Podcasts about regeneron

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Health Secretary Robert F. Kennedy Jr. endorsed the expanded use of RSV vaccines for people aged 50-59 who are at risk of severe disease, following recommendations from ACIP members he had previously fired. Biogen CEO Chris Viehbacher tried to strike a deal with Sage as the company searched for a way forward after setbacks, but Sage was not interested. In other news, late-stage stumble for Cosentyx sets Novartis back in autoimmune conditions, and Gilead eyes HIV market domination with a twice-yearly treatment. Additional stories include biotech leaders and investors urging the FDA to maintain access to Mifepristone, Regeneron scoring a nod for a bispecific drug for multiple myeloma, and the increasing demand for bioinformatics roles in the industry.

Pharma commercialization is more of an art than a science.While the focus of an executive is always on the science, the job requires a certain degree of tact. This week, senior pharma editor Lecia Bushak speaks with Justin Holko, SVP of the global oncology/hematology commercial business unit at Regeneron Pharmaceuticals, about the top commercial and marketing trends in pharma.For the second half of the show, the team delves into the paradigm-shifting vaccine advisors meeting. The new look, RFK Jr.-selected ACIP met and recommendations have been made – so what now?Music: “Deep Reflection” Artist - DP and Triple Scoop Music. Step into the future of health media at the MM+M Media Summit on October 30th, 2025 live in NYC! Join top voices in pharma marketing for a full day of forward-thinking discussions on AI, streaming, retail media, and more. Explore the latest in omnichannel strategy, personalization, media trust, and data privacy—all under one roof. Don't wait—use promo code PODCAST for $100 off your individual ticket. Click here to register! AI Deciphered is back—live in New York City this November 13th.Join leaders from brands, agencies, and platforms for a future-focused conversation on how AI is transforming media, marketing, and the retail experience. Ready to future-proof your strategy? Secure your spot now at aidecipheredsummit.com. Use code POD at check out for $100 your ticket! Check us out at: mmm-online.com Follow us: YouTube: @MMM-onlineTikTok: @MMMnewsInstagram: @MMMnewsonlineTwitter/X: @MMMnewsLinkedIn: MM+M To read more of the most timely, balanced and original reporting in medical marketing, subscribe here.

Following the June 23 OX40 webinar, Dr. Eichenfield, Dr. Simpson, and Dr. Wan continue the conversation with a look ahead at the future of OX40 therapies and their potential to change the course of disease. They also unpack the complex concept of remission in atopic dermatitis—what it means, how it's defined, and whether it's truly achievable.To watch the OX40 webinar, please click here.Disclosures:Lawrence Eichenfield, MD has served as a consultant, speaker, advisory board member, or investigator for AbbVie, Acrotech, Almirall, Amgen, Apogee, Arcutis, Attovia, Bristol Myers Squibb, Castle Biosciences, CorEvitas, Dermavant, Eli Lilly, Forte, Galderma, Incyte Corporation, Janssen, Johnson & Johnson, LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi Genzyme, Target RWE, T-Rex, and UCB.Eric Simpson, MD reports personal fees from AbbVie, Aclaris Therapeutics, Amgen, Arcutis, Astria Therapeutics, Attovia Therapeutics, Inc., Bambusa Therapeutics Inc., Castle, CorEvitas, Dermira, Eli Lilly, Evomunne, FIDE, Impetus Healthcare, Incyte, Innovaderm Reche/ Indero, Inmagene Biopharmaceuticals, Janssen, LectureLinx (LLX), Leo, NUMAB Therapeutics AG, Pfizer, Recludix Pharma, Regeneron, Roche Products Ltd, Sanofi-Genzyme, SITRYX TherapeuticsEric Simpson, MD reports grants (or serves as Principal investigator role) for AbbVie, Acrotech, Amgen, Arcutis, ASLAN, Castle, Dermavant, CorEvitas, Dermira, Eli Lilly, Incyte, Pfizer, Regeneron, Sanofi-Genzyme, Target, VeriSkinJoy Wan, MD Sun Pharmaceuticals - consulting (DMC), Astria Therapeutics - consulting (ad board), Galderma - fellowship funding (paid to Johns Hopkins)

