interested in oncology, partly because it was then and still remains one disease or a constellation of diseases that just has such a high psychological burden on patients. And through the experiences I've had, I really can understand and relate with that concept. I did my medical school at Northwestern, residency at the University of Southern California, and then my oncology fellowship at Johns Hopkins University.  And now I've been on faculty at University of California, San Diego, for about 12 years now. It's been a great experience paralleled with the fact that during these last 12 years, I've really seen how the developments in precision oncology, both targeted therapy as well as immune therapy, have really blossomed and unfolded. A large area of my research in my career has kind of focused on cancer genome and integration of novel technologies to really see how they may have clinical application. When I was in my fellowship and as a young faculty, the liquid biopsy was actually coming into development. And this was hinged upon information that had come forward in the prenatal space where some patients actually who were undergoing prenatal testing during pregnancy were found to have complex karyotypes and genomic alterations and then retrospectively found to have cancer.  And doing my fellowship at Johns Hopkins, some of the pioneers in liquid biopsy were my mentors and really kind of instilled in me that passion for really thinking through how cancer genomics can be integrated through time. And some of the research that I have been doing has been looking at clonal evolution of cancer, how cancer is changing over time, and how we can think through the right surveillance strategies to really understand how that change is occurring. The dynamics of ctDNA in retrospective cohorts have been studied and shown that, you know, there can be associations between progression-free survival and other clinical endpoints. The current paper that we are speaking about parallels that in a certain way where, rather than say, looking at clonal evolution and say, the efficacy answer of sotorasib first and then adagrasib and how frequently can adagrasib salvage patients, this looks at it from a different angle around toxicity. And I think that is a key point because, at my core, I really do enjoy the clinical aspect of complex decision making on behalf of patients weighing efficacy and toxicity that they may have as they try to get the best quality of life through this journey. Dr. Rafeh Naqash: Thank you again, Hatim, for all those insights, both from the scientific perspective as well as personal perspective. We appreciate that you chose JCOPO as the destination for your work.  And thank you for listening to JCO Precision Oncology Conversations. Don't forget to give us a rating or review and be sure to subscribe so you never miss an episode. You can find all ASCO shows at asco.org/podcasts.   The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.  Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Dr. Hatem Husain Disclosures Consulting or Advisory Role: AstraZeneca, Foundation Medicine, Janssen, NeoGenomics Laboratories, Mirati Speakers' Bureau: AstraZeneca, Janssen Institution Research Funding: Pfizer, Bristol-Myers Squibb, Regeneron, Lilly Travel, Accommodations, Expenses: AstraZeneca, Janssen, Foundation Medicine  

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Bristol Myers Squibb is seeking to broaden the use of its CAR T cell therapy, Breyanzi, to address marginal zone lymphoma as a strategy to offset losses from exclusivity. In other news, Boehringer Ingelheim has seen promising results in a Phase III trial for its lung fibrosis drug, randomilast, aimed at progressive pulmonary fibrosis. However, Pliant has experienced a stock decline following the halt of its Phase IIb/III study for idiopathic pulmonary fibrosis. Additionally, Vertex has received FDA approval for its non-opioid pain treatment, while AbbVie has secured approval for a new antibiotic. Bain's acquisition of Tanabe for $3.3 billion is also making headlines. Regeneron is currently in a legal battle with Sanofi over the Dupixent pact, and Equillium's itolizumab is undergoing testing against Humira for ulcerative colitis. On the horizon, Acelyrin and Alumis are joining forces to address immune-mediated diseases, while Eisai is seeking subq approval for Leqembi due to sluggish US sales. Job opportunities are available at ATCC, AbbVie, Regeneron Pharmaceuticals, and Dren Bio.

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

“There’s no digital feedback loop in health care, you have it in Tesla, in Netflix, in Amazon — but not in the industry that impacts every life,” Terry Myerson, CEO of Truveta, explains to Bloomberg Intelligence in this episode of the Vanguards of Health Care podcast. Myerson joins BI analyst Jonathan Palmer to discuss Truveta’s mission to aggregate and analyze health data across 30 major US health systems, covering one-third of Americans. He details the company’s work in regulatory-grade safety and efficacy research, the launch of the Truveta Genome Project with partners like Regeneron and Illumina, and the power of AI-driven insights to accelerate medical discovery. The conversation explores Truveta’s efforts to address data fragmentation, privacy, and interoperability challenges that must be solved to revolutionize patient care and life sciences.See omnystudio.com/listener for privacy information.

