Podcasts about Amgen

This episode covers: Cardiology This Week: A concise summary of recent studies 'ChatGPT, MD?' - Large Language Models at the Bedside Management decisions in myocarditis Statistics Made Easy: Mendelian randomisation Host: Emer Joyce Guests: Carlos Aguiar, Folkert Asselbergs, Massimo Imazio Want to watch that episode? Go to: https://esc365.escardio.org/event/2179 Want to watch that extended interview on 'ChatGPT, MD?': Large Language Models at the Bedside? Go to: https://esc365.escardio.org/event/2179?resource=interview Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis through an independent funding. The programme has not been influenced in any way by its funding partners. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Folkert Asselbergs, Yasmina Bououdina, Massimo Imazio, Emer Joyce, and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada.  Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Host: Emer Joyce Guest: Folkert Asselbergs Want to watch that episode? Go to: https://esc365.escardio.org/event/2179 Want to watch that extended interview on 'ChatGPT, MD?': Large Language Models at the Bedside? Go to: https://esc365.escardio.org/event/2179?resource=interview Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis through an independent funding. The programme has not been influenced in any way by its funding partners. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English language always prevails.  Declarations of interests: Stephan Achenbach, Folkert Asselbergs, Yasmina Bououdina, Emer Joyce, and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. E mma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson. Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Authors Drs. Jessica Ross and Alissa Cooper share insights into their JCO PO article, "Clinical and Pathologic Landscapes of Delta-Like Ligand 3 and Seizure-Related Homolog Protein 6 Expression in Neuroendocrine Carcinomas"  Host Dr. Rafeh Naqash and Drs. Ross and Cooper discuss the landscape of Delta-like ligand 3 (DLL3) and seizure-related homolog protein 6 (SEZ6) across NECs from eight different primary sites. TRANSCRIPT Dr. Rafeh Naqash: Hello and welcome to JCO Precision Oncology Conversations, where we bring you engaging conversations with authors of clinically relevant and highly significant JCO PO articles. I'm your host, Dr. Rafeh Naqash, podcast editor for JCO PO and an Associate Professor at the OU Health Stephenson Cancer Center. Today, I'm excited to be joined by Dr. Jessica Ross, third-year medical oncology fellow at the Memorial Sloan Kettering Cancer Center, as well as Dr. Alissa Cooper, thoracic medical oncologist at the Dana-Farber Cancer Institute and instructor in medicine at Harvard Medical School. Both are first and last authors of the JCO Precision Oncology article entitled "Clinical and Pathologic Landscapes of Delta-like Ligand 3 and Seizure-Related Homolog Protein 6 or SEZ6 Protein Expression in Neuroendocrine Carcinomas." At the time of this recording, our guest disclosures will be linked in the transcript. Jessica and Alissa, welcome to our podcast, and thank you for joining us today. Dr. Jessica Ross: Thanks very much for having us. Dr. Alissa Cooper: Thank you. Excited to be here. Dr. Rafeh Naqash: It's interesting, a couple of days before I decided to choose this article, one of my GI oncology colleagues actually asked me two questions. He said, "Rafeh, do you know how you define DLL3 positivity? And what is the status of DLL3 positivity in GI cancers, GI neuroendocrine carcinomas?" The first thing I looked up was this JCO article from Martin Wermke. You might have seen it as well, on obrixtamig, a phase 1 study, a DLL3 bi-specific T-cell engager. And they had some definitions there, and then this article came along, and I was really excited that it kind of fell right in place of trying to understand the IHC landscape of two very interesting targets. Since we have a very broad and diverse audience, especially community oncologists, trainees, and of course academic clinicians and some people who are very interested in genomics, we'll try to make things easy to understand. So my first question for you, Jessica, is: what is DLL3 and SEZ6 and why are they important in neuroendocrine carcinomas? Dr. Jessica Ross: Yeah, good question. So, DLL3, or delta-like ligand 3, is a protein that is expressed preferentially on the tumor cell surface of neuroendocrine carcinomas as opposed to normal tissue. It is a downstream target of ASCL1, and it's involved in neuroendocrine differentiation, and it's an appealing drug target because it is preferentially expressed on tumor cell surfaces. And so, it's a protein, and there are several drugs in development targeting this protein, and then Tarlatamab is an approved bi-specific T-cell engager for the treatment of extensive-stage small cell lung cancer in the second line. SEZ6, or seizure-like homolog protein 6, is a protein also expressed on neuroendocrine carcinoma cell surface. Interestingly, so it's expressed on neuronal cells, but its exact role in neuroendocrine carcinomas and oncogenesis is actually pretty poorly understood, but it was identified as an appealing drug target because, similarly to DLL3, it's preferentially expressed on the tumor cell surface. And so this has also emerged as an appealing drug target, and there are drugs in development, including antibody-drug conjugates, targeting this protein for that reason. Dr. Alissa Cooper: Over the last 10 to 15 years or so, there's been an increasing focus on precision oncology, finding specific targets that actually drive the cancer to grow, not just within lung cancer but in multiple other primary cancers. But specifically, at least speaking from a thoracic oncology perspective, the field of non-small cell lung cancer has completely exploded over the past 15 years with the discovery of driver oncogenes and then matched targeted therapies. Within the field of neuroendocrine carcinomas, including small cell lung cancer but also other high-grade neuroendocrine carcinomas, there has not been the same sort of progress in terms of identifying targets with matched therapies. And up until recently, we've sort of been treating these neuroendocrine malignancies kind of as a monolithic disease process. And so recently, there's been sort of an explosion of research across the country and multiple laboratories, multiple people converging on the same open questions about why might patients with specific tumor biologies have different kind of responses to different therapies. And so first this came from, you know, why some patients might have a good response to chemo and immunotherapy, which is the first-line approved therapy for small cell lung cancer, and we also sort of extrapolate that to other high-grade neuroendocrine carcinomas. What's the characteristic of that tumor biology? And at the same time, what are other targets that might be identifiable? Just as Jesse was saying, they're expressed on the cell surface, they're not necessarily expressed in normal tissue. Might this be a strategy to sort of move forward and create smarter therapies for our patients and therefore move really into a personalized era for treatment for each patient? And that's really driving, I think, a lot of the synthesis of this work of not only the development of multiple new therapies, but really understanding which tumor might be the best fit for which therapy. Dr. Rafeh Naqash: Thank you for that explanation, Alissa. And as you mentioned, these are emerging targets, some more further along in the process with approved drugs, especially Tarlatamab. And obviously, DLL3 was something identified several years back, but drug development does take time, and readout for clinical trials takes time. Could you, for the sake of our audience, try to talk briefly about the excitement around Tarlatamab in small cell lung cancer, especially data that has led to the FDA approval in the last year, year and a half? Dr. Alissa Cooper: Sure. Yeah, it's really been an explosion of excitement over, as you're saying, the last couple of years, and work really led by our mentor, Charlie Rudin, had identified DLL3 as an exciting target for small cell lung cancer specifically but also potentially other high-grade neuroendocrine malignancies. Tarlatamab is a DLL3-targeting bi-specific T-cell engager, which targets DLL3 on the small cell lung cancer cells as well as CD3 on T cells. And the idea is to sort of introduce the cancer to the immune system, circumventing the need for MHC class antigen presentation, which that machinery is typically not functional in small cell lung cancer, and so really allowing for an immunomodulatory response, which had not really been possible for most patients with small cell lung cancer prior to this. Tarlatamab was tested in a phase 2 registrational trial of about 100 patients and demonstrated a response rate of 40%, which was very exciting, especially compared with other standard therapies which were available for small cell lung cancer, which are typically cytotoxic therapies. But most excitingly, more than even the response rate, I think, in our minds was the durability of response. So patients whose disease did have a response to Tarlatamab could potentially have a durable response lasting a number of months or even over a year, which had previously not ever been seen in this in the relapsed/refractory setting for these patients. I think the challenge with small cell lung cancer and other high-grade neuroendocrine malignancies is that a response to therapy might be a bit easier to achieve, but it's that durability. The patient's tumors really come roaring back quite aggressively pretty quickly. And so this was sort of the most exciting prospect is that durability of response, that long potential overall survival tail of the curve really being lifted up. And then most recently at ASCO this year, Dr. Rudin presented the phase 3 randomized controlled trial which compared Tarlatamab to physician's choice of chemotherapy in a global study. And the choice of chemotherapy did vary depending on the part of the world that the patients were enrolled in, but in general, it was a really markedly positive study for response rate, for progression-free survival, and for overall survival. Really exciting results which really cemented Tarlatamab's place as the standard second-line therapy for patients with small cell lung cancer whose disease has progressed on first-line chemo-immunotherapy. So that has been very exciting. This drug was FDA approved in May of 2024, and so has been used extensively since then. I think the adoption has been pretty widespread, at least in the US, but now in this global trial that was just presented, and there was a corresponding New England Journal paper, I think really confirms that this is something we really hopefully can offer to most of our patients. And I think, as we all know, that this therapy or other therapies like it are also being tested potentially in the first-line setting. So there was data presented with Tarlatamab incorporated into the maintenance setting, which also showed exciting results, albeit in a phase 1 trial, but longer overall survival than we're used to seeing in this patient population. And we await results of the study that is incorporating Tarlatamab into the induction phase with chemotherapy as well. So all of this is extraordinarily exciting for our patients to sort of move the needle of how many patients we can keep alive, feeling functional, feeling well, for as long as possible. Dr. Rafeh Naqash: Very exciting session at ASCO. I was luckily one of the co-chairs for the session that Dr. Rudin presented it, and I remember somebody mentioning there was more progress seen in that session for small cell lung cancer than the last 30, 35 years for small cell, very exciting space and time to be in as far as small cell lung cancer. Now going to this project, Jessica, since you're the first author and Alissa's the last, I'm assuming there was a background conversation that you had with Alissa before you embarked on this project as an idea. So could you, again, for other trainees who are interested in doing research, and it's never easy to do research as a resident and a fellow when you have certain added responsibilities. Could you give us a little bit of a background on how this started and why you wanted to look at this question? Dr. Jessica Ross: Yeah, sure. So, as with many exciting research concepts, I think a lot of them are derived from the clinic. And so I think Alissa and I both see a good number of patients with small cell, large cell lung cancer, and then high-grade neuroendocrine carcinomas. And so I think this was really born out of a basic conversation of we have these drugs in development targeting these two proteins, DLL3 and SEZ6, but really what is the landscape of cancers that express these proteins and who are the patients that really might benefit from these exciting new therapies. And of course, there was some data out there, but sort of less than one would imagine in terms of, you know, neuroendocrine carcinomas can really come from anywhere in the body. And so when you're seeing a patient with small cell of the cervix, for example, like what are the chances that their cancer expresses DLL3 or expresses SEZ6? So it was really derived from this pragmatic, clinically oriented question that we had both found ourselves thinking about, and we were lucky enough at MSK, we had started systematically staining patients' tumors for DLL3, tumors that are high-grade neuroendocrine carcinomas, and then we had also more recently started staining for SEZ6 as well. And so we had this nice prospectively collected dataset with which to answer this question. Dr. Rafeh Naqash: Excellent. And Alissa, could you try to go into some of the details around which patients you chose, how many patients, what was the approach that you selected to collect the data for this project? Dr. Alissa Cooper: This is