Dr. Diwakar Davar and Dr. Jason Luke discuss novel agents in melanoma and other promising new data in the field of immunotherapy that were presented at the 2025 ASCO Annual Meeting. TRANSCRIPT Dr. Diwakar Davar: Hello. My name is Diwakar Davar, and I am welcoming you to the ASCO Daily News Podcast. I'm an associate professor of medicine and the clinical director of the Melanoma and Skin Cancer Program at the University of Pittsburgh's Hillman Cancer Center. Today, I'm joined by my colleague and good friend, Dr. Jason Luke. Dr. Luke is a professor of medicine. He is also the associate director of clinical research and the director of the Phase 1 IDDC Program at the University of Pittsburgh's Hillman Cancer Center. He and I are going to be discussing some key advancements in melanoma and skin cancers that were presented at the 2025 ASCO Annual Meeting. Our full disclosures are available in the transcript of this episode.  Jason, it is great to have you back on the podcast. Dr. Jason Luke: Thanks again so much for the opportunity, and I'm really looking forward to it. Dr. Diwakar Davar: Perfect. So we will go ahead and start talking a little bit about a couple of key abstracts in both the drug development immunotherapy space and the melanoma space. The first couple of abstracts, the first two, will cover melanoma. So, the first is LBA9500, which was essentially the primary results of RELATIVITY-098. RELATIVITY-098 was a phase 3 trial that compared nivolumab plus relatlimab in a fixed-dose combination against nivolumab alone for the adjuvant treatment of resected high-risk disease. Jason, do you want to maybe give us a brief context of what this is? Dr. Jason Luke: Yeah, it's great, thanks. So as almost all listeners, of course, will be aware, the use of anti–PD-1 immunotherapies really revolutionized melanoma oncology over the last 10 to 15 years. And it has become a standard of care in the adjuvant setting as well. But to review, in patients with stage III melanoma, treatment can be targeted towards BRAF with BRAF and MEK combination therapy, where that's relevant, or anti–PD-1 with nivolumab or pembrolizumab are a standard of care. And more recently, we've had the development of neoadjuvant approaches for palpable stage III disease. And in that space, if patients present, based on two different studies, either pembrolizumab or nivolumab plus ipilimumab can be given prior to surgery for somewhere in the 6- to 9-week range. And so all of these therapies have improved time-to-event endpoints, such as relapse-free or event-free survival. It's worth noting, however, that despite those advances, we've had a couple different trials now that have actually failed in this adjuvant setting, most high profile being the CheckMate-915 study, which looked at nivolumab plus ipilimumab and unfortunately was a negative study. So, with RELATIVITY-047, which was the trial of nivolumab plus relatlimab that showed an improvement in progression-free survival for metastatic disease, there's a lot of interest, and we've been awaiting these data for a long time for RELATIVITY-098, which, of course, is this adjuvant trial of LAG-3 blockade with relatlimab plus nivolumab. Dr. Diwakar Davar: Great. So with that, let's briefly discuss the trial design and the results. So this was a randomized, phase 3, blinded study, so double-blinded, so neither the investigators knew what the patients were getting, nor did the patients know what they were getting. The treatment investigational arm was nivolumab plus relatlimab in the fixed-dose combination. So that's the nivolumab standard fixed dose with relatlimab that was FDA approved in RELATIVITY-047. And the control arm was nivolumab by itself. The duration of treatment was 1 year. The patient population consisted of resected high-risk stage III or IV patients. The primary endpoint was investigator-assessed RFS. Stage and geography were the standard stratifying factors, and they were included, and most of the criteria were balanced across both arms. What we know at this point is that the 2-year RFS rate was 64% and 62% in the nivolumab and nivolumab-combination arms, respectively. The 2-year DMFS rate was similarly equivalent: 76% with nivolumab monotherapy, 73% with the combination. And similar to what you had talked about with CheckMate 915, unfortunately, the addition of LAG-3 did not appear to improve the RFS or DMFS compared to control in this patient population. So, tell us a little bit about your take on this and what do you think might be the reasons why this trial was negative? Dr. Jason Luke: It's really unfortunate that we have this negative phase 3 trial. There had been a lot of hope that the combination of nivolumab with relatlimab would be a better tolerated combination that increased the efficacy. So in the metastatic setting, we do have 047, the study that demonstrated nivolumab plus relatlimab, but now we have this negative trial in the adjuvant setting. And so as to why exactly, I think is a complicated scenario. You know, when we look at the hazard ratios for relapse-free survival, the primary endpoint, as well as the secondary endpoints for distant metastasis-free survival, we see that the hazard ratio is approximately 1. So there's basically no difference. And that really suggests that relatlimab in this setting had no impact whatsoever on therapeutic outcomes in terms of efficacy. Now, it's worth noting that there was a biomarker subanalysis that was presented in conjunction with these data that looked at some immunophenotyping, both from circulating T cells, CD8 T cells, as well as from the tumor microenvironment from patients who were treated, both in the previous metastatic trial, the RELATIVITY-047 study, and now in this adjuvant study in the RELATIVITY-098 study. And to briefly summarize those, what was identified was that T cells in advanced melanoma seemed to have higher expression levels of LAG-3 relative to T cells that are circulating in patients that are in the adjuvant setting. In addition to that, there was a suggestion that the magnitude of increase is greater in the advanced setting versus adjuvant. And the overall summary of this is that the suggested rationale for why this was a negative trial may have been that the target of LAG-3 is not expressed as highly in the adjuvant setting as it is in the metastatic setting. And so while the data that were presented, I think, support this kind of an idea, I am a little bit cautious that this is actually the reason for why the trial was negative, however. I would say we're not really sure yet as to why the trial was negative, but the fact that the hazard ratios for the major endpoints were essentially 1 suggests that there was no impact whatsoever from relatlimab. And this really makes one wonder whether or not building on anti–PD-1 in the adjuvant setting is feasible because anti–PD-1 works so well. You would think that even if the levels of LAG-3 expression were slightly different, you would have seen a trend in one direction or another by adding a second drug, relatlimab, in this scenario. So overall, I think it's an unfortunate circumstance that the trial is negative. Clearly there's going to be no role for relatlimab in the adjuvant setting. I think this really makes one wonder about the utility of LAG-3 blockade and how powerful it really can be. I think it's probably worth pointing out there's another adjuvant trial ongoing now of a different PD-1 and LAG-3 combination, and that's cemiplimab plus fianlimab, a LAG-3 antibody that's being dosed from another trial sponsor at a much higher dose, and perhaps that may make some level of difference. But certainly, these are unfortunate results that will not advance the field beyond where we were at already. Dr. Diwakar Davar: And to your point about third-generation checkpoint factors that were negative, I guess it's probably worth noting that a trial that you were involved with, KeyVibe-010, that evaluated the PD-1 TIGIT co-formulation of vibostolimab, MK-4280A, was also, unfortunately, similarly negative. So, to your point, it's not clear that all these third-generation receptors are necessarily going to have the same impact in the adjuvant setting, even if they, you know, for example, like TIGIT, and they sometimes may not even have an effect at all in the advanced cancer setting. So, we'll see what the HARMONY phase 3 trial, that's the Regeneron cemiplimab/fianlimab versus pembrolizumab control with cemiplimab with fianlimab at two different doses, we'll see how that reads out. But certainly, as you've said, LAG-3 does not, unfortunately, appear to have an impact in the adjuvant setting. So let's move on to LBA9501. This is the primary analysis of EORTC-2139-MG or the Columbus-AD trial. This was a randomized trial of encorafenib and binimetinib, which we will abbreviate as enco-bini going forward, compared to placebo in high-risk stage II setting in melanoma in patients with BRAF V600E or K mutant disease. So Jason, you know, you happen to know one or two things about the resected stage II setting, so maybe contextualize the stage II setting for us based on the trials that you've led, KEYNOTE-716, as well as CheckMate-76K, set us up to talk about Columbus-AD. Dr. Jason Luke: Thanks for that introduction, and certainly stage II disease has been something I've worked a lot on. The rationale for that has been that building off of the activity of anti–PD-1 in metastatic melanoma and then seeing the activity in stage III, like we just talked about, it was a curious circumstance that dating back about 7 to 8 years ago, there was no availability to use anti–PD-1 for high-risk stage II patients, even though the risk of recurrence and death from melanoma in the context of stage IIB and IIC melanoma is in fact similar or actually higher than in stage IIIA or IIIB, where anti–PD-1 was approved. And in that context, a couple of different trials that you alluded to, the Keynote-716 study that I led, as well as the CheckMate 76K trial, evaluated pembrolizumab and nivolumab, respectively, showing an improvement in relapse-free and distant metastasis-free survival, and both of those agents have subsequently been approved for use in the adjuvant setting by the US FDA as well as the European Medicines Agency.  So bringing then to this abstract, throughout melanoma oncology, we've seen that the impact of anti–PD-1 immunotherapy versus BRAF and MEK-targeted therapy have had very similar outcomes on a sort of comparison basis, both in frontline metastatic and then in adjuvant setting. So it was a totally reasonable question to ask: Could we use adjuvant BRAF and MEK inhibitor therapy? And I think all of us expected the answer would be yes. As we get into the discussion of the trial, I think the unfortunate circumstance was that the timing of this clinical trial being delayed somewhat, unfortunately, made it very difficult to accrue the trial, and so we're going to have to try to read through the tea leaves sort of, based on only a partially complete data set. Dr. Diwakar Davar: So, in terms of the results, they wanted to enroll 815 patients, they only enrolled 110. The RFS and DMFS were marginally improved in the treatment arm but certainly not significantly, which is not surprising because the trial had only accrued 16% to 18% of its complete accrual. As such, we really can't abstract from the stage III COMBI-AD data to stage II patients. And certainly in this setting, one would argue that the primary treatment options certainly remain either anti–PD-1 monotherapy, either with pembrolizumab or nivolumab, based on 716 or 76K, or potentially active surveillance for the patients who are not inclined to get treated.  Can you tell us a little bit about how you foresee drug development going forward in this space because, you know, for example, with HARMONY, certainly IIC disease is a part of HARMONY. We will know at least a little bit about that in this space. So what do you think about the stage IIB/C patient population? Is this a patient population in which future combinations are going to be helpful, and how would you think about where we can go forward from here? Dr. Jason Luke: It is an unfortunate circumstance that this trial could not be accrued at the pace that was necessary. I think all of us believe that the results would have been positive if they'd been able to accrue the trial. In the preliminary data set that they did disclose of that 110 patients, you know, it's clear there is a difference at a, you know, a landmark at a year. They showed a 16% difference, and that would be in line with what has been seen in stage III. And so, you know, I think it's really kind of too bad. There's really going to be no regulatory approach for this consideration. So using BRAF and MEK inhibition in stage II is not going to be part of standard practice moving into the future. To your point, though, about where will the field go? I think what we're already realizing is that in the adjuvant setting, we're really overtreating the total population. And so beyond merely staging by AJCC criteria, we need to move to biomarker selection to help inform which patients truly need the treatment. And in that regard, I don't think we've crystallized together as a field as yet, but the kinds of things that people are thinking about are the integration of molecular biomarkers like ctDNA. When it's positive, it can be very helpful, but in melanoma, we found that, unfortunately, the rates are quite low, you know, in the 10% to 15% range in the adjuvant setting. So then another consideration would be factors in the primary tumor, such as gene expression profiling or other considerations.  And so I think the future of adjuvant clinical trials will be an integration of both the standard AJCC staging system as well as some kind of overlaid molecular biomarker that helps to enrich for a higher-risk population of patients because on a high level, when you abstract out, it's just clearly the case that we're rather substantially overtreating the totality of the population, especially given that in all of our adjuvant studies to date for anti–PD-1, we have not yet shown that there's an overall survival advantage. And so some are even arguing perhaps we should even reserve treatment until patients progress. I think that's a complicated subject, and standard of care at this point is to offer adjuvant therapy, but certainly a lot more to do because many patients, you know, unfortunately, still do progress and move on to metastatic disease. Dr. Diwakar Davar: Let's transition to Abstract 2508. So we're moving on from the melanoma to the novel immunotherapy abstracts. And this is a very, very, very fascinating drug. It's IMA203. So Abstract 2508 is a phase 1 clinical update of IMA203. IMA203 is an autologous TCR-T construct targeting PRAME in patients with heavily pretreated PD-1-refractory metastatic melanoma. So Jason, in the PD-1 and CTLA-4-refractory settings, treatment options are either autologous TIL, response rate, you know, ballpark 29% to 31%, oncolytic viral therapy, RP1 with nivolumab, ORR about 30-ish percent. So new options are needed. Can you tell us a little bit about IMA203? Perhaps tell us for the audience, what is the difference between a TCR-T and traditional autologous TIL? And a little bit about this drug, IMA203, and how it distinguishes itself from the competing TIL products in the landscape. Dr. Jason Luke: I'm extremely enthusiastic about IMA203. I think that it really has transformative potential based on these results and hopefully from the phase 3 trial that's open to accrual now. So, what is IMA203? We said it's a TCR-T cell product. So what that means is that T cells are removed from a patient, and then they can be transduced through various technologies, but inserted into those T cells, we can then add a T-cell receptor that's very specific to a single antigen, and in this case, it's PRAME. So that then is contrasted quite a bit from the TIL process, which includes a surgical resection of a tumor where T cells are removed, but they're not specific necessarily to the cancer, and they're grown up in the lab and then given to the patient. They're both adoptive cell transfer products, but they're very different. One is genetically modified, and the other one is not. And so the process for generating a TCR-T cell is that patients are required to have a new biomarker that some may not be familiar with, which is HLA profiling. So the T-cell receptor requires matching to the concomitant HLA for which the peptide is bound in. And so the classic one that is used in most oncology practices is A*02:01 because approximately 48% of Caucasians have A*02:01, and the frequency of HLA in other ethnicities starts to become highly variable. But in patients who are identified to have A*02:01 genotype, we can then remove blood via leukapheresis or an apheresis product, and then insert via lentiviral transduction this T-cell receptor targeting PRAME. Patients are then brought back to the hospital where they can receive lymphodepleting chemotherapy and then receive the reinfusion of the TCR-T cells. Again, in contrast with the TIL process, however, these T cells are extremely potent, and we do not need to give high-dose interleukin-2, which is administered in the context of TIL. Given that process, we have this clinical trial in front of us now, and at ASCO, the update was from the phase 1 study, which was looking at IMA203 in an efficacy population of melanoma patients who were refractory at checkpoint blockade and actually multiple lines of therapy. So here, there were 33 patients and a response rate of approximately 50% was observed in this population of patients, notably with a duration of response approximately a year in that treatment group. And I realize that these were heavily pretreated patients who had a range of very high-risk features. And approximately half the population had uveal melanoma, which people may be aware is a generally speaking more difficult-to-treat subtype of melanoma that metastasizes to the liver, which again has been a site of resistance to cancer immunotherapy. So these results are extremely promising. To summarize them from what I said, it's easier to make TCR-T cells because we can remove blood from the patient to transduce the T cells, and we don't have to put them through surgery. We can then infuse them, and based on these results, it looks like the response rate to IMA203 is a little bit more than double what we expect from lifileucel. And then, whereas with lifileucel or TILs, we have to give high-dose IL-2, here we do not have to give high-dose IL-2. And so that's pretty promising. And a clinical trial is ongoing now called the SUPREME phase 3 clinical trial, which is hoping to validate these results in a randomized global study. Dr. Diwakar Davar: Now, one thing that I wanted to go over with you, because you know this trial particularly well, is what you think of the likelihood of success, and then we'll talk a little bit about the trial design. But in your mind, do you think that this is a trial that has got a reasonable likelihood of success, maybe even a high likelihood of success? And maybe let's contextualize that to say an alternative trial, such as, for example, the TebeAM trial, which is essentially a T-cell bispecific targeting GP100. It's being compared against SOC, investigator's choice control, also in a similarly heavily pretreated patient population. Dr. Jason Luke: So both trials, I think, have a strong chance of success. They are very different kinds of agents. And so the CD3 bispecific that you referred to, tebentafusp, likely has an effect of delaying progression, which in patients with advanced disease could have a value that might manifest as overall survival. With TCR-T cells, by contrast, we see a very high response rate with some of the patients going into very durable long-term benefit. And so I do think that the SUPREME clinical trial has a very high chance of success. It will be the first clinical trial in solid tumor oncology randomizing patients to receive a cell therapy as compared with a standard of care. And within that standard of care control arm, TILs are allowed as a treatment. And so it will also be the first study that will compare TCR-T cells against TILs in a randomized phase 3. But going back to the data that we've seen in the phase 1 trial, what we observe is that the duration of response is really connected to the quality of the response, meaning if you have more than a 50% tumor shrinkage, those patients do very, very well. But even in patients who have less than 50% tumor shrinkage, the median progression-free survival right now is about 4.5 months. And again, as we think about trial design, standard of care options for patients who are in this situation are unfortunately very bad. And the progression-free survival in that population is probably more like 2 months. So this is a trial that has a very high likelihood of being positive because the possibility of long-term response is there, but even for patients who don't get a durable response, they're likely going to benefit more than they would have based on standard chemotherapy or retreatment with an anti–PD-1 agent. Dr. Diwakar Davar: Really, a very important trial to enroll, a trial that is first in many ways. First of a new generation of TCR-T agents, first trial to look at cell therapy in the control arm, a new standard of efficacy, but potentially also if this trial is successful, it will also be a new standard of trial conduct, a new kind of trial, of a set of trials that will be done in the second-line immunotherapy-refractory space. So let's pivot to the last trial that we were going to discuss, which was Abstract 2501. Abstract 2501 is a first-in-human phase 1/2 trial evaluating BNT142, which is the first-in-class mRNA-encoded bispecific targeting Claudin-6 and CD3 in patients with Claudin-positive tumors. We'll talk a little bit about this, but maybe let's start by talking a little bit about Claudin-6. So Claudin-6 is a very interesting new target. It's a target that's highly expressed in GI and ovarian tumors. There are a whole plethora of Claudin-6-targeting agents, including T-cell bispecifics and Claudin-6-directed CAR-Ts that are being developed. But BNT142 is novel. It's a novel lipid nanoparticle LNP-encapsulated mRNA. The mRNA encodes an anti–Claudin-6 CD3 bispecific termed RiboMAB-021. And it then is administered to the patient. The BNT142-encoding mRNA LNPs are taken up by the liver and translated into the active drug. So Jason, tell us a little bit about this agent. Why you think it's novel, if you think it's novel, and let's talk a little bit then about the results. Dr. Jason Luke: So I certainly think this is a novel agent, and I think this is just the first of what will probably become a new paradigm in oncology drug development. And so you alluded to this, but just to rehash it quickly, the drug is encoded as genetic information that's placed in the lipid nanoparticle and then is infused into the patient. And after the lipid nanoparticles are taken up by the liver, which is the most common place that LNPs are usually taken up, that genetic material in the mRNA starts to be translated into the actual protein, and that protein is the drug. So this is in vivo generation, so the patient is making their own drug inside their body. I think it's a really, really interesting approach. So for any drug that could be encoded as a genetic sequence, and in this case, it's a bispecific, as you mentioned, CD3-Claudin-6 engager, this could have a tremendous impact on how we think about pharmacology and novel drug development moving into the future in oncology. So I think it's an extremely interesting drug, the like of which we'll probably see only more moving forward. Dr. Diwakar Davar: Let's maybe briefly talk about the results. You know, the patient population was heavily pretreated, 65 or so patients, mostly ovarian cancer. Two-thirds of the patients were ovarian cancer, the rest were germ cell and lung cancer patients. But let's talk a little bit about the efficacy. The disease control rate was about 58% in the phase 1 population as a whole, but 75% in the ovarian patient population. Now tell us a little bit about the interesting things about the drug in terms of the pharmacokinetics, and also then maybe we can pivot to the clinical activity by dose level. Dr. Jason Luke: Well, so they did present in their presentation at ASCO a proportionality showing that as higher doses were administered, that greater amounts of the drug were being made inside the patient. And so that's an interesting observation, and it's an important one, right? Suggesting that the pharmacology that we classically think of by administering drugs by IV, for example, would still be in play. And that did translate into some level of efficacy, particularly at the higher dose levels. Now, the caveat that I'll make a note of is that disease control rate is an endpoint that I think we have to be careful about because what that really means is sometimes a little bit unclear. Sometimes patients have slowly growing tumors and so on and so forth. And the clinical relevance of disease control, if it doesn't last at least 6 months, I think is probably pretty questionable. So I think these are extremely interesting data, and there's some preliminary sense that getting the dose up is going to matter because the treatment responses were mostly observed at the highest dose levels. There's also a caveat, however, that across the field of CD3 bispecific molecules like this, there's been quite a bit of heterogeneity in terms of the response rate, with some of them only really generating stable disease responses and other ones having more robust responses. And so I think this is a really interesting initial foray into this space. My best understanding is this molecule is not moving forward further after this, but I think that this really does set it up to be able to chase after multiple different drug targets on a CD3 bispecific backbone, both in ovarian cancer, but then basically across all of oncology. Dr. Diwakar Davar: Perfect. This is a very new sort of exciting arena where we're going to be looking at, in many ways, these programmable constructs, whether we're looking at in vivo-generated, in this case, a T-cell bispecific, but we've also got newer drugs where we are essentially giving drugs where people are generating in vivo CAR T, and also potentially even in vivo TCR-T. But certainly lots of new excitement around this entire class of drugs. And so, what we'd like to do at this point in time is switch to essentially the fact that we've got a very, very exciting set of data at ASCO 2025. You've heard from Dr. Luke regarding the advances in both early drug development but also in advanced cutaneous melanoma. And Jason, as always, thank you so much for sharing your very valuable and great, fantastic insights with us on the ASCO Daily News Podcast. Dr. Jason Luke: Well, thanks again for the opportunity. Dr. Diwakar Davar: And thank you to our listeners for taking your time to listen today. You will find the links to the abstracts that we discussed today in the transcript of this episode. And finally, if you value the insights that you hear on the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. Disclaimer: 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. Follow today's speakers:    Dr. Diwakar Davar    @diwakardavar    Dr. Jason Luke @jasonlukemd Follow ASCO on social media:     @ASCO on Twitter       ASCO on Bluesky   ASCO on Facebook       ASCO on LinkedIn   Disclosures:     Dr. Diwakar Davar:      Honoraria: Merck, Tesaro, Array BioPharma, Immunocore, Instil Bio, Vedanta Biosciences     Consulting or Advisory Role: Instil Bio, Vedanta Biosciences     Consulting or Advisory Role (Immediate family member): Shionogi     Research Funding: Merck, Checkmate Pharmaceuticals, CellSight Technologies, GSK, Merck, Arvus Biosciences, Arcus Biosciences     Research Funding (Inst.): Zucero Therapeutics     Patents, Royalties, Other Intellectual Property: Application No.: 63/124,231 Title: COMPOSITIONS AND METHODS FOR TREATING CANCER Applicant: University of Pittsburgh–Of the Commonwealth System of Higher Education Inventors: Diwakar Davar Filing Date: December 11, 2020 Country: United States MCC Reference: 10504-059PV1 Your Reference: 05545; and Application No.: 63/208,719 Enteric Microbiotype Signatures of Immune-related Adverse Events and Response in Relation to Anti-PD-1 Immunotherapy     Dr. Jason Luke:     Stock and Other Ownership Interests: Actym Therapeutics, Mavu Pharmaceutical, Pyxis, Alphamab Oncology, Tempest Therapeutics, Kanaph Therapeutics, Onc.AI, Arch Oncology, Stipe, NeoTX     Consulting or Advisory Role: Bristol-Myers Squibb, Merck, EMD Serono, Novartis, 7 Hills Pharma, Janssen, Reflexion Medical, Tempest Therapeutics, Alphamab Oncology, Spring Bank, Abbvie, Astellas Pharma, Bayer, Incyte, Mersana, Partner Therapeutics, Synlogic, Eisai, Werewolf, Ribon Therapeutics, Checkmate Pharmaceuticals, CStone Pharmaceuticals, Nektar, Regeneron, Rubius, Tesaro, Xilio, Xencor, Alnylam, Crown Bioscience, Flame Biosciences, Genentech, Kadmon, KSQ Therapeutics, Immunocore, Inzen, Pfizer, Silicon Therapeutics, TRex Bio, Bright Peak, Onc.AI, STipe, Codiak Biosciences, Day One Therapeutics, Endeavor, Gilead Sciences, Hotspot Therapeutics, SERVIER, STINGthera, Synthekine     Research Funding (Inst.): Merck , Bristol-Myers Squibb, Incyte, Corvus Pharmaceuticals, Abbvie, Macrogenics, Xencor, Array BioPharma, Agios, Astellas Pharma , EMD Serono, Immatics, Kadmon, Moderna Therapeutics, Nektar, Spring bank, Trishula, KAHR Medical, Fstar, Genmab, Ikena Oncology, Numab, Replimmune, Rubius Therapeutics, Synlogic, Takeda, Tizona Therapeutics, Inc., BioNTech AG, Scholar Rock, Next Cure     Patents, Royalties, Other Intellectual Property: Serial #15/612,657 (Cancer Immunotherapy), and Serial #PCT/US18/36052 (Microbiome Biomarkers for Anti-PD-1/PD-L1 Responsiveness: Diagnostic, Prognostic and Therapeutic Uses Thereof)     Travel, Accommodations, Expenses: Bristol-Myers Squibb, Array BioPharma, EMD Serono, Janssen, Merck, Novartis, Reflexion Medical, Mersana, Pyxis, Xilio