APAC stocks traded higher as the region reacted to US President Trump's delay of tariffs against Canada and Mexico for a month.However, the new 10% tariff on all China exports to the US took effect after the deadline passed.Furthermore, China is to levy countermeasures on some US imported products with 15% tariffs on coal and LNG, as well as 10% tariff on oil, agricultural machines and some autos from the US.European equity futures indicate a slightly lower cash market open with Euro Stoxx 50 future down 0.1% after the cash market closed with losses of 1.3% on Monday.DXY was boosted by Chinese retaliatory measures, EUR/USD is back below 1.03 and Cable is sub-1.24.Looking ahead, highlights include US JOLTS Job Openings, NZ HLFS Jobs, Riksbank Minutes, Fed's Bostic & Daly, Supply from UKEarnings from UBS, BNP Paribas, Vodafone, Diageo, Infineon, BMPS, Intesa Sanpaolo, Ferrari, AMD, Google, Snapchat, Chipotle, Amgen, Paypal, Spotify, Pfizer, Regeneron, PepsiCo, Merck, Estee Lauder, Marathon Petroleum.Read the full report covering Equities, Forex, Fixed Income, Commodites and more on Newsquawk

New 10% tariffs on China exports to the US have taken effect; China is to levy countermeasures on some US imported products with 15% tariffs on coal and LNG, as well as 10% tariff on oil, agricultural machines and some autos from the US.European bourses trade tentatively, Tech buoyed by strength in Infineon; US futures are modestly lower.DXY is flat, JPY underperforms, unwinding the prior day's strength, and Antipodeans lag.Bonds pullback but remain above Monday's lows as we await tariff updates from US/China.Crude softer amid Canada/Mexico tariff delays and China tariff retaliation.Looking ahead, US JOLTS Job Openings, NZ HLFS Jobs. Speakers including Fed's Bostic & Daly.Earnings from BMPS, Intesa Sanpaolo, Ferrari, AMD, Google, Snapchat, Chipotle, Amgen, Paypal, Spotify, Pfizer, Regeneron, PepsiCo, Merck, Estee Lauder, Marathon Petroleum & Ball.Read the full report covering Equities, Forex, Fixed Income, Commodites and more on Newsquawk

Join Lee Rennick from the CIO100 with Bob McCowan, SVP & CIO, Regeneron as he discusses the award-winning Centralized Data Project, tech modernization, cloud native approach to data and leadership. This is not to be missed. 

On this episode, hear the 2024 updates on COVID-19, long COVID and the latest developments in research in rheumatology. Hosted by Dr. Leonard Calabrese. Intro 0:12 In this episode 0:21 Coming up on Healio Rheuminations 0:56 COVID-19, long COVID and the rheumatologist with Leonard Calabrese, DO 2:19 Questions 3:12 Long COVID 4:46 Calabrese's bias 10:15 The evidence 13:08 Auto antibodies 14:54 Why does the body develop auto antibodies? 17:47 COVID-19 and epidemiologic association 22:25 New clinical entity 26:40 Therapeutic implications 31:00 In conclusion 32:00 Thanks for listening 33:18 Leonard H. Calabrese, DO, is the chief medical editor, Healio Rheumatology, and professor of medicine, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, and RJ Fasenmyer chair of clinical immunology at the Cleveland Clinic. Disclosures: Calabrese reports professional relationships with AbbVie, AstraZeneca, Bristol Myers Squibb, Galvani, Genentech, GlaxoSmithKline, Janssen, Novartis, Regeneron, Sanofi and UCB. We'd love to hear from you! Send your comments/questions to Dr. Brown at rheuminationspodcast@healio.com. Follow us on Twitter @HRheuminations @AdamJBrownMD @HealioRheum.

Drs. Safa Rahmani and Sarwar Zahid join the podcast to preview the January 2025 edition of Retinal Physician, found online at http://www.retinalphysician.com.Relevant Financial Disclosures: Dr. Sridhar has consulted for Genentech and Regeneron.You can claim CME credits for prior episodes via the AAO website. Visit https://www.aao.org/browse-multimedia?filter=Audi

In this week's Market Mondays, we explore some of the hottest financial topics and stock predictions. We kick things off with Apple's latest announcement of "Apple Intelligence." Could this new development impact the stock, and how should investors prepare?Next, we dive into Tesla's long-term prospects—do we still see $TSLA hitting $300 a share by 2027? We also cover SPLG and whether it's a solid investment, as well as Ethereum's current status and what's holding it back.For those watching high-growth stocks, we discuss how high MicroStrategy (MSTR) could go and evaluate whether Regeneron is a buy at $933. Plus, we analyze ASML's unique position in the market.In addition, Rashad addresses some recent criticisms and shares exciting news about EYL's housing development project in Ghana and what this means for the future.To top it off, we talk to Robinhood's Vlad Tenev about the future of the platform, new trading features, and the debut of trading contracts on the presidential election.#MarketMondays #AppleIntelligence #Tesla #SPLG #Ethereum #MSTR #Regeneron #ASML #Robinhood #Investing #EYLSupport this podcast at — https://redcircle.com/marketmondays/donationsAdvertising Inquiries: https://redcircle.com/brandsPrivacy & Opt-Out: https://redcircle.com/privacy