perhaps a strength but also maybe a limitation of this dataset is, as Jesse alluded to, our pathology colleagues are really the stars of this paper here because we were lucky enough at MSK that they were really forethinking. They are absolute experts in the field and really forward-thinking people in terms of what information might be needed in the future to drive treatment decision-making. And so, as Jesse had said, small cell lung cancer tumor samples reflexively are stained for DLL3 and SEZ6 at MSK if there's enough tumor tissue. The other high-grade neuroendocrine carcinomas, those stains are performed upon physician request. And so that is a bit of a mixed bag in terms of the tumor samples we were able to include in this dataset because, you know, upon physician request depends on a number of factors, but actually at MSK, a number of physicians were requesting these stains to be done on their patients with high-grade neuroendocrine cancers of of other histologies. So we looked at all tumor samples with a diagnosis of high-grade neuroendocrine carcinoma of any histology that were stained for these two stains of interest. You know, I can let Jesse talk a bit more about the methodology. She was really the driver of this project. Dr. Jessica Ross: Yeah, sure. So we had 124 tumor samples total. All of those were stained for DLL3, and then a little less than half, 53, were stained for SEZ6. As Alissa said, they were from any primary site. So about half of them were of lung origin, that was the most common primary site, but we included GI tract, head and neck, GU, GYN, even a few tumors of unknown origin. And again, that's because I think a lot of these trials are basket trials that are including different high-grade neuroendocrine carcinomas no matter the primary site. And so we really felt like it was important to be more comprehensive and inclusive in this study. And then, methodologically, we also defined positivity in terms of staining of these two proteins as anything greater than or equal to 1% staining. There's really not a defined consensus of positivity when it comes to these two novel targets and staining for these two proteins. But in the Tarlatamab trials, for some of the correlative work that's been done, they use that 1% cutoff, and we just felt like being consistent with that and also using a sort of more pragmatic yes/no cutoff would be more helpful for this analysis. Dr. Alissa Cooper: And that was a point of discussion, actually. We had contemplated multiple different schemas, actually, for how to define thresholds of positivity. And I know you brought up that question before, what does it mean to be DLL3 positive or DLL3 high? I think you were alluding to prior that there was a presentation of obrixtamig looking at extra-pulmonary neuroendocrine carcinomas, and they actually divvied up the results between DLL3 50% or greater versus DLL3 low under 50%. And they actually did demonstrate differential efficacy certainly, but also some differential safety as well, which is very provocative and that kind of analysis has not been presented for other novel therapies as far as I'm aware. I could be wrong, but as far as I'm aware, that was sort of the first time that we saw a systematic presentation of considering patients to be, quote unquote, "high" or "low" in these sort of novel targets. I think it is important because the label for Tarlatamab does not require any DLL3 expression at all, actually. So it's not hinging upon DLL3 expression. They depend on the fact that the vast majority of small cell lung cancer tumors do express DLL3, 85% to 90% is what's been demonstrated in a few studies. And so, there's not prerequisite testing needed in that regard, but maybe for these extra-pulmonary, other histology neuroendocrine carcinomas, maybe it does matter to some degree. Dr. Rafeh Naqash: Definitely agree that this evolving landscape of trying to understand whether an expression for something actually really does correlate with, whether it's an immune cell engager or an antibody-drug conjugate is a very evolving and dynamically moving space. And one of the questions that I was discussing with one of my friends was whether IHC positivity and the level of IHC positivity, as you've shown in one of those plots where you have double positive here on the right upper corner, you have the double negative towards the left lower, whether that somehow determines mRNA expression for DLL3. Obviously, that was not the question here that you were looking at, but it does kind of bring into question certain other aspects of correlations, expression versus IHC. Now going to the figures in this manuscript, very nicely done figures, very easy to understand because I've done the podcast for quite a bit now, and usually what I try to do first is go through the figures before I read the text, and and a lot of times it's hard to understand the figures without reading the text, but in your case, specifically the figures were very, very well done. Could you give us an overview, a quick overview of some of the important results, Jessica, as far as what you've highlighted in the manuscript? Dr. Jessica Ross: Sure. So I think the key takeaway is that, of the tumors in our cohort, the majority were positive for DLL3 and positive for SEZ6. So about 80% of them were positive for DLL3 and 80% were positive for SEZ6. About half of the tumors were stained for both proteins, and about 65% of those were positive as well. So I think if there's sort of one major takeaway, it's that when you're seeing a patient with a high-grade neuroendocrine carcinoma, the odds are that their tumor will express both of these proteins. And so that can sort of get your head thinking about what therapies they might be eligible for. And then we also did an analysis of some populations of interest. So for example, we know that non-neuroendocrine pathologies can transform into neuroendocrine tumors. And so we specifically looked at that subset of patients with transformed tumors, and those were also- the majority of them were positive, about three-quarters of them were positive for both of these two proteins. We looked at patients with brain met samples, again, about 70% were positive. And then I'd say the last sort of population of interest was we had a subset of 10 patients who had serial biopsies stained for either DLL3 or SEZ6 or both. In between the two samples, these patients were treated with chemotherapy. They were not treated with targeted therapy, but interestingly, in the majority of cases, the testing results were concordant, meaning if it was DLL3 positive to begin with, it tended to remain DLL3 positive after treatment. And so I think that's important as well as we think about, you know, a patient who maybe had DLL3 testing done before they received their induction chemo-IO, we can somewhat confidently say that they're probably still DLL3 positive after that treatment. And then finally, we did do a survival analysis among specifically the patients with lung neuroendocrine carcinomas. We looked at whether DLL3 expression affected progression-free survival on first-line platinum-etoposide, and then we looked at did it affect overall survival. And we found that it did not have an impact or the median progression-free survival was similar whether you were DLL3 positive or negative. But interestingly, with overall survival, we found that DLL3 positivity actually correlated with slightly improved overall survival. These were small numbers, and so, you know, I think we have to interpret this with caution, for sure, but it is interesting. I think there may be something to the fact that five of the patients who were DLL3 positive were treated with DLL3-targeting treatments. And so this made me think of, like in the breast cancer world, for example, if you have a patient with HER2-positive disease, it initially portended worse prognosis, more aggressive disease biology, but on the other hand, it opens the door for targeted treatments that actually now, at least with HER2-positive breast cancer, are associated with improved outcomes. And so I think that's one finding of interest as well. Dr. Rafeh Naqash: Definitely proof-of-concept findings here that you guys have in the manuscript. Alissa, if I may ask you, what is the next important step for a project like this in your mind? Dr. Alissa Cooper: Jesse has highlighted a couple of key findings that we hope to move forward with future investigative studies, not necessarily in a real-world setting, but maybe even in clinical trial settings or in collaboration with sponsors. Are these biomarkers predictive? Are they prognostic? You know, those are still- we have some nascent data, data has been brewing, but I think that we we still don't have the answers to those open questions, which I think are critically important for determining not only clinical treatment decision-making, but also our ability to understand sequencing of therapies, prioritization of therapies. I think a prospective, forward-looking project, piggybacking on that paired biopsy, you know, we had a very small subset of patients with paired biopsies, but a larger subset or cohort looking at paired biopsies where we can see is there evolution of these IHC expression, even mRNA expression, as you're saying, is there differential there? Are there selection pressures to targeted therapies? Is there upregulation or downregulation of targets in response not just to chemotherapy, but for example, for other sort of ADCs or bi-specific T-cell engagers? I think those are going to be critically important future studies which are going to be a bit challenging to do, but really important to figure out this key clinical question of sequencing, which we're all contemplating in our clinics day in and day out. If you have a patient, and these patients often can be sick quite quickly, they might have one shot of what's the next treatment that you're going to pick. We can't guarantee that every patient is going to get to see every therapy. How can you help to sort of answer the question of like what should you offer? So I think that's the key question sort of underlying any future work is how predictive or prognostic are these biomarkers? What translational or correlative studies can we do on the tissue to understand clinical treatment decision-making? I think those are the key things that will unfold in the next couple of years. Dr. Rafeh Naqash: The last question for you, Alissa, that I have is, you are fairly early in your career, and you've accomplished quite a lot. One of the most important things that comes out from this manuscript is your mentorship for somebody who is a fellow and who led this project. For other junior investigators, early-career investigators, how did you do this? How did you manage to do this, and how did you mentor Jessica on this project with some of the lessons that you learned along the way, the good and other things that would perhaps help other listeners as they try to mentor residents, trainees, which is one of the important things of what we do in our daily routine? Dr. Alissa Cooper: I appreciate you calling me accomplished. Um, I'm not sure how true that is, but I appreciate that. I didn't have to do a whole lot with this project because Jesse is an extraordinarily smart, driven, talented fellow who came up with a lot of the clinical questions and a lot of the research questions as well. And so this project was definitely a collaborative project on both of our ends. But I think what was helpful from both of our perspectives is from my perspective, I could kind of see that this was a gap in the literature that really, I think, from my work leading clinical trials and from treating patients with these kinds of cancers that I really hoped to answer. And so when I came to Jessica with this idea as sort of a project to complete, she was very eager to take it and run with it and also make it her own. You know, in terms of early mentorship, I have to admit this was the first project that I mentored, so it was a great learning experience for me as well because as an early-career clinician and researcher, you're used to having someone else looking over your shoulder to tell you, "Yes, this is a good journal target, here's what we can anticipate reviewers are going to say, here are other key collaborators we should include." Those kind of things about a project that don't always occur to you as you're sort of first starting out. And so all of that experience for me to be identifying those more upper-level management sort of questions was a really good learning experience for me. And of course, I was fantastically lucky to have a partner in Jesse, who is just a rising star. Dr. Jessica Ross: Thank you. Dr. Rafeh Naqash: Well, excellent. It sounds like the first of many other mentorship opportunities to come for you, Alissa. And Jessica, congratulations on your next step of joining and being faculty, hopefully, where you're training. Thank you again, both of you. This was very insightful. I definitely learned a lot after I reviewed the manuscript and read the manuscript. Hopefully, our listeners will feel the same. Perhaps we'll have more of your work being published in JCO PO subsequently. Dr. Alissa Cooper: Hope so. Thank you very much for the opportunity to chat today. Dr. Jessica Ross: Yes, thank you. This was great. Dr. Rafeh Naqash: Thank you for listening to JCO Precision Oncology Conversations. Don't forget to give us a rating or review and be sure to subscribe so as you never miss an episode. You can find all ASCO shows at asco.org/podcasts. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Disclosures: Dr. Alissa Jamie Cooper Honoraria Company: MJH Life Scienes, Ideology Health, Intellisphere LLC, MedStar Health, Physician's Education Resource, LLC,  Gilead Sciences, Regeneron, Daiichi Sankyo/Astra Zeneca, Novartis,  Research Funding: Merck, Roche, Monte Rosa Therapeutics, Abbvie, Amgen, Daiichi Sankyo/Astra Zeneca Travel, Accommodations, Expenses: Gilead Sciences