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 Anna Henderson, MD, a pediatric gastroenterologist at Northern Light Health in Maine, about bone mineral density in EoE patients. They discuss a paper she co-authored on the subject. 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, Sanofi, Regeneron, and Takeda. Ryan introduces co-host Holly Knotowicz.   [1:17] Holly introduces today's topic, eosinophilic esophagitis (EoE), and bone density.   [1:22] Holly introduces today's guest, Dr. Anna Henderson, a pediatric gastroenterologist at Northern Light Health in Maine.   [1:29] During her pediatric and pediatric gastroenterology training at Cincinnati Children's Hospital, she took a special interest in eosinophilic esophagitis. In 2019, Dr. Henderson received APFED's NASPGHAN Outstanding EGID Abstract Award.   [1:45] Holly, a feeding therapist in Maine, has referred many patients to Dr. Henderson and is excited to have her on the show.   [2:29] Dr. Henderson is a wife and mother. She loves to swim and loves the outdoors. She practices general pediatric GI in Bangor, Maine, at a community-based academic center.   [2:52] Her patient population is the northern two-thirds of Maine. Dr. Henderson feels it is rewarding to bring her expertise from Cincinnati to a community that may not otherwise have access to specialized care.   [3:13] Dr. Henderson's interest in EoE grew as a GI fellow at Cincinnati Children's. Her research focused on biomarkers for disease response to dietary therapies and EoE's relationship to bone health.   [3:36] As a fellow, Dr. Henderson rotated through different specialized clinics. She saw there were many unanswered questions about the disease process, areas to improve treatment options, and quality of life for the patients suffering from these diseases.   [4:00] Dr. Henderson saw many patients going through endoscopies. She saw the social barriers for patients following strict diets. She saw a huge need in EoE and jumped on it.   [4:20] Ryan grew up with EoE. He remembers the struggles of constant scopes, different treatment options, and dietary therapy. Many people struggled to find what was best for them before there was a good approved treatment.   [4:38] As part of Ryan's journey, he learned he has osteoporosis. He was diagnosed at age 18 or 19. His DEXA scan had such a low Z-score that they thought the machine was broken. He was retested.   [5:12] Dr. Henderson explains that bone mineral density is a key measure of bone health and strength. Denser bones contain more minerals and are stronger. A low bone mineral density means weaker bones. Weaker bones increase the risk of fracture.   [5:36] DEXA scan stands for Dual Energy X-ray Absorptiometry scan. It's a type of X-ray that takes 10 to 30 minutes. A machine scans over their bones. Typically, we're most interested in the lumbar spine and hip bones.   [5:56] The results are standardized to the patient's height and weight, with 0 being the average. A negative number means weaker bones than average for that patient's height and weight. Anything positive means stronger bones for that patient's height and weight.   [6:34] A lot of things can affect a patient's bone mineral density: genetics, dietary history, calcium and Vitamin D intake, and medications, including steroid use. Prednisone is a big risk factor for bone disease.   [7:07] Other risk factors are medical and auto-immune conditions, like celiac disease, and age. Any patient will have their highest bone density in their 20s to 30s. Females typically have lower bone mineral density than males.   [7:26] The last factor is lifestyle. Patients who are more active and do weight-bearing exercises will have higher bone mineral density than patients who have more of a sedentary lifestyle.   [7:56] Ryan was told his bone mineral density issues were probably a side-effect of the long-term steroids he was on for his EoE. Ryan is now on benralizumab for eosinophilic asthma. He is off steroids.   [8:36] Dr. Henderson says the research is needed to find causes of bone mineral density loss besides glucocorticoids.   [8:45] EoE patients are on swallowed steroids, fluticasone, budesonide, etc. Other patients are on steroids for asthma, eczema, and allergic rhinitis. These may be intranasal steroids or topical steroids.   [9:01] Dr. Henderson says we wondered whether or not all of those steroids and those combined risks put the EoE population at risk for low bone mineral density. There's not a lot published in that area.   [9:14] We know that proton pump inhibitors can increase the risk of low bone mineral density. A lot of EoE patients are on proton pump inhibitors.   [9:23] That was where Dr. Henderson's interest started. She didn't have a great way to screen for bone mineral density issues or even know if it was a problem in her patients more than was expected in a typical patient population.   [9:57] Holly wasn't diagnosed with EoE until she was in her late 20s. She was undiagnosed but was given prednisone for her problems. Now she wonders if she should get a DEXA scan.   [10:15] Holly hopes the listeners will learn something and advocate for themselves or for their children.   [10:52] If a patient is concerned about their bone mineral density, talking to your PCP is a perfect place to start. They can discuss the risk factors and order a DEXA scan and interpret it, if needed.   [11:11] If osteoporosis is diagnosed, you should see an endocrinologist, specifically to discuss therapy, including medications called bisphosphonates.   [11:36] From an EoE perspective, patients can talk to their gastroenterologist about what bone mineral density risk factors may be and if multiple risk factors exist. Gastroenterologists are also more than capable of ordering DEXA scans and helping their patients along that journey.   [11:53] A DEXA scan is typically the way to measure bone mineral density. It's low radiation, it's easy, it's fast, and relatively inexpensive.   [12:10] It's also useful in following up over time in response to different interventions, whether or not that's stopping medications or starting medications.   [12:30] Dr. Henderson co-authored a paper in the Journal of Pediatric Gastroenterology and Nutrition, called “Prevalence and Predictors of Compromised Bone Mineral Density in Pediatric Eosinophilic Esophagitis.” The study looked at potential variables.   [12:59] The researchers were looking at chronic systemic steroid use. They thought it was an issue in their patients, especially patients with multiple atopic diseases like asthma, eczema, and allergic rhinitis. That's where the study started.   [13:22] Over the years, proton pump inhibitors have become more ubiquitous, and more research has come out. The study tried to find out if this was an issue or not. There weren't any guidelines for following these patients, as it was a retrospective study.    [13:42] At the time, Dr. Henderson was at a large institution with a huge EoE population. She saw that she could do a study and gather a lot of information on a large population of patients. Studies like this are the start of figuring out the guidelines for the future.   [14:34] Dr. Henderson wanted to determine whether pediatric patients with EoE had a lower-than-expected bone mineral density, compared to their peers. [14:44] Then, if there were deficits, she wanted to determine where they were more pronounced. Were they more pronounced in certain subgroups of patients with EoE?   [14:59] Were they patients with an elemental diet? Patients with an elimination diet? Were they patients on steroids or PPIs? Were they patients with multiple atopic diseases? Is low bone mineral density just a manifestation of their disease processes?   [15:14] Do patients with active EoE have a greater propensity to have low bone mineral density? The study was diving into see what the potential risk factors are for this patient population.   [15:45] The study was a retrospective chart review. They looked at patients aged 3 to 21. You can't do a DEXA scan on a younger patient, and 21 is when people leave pediatrics.   [16:03] These were all patients who had the diagnosis of EoE and were seen at Cincinnati Children's in the period between 2014 and 2017. That period enabled full ability for chart review. Then they looked at the patients who had DEXA scans.   [16:20] They did a manual chart review of all of the patients and tried to tease out what the potential exposures were. They looked at demographics, age, sex, the age of the diagnosis of EoE, medications used, such as PPIs, and all different swallowed steroids.   [16:44] They got as complete a dietary history as they could: whether or not patients were on an elemental diet, whether that was a full elemental diet, whether they were on a five-food, six-food, or cow's milk elimination diet.   [16:58] They teased out as much as they could. One of the limitations of a retrospective chart review is that you can't get some of the details, compared to doing a prospective study. For example, they couldn't tease out the dosing or length of therapy, as they would have liked.   [17:19] They classified those exposures as whether or not the patient was ever exposed to those medications, whether or not they were taking them at the time of the DEXA scan, or if they had been exposed within the year before the DEXA scan.   [17:40] They also looked at whether the patients had other comorbid atopic disorders, to see if those played a role, as well.   [18:03] The study found that there was a slightly lower-than-expected bone mineral density in the patients. The score was -0.55, lower than average but not diagnostic of a low bone mineral density, which would be -2 or below.   [18:27] There were 23 patients with low bone mineral density scores of -2 or below. That was 8.6% of the study patients. Typically, only 2.5% of the population would have that score. It was hard to tease out the specific risk factors in a small population of 23.   [18:57] They looked at what the specific risk factors were that were associated with low bone mineral density, or bone mineral density in general.   [19:12] After moving from Colorado, Holly has transferred to a new care team, and doctors wanted her baseline Vitamin D and Calcium levels. No one had ever tested that on her before. Dr. Henderson says it's hard because there's nothing published on what to do.   [19:58] The biggest surprise in the study was that swallowed steroids, or even combined steroid exposure, didn't have any effect on bone mineral density. That was reassuring, in light of what is known about glucocorticoid use.   [20:16] The impact of PPI use was interesting. The study found that any lifetime use of PPIs did seem to decrease bone mineral density. It was difficult to tease out the dosing and the time that a patient was on PPIs.   [20:34] Dr. Henderson thinks that any lifetime use of PPIs is more of a representation of their cumulative use of PPIs. At the time of the study, from 2014 to 2017, PPIs were still very much first-line therapy for EoE; 97% of the study patients had taken PPIs at some time.   [21:02] There are so many more options now for therapy when a patient has a new diagnosis of EoE, especially with dupilumab now being an option.   [21:11] Dr. Henderson speaks of patients who started on PPIs and have stayed on them for years. This study allows her to question whether we need to continue patients on PPIs. When do we discuss weaning patients off PPIs, if appropriate?   [22:05] Ryan says these podcasts are a great opportunity for the community at large and also for the hosts. He just wrote himself a note to ask his endocrinologist about coming off PPIs.   [22:43] Dr. Henderson says that glucocorticoid use is a known risk factor for low bone mineral density and osteoporosis. In the asthma population, inhaled steroids can slightly decrease someone's growth potential while the patient is taking them.   [23:10] From those two facts, it was thought that swallowed steroids would have a similar effect. But since they're swallowed and not systemic, maybe things are different.   [23:23] It was reassuring to Dr. Henderson that what her study found was that the swallowed steroid didn't affect bone mineral density. There was one other study that found that swallowed steroids for EoE did not affect someone's height.   [23:51] Dr. Henderson clarifies that glucocorticoids include systemic steroids like prednisone and hydrocortisone.     [23:57] Based on Dr. Henderson's retrospective study, fluticasone as a swallowed steroid did not affect bone mineral density. It was hard to tease out the dosing, but the cumulative use did not seem to result in a deficit for bone mineral density.   [24:16] Holly shared that when she tells a family of a child she works with that the child's gastroenterologist will likely recommend steroids, she will now give them the two papers Dr. Henderson mentioned. There are different types of steroids. The average person doesn't know the difference.   [25:15] Dr. Henderson thinks that for patients who have multiple risk factors for low bone mineral density, it is reasonable to have a conversation about bone health with their gastroenterologist to see whether or not a DEXA scan would be worth it.   [25:56] If low bone mineral density is found, that needs to be followed up on.   [26:03] There are no great guidelines, but this study is a good start on what these potential risk factors are. We need some more prospective studies to look at these risk factors in more detail than Dr. Henderson's team teased out in this retrospective study.   [26:23] Dr. Henderson tells how important it is for patients to participate in prospective longitudinal studies for developing future guidelines.   [26:34] Holly points out that a lot of patients are on restrictive diets. It's important to think about the whole picture if you are starting a medication or an elimination, or a restricted diet. You have to think about the impact on your body, overall.   [27:11] People don't think of dietary therapy as medication, but it has risks and benefits involved, like a medication.   [27:50] Dr. Henderson says, in general, lifestyle management is the best strategy for managing bone health. Stay as active as you can with weight-bearing exercises and eating a well-balanced diet. If you are on a restrictive diet, make sure it's well-balanced.   [28:12] Dr. Henderson says a lot of our patients have feeding disorders, so they see feeding specialists like Holly. A balanced diet is hard when kids are very selective in their eating habits.   [29:10] Dr. Henderson says calcium and Vitamin D are the first steps in how we treat patients with low bone mineral density. A patient who is struggling with osteoporosis needs to discuss it with their endocrinologist for medications beyond supplementation.   [29:31] Ryan reminds listeners who are patients always to consult with their medical team. Don't go changing anything up just because of what we're talking about here. Ask your care team some good questions.   [29:47] Dr. Henderson would like families to be aware, first, that some patients with EoE will have bone mineral density loss, especially if they are on PPIs and restrictive diets. They should start having those discussions with their providers.   [30:04] Second, Dr. Henderson would like families to be reassured that swallowed steroids and combined steroid exposure didn't have an impact on bone mineral density. Everyone can take that away from today's chat.   [30:18] Lastly, Dr. Henderson gives another plug for patient participation in prospective studies, if they're presented with the opportunity. It's super important to be able to gather more information and make guidelines better for our patients. [30:35] Holly thanks Dr. Henderson for coming on Real Talk — Eosinophilic Diseases and sharing her insights on bone mineral density, and supporting patients in Maine.   [30:57] Dr. Henderson will continue to focus on the clinical side. She loves doing outreach clinics in rural Maine. It's rewarding, getting to meet all of these patients and taking care of patients who would otherwise have to travel hours to see a provider.   [32:01] Ryan thinks the listeners got a lot out of this. For our listeners who would like to learn more about eosinophilic disorders, please visit APFED.org and check out the links in the show notes.   [32:11] If you're looking to find specialists who treat eosinophilic disorders, we encourage you to use APFED's Specialist Finder at APFED.org/specialist.   [32:19] 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.   [32:28] Ryan thanks Dr. Henderson for joining us today for this great conversation. Holly also thanks APFED's Education Partners Bristol Myers Squibb, Sanofi, Regeneron, and Takeda for supporting this episode.   Mentioned in This Episode: Anna Henderson, MD, a pediatric gastroenterologist at Northern Light Health in Maine Cincinnati Children's “Prevalence and Predictors of Compromised Bone Mineral Density in Pediatric Eosinophilic Esophagitis.” Journal of Pediatric Gastroenterology and Nutrition   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, Sanofi, Regeneron, and Takeda.   Tweetables:   “DEXA scan stands for dual-energy X-ray absorptiometry scan. It's a type of X-ray where a patient lies down for 10 to 30 minutes. A machine scans over their bones. Typically, we're most interested in the lumbar spine and hip bones.” — Anna Henderson, MD   “We wondered whether or not all of those steroids and those combined risks even put our EoE population at risk for low bone mineral density. There's not a lot published in that area.” — Anna Henderson, MD   “If a patient is worried [about their bone mineral density], their PCP is a perfect place to start for that. They're more than capable of discussing the risk factors specific for that patient, ordering a DEXA scan, and interpreting it if need be.” — Anna Henderson, MD   “I think we need some more prospective studies to look at these risk factors in a little bit more detail than we were able to tease out in our retrospective review.” — Anna Henderson, MD   “Just another plug for the participation in prospective studies, if you're presented with the opportunity. It's super important to be able to gather more information and to be able to make guidelines better for our patients about these risks.” — Anna Henderson, MD

In this episode of Beekeeping Today Podcast, we welcome an inspiring young voice in honey bee research—Atreya Manaswi, a high school senior and top 40 finalist in the 2025 Regeneron Science Talent Search. Atreya shares the fascinating journey that began with a fishing trip and led to a multi-year research project aimed at controlling one of the most damaging pests of honey bees: the small hive beetle. Working under mentorship from the USDA and University of Florida, Atreya developed a new organic bait based on the volatile compounds found in beer. He didn't stop there—he designed a solar-powered, 3D-printed trap equipped with LED sensors and a Raspberry Pi to count beetles automatically and predict future infestations using artificial intelligence. His bait-and-trap system could offer a cleaner, more sustainable, and reusable alternative to traditional beetle traps. Atreya also talks about his picture book The Bee Story, his outreach work with youth and beekeeping clubs, and his upcoming studies at Yale University. His dedication to pollinator health and science communication offers a hopeful glimpse into the future of bee research. Whether you're a beekeeper dealing with small hive beetles or just curious about next-gen solutions, you won't want to miss this conversation. Websites from the episode and others we recommend: Atreya on Regeneron-STS Website: https://www.societyforscience.org/regeneron-sts/2025-student-finalists/atreya-manaswi/ Atreya's Website: https://www.atreyamanaswi.com  Atreya's Book on Amazon: https://www.amazon.com/Bee-Story-Atreya-Manaswi/dp/B0BMSZSR2H Honey Bee Health Coalition: https://honeybeehealthcoalition.org The National Honey Board: https://honey.com Honey Bee Obscura Podcast: https://honeybeeobscura.com   Copyright © 2025 by Growing Planet Media, LLC     ______________ Betterbee is the presenting sponsor of Beekeeping Today Podcast. Betterbee's mission is to support every beekeeper with excellent customer service, continued education and quality equipment. From their colorful and informative catalog to their support of beekeeper educational activities, including this podcast series, Betterbee truly is Beekeepers Serving Beekeepers. See for yourself at www.betterbee.com This episode is brought to you by Global Patties! Global offers a variety of standard and custom patties. Visit them today at http://globalpatties.com and let them know you appreciate them sponsoring this episode!  Thanks to Bee Smart Designs as a sponsor of this podcast! Bee Smart Designs is the creator of innovative, modular and interchangeable hive systems made in the USA using recycled and American sourced materials. Bee Smart Designs - Simply better beekeeping for the modern beekeeper.   Thanks to Dalan who is dedicated to providing transformative animal health solutions to support a more sustainable future. Dalan's vaccination against American Foulbrood (AFB) is a game changer. Vaccinated queens protect newly hatched honeybee larvae against AFB using the new Dalan vaccine. Created for queen producers and other beekeepers wanting to produce AFB free queens.  Retailers offering vaccinated queens and packages:  https://dalan.com/order-vaccinated-queens/   More information on the vaccine: https://dalan.com/media-publications/ Thanks to Strong Microbials for their support of Beekeeping Today Podcast. Find out more about their line of probiotics in our Season 3, Episode 12 episode and from their website: https://www.strongmicrobials.com Thanks for Northern Bee Books for their support. Northern Bee Books is the publisher of bee books available worldwide from their website or from Amazon and bookstores everywhere. They are also the publishers of The Beekeepers Quarterly and Natural Bee Husbandry. _______________ We hope you enjoy this podcast and welcome your questions and comments in the show notes of this episode or: questions@beekeepingtodaypodcast.com Thank you for listening!  Podcast music: Be Strong by Young Presidents; Epilogue by Musicalman; Faraday by BeGun; Walking in Paris by Studio Le Bus; A Fresh New Start by Pete Morse; Wedding Day by Boomer; Christmas Avenue by Immersive Music; Red Jack Blues by Daniel Hart; Original guitar background instrumental by Jeff Ott. Beekeeping Today Podcast is an audio production of Growing Planet Media, LLC Copyright © 2025 by Growing Planet Media, LLC

This engaging and informative webinar explores the role of OX40 and OX40L in pediatric dermatology. OX40: Innovative Insights and Therapeutic Potential in Pediatric Dermatology brings together experts in the field to discuss emerging research, mechanisms of action, and the implications of targeting the OX40 pathway for treating chronic inflammatory skin diseases in children. To view the video version of this webinar, please click here. Disclosures:Lawrence Eichenfield, MD has served as a consultant, speaker, advisory board member, or investigator for AbbVie, Acrotech, Almirall, Amgen, Apogee, Arcutis, Attovia, Bristol Myers Squibb, Castle Biosciences, CorEvitas, Dermavant, Eli Lilly, Forte, Galderma, Incyte Corporation, Janssen, Johnson & Johnson, LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi Genzyme, Target RWE, T-Rex, and UCB.Eric Simpson, MD reports personal fees from AbbVie, Aclaris Therapeutics, Amgen, Arcutis, Astria Therapeutics, Attovia Therapeutics, Inc., Bambusa Therapeutics Inc., Castle, CorEvitas, Dermira, Eli Lilly, Evomunne, FIDE, Impetus Healthcare, Incyte, Innovaderm Reche/ Indero, Inmagene Biopharmaceuticals, Janssen, LectureLinx (LLX), Leo, NUMAB Therapeutics AG, Pfizer, Recludix Pharma, Regeneron, Roche Products Ltd, Sanofi-Genzyme, SITRYX TherapeuticsEric Simpson, MD reports grants (or serves as Principal investigator role) for AbbVie, Acrotech, Amgen, Arcutis, ASLAN, Castle, Dermavant, CorEvitas, Dermira, Eli Lilly, Incyte, Pfizer, Regeneron, Sanofi-Genzyme, Target, VeriSkinJoy Wan, MD Sun Pharmaceuticals - consulting (DMC), Astria Therapeutics - consulting (ad board), Galderma - fellowship funding (paid to Johns Hopkins)

In this special episode recorded at 85th Scientific Sessions of the American Diabetes Association (ADA 2025), hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and co-director of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, take a deep dive into the REDEFINE 1 and REDEFINE 2 trials with trial investigators W. Timothy Garvey, MD, of University of Alabama at Birmingham, and Melanie Davies, MD, of the University of Leicester. REDEFINE 1 was a 68-week, phase 3a trial enrolling over 3400 adults without diabetes but with obesity or overweight and at least one comorbidity. Participants received once-weekly CagriSema, semaglutide alone, cagrilintide alone, or placebo alongside lifestyle intervention. Key outcome: CagriSema led to a mean weight loss of 20.4%, vs 3.0% with placebo. Over 50% of participants on CagriSema reached a non-obese BMI. Gastrointestinal side effects were common (80%), but mostly mild to moderate. REDEFINE 2 enrolled 1206 adults with type 2 diabetes and overweight or obesity, randomized to CagriSema or placebo for 68 weeks. Key outcome: CagriSema led to 13.7% mean weight loss, vs 3.4% with placebo. 73.5% achieved an HbA1c ≤6.5% vs 15.9% on placebo. Significant improvements were seen across all weight loss and glycemic endpoints. The speakers also highlight the agent's favorable side effect profile, flexibility in real-world dosing, and benefits in body composition and physical function. Garvey emphasizes the shift toward complication-centric obesity care, underscoring the need for clinician-guided treatment beyond online prescription models. The conversation closes with a look ahead to REDEFINE 3—a cardiovascular outcomes trial including patients with and without diabetes—and other ongoing studies in the REDEFINE and REIMAGINE trial programs. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others. Relevant disclosures for Garvey include Boehringer-Ingelheim, Novo Nordisk, Eli Lilly and Company, Merck & Co., Inc., Alnylam Pharmaceuticals, Inc., Fractyl Health, Inc., Inogen, Epitomee, Pfizer Inc., and Neurovalens. Relevant disclosures for Davies include Abbie, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly and Company, GSK, Novo Nordisk, Pfizer, Regeneron, Roche, Sanofi, and Zealand Pharma. References: Garvey WT, Blüher M, Osorto Contreras CK, et al. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity. The New England Journal of Medicine. Published online June 22, 2025. doi: 10.1056/NEJMoa2502081 Davies MJ, Bajaj HS, Broholm C. Cagrilintide–Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes. The New England Journal of Medicine. Published online June 22, 2025. doi: 10.1056/NEJMoa2502082

Dr. John Sweetenham and Dr. Erika Hamilton highlight key abstracts that were presented at ASCO25, including advances in breast and pancreatic cancers as well as remarkable data from the use of structured exercise programs in cancer care. Transcript Dr. Sweetenham: Hello, and welcome to the ASCO Daily News Podcast. I'm your host, Dr. John Sweetenham. Today, we'll be discussing some of the key advances and novel approaches in cancer care that were presented at the 2025 ASCO Annual Meeting. I'm delighted to be joined again by the chair of the Meeting's Scientific Program, Dr. Erika Hamilton. She is a medical oncologist and director of breast cancer and gynecologic cancer research at the Sarah Cannon Research Institute in Nashville, Tennessee.  Our full disclosures are available in the transcript of this episode. Dr. Hamilton, congratulations on a fantastic meeting. From the practice-changing science to the world-renowned speakers at this year's Meeting, ASCO25 really reflected the amazing progress we're seeing in oncology today and the enormous opportunities that lie ahead of us. And thanks for coming back on to the podcast today to discuss some of these advances. Dr. Hamilton: Thanks, Dr. Sweetenham. I'm happy to join you today. It really was an impactful ASCO Annual Meeting. I probably am biased, but some great research was presented this year, and I heard lots of great conversations happening while we were there. Dr. Sweetenham: Yeah, absolutely. There was a lot of buzz, as well as a lot of media buzz around the meeting this year, and I think that's probably a good place to start. So I'd like to dive into abstract number LBA3510. This was the CHALLENGE trial, which created a lot of buzz at the meeting and subsequently in the media. This is the study that was led by the NCI Canada Clinical Trials Group, which was the first randomized phase 3 trial in patients with stage III and high-risk stage II colon cancer, which demonstrated that a post-treatment structured exercise program is both feasible and effective in improving disease-free survival in this patient group. The study was performed over a long period of time and in many respects is quite remarkable. So, I wonder if you could give us your thoughts about this study and whether you think that this means that our futures are going to be full of structured exercise programs for those patients who may benefit. Dr. Hamilton: It's a fantastic question. I think that this abstract did create a lot of buzz. We were very excited when we read it. It was highlighted in one of the Clinical Science Symposium sessions. But briefly, this was a phase 3 randomized trial. It was conducted at 55 centers, so really a broad experience, and patients that had resected colon cancer who completed adjuvant therapy were allowed to participate. There were essentially 2 groups: a structured exercise program, called ‘the exercise group,' or health education materials alone, so that was called just ‘the health education group.' And this was a 3-year intervention, so very high quality. The primary end point, as you mentioned, was disease-free survival. This actually accrued from 2009 to 2024, so quite a lift, and almost 900 patients underwent randomization to the exercise group or the health education group. And at almost 8 years of follow-up, we saw that the disease-free survival was significantly longer in the exercise group than the health education group. This was essentially 80.3% of patients were disease-free in exercise and 73.9% in the health education group. So a difference of over 6 percentage points, which, you know, at least in the breast cancer world, we make decisions about whether to do chemotherapy or not based on these kind of data. We also looked at overall survival in the exercise group and health education group, and the 8-year overall survival was 90.3% in the exercise group and 83.2% in the health education group. So this was a difference of 7.1%. Still statistically significant. I think this was really a fantastic effort over more than a decade at over 50 institutions with almost 900 patients, really done in a very systematic, high-intervention way that showed a fantastic result. Absolutely generalizable for patients with colon cancer. We have hints in other cancers that this is beneficial, and frankly, for our patients for other comorbidities, such as cardiovascular, etc., I really think that this is an abstract that deserved the press that it received. Dr. Sweetenham: Yeah, absolutely, and it is going to be very interesting, I think, over the next 2 or 3 years to see how much impact this particular study might have on programs across the country and across the world actually, in terms of what they do in this kind of adjuvant setting for structured exercise. Dr. Hamilton: Absolutely.  So let's move on to Abstract 3006. This was an NCI-led effort comparing genomic testing using ctDNA and tissue from patients with less common cancers who were enrolled in but not eligible for a treatment arm of the NCI-MATCH trial. Tell us about your takeaways from this study. Dr. Sweetenham: Yeah, so I thought this was a really interesting study based, as you said, on NCI-MATCH. And many of the listeners will probably remember that the original NCI-MATCH study screened almost 6,000 patients to assess eligibility for those who had an actionable mutation. And it turned out that about 60% of the patients who went on to the study had less common tumors, which were defined as anything other than colon, rectum, breast, non–small cell lung cancer, or prostate cancer. And most of those patients lacked an eligible mutation of interest and so didn't get onto a trial therapy. But with a great deal of foresight, the study group had actually collected plasma samples from these patients so that they would have the opportunity to look at circulating tumor DNA profiles with the potential being that this might be another way for testing for clinically relevant mutations in some of these less common cancer types. So initially, they tested more than 2,000 patients, and to make a somewhat complicated story short, there was a subset of five histologies with a larger representation in terms of sample size. And these were cholangiocarcinoma, small cell lung cancer, esophageal cancer, pancreatic, and salivary gland cancer. And in those particular tumors, when they compared the ctDNA sequencing with the original tumor, there was a concordance there of around 84%, 85%. And in the presentation, the investigators go on to list the specific mutated genes that were identified in each of those tumors. But I think that the other compelling part of this study from my perspective was not just that concordance, which suggests that there's an opportunity there for the use of ctDNA instead of tumor biopsies in some of these situations, but what was also interesting was the fact that there were several clinically relevant mutations which were detected only in the circulating tumor DNA. And a couple of examples of those included IDH1 for cholangiocarcinoma, BRAF and p53 in several histologies, and microsatellite instability was most prevalent in small cell lung cancer in the ctDNA. So I think that what this demonstrates is that liquid biopsy is certainly a viable screening option for patients who are being assessed for matching for targeted therapies in clinical trials. The fact that some of these mutations were only seen in the ctDNA and not in the primary tumor specimen certainly suggests that there's some tumor heterogeneity. But I think that for me, the most compelling part of this study was the fact that many of these mutations were only picked up in the plasma. And so, as the authors concluded, they believe that a comprehensive gene profiling with circulating tumor DNA probably should be included as a primary screening modality in future trials of targeted therapy of this type. Dr. Hamilton: Yeah, I think that that's really interesting and mirrors a lot of data that we've been seeing. At least in breast cancer, you know, we still do a biopsy up front to make sure that our markers, we're still treating the right disease that we think we are. But it really speaks to the utility of using ctDNA for serial monitoring and the emergence of mutations. Dr. Sweetenham: Absolutely. And you mentioned breast cancer, and so I'd like to dwell on that for a moment here because obviously, there was a huge amount of exciting breast cancer data presented at the meeting this year. And in particular, I'd like to ask you about LBA1008, the DESTINY-Breast09 clinical trial, which I think has the potential to establish a new first-line standard of care for metastatic HER2+ breast cancer. And that's an area where we haven't seen a whole lot of innovation for around a decade now. So can you give us some of the highlights of this trial and what your thinking is, having seen the results? Dr. Hamilton: Yeah, absolutely. So this was a trial in the first-line metastatic HER2 setting. So this was looking at trastuzumab deruxtecan. We certainly have had no shortage of reports around this drug, initially approved for later lines. DESTINY-Breast03 brought it into our second-line setting for HER2+ disease and we're now looking at DESTINY-Breast09 in first-line. So this actually was a 3-arm trial where patients were randomized 1:1:1 against standard taxane/trastuzumab/pertuzumab in one arm; trastuzumab deruxtecan with pertuzumab in another arm; and then a third arm, trastuzumab deruxtecan alone. And what we did not see reported was that trastuzumab deruxtecan-alone arm. But we did have reports from the trastuzumab deruxtecan plus pertuzumab versus the chemo/trastuzumab/pertuzumab. And what we saw was a statistically significant improvement in median progression-free survival, 26.9 months up to 40.7, so an improvement of 13.8 months, over a year in PFS. Not to mention that we're now in the 40-month range for PFS in first-line disease. Really, across all subgroups, we really weren't able to pick out a subset of patients that did not benefit. We did see about a 12% ILD rate with trastuzumab deruxtecan. That really is on par with what we've seen in other studies, around 10%-15%. I think that this is going to become a new standard of care in the first-line. I think it did leave some unanswered questions. We saw some data from the PATINA trial this past San Antonio Breast, looking at the addition of endocrine therapy with or without a CDK4/6 inhibitor, palbociclib, for those patients that also have ER+ disease, after taxane has dropped out in the first-line setting. So how we're going to kind of merge all this together is, I suspect that there are going to be patients that we or they just don't have the appetite to continue 3 to 4 years of trastuzumab deruxtecan. And so we're probably going to be looking at a maintenance-type strategy for them, maybe integrating the PATINA data there. But how we really put this into practice in the first-line setting and if or when we think about de-escalating down from trastuzumab deruxtecan to antibody therapy are some lingering questions. Dr. Sweetenham: Okay, so certainly is going to influence practice, but watch this space for a little bit longer, it sounds as though that's what you're saying. Dr. Hamilton: Absolutely.  So let's move on to GI cancer. Abstract 4006 reported preliminary results from the randomized phase 2 study of elraglusib in combination with gemcitabine/nab-paclitaxel versus the chemo gemcitabine/nab-paclitaxel alone in patients with previously untreated metastatic pancreatic cancer. Can you tell us more about this study? Dr. Sweetenham: Yeah, absolutely. As you mentioned, elraglusib is actually a first-in-class inhibitor of GSK3-beta, which has multiple potential actions in pancreatic cancer. But the drug itself may be involved in mediating drug resistance as well as in some tumor immune response modulation. Some of that's not clearly understood, I believe, right now. But certainly, preclinical data suggests that the drug may be effective in preclinical models and may also be effective in combination with chemotherapy and potentially with immune-modulating agents as well. So this particular study, as you said, was an open-label, randomized phase 2 study in which patients with pancreatic cancer were randomized 2:1 in favor of the elraglusib plus GMP—gemcitabine and nab-paclitaxel—versus the chemotherapy alone. And upon completion of the study, which is not right now, median overall survival was the primary end point, but there are a number of other end points which I'll talk about in just a moment. But the sample size was planned to be around 207 patients. The primary analysis included 155 patients in the combination arm versus 78 patients in the gemcitabine/nab-paclitaxel arm. Overall, the 1-year overall survival rate was 44.1% for the patients in the elraglusib-containing arm versus 23.0% in the patients receiving gemcitabine/nab-paclitaxel only. When they look at the median overall survival, it was 9.3 months for the experimental arm versus 7.2 months for chemotherapy alone. So put another way, there's around a 37% reduction in the risk of death with the use of this combination arm. The treatment was overall well-tolerated. There were some issues with grade 1 to 2 transient visual impairment in a large proportion of the patients. The most common treatment-related adverse effects with the elraglusib/GMP combination was transient visual impairment, which affected around 60% of the patients. Most of the more serious treatment-related adverse events included neutropenia, anemia, and fatigue in 50%, 25%, and 16% of the patients, respectively. So the early results from this study show a significant benefit for 1-year overall survival and for median overall survival with, as I mentioned above, a significant reduction in the risk of death. The authors went on to mention that the median overall survival for the control arm in this study is somewhat lower than in other comparable trials, but they think that this may be related to a more advanced disease burden in this particular study. Of interest to me was that right now: there is no apparent difference in progression-free survival between the 2 arms of this study. The authors described this as potentially indicating that this may be related in some way to immune modulation and immune effects on the tumor, which, if I'm completely honest, I don't totally understand. And so, the improvement in overall survival, as far as I can see at the moment, is not matched by an improvement in progression-free survival. So I think we probably need to wait for more time to elapse to see what happens with the study. And so, I think it certainly is an interesting study, and the results are intriguing, but I think it's probably a little early for it to actually shift the treatment paradigm in this disease. Dr. Hamilton: Fantastic. I think we've been waiting for advances in pancreatic cancer for a long time, but this, not unlike others, we learn more and then learn more we don't realize, so. Dr. Sweetenham: Right. Let's shift gears at this point and talk about a couple of other abstracts in kind of a very different space. Let's start out with symptom management for older adults with cancer. We know that undertreated symptoms are common among the older patient population, and Abstract 11002 reported on a randomized trial that demonstrated the effects of remote monitoring for older patients with cancer in terms of kind of symptoms and so on. Can you tell us a little bit about this study and whether you think this approach will potentially improve care for older patients? Dr. Hamilton: Yeah, I really liked this abstract. It was conducted through the Veterans Affairs, and it was based in California, which I'm telling you that because it's going to have a little bit of an implication later on. But essentially, adults that were 75 years or older who were Medicare Advantage beneficiaries were eligible to participate. Forty-three clinics in Southern California and Arizona, and patients were randomized either into a control group of usual clinic care alone, or an intervention group, which was usual care plus a lay health worker-led proactive telephone-based weekly symptom assessment, and this was for 12 months using the validated Edmonton Symptom Assessment System. So, there was a planned enrollment of at least 200 patients in each group. They successfully met that. And this lay health worker reviewed assessments with a physician assistant, who conducted follow-up for symptoms that changed by 2 points from a prior assessment or were rated 4 or greater. So almost a triage system to figure out who needed to be reached out to and to kind of work on symptoms. What I thought was fantastic about this was it was very representative of where it enrolled. There were actually about 50% of patients enrolled here that were Hispanic or Latinos. So some of our underserved populations and really across a wide variety of tumor types. They found that the intervention group had 53% lower odds of emergency room use, 68% lower odds of hospital use than the control group. And when they translated this to actual total cost of care, this was a savings of about $12,000 U.S. per participant and 75% lower odds of a death in an acute care facility. So I thought this was really interesting for a variety of reasons. One, certainly health care utilization and cost, but even more so, I think any of our patients would want to prevent hospitalizations and ER visits. Normally, that's not a fantastic experience having to feel poorly enough that you're in the emergency room or the hospital. And really showing in kind of concrete metrics that we were able to decrease this with this intervention. In terms of sustainability and scalability, I think the question is really the workforce to do this. Obviously, you know, this is going to take dedicated employees to have the ability to reach out to these patients, etc., but I think in value-based care, there's definitely a possibility of having reimbursement and having the funds to institute a program like this. So, definitely thought-provoking, and I hope it leads to more interventions. Dr. Sweetenham: Yeah, we've seen, over several years now, many of these studies which have looked at remote symptom monitoring and so on in this patient population, and many of them do show benefits for that in kinds of end points, not the least in this study being hospitalization and emergency room avoidance. But I think the scalability and personnel issue is a huge one, and I do wonder at some level whether we may see some AI-based platforms coming along that could actually help with this and provide interactions with these patients outside of actual real people, or at least in combination with real people. Dr. Hamilton: Yeah, that's a fantastic point.  So let's talk a little bit about clinical trials. So eligibility assessment for oncology clinical trials, or prescreening, really relies on manual review of unstructured clinical notes. It's time-consuming, it's prone to errors, and Abstract 1508 reported on the final analysis of a randomized trial that looked at the effect of human-AI teams prescreening for clinical trial eligibility versus human-only or AI-only prescreening. So give us more good news about AI. What did the study find? Dr. Sweetenham: Yeah, this is a really, a really interesting study. And of course, any of us who have ever been involved in clinical trials will know that accrual is always a problem. And I think most centers have attempted, and some quite successfully managed to develop prescreening programs so that patients are screened by a health care provider or health care worker prior to being seen in the clinic, and the clinical investigator will then already know whether they're going to be eligible for a trial or not. But as you've already said, it's a slow process. It's typically somewhat inefficient and requires a lot of time on the part of the health care workers to actually do this in a successful way. And so, this was a study from Emory University where they took three models of ways in which they could assess the accuracy of the prescreening of charts for patients who are going to be considered for clinical trials. One of these was essentially the regular way of having two research coordinators physically abstract the charts. The second one was an AI platform which would extract longitudinal EHR data. And then the third one was a combination of the two. So the AI would be augmented by the research coordinator or the other way around. As a gold standard, they had three independent oncology reviewers who went through all of these charts to provide what they regarded as being the benchmark for accuracy. In a way, it's not a surprise to me because I think that a number of other systems which have used this combination of human verification of AI-based tools, it actually ultimately concluded that the combination of the two in terms of chart accuracy was for the most part better than either one individually, either the research coordinator or the AI alone. So I'll give you just a few examples of where specifically that mattered. The human plus AI platform was more accurate in terms of tumor staging, in terms of identifying biomarker testing and biomarker results, as well as biomarker interpretation, and was also superior in terms of listing medications. There are one or two other areas where either the AI alone was somewhat more accurate, but the significant differences were very much in favor of a combination of human + AI screening of these patient charts. So, in full disclosure, this didn't save time, but what the authors reported was that there were definite efficiency gains, and presumably this would actually become even more improved once the research coordinators were somewhat more comfortable and at home with the AI tool. So, I thought it was an interesting way of trying to enhance clinical trial accrual up front by this combination of humans and technology, and I think it's going to be interesting to see if this gets adopted at other centers in the future. Dr. Hamilton: Yeah, I think it's really fascinating, all the different places that we can be using AI, and I love the takeaway that AI and humans together are better than either individually. Dr. Sweetenham: Absolutely.  Thanks once again, Dr. Hamilton, for sharing your insights with us today and for all of the incredible work you did to build a robust program. And also, congratulations on what was, I think, a really remarkable ASCO this year, one of the most exciting for some time, I think. So thank you again for that. Dr. Hamilton: Thanks so much. It was really a pleasure to work on ASCO 2025 this year. Dr. Sweetenham: And thank you to our listeners for joining us today. You'll find links to all the abstracts we discussed today in the transcript of this episode. Be sure to catch up on all of our coverage from the Annual Meeting. You can catch up on my daily reports that were published each day of the Annual Meeting, featuring the key science and innovations presented. And we'll have wrap-up episodes publishing in June, covering the full spectrum of malignancies from ASCO25. If you value the insights you hear on the ASCO Daily News Podcast, please remember to rate, review, and subscribe wherever you get your podcasts. Disclaimer: 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.   More on today's speakers: Dr. John Sweetenham   Dr. Erika Hamilton @erikahamilton9   Follow ASCO on social media:  @ASCO on Twitter  ASCO on Bluesky  ASCO on Facebook   ASCO on LinkedIn     Disclosures:     Dr. John Sweetenham:     No relationships to disclose    Dr. Erika Hamilton: Consulting or Advisory Role (Inst): Pfizer, Genentech/Roche, Lilly, Daiichi Sankyo, Mersana, AstraZeneca, Novartis, Ellipses Pharma, Olema Pharmaceuticals, Stemline Therapeutics, Tubulis, Verascity Science, Theratechnologies, Accutar Biotechnology, Entos, Fosun Pharma, Gilead Sciences, Jazz Pharmaceuticals, Medical Pharma Services, Hosun Pharma, Zentalis Pharmaceuticals, Jefferies, Tempus Labs, Arvinas, Circle Pharma, Janssen, Johnson and Johnson   Research Funding (Inst): AstraZeneca, Hutchison MediPharma, OncoMed, MedImmune, Stem CentRx, Genentech/Roche, Curis, Verastem, Zymeworks, Syndax, Lycera, Rgenix, Novartis, Millenium, TapImmune, Inc., Lilly, Pfizer, Lilly, Pfizer, Tesaro, Boehringer Ingelheim, H3 Biomedicine, Radius Health, Acerta Pharma, Macrogenics, Abbvie, Immunomedics, Fujifilm, eFFECTOR Therapeutics, Merus, Nucana, Regeneron, Leap Therapeutics, Taiho Pharmaceuticals, EMD Serono, Daiichi Sankyo, ArQule, Syros Pharmaceuticals, Clovis Oncology, CytomX Therapeutics, InventisBio, Deciphera, Sermonix Pharmaceuticals, Zenith Epigentics, Arvinas, Harpoon, Black Diamond, Orinove, Molecular Templates, Seattle Genetics, Compugen, GI Therapeutics, Karyopharm Therapeutics, Dana-Farber Cancer Hospital, Shattuck Labs, PharmaMar, Olema Pharmaceuticals, Immunogen, Plexxikon, Amgen, Akesobio Australia, ADC Therapeutics, AtlasMedx, Aravive, Ellipses Pharma, Incyte, MabSpace Biosciences, ORIC Pharmaceuticals, Pieris Pharmaceuticals, Pieris Pharmaceuticals, Pionyr, Repetoire Immune Medicines, Treadwell Therapeutics, Accutar Biotech, Artios, Bliss Biopharmaceutical, Cascadian Therapeutics, Dantari, Duality Biologics, Elucida Oncology, Infinity Pharmaceuticals, Relay Therapeutics, Tolmar, Torque, BeiGene, Context Therapeutics, K-Group Beta, Kind Pharmaceuticals, Loxo Oncology, Oncothyreon, Orum Therapeutics, Prelude Therapeutics, Profound Bio, Cullinan Oncology, Bristol-Myers Squib, Eisai, Fochon Pharmaceuticals, Gilead Sciences, Inspirna, Myriad Genetics, Silverback Therapeutics, Stemline Therapeutics