The best biotech and pharmaceutical innovations mean nothing if they can't be protected—and protected fast. Our next guest, Josh Goldberg, is solving this challenge as co-managing partner at Nath, Goldberg & Meyer, the #1 ranked patent law firm for biotech and pharmaceutical technologies. With nearly three decades of IP law experience and a unique background as a lab researcher, Josh brings an insider's understanding of how innovation actually happens. He's helped industry leaders like Amgen, Takeda, and GlaxoSmithKline turn breakthrough treatments into patent-protected portfolios—often in under a year instead of the typical four-year timeline. Driven by a passion for focus and strategic IP timing, Josh shares his pioneering approach to biotech and pharmaceutical patent prosecution. Join us to discover how smart IP strategy drives licensing power, regulatory success, and company valuation. Let's go!Episode Highlights:Focus drives success – Companies fail by trying to do everything at once; staying deliberate and focused is key to making real impactOne-year patent timelines vs. four years – Josh uses USPTO's Track 1 program to secure patents in record time, improving fundraising and M&A positioningClient-centered approach wins – Listening to unique client needs instead of one-size-fits-all strategies earned the firm its #1 rankingDiagnostic patents are back – New USPTO Director signals the patent office is "open for business" again after a decade of restrictionsScientist turned patent attorney – Josh's lab background gives him insider understanding of how innovation actually happensAbout our Guest: Joshua is the patent attorney innovation-driven pharmaceutical companies call when they need to turn complicated technologies into protected assets in record time.As co-managing partner at Nath, Goldberg & Meyer—the #1 ranked patent law firm for biotech and pharmaceutical technologies in both 2024 and 2025—Joshua leads IP efforts across industries like biotech, pharma, agriculture, renewable energy, and advanced materials. Whether it's a blockbuster acne treatment like DUAC, a vitamin D analog lotion like Sorilux, OTC solutions like Salonpas and Germagic, or a leading drug used to reduce stomach acid and treat conditions like GERD, ulcers, and heartburn—like Protonix—Joshua helps turn high-stakes R&D into patent-protected portfolios, often in under a year instead of the typical four-year timeline.Though his climate and agricultre IP expertise has made him famous as the “green patent guy,” Joshua moves between disciplines skillfully and has helped industry leaders like Amgen, Takeda, Guilford Pharmaceuticals, Mayne, and Stiefel Laboratories (which was acquired by GlaxoSmithKline) build pharma portfolios that hold up under investor, acquirer, and FDA scrutiny.His journey didn't begin in IP law, but in the lab, researching experimental pharmaceutical delivery systems. It gave him an edge most attorneys don't have: understanding how innovation actually happens, and how to protect it without slowing a business down. Links Supporting This Episode: Nath, Goldberg & Meyer Website: CLICK HEREJoshua Goldberg LinkedIn page: CLICK HERENath, Goldberg & Meyer LinkedIn: CLICK HEREMike Biselli LinkedIn page: CLICK HEREMike Biselli Twitter page:...