Anne Wojcicki, founder of 23andMe, has successfully repurchased the genetic testing firm out of bankruptcy through her non-profit TTAM for $305 million, surpassing a prior winning bid from Regeneron. The deal, which excludes the company's liabilities, may ease public concerns over genetic data transfers, given Wojcicki's continued leadership. The acquisition still requires court approval, while … Continue reading Anne Wojcicki Reclaims 23andMe in $305M Deal #1827 → The post Anne Wojcicki Reclaims 23andMe in $305M Deal #1827 appeared first on Geek News Central.

Anne Wojcicki, founder of 23andMe, has successfully repurchased the genetic testing firm out of bankruptcy through her non-profit TTAM for $305 million, surpassing a prior winning bid from Regeneron. The deal, which excludes the company's liabilities, may ease public concerns over genetic data transfers, given Wojcicki's continued leadership. The acquisition still requires court approval, while … Continue reading Anne Wojcicki Reclaims 23andMe in $305M Deal #1827 → The post Anne Wojcicki Reclaims 23andMe in $305M Deal #1827 appeared first on Geek News Central.

The U.S. and China have reached a framework for a trade deal, marking progress in the London talks between both nations. Bankrupt23andMe is up for sale, and drugmaker Regeneron is at the negotiating table. CEO Dr. Len Schleifer discusses the value of genetic data in medicine, explaining the role DNA plays in developing drug therapies. Plus, Elon Musk has posted an X of regret after publicly clashing with President Trump on social media, and CNBC's Robert Frank reports on Jimmy Buffett's $275 million estate, currently caught between the Margaritaville empire's two trustees.  Dr. Len Schleifer - 14:18Robert Frank - 29:14 In this episode: Robert Frank, @robtfrankBecky Quick, @BeckyQuickJoe Kernen, @JoeSquawkKatie Kramer, @Kramer_Katie

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Metsera's new long-acting amylin injection, met-233i, has shown promising weight loss results over eight months, leading to a rise in shares. Meanwhile, CDC vaccine advisors are either being pushed out or leaving their positions. Other top stories include Sirna's expansion beyond the liver, Keros returning $375 million to investors, and ACIP members receiving termination notices. In vitro cell research is focused on slowing aging and preventing age-related diseases. Updates on Merck's oral PCSK9 inhibitor, Sanofi and Regeneron's Dupixent effectiveness, and Avidity's muscular dystrophy drug are also highlighted.The expansion of RNA therapeutics is discussed, with multiple companies aiming to target small interfering RNA to various organs by 2030. Uniqure's regulatory progress in developing a gene therapy for Huntington's disease has sparked optimism, although past disappointments for patients are noted. Perspective Therapeutics presents new data on neuroendocrine tumor treatment at ASCO25. Concerns about RFK Jr.'s vaccine campaign and its potential to increase distrust in vaccines are raised in the editorial. Cancer news, cell and gene therapy updates, upcoming events, job listings, and a call for reader suggestions on coverage topics are also covered.

Mumbai markets are leading the global pack — but can sky-high valuations in cement and defense stocks hold? Hosted by Michelle Martin with Ryan Huang, we unpack India’s stunning 10% rally and what’s driving the bull run. JPMorgan’s bullish on beaten-down biotech: hear why Eli Lilly, Gilead, Merck, Regeneron, and Bristol Myers are back on their radar. DocuSign gets punished despite strong earnings — what’s spooking investors? Keppel DC REIT climbs back into the STI on AI-data centre bets, while Hello Kitty’s parent Sanrio outpaces Toyota. Plus, the Straits Times Index movers: CDL, Yangzijiang, and DFI Retail. See omnystudio.com/listener for privacy information.

Time now for our daily Tech and Business Report. KCBS Radio news anchor Steve Scott spoke with Bloomberg's Steven Church. The fate of the bankrupt South San Francisco genetics company 23andMe is once again up in the air. This comes after biotech company Regeneron sought to acquire the company for 236 million dollars last month. JHVEPhoto / Getty Images

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in the Pharma and Biotech world.Jefferies predicts an increase in small tuck-in deals in the biotech industry as companies face challenges accessing capital. Companies and industry groups are offering solutions to mitigate the impact of Trump tariffs on rare disease, cell, and gene therapy. Pitchbook suggests a shift towards more sustainable investing in biotech VC firms. Gilead is gearing up to challenge J&J in the $20 billion multiple myeloma CAR-T market. PTP's generative AI is revolutionizing data summaries for biotech QC workflows. Sanofi recently acquired Blueprint for $9.5 billion, while BMS has committed up to $11 billion with Biontech. Lilly has signed a deal worth up to $870 million, and Regeneron is investing nearly $2 billion in a Chinese obesity drug. Merck's CEO is emphasizing diversity in operations following the defeat of an anti-DEI measure. Immuno-oncology drugs Keytruda and Opdivo may face scrutiny in the near future.In other news, Vigil Neuroscience's Trem2 antibody for a rare brain disease failed in a Phase II trial shortly after Sanofi's acquisition of the company. Analysts believe the results were not surprising and should not impact the deal. Lilly has signed a deal worth up to $870 million to develop a long-acting GLP-1 obesity drug, while the FDA is committed to making rare disease drugs available at the first sign of promise. Pharma tuck-in deals are increasing after a slow first quarter for small biotechs. BioAgc Biologics will be attending Bio International in Boston to discuss their global drug production capabilities.Stay tuned for more updates on investing in research, welcoming global talent, the biotech VC cycle, Gilead's challenge to J&J in the multiple myeloma CAR-T market, and much more. Upcoming events and job listings in the pharmaceutical industry are also featured in our newsletter.Thank you for tuning in to Pharma and Biotech daily.

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Bob McCowan, CIO at Regeneron, joins host Maryfran Johnson for this CIO Leadership Live interview. They discuss fostering high-performance tech teams, the benefits of a science-driven company culture, evolving CIO role as business change agents, the vital connection between digital business and data architectures, and more. This episode is sponsored by Vasion Print, formerly known as PrinterLogic, which lets customers simplify infrastructure and maximize resources by replacing print servers with direct IP, serverless printing. Schedule a demo at Vasion.com.