When Abivax released stunning phase 3 results for ulcerative colitis, its 600% stock price surge froze Euronext for 45 minutes.Philip meets Abivax CEO Marc de Garidel in Vienna, Austria, to go behind the scenes of a remarkable biotech turnaround.Marc discusses the processes involved in executing the phase 3 trial that beat even Abivax's own phase 2 data. He also talks about France's biotech ecosystem and the importance of having the right team.⭐️ ABOUT THE SPEAKERMarc de Garidel joined Abivax as CEO in 2023. Prior to this, he led two biotech companies through billion-dollar exits (CinCor Pharma and Corvidia Therapeutics). He also served as CEO of Ipsen from 2010 to 2016, and has worked at the likes of Amgen and Eli Lilly.

This accredited continuing education program is supported by an educational grant from Sanofi. Credit for the program can be obtained by visiting https://checkrare.com/learning/p-consider-rare-suspecting-and-diagnosing-cidp/ . This program, led by Jeffrey Allen, MD, Professor of Neurology at the University of Minnesota provides an overview on the diagnostic delays that often occur in patients with CIDP as well as best practices to suspect and diagnose this rare condition more efficiently. This activity has been designed to meet the educational needs of physicians specializing in family medicine, pediatrics, and neurology. Other members of the care team may also participate.Learning ObjectivesAfter participating in the activity, learners should be better able to:Describe the early symptoms of CIDP.List best practices which can be used to diagnose CIDP more efficiently.Faculty Jeffrey Allen, MDProfessor of NeurologyDepartment of NeurologyDivision of Neuromuscular MedicineUniversity of MinnesotaMinneapolis, MNDisclosure StatementAccording to the disclosure policy of the Academy, all faculty, planning committee members, editors, managers and other individuals who are in a position to control content are required to disclose any relationships with any ineligible company(ies). The existence of these relationships is not viewed as implying bias or decreasing the value of the activity. Clinical content has been reviewed for fair balance and scientific objectivity, and all of the relevant financial relationships listed for these individuals have been mitigated.Disclosure of relevant financial relationships are as follows:Faculty Educator/PlannerDr. Scott discloses Consultant/Educational talks: Annexon, Alexion, Amgen, CSL Behring, Takeda,BioCryst, Grifols, Argenx, Sanofi, Immunovant, ImmunoAbs, Octapharma, Alnylam, AstraZeneca, Dianthus, Johnson & Johnson, Laboratoire Français du Fractionnement et des Biotechnologies, Nuvig, Akcea Therapeutics, ImmunoPharma,Pfizer.Community Faculty/Patient (Christine Eleeson): No relevant financial relationships with any ineligible companies.Other Planners for this activity have no relevant financial relationships with any ineligible companies.This activity will review off-label or investigational information.The opinions expressed in this educational activity are those of the faculty, and do not represent those of the Academy or CheckRare CE. This activity is intended as a supplement to existing knowledge, published information, and practice guidelines. Learners should appraise the information presented critically, and draw conclusions only after careful consideration of all available scientific information.Accreditation and Credit DesignationIn support of improving patient care, this activity has been planned and implemented by American Academy of CME, Inc. and CheckRare CE. American Academy of CME, Inc. is Jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.PhysiciansAmerican Academy of CME, Inc., designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Other HCPsOther members of the care team will receive a certificate of participation.There are no fees to participate in the activity.  Participants must review the activity information including the learning objectives and disclosure statements, as well as the content of the activity. To receive CME credit for your participation, please complete the pre-and post-program assessments. Your certificate will be emailed to you within 30 days.PrivacyFor more information about the American Academy of CME privacy policy, please access http://www.academycme.org/privacy.htm  For more information about CheckRare's privacy policy, please access https://checkrare.com/privacy/ContactFor any questions, please contact: CEServices@academycme.orgCopyright© 2025. This CME-certified activity is held as copyrighted © by American Academy of CME and CheckRare CE. Through this notice, the Academy and CheckRare CE grant permission of its use for educational purposes only. These materials may not be used, in whole or in part, for any commercial purposes without prior permission in writing from the copyright owner(s).

In der heutigen Folge sprechen die Finanzjournalisten Anja Ettel und Philipp Vetter über Robotikfantasie bei Xpeng, die Weihnachtsüberraschung von FedEx und den Shutdown-Schub für Pharma. Außerdem geht es um Merck, Johnson&Johnson, Amgen, CoreWeave, Nvidia, Softbank, Micron, Oracle, Palantir, Merck KGaA, Siemens Healthineers, UPS, Bayer, Amazon, Alphabet, Microsoft, iShares Core MSCI World ETF (WKN: A0RPWH), Amundi MSCI All Country World ETF (WKN: LYX00C), Vanguard S&P 500 ETF (WKN: A1JX53), iShares Nasdaq 100 ETF (WKN: A0YEDL), Amundi Core Stoxx Europe 600 ETF (WKN: LYX0Q0), Xtrackers MSCI Japan ETF (WKN: DBX1MJ), iShares MSCI China ETF (WKN: A2PGQN), Xtrackers Artificial Intelligence & Big Data ETF (WKN: A2N6LC), Alphabet, Apple, Nvidia und Palantir, Euwax Gold II (WKN: EWG2LD), Xetra Gold (WKN: A0S9GB), Global X Infrastructure ETF (WKN: A40E7B), Vanguard FTSE All World (WKN: A2PKXG), SPDR MSCI All Country World ETF (WKN: A1JJTC), Xtrackers MSCI Emerging Markets ETF (WKN: A12GVR), Vanguard FTSE Emerging Markets ETF (WKN: A2PLTC), iShares EUR High Yield Corporate Bond (WKN: A2DUCZ) und PIMCO Euro Short-Term High Yield Corporate Bond (WKN: A2DLP1). Unter diesem Link könnt ihr euch kostenlos für die Masterclass anmelden: https://form.jotform.com/Product_Unit/masterclass-boersenweisheiten. 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. +++ 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

Wall Street closed with a split performance as the Dow Jones surged to a new record, powered by healthcare heavyweights like Merck, Amgen, and Johnson & Johnson, while the Nasdaq slipped amid renewed pressure on AI-linked names. Meanwhile, new ADP data hinted at a cooling labor market, adding another layer of complexity for investors. With Washington inching closer to ending the historic government shutdown, we break down what these market moves say about shifting investor sentiment with Jason Britton, Founder and CIO of Reflection Asset Management. Produced/Presented: Ryan HuangSee omnystudio.com/listener for privacy information.

Dr. Adam Kilian, Director of the Rheumatology Fellowship Training Program at the St. Louis University School of Medicine, focuses on IgG4-related disease, a rare multi-organ disease that has only recently been recognized due to significant diagnostic challenges. The MITIGATE trial is a landmark study that demonstrated that the first FDA-approved treatment, UPLIZNA from Amgen, provides an effective, targeted, steroid-free therapy. The approval of this drug is driving awareness in the medical community about IgG4-RD and whether the disease should be considered after inconclusive results for other suspected conditions. Adam explains, "IgG4-related disease is a rare disease that affects many organ systems. It's a chronic systemic, fibroinflammatory disease that can affect almost any organ system. And it will usually present with these tumor-like inflammatory masses that can cause scarring and lead to organ failure." "Our understanding of it continues to evolve, and it's had a really interesting story over the last century because IgG4-related disease affects so many different organ systems. Over the past century, there were actually many different diagnoses that were recognized, which now all fall under the umbrella of IgG4-related disease. Different scientists and physicians around the world over the years recognized the different manifestations of the disease in the pancreas, in the lymph nodes, in the head and neck, in the kidneys, or in the blood vessels. And it's only been in the last 20 years or so that we have recognized that actually all of these different disease entities from the last century are actually all manifestations of this disease, IgG4, IgG4-related disease." "The clinical trial is called the MITIGATE trial, and it's a very seminal clinical trial in rheumatology from the last several years. This was the first-ever phase three double-blind, placebo-controlled, randomized controlled trial in IgG4-related disease. This was a huge trial. It was global. It was conducted in 22 countries with multiple specialties coordinating this trial. It was 52 weeks long, and its purpose was to evaluate the effectiveness and the safety of UPLIZNA in patients who have IgG4-related disease."  #MITIGATETrial #IgG4RelatedDisease #IgG4RD #UPLIZNA UPLIZNA Listen to the podcast here

Dr. Adam Kilian, Director of the Rheumatology Fellowship Training Program at the St. Louis University School of Medicine, focuses on IgG4-related disease, a rare multi-organ disease that has only recently been recognized due to significant diagnostic challenges. The MITIGATE trial is a landmark study that demonstrated that the first FDA-approved treatment, UPLIZNA from Amgen, provides an effective, targeted, steroid-free therapy. The approval of this drug is driving awareness in the medical community about IgG4-RD and whether the disease should be considered after inconclusive results for other suspected conditions. Adam explains, "IgG4-related disease is a rare disease that affects many organ systems. It's a chronic systemic, fibroinflammatory disease that can affect almost any organ system. And it will usually present with these tumor-like inflammatory masses that can cause scarring and lead to organ failure." "Our understanding of it continues to evolve, and it's had a really interesting story over the last century because IgG4-related disease affects so many different organ systems. Over the past century, there were actually many different diagnoses that were recognized, which now all fall under the umbrella of IgG4-related disease. Different scientists and physicians around the world over the years recognized the different manifestations of the disease in the pancreas, in the lymph nodes, in the head and neck, in the kidneys, or in the blood vessels. And it's only been in the last 20 years or so that we have recognized that actually all of these different disease entities from the last century are actually all manifestations of this disease, IgG4, IgG4-related disease." "The clinical trial is called the MITIGATE trial, and it's a very seminal clinical trial in rheumatology from the last several years. This was the first-ever phase three double-blind, placebo-controlled, randomized controlled trial in IgG4-related disease. This was a huge trial. It was global. It was conducted in 22 countries with multiple specialties coordinating this trial. It was 52 weeks long, and its purpose was to evaluate the effectiveness and the safety of UPLIZNA in patients who have IgG4-related disease."  #MITIGATETrial #IgG4RelatedDisease #IgG4RD #UPLIZNA UPLIZNA Download the transcript here