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

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Regeneron's shares have dropped due to the failure of their dupixent follow-up drug, while Sanofi has acquired Blueprint for $9.5 billion to expand their rare disease portfolio. Bristol Myers Squibb is collaborating with Biontech on a bispecific antibody for solid tumors, and Amgen's imdelltra has shown a 40% increase in survival for small cell lung cancer at ASCO. Moderna has received FDA approval for their next-gen COVID-19 vaccine, and AstraZeneca is partnering with AI companies to stop cancer at all stages. Keros has cut 45% of its workforce along with a pulmonary hypertension drug, and Jazz has presented new cancer data at ASCO. FDA actions are pending for companies like Merck, Gilead, and Regeneron/Sanofi.The implications of the overturning of the FDA's lab-developed tests rule in a post-Chevron legal landscape are discussed, where power has shifted from federal agencies to the courts. Upcoming FDA decisions, including Gilead's HIV prophylaxis lenacapavir, are highlighted, along with new FDA guidelines on nitrosamine testing for the pharmaceutical industry. Jazz Pharmaceuticals is in the "goldilocks zone" with new cancer data at ASCO25, showcasing results from acquisitions made over the past five years. Zeiss introduces an AI-powered spatial biology solution for research labs. Other news includes updates from ASCO25, cell and gene therapy developments, and upcoming events in the biopharma industry.

On this week's episode, Chris Garabedian, Josh Schimmer, Nina Kjellson, Mike Yee, and Tim Opler kick off with breaking data from Summit and Akeso's lung cancer therapy, exploring the results and potential next steps for the treatment. The current state of biotech M&A is the next topic of conversation, with continued macroeconomic uncertainty and investor preferencefor commercial-stage companies over clinical-stage deals highlighted. The hosts note that industry challenges preceded recent government agency upheavals, with the industry seeing a wave of shutdowns, noting iTeos as one of those companies most recently impacted. The conversation touches on Bruce Booth's "Biotech Wisdom of the Crowds" blog for additional market perspective. On the policy front NIH funding adjustments for early research and the Trump administration'scancellation of Moderna's $600M bird flu vaccine contract are overviewed. The FDA's upcoming listening tour is also noted, where industry leaders will provide feedback to regulators. Next, the group analyzes Prothena's Phase 3 data in AL amyloidosis. Looking ahead, the hosts preview ASCO 2025 andthe Jefferies Healthcare Conference, where attendees look forward to hearing from Marty Makary. The episode concludes with Regeneron's acquisition of 23andMe, examining implications for genetic data privacy and congressional legislation. *This episode aired on May 30, 2025.

In der heutigen Folge sprechen die Finanzjournalisten Anja Ettel und Holger Zschäpitz über TACO und TALO, das Comeback der Mag7 und was diese Woche sonst noch wichtig wird. Außerdem geht es um Nvidia, Costco, Regeneron, Sanofi, Gap, Palantir, Astra Zeneca, Daiichi Sankyo, Bristol Myers Squibb, Biontech, Merck KGaA, Pfizer, Tempus AI, ARK Genomic Revolution ETF (WKN: A08AY), ARK Innovation ETF (WKN: A14Y8H), Invesco S&P 500 ETF (WKN: A1CYW7), Xtrackers S&P 500 Swap ETF (WKN: DBX0F2) und Scalable MSCI AC World Xtrackers ETF (WKN: DBX1SC). Wir freuen uns an Feedback über aaa@welt.de. Noch mehr "Alles auf Aktien" findet Ihr bei WELTplus und Apple Podcasts – inklusive aller Artikel der Hosts und AAA-Newsletter.[ Hier bei WELT.](https://www.welt.de/podcasts/alles-auf-aktien/plus247399208/Boersen-Podcast-AAA-Bonus-Folgen-Jede-Woche-noch-mehr-Antworten-auf-Eure-Boersen-Fragen.html.) [Hier] (https://open.spotify.com/playlist/6zxjyJpTMunyYCY6F7vHK1?si=8f6cTnkEQnmSrlMU8Vo6uQ) findest Du die Samstagsfolgen Klassiker-Playlist auf Spotify! Disclaimer: Die im Podcast besprochenen Aktien und Fonds stellen keine spezifischen Kauf- oder Anlage-Empfehlungen dar. Die Moderatoren und der Verlag haften nicht für etwaige Verluste, die aufgrund der Umsetzung der Gedanken oder Ideen entstehen. Hörtipps: Für alle, die noch mehr wissen wollen: Holger Zschäpitz können Sie jede Woche im Finanz- und Wirtschaftspodcast "Deffner&Zschäpitz" hören. Außerdem bei WELT: Im werktäglichen Podcast „Das bringt der Tag“ geben wir Ihnen im Gespräch mit WELT-Experten die wichtigsten Hintergrundinformationen zu einem politischen Top-Thema des Tages. +++ Werbung +++ Du möchtest mehr über unsere Werbepartner erfahren? [**Hier findest du alle Infos & Rabatte!**](https://linktr.ee/alles_auf_aktien) Impressum: https://www.welt.de/services/article7893735/Impressum.html Datenschutz: https://www.welt.de/services/article157550705/Datenschutzerklaerung-WELT-DIGITAL.html

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.The Summit's bispecific drug missed the survival endpoint in a global Phase III trial, but analysts remain optimistic about its potential to appeal to both Eastern and Western patient populations. Sanofi and Regeneron saw their shares tumble after a follow-up drug failed a Phase III COPD test. RFK Jr.'s report on health was found to have fake citations, casting doubt on its credibility. Astellas made a $1.5 billion bet on a Chinese collaboration for a cancer drug. In other news, Merck CEO emphasized the importance of diversity, while other companies faced setbacks and layoffs. AGC Biologics will be at BIO International to discuss their capabilities in drug production.

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

The Fed's preferred inflation measure – PCE – coming in as expected this morning as tariff whiplash continues: Carl Quintanilla, Sara Eisen, and David Faber broke down the numbers, along with the latest on the trade front (including a live reaction from Beijing to the President's new claims China's “totally violated” their agreement with the US). Charles Schwab's Chief Investment Strategist arguing: don't watch trade, but the jobs report next week… Hear why. Plus: a look at the Fed's next steps from here according to Former Fed Vice Chair Alan Blinder.  Also in focus: retail wreckage, as Gap becomes the latest name to slump on big tariff impacts… Top retail analyst Matthew Boss broke down the stocks he'd buy – and avoid – here; Regeneron shares on pace for their worst day since 2011 on new drug trial results; a look at one key part of the VC economy that's coming under pressure due to policy; and more on what's driving Hamptons rental demand to low tides.  Squawk on the Street Disclaimer

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 Bethany Doerfler, MS, RDN, a clinical research dietician specializing in lifestyle management of digestive diseases at Northwestern Medicine. Ryan and Holly discuss managing nutritional deficiencies in patients with non-EoE EGIDs and a study Bethany worked on. 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, Sanofi, Regeneron, and Takeda. Ryan introduces co-host Holly Knotowicz.   [1:17] Holly introduces today's topic, common nutritional deficiencies that affect those with eosinophilic gastrointestinal diseases that occur in the GI tract lower than the esophagus (non-EoE EGIDs).   [1:31] Holly introduces today's guest, Bethany Doerfler, a clinical research dietician specializing in lifestyle management of digestive diseases, including gastroesophageal reflux disease, motility disorders, and eosinophilic diseases.   [1:45] Bethany currently practices as part of a multi-disciplinary team in a digestive health institute at Northwestern Medicine.   [2:03] Bethany began working with this disorder almost 20 years ago. She worked with Dr. Gonsalves and Dr. Hirano at Northwestern. Dr. Gonsalves invited her to work with EoE patients. Bethany had not heard of EoE.   [2:59] Bethany says the lens that we've used to look at food as the trigger and also a therapeutic agent in the esophagus, we're looking at in non-EoE EGIDs as well; at the same time, trying to make sure that we're honoring the other parts of our patient's lives.   [3:27] Before Bethany started working in GI at Northwestern, she worked in the Wellness Institute, doing nutrition for patients at Northwestern. Bethany has a research background in epidemiology and she wanted to see better nutrition research in GI.   [3:56] Through a friend, Bethany connected with the Chief of GI at that point. Northwestern had never had a dietician working in GI.   [4:08] Bethany is pleased to see a trend in healthcare of thinking about the patient as a whole person, including diet, psychological wellness, physical health, exercise, sleep, and more. Bethany wanted to see more research on GI disorders.   [4:38] Bethany says that eosinophils in the esophagus indicate that something is irritating the tissues, such as reflux, food triggers, aeroallergens, and other things.   [4:58] Eosinophils do belong in the stomach, the small intestine, and the colon. The challenge for researchers has been, how many, where are they supposed to live, and what are they supposed to look like.   [5:10] There is eosinophilic gastritis, where eosinophils can infiltrate the stomach, causing a lot of inflammatory responses that make patients sick. We see that in all parts of the small intestine and less commonly, in the colon, as well.   [5:32] It's a good reminder for listeners that eosinophils are white blood cells. When they're in the tissues, they can swell things up and cause the body to have this inflammatory response in these lower GI tract organs.   [5:49] The symptoms patients can experience are vomiting, diarrhea, and abdominal pain, among other things.   [6:14] The nomenclature for this subset of eosinophil-associated diseases has changed and Bethany says to hang tight, there is lots of work underway to nail this down further in the next couple of months to a year.   [6:29] The last guidelines were published by a Delphi Consensus in 2022. The experts in the field got together and voted on the scientific accuracy of certain statements to develop cut points for how to grade.   [6:48] The experts are asking questions like: What counts as eosinophilic gastritis? What do we think are some of the symptoms and the clinical findings so that we all are looking at things through the same lens?   [7:02] To get to these consensus statements, there's a lot of discussion, agreement, and good collegial discussions about making sure that we're looking at this accurately.   [7:12] We're trying to give the right names to the right disorders and give clear diagnostic criteria, so that we're helping our patients get a diagnosis, and we're not labeling something incorrectly and sticking someone with an inaccurate diagnosis.   [7:36] The proper terminology is eosinophilic gastritis in the stomach, eosinophilic enteritis in the small intestine, eosinophilic colitis in the colon, and eosinophilic gastroenteritis where the stomach and the small bowel are involved.   [7:53] There's more to come on the clinical criteria of what makes that diagnosis but we're getting the names and the numbers right.   [8:03] Holly agrees that having the symptoms given a named diagnosis is important to patients, knowing that researchers are looking into their illness.   [9:00] Bethany notes that the diagnosis also means that there are opportunities for medical therapy, cut points for which medicines or therapies work or not, and billing codes. If we can't bill insurance companies, patients might not get certain services.    [9:28] Ryan tells how beneficial it was for him to have access to multi-disciplinary teams and see specialists he might not have seen without the proper diagnosis and just thought it was a GI issue. He was fortunate to see a dietician and start dietary therapy.   [9:53] Bethany says the dietician's priority is the patient's health and wellness.   [10:13] These disorders carry clinical non-gastrointestinal manifestations: fatigue, concern over what to eat, food access issues, family support, and other food allergies. These are important things for a dietician to consider.   [10:37] Are patients growing as they should? Do they feel like they have enough to eat? Do they feel excluded in social settings? There's a list of important things that we want to be looking at. That's why it's important to have a multi-disciplinary approach.   [11:07] First, Bethany wants to see that her patients are physically and nutritionally well. That's a priority if we're going to try to get rid of some of the food triggers that could be exacerbating the disease.   [11:20] Before Bethany takes anything out of someone's diet, she wants to make sure that they're getting enough of the good stuff to help them feel good and grow.   [11:29] From a diet therapy perspective, Bethany is trying to apply a food removal or substitution protocol to other spots outside the esophagus. They're seeing that some of the triggers are very similar, both in the stomach and small intestine.   [12:09] Dr. Gonsalves, Dr. Hirano, and Bethany did a study, The Elemental Study, where they wanted to uncover if food proteins carried the same trigger risk in the stomach and small intestine as they do in the esophagus.   [12:35] They put their patients on a hypoallergenic elemental formula for a period, followed up, and looked at their biopsies of the stomach and small intestine. Fifteen wonderful patients made it through the trial.   [12:56] One hundred percent of the patients achieved disease remission and felt better. There were some genetic alterations in the patients. Then they started the process of reintroducing foods over the year.   [13:15] That was not part of the original grant but was the team's clinical interest to see what it is that people are allergic to. Some of the common suspects: wheat, dairy, eggs, soy, and nuts, were found to be very common triggers for EoG and EoN, as well.   [13:47] The benefit of working with a dietician as part of your team is, first, we can remediate things the disease has caused nutritionally, and second, we can think about how diet can be a therapeutic tool to use with medications or instead of medication.   [14:15] If you want to use nutrition therapeutically, you don't have to stay there if it's not the right time to be taking things out of your diet. We have some good, safe, medical therapies. You can find your food triggers but you don't have to pick that lane forever.   [14:42] Holly and Ryan relate their experiences with traveling abroad and going on medical therapies when they can't stay on their diets.   [15:57] Bethany says low levels of vitamins and minerals in the blood can be caused by a disorder or an elimination diet. In the U.S., dairy is the biggest source of protein for young kids. It's also the biggest source of calcium and vitamin D.   [16:22] Dieticians often say, if we are going to use dietary therapy for EoE or non-EoE EGIDs, we have to think of this as a substitution diet. If we remove something, we have to replace it with something equally nutrient-dense.   [16:39] Bethany and her group look at serum values of Vitamin D, B12, and iron they assess for patients. For kids, instead of drawing blood, they piece together what they're taking against what they need and see if there are gaps to fill with food or supplements.   [17:32] In patients with non-EoE EGIDs, Bethany says we see the disease intersect with the food supply. When we take milk out, we're cutting the biggest source of calcium and Vitamin D. We have to replace calcium and Vitamin D.   [17:55] In the 1950s, a public health law allowed wheat to be enriched with folic acid and other B vitamins and iron. When we cut out wheat, our patients aren't getting enough iron or B vitamins. We have to replace those.   [18:16] For patients who have eosinophils in their stomach and small intestine, their absorption in the small bowel may be directly impacted.   [18:26] People can have low levels of protein in their blood, maybe because they're eating insufficient protein or maybe because the disease doesn't allow them to absorb protein sufficiently when there's swelling in the small intestine.   [18:44] There are other nutrients, like zinc, for people who have diarrhea, and magnesium if you can't eat a lot of whole grains and nuts, There are quite a few nutrients that Bethany is broadly looking at.   [18:54] Based on the absorption in the small intestine, patients' doctors need to look at their B12, folic acid, iron levels, and Vitamin D.   [19:12] Holly loves Bethany's terminology of replacing, not just eliminating, foods. She will use that terminology with her patients to make it feel more supportive for them.   [20:40] A lot of people want to get all their nutrients through their food. That's not always practical. Vitamin D is hard to get exclusively in your diet if you're not drinking milk or eating wild-caught fish. You have to rely on fortified foods or add supplements.   [21:15] One, we want to take a look at your diet and ask how are your calories. We want to make sure you're eating enough. Two, if we suspect there are some vitamin deficiencies, we check your blood or just empirically supplement you.   [21:36] Supplementation should be done carefully. There are some vitamins where you can get too much of a good thing. Vitamins stored in the fat need to be at levels sufficient for repletion, dictated by age and gender. Dieticians know what to recommend.   [22:19] For patients who have non-EoE EGIDs, some have tentative swallowing, so Bethany tries to do as many liquid or chewable safe options for supplements as possible.   [23:46] Holly works with patients who have feeding difficulty, so she appreciates the liquid and chewable supplements for easier swallowing and quicker absorption.    [24:08] Bethany mentions that some fortified oat, corn, and rice breakfast cereals are highly enriched with B vitamins and iron. Look at the labels. It can be a way to layer in more vitamins without purchasing a supplement.   [25:24] Holly doesn't think patients understand how valuable a good dietician can be. She had one patient with celiac who was taking a supplement with gluten in it! She reminds listeners to always consult your care team before making any changes to your treatment plan.   [25:59] Bethany's favorite thing to talk about is foods and where to find what. If listeners have questions, she is happy to post answers on the website.   [26:25] The American Academy of Pediatrics says a cup of vitamin-fortified juice a day is not too much sugar and is a good source of Vitamin C and other nutrients. The calcium and Vitamin D you get from a cup of fortified juice is very value-available.   [26:46] In the non-dairy drink world, some are nicely fortified and some are not. If you make your almond milk, you're missing out on the fortifications.   [27:11] Bethany likes some of the fortified juices and some of the enriched non-dairy milk options. Those are the best ways to get calcium and Vitamin D for people who need calories. Instead of water with meals, substitute an enriched drink with meals.   [27:33] Some people struggle with protein, probably because of their level of food restriction. The typical animal proteins are great. If you can do soy, a cup of soy milk has eight grams of protein. Soy is a complete protein that mimics animal proteins.   [28:04] Cook your cereal in soy milk. Use it as the base of a smoothie. This is before getting into protein powders. Try legume-based proteins, if you can handle legumes. Your supplements have to be personalized. That's the tricky part.   [28:30] If you have a lot of food allergies or intolerances, it may be worth talking to your gastroenterologist, allergist, or dietician about adding elemental formula as a supplement. Bethany uses it often with food allergy patients as a safe supplement.   [29:31] Bethany primarily treats adults but also young adults transitioning from the pediatric side into the adult world. Sometimes a feeding difficulty follows patients into adult treatment. We need everyone at the table to treat this immune-mediated disease.   [30:32] Patient advocacy groups like APFED have ways to help you find dieticians. Also, the Academy of Nutrition and Dietetics has “Find a Specialist” on their website. Eatright.org. Dieticians can do telehealth if you are not near one.   [31:45] If the practice that you're in doesn't have a dietician, you could gently suggest they have one join the practice, or consult with the practice. Patient advocacy is strong.   [33:12] Bethany talks about getting an appointment with a dietician. On the pediatric side, it has to do with the billing code. Ask your insurance if they cover medical nutrition therapy, Billing Code 97802, and for which diseases. Insurance may have stipulations.   [34:14] If medical nutrition therapy is not a covered benefit, ask the dietician if they can do a sliding scale. Holly says she has seen plans in several states where the patient can use the HSA or FSA card to pay for medical nutrition therapy.   [34:49] Bethany believes in the pediatric world, where growth and development are concerns, there's a little bit better coverage.   [34:59] On the adult side, if Bethany has other diagnoses, like high blood pressure, or diabetes, she is also billing for those because she makes sure what she recommends is also in line with what is good for their heart and wellness in general.   [35:55] Bethany was intrigued to learn food proteins do trigger disease activity for our patients in the stomach and small intestine, just as in the esophagus.   [36:20] In the Elemental Trial, they were surprised to learn people with non-EoE EGIDs had more allergies than expected. They were more likely to have more than just one or two. They were also more likely to have rare food allergies like legumes or grains.   [36:43] A patient may want to learn all their food triggers, but they may be a highly allergic person and it may not be worth trying to remove all their food triggers.   [37:06] Bethany wants to remind listeners that the diet approach should be a substitution diet. If you take things out, you've got to replace them with other plants.   [37:18] There's great crossover nutrition between fruits and vegetables. Seeds are great as a fill-in for nuts. There are plenty of other whole grains out there besides wheat. There are lots of good ways to get that nutritional balance into your diet.   [37:31] For anyone who's eliminating a food group, even if you're substituting it, it's a good idea to talk to your doctor about filling in with a good multivitamin, multimineral supplement.   [37:59] Bethany says it's fun working with colleagues to look for other ways to look at this nutrition lens for patients with Non-EoE EGIDs.   [38:14] They are looking at noninvasive ways to find eosinophils to go faster with helping people find their food triggers without having to scope them.   [38:28] Bethany is hoping with that research to be able to help people learn how they can cheat, like having pizza once a month if they are allergic to dairy. That's a question for your care team, but we don't have a great science-based way to answer that.   [38:53] As we study more noninvasive ways to get at eosinophilic activity, we can give patients a little bit more freedom and quality of life. That's what Bethany is working on next.   [39:58] Holly thanks Bethany Doerfler for joining us on Real Talk — Eosinophilic Diseases. For our listeners, to learn more about eosinophilic disorders, please visit APFED.org and check out the links in the show notes.   [40:11] If you're looking to find specialists who treat eosinophilic disorders, we encourage you to use APFED's Specialist Finder at APFED.org/specialist.   [40:21] 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.   [40:34] Holly thanks Bethany for joining us today. Holly also thanks APFED's Education Partners Bristol Myers Squibb, Sanofi, Regeneron, and Takeda for supporting this episode.   Mentioned in This Episode: Bethany Doerfler, MS, RD, Clinical Research Dietician specializing in lifestyle management of digestive diseases at Northwestern Medicine Dr. Nirmala Gonsalves Dr. Ikuo Hirano (In Memoriam) The Elemental Study, Gonsalves, Doerfler, Hirano Academy of Nutrition and Dietetics   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, Sanofi, Regeneron, and Takeda.   Tweetables:   “The lens that we've used to look at food as the trigger and also a therapeutic agent in the esophagus, we're doing that in non-EoE EGIDs as well, and at the same time, trying to make sure that we're honoring the other parts of our patient's lives.” — Bethany Doerfler, RD   “We are trying to give the right names to the right disorders and give clear diagnostic criteria so that we're helping our patients get a diagnosis, and we're not labeling something incorrectly and sticking someone with a diagnosis that isn't accurate.” — Bethany Doerfler, RD   “The diagnosis also means that there are opportunities for medical therapy, cut points for which we decide if medicines or other therapies work or not, and billing codes. If we can't bill insurance companies, patients may not be privy to certain services.” — Bethany Doerfler, RD   “Look at the [fortified cereal] labels. You'd be surprised how much they look like a multivitamin, not only for B vitamins but for iron. … It can be a fantastic way to layer in more vitamins without having to think about purchasing a supplement.” — Bethany Doerfler, RD   “There's great crossover nutrition between fruits and vegetables. Seeds are great as a fill-in for nuts. There are plenty of other whole grains out there besides wheat. There are lots of good ways for us to get that nutritional balance into your diet.” — Bethany Doerfler, RD