In der heutigen Folge sprechen die Finanzjournalisten Anja Ettel und Philipp Vetter über wacklige KI-Börsen, den neuen Plan für Siemens Healthineers und was diese Woche sonst noch wichtig wird. Außerdem geht es um Palantir, Nvidia, Meta, Microsoft, ASML, SAP, Infineon, Volkswagen, Siemens, Altair, Rumble, Northern Data, Merck & Co., Amgen, Regeneron Pharmaceuticals, Sanofi, AstraZeneca, Novo Nordisk, Eli Lilly, Robinhood und Walmart. 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. +++ 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

This episode covers: Cardiology this Week: A concise summary of recent studies Lp(a) - What to expect in the very near future Myocardial infarction in older and frail adults Mythbusters: is beetroot good for your heart? Host: Rick Grobbee Guests: JP Carpenter, Vijay Kunadian, Erik Stroes Want to watch that episode? Go to: https://esc365.escardio.org/event/2177 Want to watch that extended interview on Lp(a), go to: https://esc365.escardio.org/event/2177?resource=interview   Disclaimer  ESC TV Today is supported by Bristol Myers Squibb and Novartis through an independent funding. The programme has not been influenced in any way by its funding partners. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English language always prevails.    Declarations of interests Stephan Achenbach, Yasmina Bououdina, Rick Grobbee, Nicolle Kraenkel, Vijay Kunadian and Erik Stroes have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh speaks with Leonel Venegas, a seasoned quality and regulatory professional who has worked with global leaders including Alexion, Merck, Johnson & Johnson (Ethicon & Cordis), Amgen, and Medtronic.Leonel shares how integrating Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP) is essential to successful combination-product development. He discusses his journey from chemist to regulatory-affairs expert, uncovering common disconnects between pharma and device cultures, and the critical role of design controls, risk management, and timelines.The conversation also explores GMP and process validation, IDE vs. IND pathways, the challenges of rare-disease programs, and how understanding the cost of quality can reshape testing strategies. Leonel closes by reflecting on becoming a Lean Six Sigma Black Belt and what continuous improvement really looks like in combination-product development.⏱ Timestamps00:00 – Welcome & Introduction00:52 – Integrating GLP, GCP & GMP02:22 – Challenges in Developing Combination Products04:02 – Device-Led Combination Products07:35 – Working with Rare Diseases09:58 – GMP & Process Validation15:08 – Clinical Trials: Drug vs Device19:22 – Cost of Quality & Six Sigma25:12 – Conclusion & Contact InformationLeonel Venegas is the Founder of Precision Regulatory Consulting LLC and an expert in quality and regulatory affairs with over two decades of experience across six global pharma and medtech leaders, including Alexion, Merck, Johnson & Johnson (Ethicon & Cordis), Amgen, and Medtronic.He is certified by ASQ as a CMQ/OE, CQE, CBA, and CSSBB, and holds an M.S. in Regulatory Affairs. Leonel specializes in combination products, medical devices, and IVDs, integrating GLP, GCP, GMP, and GVP principles into complex global development programs.

AMD mit leichten Gewinnmitnahmen, Arista Networks, Pinterest und Super Micro unter Druck – vor allem wegen dünner Margen. Astera Labs dagegen überzeugt mit starken Zahlen und optimistischem Ausblick. Auch außerhalb des Tech-Sektors tut sich einiges: Rivian profitiert von robusten Ergebnissen, Amgen glänzt mit beeindruckenden Zahlen. Im Konsumbereich zeigt sich Schwäche: McDonald's verfehlt die Erwartungen, CAVA senkt den Ausblick und Apollo zieht sich offenbar von der geplanten Übernahme von Papa John's zurück. Um so erfreulicher, dass der ISM-Dienstleistungsindex für den Oktober über den Zielen lag. Abonniere den Podcast, um keine Folge zu verpassen! ____ Folge uns, um auf dem Laufenden zu bleiben: • X: http://fal.cn/SQtwitter • LinkedIn: http://fal.cn/SQlinkedin • Instagram: http://fal.cn/SQInstagram

Die Futures erholen sich deutlich von den Tiefs – nach dem starken Abverkauf im Nasdaq 100 sehen wir das klassische Muster: eine Gegenbewegung nach unten überverkauften Tech-Werten. Laut Bespoke Investment geht es historisch am Folgetag oft wieder bergauf. AMD mit leichten Gewinnmitnahmen, Arista Networks, Pinterest und Super Micro unter Druck – vor allem wegen dünner Margen. Astera Labs dagegen überzeugt mit starken Zahlen und optimistischem Ausblick. Auch außerhalb des Tech-Sektors tut sich einiges: Rivian profitiert von robusten Ergebnissen, Amgen glänzt mit beeindruckenden Zahlen. Im Konsumbereich zeigt sich Schwäche: McDonald's verfehlt die Erwartungen, CAVA senkt den Ausblick – und Apollo zieht sich offenbar von der geplanten Übernahme von Papa John's zurück. Heute richtet sich der Blick auf den ISM-Dienstleistungsindex (16 Uhr MEZ). Fällt der schwach aus, könnte der Wall Street erneut Gegenwind drohen. Ein Podcast - featured by Handelsblatt. +++ Alle Rabattcodes und Infos zu unseren Werbepartnern findet ihr hier: https://linktr.ee/wallstreet_podcast +++ +++ Hinweis zur Werbeplatzierung von Meta: https://backend.ad-alliance.de/fileadmin/Transparency_Notice/Meta_DMAJ_TTPA_Transparency_Notice_-_Ad_Alliance_approved.pdf +++ Der Podcast wird vermarktet durch die Ad Alliance. Die allgemeinen Datenschutzrichtlinien der Ad Alliance finden Sie unter https://datenschutz.ad-alliance.de/podcast.html Die Ad Alliance verarbeitet im Zusammenhang mit dem Angebot die Podcasts-Daten. Wenn Sie der automatischen Übermittlung der Daten widersprechen wollen, klicken Sie hier: https://datenschutz.ad-alliance.de/podcast.html Impressum: https://www.360wallstreet.de/impressum

Novartis started the week early with a Sunday afternoon announcement of the acquisition of neuromuscular drug developer Avidity Biosciences for $12B. That's the second biggest buy of the year after Johnson & Johnson's January acquisition of Intra-Cellular. The Avidity buy could read through positively to Dyne Therapeutics, as both are aiming to treat neuromuscular ailments with RNA-targeting therapies. Dyne shares have nearly doubled over the past month, jumping approximately 40% after Novartis' news dropped.  The Avidity deal is the latest in an uptick on the pharma M&A front. Also this week, Eli Lilly doubled down on gene therapy with a pick up of Adverum Biotechnologies and its lead program for wet age-related macular degeneration. And Roche, which last month acquired 89bio in a $3.5 billion deal centered on a MASH candidate, said in its third-quarter earnings call on Thursday that more deals could be in the future. Finally, beyond the big guys, Leerink Partners predicts which small- to mid-cap firms might also be on the hunt for new pipeline goodies.  Following the dealmaking news, Novartis held its earning call on Tuesday. CEO Vas Narasimhan downplayed the deals Pfizer, AstraZeneca and Amgen have made with the White House, saying they don't address the root of the drug pricing problem President Donald Trump hopes to solve.   On other earnings calls, BioMarin announced plans to divest the hemophilia gene therapy Roctavian. Regeneron faced further questions about Eylea and issues with the Catalent plant that's been tripping up its regulatory applications. But the company didn't address last week's news that it was dropping a CAR T asset picked up from 2seventy bio. These are but two of the latest examples of underperforming assets in the cell and gene therapy space.  BridgeBio had positive news for patients with limb-girdle muscular dystrophy this week after acing a Phase III trial for an investigational substrate supplementation therapy. Analysts predict the asset could be before the FDA later this year or early next.   Finally, with the U.S. government shutdown going on a month, BioSpace takes a look at how the FDA is operating. 

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving deep into a series of significant events that are shaping the future of drug development and patient care.Starting with Merck KGaA, their decision to close the Active Pharmaceutical Ingredient plant in Arklow, Ireland by 2028 marks a pivotal shift in their manufacturing strategy. This move follows a strategic review and is emblematic of broader industry trends where companies reassess their operational strategies for greater efficiency. While this decision may impact the local workforce and supply chain dynamics, it underscores a wider reevaluation within the industry regarding sourcing strategies and optimizing production capabilities.Turning to regulatory news, Amgen and AstraZeneca have achieved a notable milestone with Tezspire, which has received approval for a second indication in both the U.S. and Europe. This success highlights the strategic importance of expanding drug indications to maximize therapeutic potential and market reach. The approval also reflects a trend where robust clinical data supports regulatory endorsements across various regions, enhancing the global footprint of pharmaceutical innovations.In manufacturing developments, Galderma is making headlines with a $650 million investment in U.S.-based production facilities for Nemluvio. This commitment to domestic manufacturing aligns with industry-wide movements towards reshoring production to bolster supply chain resilience. As demand for dermatological products increases, enhancing local infrastructure promises not only to meet market needs but also to secure supply stability in uncertain times.Meanwhile, Moderna's recent decision to discontinue its congenital cytomegalovirus vaccine program after disappointing Phase 3 results illustrates the inherent uncertainties present in vaccine development. Despite extensive efforts, the vaccine did not demonstrate sufficient efficacy in preventing CMV infections among women. This outcome serves as a reminder of the critical role that robust clinical trial data plays in guiding strategic decisions within pharmaceutical pipelines. While mRNA technology has seen success against COVID-19, this setback highlights complexities involved when tackling other viral pathogens, potentially redirecting Moderna's focus towards more promising candidates.Roche is navigating through challenges such as currency fluctuations and slower-than-expected pharmaceutical sales in its third quarter. Despite these headwinds, Roche projects confidence in its long-term growth strategies, showcasing resilience through its diversified portfolio. Furthermore, Roche's decision to discontinue five Chugai solid tumor assets reflects broader industry movements towards reassessment and realignment within pipelines. Such decisions often emerge from early-phase trials failing to meet expected outcomes or shifts towards areas with greater promise, enabling companies like Roche to streamline resources towards more viable therapeutic areas.Compliance remains under scrutiny at Nephron Pharmaceuticals as ongoing FDA issues emphasize the necessity of maintaining stringent quality standards throughout manufacturing processes. Such regulatory challenges highlight the criticality of ensuring product safety and efficacy within the industry.On the technological front, the integration of artificial intelligence into life sciences commercialization is transforming industry landscapes. Though many organizations are still catching up with this digital shift, those that have embraced AI are experiencing significant improvements in efficiency and patient engagement. As companies continue embedding AI into their strategic frameworks, these initiatives promise to redefine operational paradigms and open new paths for growth.The landscape remains dynaSupport the show

Sean Bruich, Senior Vice President of AI, Engineering and Data Science at Amgen, joins Barbara Kahn and Dr. Americus Reed, II to discuss how AI's rapid evolution is transforming industries—not by replacing humans, but by creating new opportunities that blend human expertise with advanced technology to drive innovation and efficiency. Hosted on Acast. See acast.com/privacy for more information.

Your process works perfectly at two-liter bench scale. Then you hit fifty liters and titer drops 20%. By two hundred liters, aggregation appears and charge variants shift. Your management team asks: "How long to fix this?" The honest answer? Three to twelve month, because you're flying blind.In Part 2 of this Quality by Design Master Class, David Brühlmann reveals why scale-up chaos isn't inevitable. It's a solvable engineering problem. Drawing on experience leading bioprocess innovation at Merck and guiding biotech companies through CMC development, David delivers the process control framework that transforms reactive troubleshooting into predictive manufacturing.The core truth: eighty percent of quality problems stem from twenty percent of your process variables. David shows how to identify Critical Process Parameters, implement intelligent control strategies, and leverage hybrid modeling that reduces experiments by 60-80%. With case studies from Genentech and Amgen, you'll gain the blueprint that turns QbD requirements into competitive advantage.Part 1 taught you what to build and measure. Part 2 shows you how to control your process to consistently deliver commercial-scale quality.Topics Discussed:The common pitfalls of scaling up manufacturing from bench to production, and why process control must go beyond end-product testing (02:10)Overview of the QbD framework: Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), and the focus of this episode - Control Strategies for manufacturing (05:00)Identifying and monitoring Critical Process Parameters (CPPs) and their impact on quality, with real-world examples from Genentech's monoclonal antibody platform (08:20)Structure of an effective manufacturing control strategy: Input, process, and output controls - including practical details on real-time monitoring and release testing (11:00)The role of hybrid modeling and machine learning in accelerating process optimization, and how this approach can dramatically reduce the experimental burden (13:30)Real examples of improved outcomes and efficiency through model-based control strategies, and why training and process understanding are essential for team success (16:10)A quick, actionable exercise biotech teams can use to map process risks and identify critical control points (16:55)Whether you're part of a start-up or a large biotech firm, this episode offers clear, strategic steps for implementing QbD and improving process reliability. Don't forget to listen to Part 1 for more on QTPP and CQA, and visit www.bruehlmann-consulting.com for additional resources.Next step:Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callPreparing for your IND? We're building a CMC Dashboard in Excel to help biotech founders track tasks, timelines, and risks in one place. Join the waitlist for early access at https://scale-your-impact.notion.site/27dd9c6ba679804b80a7ce439d56c91a?pvs=105

Host: Susanna Price Guest: Stephanie Schwarting Want to watch the episode? Go to: https://esc365.escardio.org/event/2176 Want to watch the extended interview on Arrhythmias in Cardiac Amyloidosis? Go to: https://esc365.escardio.org/event/2176?resource=interview Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis through an independent funding. The programme has not been influenced in any way by its funding partners. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests:  Stephan Achenbach, Yasmina Bououdina, Nicolle Kraenkel and Susanna Price have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder Mycardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada.  Stephanie Schwarting has declared to have potential conflicts of interest to report: advisory board for Alnylam, Bayer, Pfizer; principal investigator in trials sponsored by Alexion, Novo Nordisk and Intellia. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Sean Bruich, Senior Vice President of AI, Engineering and Data Science at Amgen, joins Barbara Kahn and Dr. Americus Reed, II to discuss how AI's rapid evolution is transforming industries—not by replacing humans, but by creating new opportunities that blend human expertise with advanced technology to drive innovation and efficiency. Hosted on Acast. See acast.com/privacy for more information.