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

¡ALERTA FINANCIERA CON SABOR A BARRIO CHINO! ¿Harto de que la economía te suene a chino mandarín (o a arameo antiguo, que viene a ser lo mismo)? Tranqui, que aquí te lo contamos como si estuviéramos de cañas, pero con datos que te harán flipar más que un episodio de Black Mirror. En el menú de hoy: El Tío Sam pierde su corona de Rey Midas: Moody's le da un capón crediticio y lo deja tiritando. ¿Consecuencias? Pues que igual la próxima vez que pida prestado le cobran hasta por respirar. Analizamos la deuda que crece más rápido que la mala hierba. La Guerra de los Aranceles (Temporada 37): Trump amenaza con ponerle un impuesto hasta al aire que importamos de Europa. Apple, Volkswagen, Mercedes-Benz... ¡todos a cubierto! ¿Quién paga la fiesta? Spoiler: probablemente tú. Inteligencia Artificial: ¿Amiga o Enemiga?: Desde Nvidia y sus dramas con China hasta CoreWeave (¿quién?) y los robots que te quitarán el curro mientras Jony Ive (ex Apple) diseña su carcasa. Prepara el currículum para pasear perros. Cripto-Locura y Bancos Despistados: Coinbase se cuela en el S&P 500 (¡ole sus... bitcoins!) mientras los grandes bancos como JPMorgan se apuntan a la moda de las stablecoins después de haberlas puesto a parir. La coherencia, bien, gracias. El Drama del Carrito de la Compra: Walmart vs. Trump en un combate de pesos pesados por los precios. Target y Home Depot ven cómo el consumidor se aprieta el cinturón hasta ahogarse. ¿Compramos hoy o esperamos a las rebajas del Apocalipsis? Movidas Farmacéuticas: Novo Nordisk (los de Ozempic) cambia de jefe en plena tormenta y 23andMe vende tus genes al mejor postor (Regeneron). ¡Tu ADN vale pasta, amigo! Y mucho más: chanchullos de directivos vendiendo acciones (Palantir, D-Wave), la odisea de Boeing para no estrellarse (otra vez), y por qué BYD le está comiendo la tostada a Tesla en Europa. Todo esto servido con una buena dosis de ironía, un poquito de mala leche (constructiva, eso sí) y la perspectiva de quien ha visto más crisis que capítulos repetidos de Los Simpson. No te prometemos hacerte rico, pero unas risas (y alguna que otra idea para no palmar pasta) te echas seguro. ¡Dale al PLAY, bribón/a! Y si te mola el salseo financiero: ❤️ Likea si te hemos abierto los ojos (o te hemos dejado más confundido, que también tiene mérito). Comenta qué empresa crees que la va a pifiar más o cuál es tu apuesta ganadora. ¡Se abre debate! Comparte con ese colega que siempre está hablando de invertir y no tiene ni idea (o contigo mismo, para la posteridad). Suscríbete para no perderte ni una migaja de este festín de números y verdades incómodas.

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.

Dr. John Sweetenham and Dr. Erika Hamilton discuss top abstracts that will be presented at the 2025 ASCO Annual Meeting, including research on tech innovations that could shape the future of oncology. Transcript Dr. John Sweetenham: Hello, and welcome to the ASCO Daily News Podcast. I'm your host, Dr. John Sweetenham, and I'm delighted to be joined today by Dr. Erika Hamilton, a medical oncologist and director of breast cancer and gynecologic cancer research at the Sarah Cannon Research Institute in Nashville, Tennessee. Dr. Hamilton is also the chair of the 2025 ASCO Annual Meeting Scientific Program, and she's here to tell us about some of the key abstracts, hot topics, and novel approaches in cancer care that will be featured at this year's Annual Meeting. Our full disclosures are available in the transcript of this episode. Dr. Hamilton, it's great to have you on the podcast today, and thanks so much for being here. Dr. Erika Hamilton: Thanks, Dr. Sweetenham. I'm glad to be here. Dr. John Sweetenham: Dr. Hamilton, the Presidential Theme of the Annual Meeting this year is ‘Driving Knowledge to Action: Building a Better Future,' and that's reflected in many of the sessions that will focus on action-oriented guidance to improve care for our patients. And as always, there'll be great presentations on practice-changing abstracts that will change treatment paradigms and transform care. Can you tell us about some of the hot topics this year and what you're particularly excited about? Dr. Erika Hamilton: You're right. Dr. Robin Zon's theme is ‘Driving Knowledge to Action: Building a Better Future,' and you're going to see that theme really interlaced throughout the ASCO program this year. We had a record number of submissions. Over 5,000 abstracts will be published, and there'll be about 3,000 presentations, either in oral format or poster presentations. We have 200 dynamic sessions. Many of the discussants will be highlighting key takeaways and how we can translate action-oriented guidance to better treat our patients to build a better future. Our state-of-the-art science will include a Plenary Session. This will feature presentations as well as discussion of each of the presentations for clinical late-breaking abstracts. We have Clinical Science Symposia that I'm particularly excited about this year. These will feature key abstracts as well as discussions and a foundational talk around the subject. We're covering novel antibody-drug conjugate targets, turning “cold” tumors “hot” to include CAR T, as well as the future of cancer detection. There'll be rapid oral abstracts, case-based panels, and this will also feature interactive audience polling and case discussions. I also want to highlight the community connection opportunities. There will be 13 Communities of Practice that will be meeting on-site during ASCO, and there's also really a plethora of networking opportunities for trainees and early-career professionals, a Women's Networking Center, a patient advocate space, and I'm happy to report there will also be live music out on the terrace this year at ASCO. Dr. John Sweetenham: Well, that's going to be a really great addition. I have to say, I think this is always a special time of year because excitement starts to mount as the meeting gets closer and closer. And once the abstracts are out there, I certainly personally feel that the excitement builds. Talking of abstracts, let's dive into some of the key abstracts for this year's meeting. I'd like to start out by asking you about Abstract 505. This reports on 15-year outcomes for women with premenopausal hormone receptor-positive early breast cancer in the SOFT and TEXT trials. It assesses the benefits of adjuvant exemestane and ovarian function suppression or tamoxifen and ovarian function suppression. So, could you talk us through this and tell us what you think the key takeaways from this abstract are? Dr. Erika Hamilton: Absolutely. This is essentially the SOFT and TEXT trials. They are trials that we've been following for quite some time, evidenced by the 15-year outcome. And I think it really answers two very important questions for us regarding adjuvant endocrine therapy for patients that are facing hormone receptor-positive disease. The benefit of ovarian function suppression for one, and then second, the benefit of exemestane over tamoxifen, which is our SERM [selective estrogen receptor modulator]. So, in terms of the SOFT trial, when we talk about distance recurrence-free interval, which I really think is probably the most meaningful because secondary cancers, et cetera, are not really what we're getting at here. But in terms of distant recurrence-free interval, certainly with tamoxifen, using tamoxifen plus ovarian function suppression adds a little bit. But where we really get additional benefits are by moving to exemestane, an aromatase inhibitor with the ovarian function suppression. So, for example, in SOFT, for distant recurrence-free interval for patients that have received prior chemotherapy, the distance recurrence-free interval was 73.5% with tamoxifen, bumped up just a tiny bit to 73.8% with ovarian function suppression. But when we used both ovarian function suppression and switched to that aromatase inhibitor, we're now talking about 77.6%. It may seem like these are small numbers, but when we talk about an absolute benefit of 4%, these are the type of decisions that we decide whether to offer chemotherapy based on. So, really just optimizing endocrine therapy really can provide additional benefits for these patients. Just briefly, when we turn to TEXT, similarly, when we look at distance recurrence-free interval for our patients that are at highest risk and receive chemotherapy, tamoxifen and ovarian function suppression, 79%; 81% with exemestane and ovarian function suppression. And when we talk about our patients that did not receive chemotherapy, it increased from 91.6% up to 94.6%—very similar that 3% to 4% number. So, I think that this is just very important information when counseling our patients about the decisions that they're going to make for themselves in the adjuvant setting and how much we want to optimize endocrine therapy. Dr. John Sweetenham: Thanks so much for your insight into that. Dr. Erika Hamilton: Yeah, absolutely. So, let's turn to hematologic malignancies. Abstract 6506 reports exciting results on the new agent ziftomenib in relapsed/refractory NPM1-mutant acute myeloid leukemia. This is a phase 1b clinical activity study and safety results. This was the pivotal KOMET-001 study. And my question is, will this new agent fulfill an unmet need in this NPM1 space? Dr. John Sweetenham: Yeah, great question. And I think the answer is almost certainly ‘yes'. So, just as some brief background, NPM1 mutation is known to be a driver of leukemogenesis in around 30% of patients with AML, and it's a poor prognostic factor. And typically, about 50% of these patients will relapse within a year of their first-line therapy, and only around 10% of them will get a subsequent complete remission with salvage therapy. Menin inhibitors, which disrupt the interaction between menin and KMT2A, are known to be active in NPM1-mutated as well as in KMT2A-rearranged AML. And ziftomenib is a selective oral menin inhibitor, which in this study was evaluated at a dose of 600 mg once a day, as you mentioned, a phase 1b/2 study, which is multicenter and presented by Dr. Eunice Wang from Roswell Park. It's a relatively large study of 112 patients who were treated with this standard dose with relatively short median follow-up at this time. The median age was 69 years, and median prior therapies were two, but with a range of one to seven. And I think very importantly, 60% of these patients had previously been treated with venetoclax, and 23% of them had had a prior transplant. Looking at the results overall for this study, the overall response rate was 35%, which is actually quite impressive. Specifically for those patients in the phase 2 part of the study, around 23% achieved a CR [complete remission] or CRh [complete remission with partial hematologic recovery]. What's very interesting in my mind is that the response rates were comparable in venetoclax-naive and venetoclax-exposed patients. And the drug was very well tolerated, with only 3% of patients having to discontinue because of treatment-related adverse events. And I think the authors appropriately conclude that, first of all, the phase 2 primary endpoint in the study was met, and that ziftomenib achieved deep and durable responses in relapsed and refractory NPM1-mutated AML, regardless of prior venetoclax, with good tolerance of the drug. And so, I think putting all of this together, undoubtedly, these data do support the potential use of this agent as monotherapy and as a new option for those patients who have relapsed or refractory NPM1-mutated acute myeloid leukemia. So, let's move on a little bit more now and change the subject and change gears completely and talk about circulating tumor DNA [ctDNA]. This has been a hot topic over a number of years now, and at this year's meeting, there are quite a few impactful studies on the use of ctDNA. We have time to focus on just one of these, and I wanted to get your thoughts on Abstract 4503. This is from the NIAGARA trial, which looks at ctDNA in patients with muscle-invasive bladder cancer who receive perioperative durvalumab. Could you tell us a little bit about this study? Dr. Erika Hamilton: So, this was the phase 3 NIAGARA trial, and this is literally looking for patients with muscle-invasive bladder cancer that are cisplatin-eligible, and the addition of durvalumab to neoadjuvant chemotherapy. So here, this is a planned exploratory analysis of ctDNA and the association with clinical outcomes from NIAGARA. So, this is really the type of study that helps us determine which of our patients are more likely to have a good outcome and which of our patients are more likely not to. There were 1,000 randomized patients in this study, and 462 comprised the biomarker-evaluable population. There were about half in the control arm and half in the durvalumab arm. And overall, the ctDNA-positive rate at baseline was about 57%, or a little over half, and that had decreased to about 22% after neoadjuvant treatment. ctDNA clearance rates from baseline to pre-radical cystectomy was about 41% among those with durvalumab and 31% among those in control. And the non-pCR rate was 97% among patients with pre-cystectomy ctDNA-positive status. So, this really gives us some information about predicting who is going to have better outcomes here. We did see a disease-free survival benefit with perioperative durvalumab, and this was observed in post-cystectomy ctDNA-positive as well as the ctDNA-negative groups. Shifting gears now to GI cancer, Abstract 3506 is a long-term safety and efficacy study of sotorasib plus panitumumab and FOLFIRI for previously treated KRAS G12C-mutated metastatic colorectal cancer. And this is the CodeBreaK-101 study. What are your thoughts on this study? Dr. John Sweetenham: Yeah, thanks. A very interesting study, and this abstract builds upon the phase 3 CodeBreaK-300 trial, which I think has just been published in the Journal of Clinical Oncology. This showed that the combination of sotorasib and panitumumab improved clinical outcomes in patients with chemorefractory KRAS G12C-mutated metastatic colorectal cancer. The current abstract, as you mentioned, reports the CodeBreaK-101 trial. And this was a phase 1b trial where FOLFIRI therapy was added to sotorasib and panitumumab in previously treated patients with KRAS G12C-mutated metastatic colorectal cancer. The abstract reports the overall and progression-free survival results, as well as some updated safety and response data. So, in this study, patients with this particular mutation who had received at least one prior systemic treatment but were KRAS G12C inhibitor-naive were enrolled into an expansion cohort of the CodeBreaK-101 protocol. And these patients received what apparently now recommended as the standard phase 2 dose of sotorasib of 960 mg daily, plus panitumumab and a standard dose of FOLFIRI. And the primary endpoint of the study was safety, and secondary endpoints included confirmed response, overall response, and progression-free survival, as assessed by the investigator. And by November of last year, 40 patients had been enrolled into this study. Common treatment-related adverse events were cutaneous; some patients developed neutropenia, and stomatitis was fairly widespread. Discontinuation of sotorasib because of adverse events was only seen in 1% of patients, although patients did have to discontinue because of toxicity from some of the other agents in the combination. Looking at the results of this study, the updated objective response rate was 57.5%, and the disease control rate was estimated at 92%, going on 93%, with a median time to response of 1.6 months and a median response duration of 6 months. After a median follow-up of 29.2 months, the median progression-free survival was 8.2 months, and the overall survival 17.9 months. So, the authors have concluded that this combination, including sotorasib, panitumumab, and FOLFIRI, does appear to show quite promising long-term efficacy in pretreated patients with this specific mutation. The ongoing phase 3 study they mentioned, CodeBreaK-301, is aiming to evaluate this combination against the standard of care in the first-line setting for patients with KRAS G12C-mutated colorectal cancer. So, promising results, and we'd be very interested to see how this particular combination performs in the frontline. Dr. Erika Hamilton: Fantastic. Thanks so much for sharing that. Let's shift gears again and really talk about digital technology. I feel that we're all going to have to get much better with this, and really, there are a lot of promises for our patients coming here. There are a lot of abstracts at ASCO that are focusing on innovations in digital technology, including a really interesting psychosocial digital application for caregivers of patients that are undergoing hematopoietic stem cell transplantation. Can you tell us a little bit about this? It's Abstract 11000. Dr. John Sweetenham: Yeah, absolutely. This abstract certainly caught my eye, and I think it's intriguing for a number of reasons, partly because it's app-based, and partly also because it specifically addresses caregiver burden and caregiver needs in the oncology setting, which I think is especially important. And although the context, the clinical context of this study, is hematopoietic stem cell transplantation, I think it has potential applications way beyond that. We all know that caregivers of patients undergoing stem cell transplantation have significant quality-of-life struggles. They are well-documented to have significant psychological and emotional strain before, during, and after stem cell transplantation. And this abstract describes an application called BMT-CARE, which is aimed at improving caregivers' quality of life, caregiver burden, mood symptoms, and coping skills, and so on. So, this was a single-center, randomized trial from MGH [Massachusetts General Hospital] of this app for stem cell transplant caregivers, compared with usual care in those individuals. And the eligible patients, or eligible individuals, were adults caring for patients with heme malignancy undergoing either an autologous or an allogeneic stem cell transplant. Patients were randomly assigned either to use the app or for usual care. And the app itself—and I think it'll be interesting to actually see this at the meeting and visualize it and see how user-friendly and so on it is—but it comprises five modules, which integrate psychoeducation, behavior change, stress management, and they're delivered through a kind of interactive platform of educational games and videos. And then participants were self-reporting at baseline and then 60 days after transplant. So, around 125 patients were enrolled in this study, of around 174 who were initially approached. So, just over 70% uptake from caregivers, which is, I think, relatively high, and evenly distributed between the two randomized arms. And the majority of the participants were spouses. And at 60 days post-stem cell transplant, the intervention participants reported a better quality of life compared with those who received usual care. If you break this down a little bit more, these participants reported lower caregiving burden, lower incidence of depression, fewer PTSD symptoms, and overall better coping skills. So, the authors conclude that this particular app, a digital health intervention, led to pretty substantial improvements in quality of life for these caregivers. So, intriguing. As I said, it'll be particularly interesting to see how this thing looks during the meeting. But if these kind of results can be reproduced, I think this sort of application has potential uses way beyond the stem cell transplant setting. Dr. Erika Hamilton: Yeah, I find that just so fascinating and very needed. I think that the caregiving role is often underestimated in how important that is for the patient and the whole family, and really giving our caregivers more tools in their toolbox certainly is quite helpful. Dr. John Sweetenham: Absolutely. Well, the meeting is getting closer, and as I mentioned earlier, I think anticipation is mounting. And I wanted to say thanks so much to you for chatting with me today about some of the interesting advances in oncology that we're going to see at this year's meeting. There is a great deal more to come. Our listeners can access links to the studies we've discussed today in the transcript of this episode. I'm also looking forward, Dr. Hamilton, to having you back on the podcast after the Annual Meeting to dive into some of the late-breaking abstracts and some of the other key science that's captured the headlines this year. So, thanks once again for joining me today. Dr. Erika Hamilton: Thanks so much for having me. Pleasure. Dr. John Sweetenham: And thank you to our listeners for joining us today. Be sure to catch my “Top Takeaways from ASCO25.” These are short episodes that will drop each day of the meeting at 5:30 p.m. Eastern Time. So, subscribe to the ASCO Daily News Podcast wherever you prefer to listen, and join me for concise analyses of the meeting's key abstracts.   Disclaimer: 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.   More on today's speakers: Dr. John Sweetenham   Dr. Erika Hamilton @erikahamilton9   Follow ASCO on social media:  @ASCO on Twitter  ASCO on Bluesky  ASCO on Facebook   ASCO on LinkedIn     Disclosures:     Dr. John Sweetenham:     No relationships to disclose  Dr. Erika Hamilton: Consulting or Advisory Role (Inst): Pfizer, Genentech/Roche, Lilly, Daiichi Sankyo, Mersana, AstraZeneca, Novartis, Ellipses Pharma, Olema Pharmaceuticals, Stemline Therapeutics, Tubulis, Verascity Science, Theratechnologies, Accutar Biotechnology, Entos, Fosun Pharma, Gilead Sciences, Jazz Pharmaceuticals, Medical Pharma Services, Hosun Pharma, Zentalis Pharmaceuticals, Jefferies, Tempus Labs, Arvinas, Circle Pharma, Janssen, Johnson and Johnson   Research Funding (Inst): AstraZeneca, Hutchison MediPharma, OncoMed, MedImmune, Stem CentRx, Genentech/Roche, Curis, Verastem, Zymeworks, Syndax, Lycera, Rgenix, Novartis, Millenium, TapImmune, Inc., Lilly, Pfizer, Lilly, Pfizer, Tesaro, Boehringer Ingelheim, H3 Biomedicine, Radius Health, Acerta Pharma, Macrogenics, Abbvie, Immunomedics, Fujifilm, eFFECTOR Therapeutics, Merus, Nucana, Regeneron, Leap Therapeutics, Taiho Pharmaceuticals, EMD Serono, Daiichi Sankyo, ArQule, Syros Pharmaceuticals, Clovis Oncology, CytomX Therapeutics, InventisBio, Deciphera, Sermonix Pharmaceuticals, Zenith Epigentics, Arvinas, Harpoon, Black Diamond, Orinove, Molecular Templates, Seattle Genetics, Compugen, GI Therapeutics, Karyopharm Therapeutics, Dana-Farber Cancer Hospital, Shattuck Labs, PharmaMar, Olema Pharmaceuticals, Immunogen, Plexxikon, Amgen, Akesobio Australia, ADC Therapeutics, AtlasMedx, Aravive, Ellipses Pharma, Incyte, MabSpace Biosciences, ORIC Pharmaceuticals, Pieris Pharmaceuticals, Pieris Pharmaceuticals, Pionyr, Repetoire Immune Medicines, Treadwell Therapeutics, Accutar Biotech, Artios, Bliss Biopharmaceutical, Cascadian Therapeutics, Dantari, Duality Biologics, Elucida Oncology, Infinity Pharmaceuticals, Relay Therapeutics, Tolmar, Torque, BeiGene, Context Therapeutics, K-Group Beta, Kind Pharmaceuticals, Loxo Oncology, Oncothyreon, Orum Therapeutics, Prelude Therapeutics, Profound Bio, Cullinan Oncology, Bristol-Myers Squib, Eisai, Fochon Pharmaceuticals, Gilead Sciences, Inspirna, Myriad Genetics, Silverback Therapeutics, Stemline Therapeutics

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

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Regeneron has acquired ownership of 23andme for $256 million, promising to comply with consumer privacy policies. Makary's proposed rare disease pathway has sparked hope but raised questions among experts. At the American Society of Gene and Cell Therapy meeting, the first personalized in vivo CRISPR therapy was reported. The FDA has cleared the first Alzheimer's blood test, potentially boosting uptake of Alzheimer's disease therapies. Bio-Rad's new Center for Excellence is redefining antibody discovery with their Pioneer Antibody Discovery Platform. FDA regulations are unlikely to save money for the industry, and Applied Therapeutics' rare disease treatment has failed in late-stage trials. The memory gap in forgotten diseases is making a dangerous comeback, and Novo CEO's sudden exit has raised concerns among analysts.FDA Commissioner Marty Makary's proposal for a 'conditional approval' pathway for rare diseases has sparked hope among biopharma companies, but experts are raising concerns about safety, access, and liability due to a lack of details. The FDA and NIH are accelerating the shift away from animal research, which has raised questions about safety and implementation. Meanwhile, FDA cuts have led to chaos in planning for upcoming advisory committee meetings. The Trump administration's efforts to slash regulations may not necessarily benefit the industry as anticipated. Sarepta is seeking to strengthen its case for Elevidys with data in older kids, while other companies such as Incyte and Lilly are making progress with their drug approvals. Overall, the biopharma industry is facing challenges and uncertainties in navigating the evolving regulatory landscape.

Ohne Aktien-Zugang ist's schwer? Starte jetzt bei unserem Partner Scalable Capital. Alle weiteren Infos gibt's hier: scalable.capital/oaws. Aktien + Whatsapp = Hier anmelden. Lieber als Newsletter? Geht auch. Das Buch zum Podcast? Jetzt lesen. Regeneron kauft 23andMe. Trump pusht 30-jährige Zinsen auf 5%. Trump mag die Kombo von Apple & Alibaba nicht. Xiaomi macht eigene Chips. NVIDIA ist offen für fremde Chips. Novavax darf endlich impfen. Ryanair-CEO will die 100 Millionen Bonus knacken. Wieso betreibt Ticketmaster eigene Konzerthallen? Das Flywheel von Live Nation (WKN: A0H0VZ) ist die Antwort. Atomkraft erlebt grade ein Revival. Südkorea ist der vielleicht größte Profiteur. Konkret: Korea Electric (WKN: 893161) und Doosan Škoda Power (WKN: A410GL). Diesen Podcast vom 20.05.2025, 3:00 Uhr stellt dir die Podstars GmbH (Noah Leidinger) zur Verfügung.

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"

In today's episode:Trump posts a video about the Clinton body countMoody's downgrades the US credit rating, does it matter?23andMe is being acquired by RegeneronAnother CBS exec leaves the company in the midst of settlement talks in the Trump lawsuit and a Paramount mergerTrump bring the autopen front and centerJoe Biden sounds old, tired, and dementia-stricken in the Robert Hur videoThe public conversation has now reached the always inevitable "wondering if Biden's presidency counted at all" phaseMaureen Dowd and other 'journalists' note that mistakes were made, but not by themJoe Biden as Fall Guy and scapegoat and the avoidance of accountabilityThe reports of Biden's cancer diagnosis, combined with the 'cancer moonshot' give Biden an exit rampThe Supreme Court allows the Trump admin to remove TPS from VenezuelansSyria signs a major port deal almost immediately upon returning to the "global community"The Regime's candidate for president of Poland underperforms and becomes the underdogSovereign nationalism is on the march in PortugalThe fake Romainian election is stolen for the Regime-aligned candidate, but there's more going onThe Big Project comes into viewTrump and Putin have a successful phone call.Connect with Be Reasonable: https://linktr.ee/imyourmoderatorLinks, articles, ideas - follow the info stream at t.me/veryreasonableHear the show when it's released. Become a paid subscriber at imyourmoderator.substack.comVisit the show's sponsors:Diversify your assets into Bitcoin: https://partner.river.com/reasonableDiversify your assets into precious metals: reasonablegold.comJoin the new information infrastructure - get Starlink: https://www.starlink.com/residential?referral=RC-1975306-67744-74Other ways to support the work:ko-fi.com/imyourmoderatorDonate btc via coinbase: 3MEh9J5sRvMfkWd4EWczrFr1iP3DBMcKk5Make life more comfortable: mypillow.com/reasonableMerch site:https://cancelcouture.myspreadshop.com/https://cancelcouture.comFollow the podcast info stream: t.me/veryreasonableYouTube: https://www.youtube.com/@imyourmoderatorOther social platforms: Truth Social, Gab, Rumble, or Gettr - @imyourmoderator Become a member at https://plus.acast.com/s/be-reasonable-with-your-moderator-chris-paul. Hosted on Acast. See acast.com/privacy for more information.

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.

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.

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.

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.

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