This episode covers: Cardiology This Week: A concise summary of recent studies Arrhythmias in cardiac amyloidosis Taking the 'O' out of HOCM: managing LVOT obstruction Snapshots Host: Susanna Price Guests: Carlos Aguiar, Stephanie Schwarting, Ahmad Masri Want to watch that episode? Go to: https://esc365.escardio.org/event/2176 Want to watch that extended interview on Arrhythmias in Cardiac Amyloidosis? Go to: https://esc365.escardio.org/event/2176?resource=interview Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis through an independent funding. The programme has not been influenced in any way by its funding partners. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Nicolle Kraenkel and Susanna Price have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder Mycardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Ahmad Masri has declared to have potential conflicts of interest to report: research grants from Pfizer, Ionis, Attralus, Cytokinetics and Janssen. Consulting fees from Cytokinetics, BMS, BridgeBio, Pfizer, Ionis, Lexicon, Attralus, Alnylam, Haya, Alexion, Akros, Edgewise, Rocket, Lexeo, Prothena, BioMarin, AstraZeneca, Avidity, Neurimmune, and Tenaya. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Stephanie Schwarting has declared to have potential conflicts of interest to report: advisory board for Alnylam, Bayer, Pfizer; principal investigator in trials sponsored by Alexion, Novo Nordisk and Intellia. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Recent developments in these industries underscore a period of significant scientific progress, regulatory maneuvers, and strategic investments.One notable event was AstraZeneca and Daiichi Sankyo's success at the European Society for Medical Oncology Congress 2025. Their antibody-drug conjugate, Datroway, demonstrated superior efficacy compared to Gilead's Trodelvy in the first global head-to-head trial involving Trop2-targeted therapies. This reflects the increasing focus on antibody-drug conjugates as precision medicine tools that offer targeted treatment options with potentially improved outcomes over traditional chemotherapy.In a move highlighting the ongoing trend of bolstering domestic production capacities, Merck is making a substantial $3 billion investment in a small molecule drug plant in Virginia. This is part of a broader $70 billion commitment to expand manufacturing and R&D capabilities in the U.S. Such strategic investments are crucial for maintaining competitive advantage and ensuring drug availability while meeting rising demands and streamlining supply chains.Turning to regulatory updates, the FDA has approved Amgen and AstraZeneca's Tezspire for chronic rhinosinusitis with nasal polyps. This marks Tezspire's second indication, following its initial approval for severe asthma in 2021. The expanded approval showcases the drug's versatility and represents a strategic push to enhance its market presence against competitors like Dupixent.In oncology, Merck's Keytruda and Astellas/Pfizer's Padcev have made headlines with compelling results in muscle-invasive bladder cancer. The combination therapy reduced the risk of death by 50%, reinforcing Keytruda's position as a cornerstone immunotherapy across multiple cancer types. This result not only augments treatment options but also signifies the potential for combination regimens to enhance patient outcomes.Roche has expanded the indication of its aging oncology drug Gazyva to treat lupus nephritis, demonstrating strategic repurposing efforts to extend the lifecycle of existing therapies. While this expansion into autoimmune diseases comes late in Gazyva's lifecycle, it highlights a growing trend of capitalizing on established drugs for new therapeutic areas.AstraZeneca and Daiichi Sankyo's Enhertu showed robust efficacy in early breast cancer treatment, potentially reshaping therapeutic strategies by offering new hope for early intervention. Similarly, Novartis' Pluvicto demonstrated promise in slowing hormone-sensitive prostate cancer progression, underscoring the potential of radioligand therapies in oncology.However, not all developments have been positive. AstraZeneca faced setbacks when its Imfinzi and Lynparza combination failed to meet survival goals in ovarian cancer, underscoring the challenges inherent in oncology drug development and the stringent benchmarks set by regulatory authorities like the FDA.The industry is also witnessing significant advancements in next-generation ADCs, as evidenced by Tubulis' 59% response rate in early clinical trials, which has attracted substantial investor interest. Additionally, Grail's Galleri cancer blood test is progressing towards FDA review with enhanced performance data, potentially revolutionizing cancer screening and early detection practices.These scientific and regulatory milestones are complemented by strategic investments in bioconjugation technologies. Cohance Life Sciences' $10 million investment in NJ Bio to enhance GMP bioconjugation capabilities exemplifies this trend. Such investments are crucial for advancing ADC development, which remains a focal point for innovative cancer therapies.Overall, these developments reflect a dynamic phase for the pharmaceutical and biotech sectors characterized by signSupport the show

Audio roundup of selected biopharma industry content from Scrip over the business week ended October 10, 2025. In this episode: biopharma financing regaining optimism; larger CAR-T indications to strain healthcare capacity; Galderma punching above weight in dermatology; Amgen's direct-to-patient Repatha program; and Datroway's survival success in breast cancer. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-JZ326HAB2ZHB7E3Z5PNIUBITQQ/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

his Week in Review covers 5 episodes from October 06 to October 10, featuring major developments in the pharmaceutical and biotech industries.Episodes included:1. Pharma and Biotech Daily: Novo's Acquisition, FDA Breakthroughs, and Industry Updates2. Pharma and Biotech Daily: Top Stories in the Industry from Zenas to Lilly3. Pharma and Biotech Daily: Tariff Impact, Promising Trials, and Industry Leaders4. Pharma and Biotech Daily: The Latest in Cell and Gene Therapy, M&A Activity, and Regulatory Updates5. The Essential Updates in Pharma and Biotech: Your Daily Dose of What MattersKey topics covered:- Strategic acquisitions and partnerships- Regulatory updates and FDA approvals- Clinical trial results and breakthroughs- Industry trends and market developmentsStay informed with Pharma Daily's comprehensive coverage of the pharmaceutical and biotech worldSupport the show

Host: Susanna Price Guest: Rudolf de Boer Want to watch that extended interview on AI in echocardiography? Go to: https://esc365.escardio.org/event/2175?resource=interview Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsors.  This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Nicolle Kraenkel and Susanna Price have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder Mycardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Rudolf de Boer has declared to have potential conflicts of interest to report: the institution of Rudolf de Boer has received research grants and/or fees from Alnylam, AstraZeneca, Abbott, Bristol-Myers Squibb, NovoNordisk, and Roche; Rudolf de Boer has had speaker engagements with and/or received fees from and/or served on an advisory board for Abbott, AstraZeneca, Bristol Myers Squibb, NovoNordisk, Roche, and Zoll; Rudolf de Boer received travel support from Abbott and NovoNordisk. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

This episode covers: Cardiology This Week: A concise summary of recent studies Visceral adiposity: paradigm shift in HFpEF management Artificial Intelligence in echocardiography Milestones: ISIS-2 Host: Susanna Price Guests: Carlos Aguiar, Milton Packer, Rudolf de Boer Want to watch the episode? Go to: https://esc365.escardio.org/event/2175 Want to watch the extended interview on AI in echocardiography? Go to: https://esc365.escardio.org/event/2175?resource=interview Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsors. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Nicolle Kraenkel and Susanna Price have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder Mycardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Rudolf de Boer has declared to have potential conflicts of interest to report: the institution of Rudolf de Boer has received research grants and/or fees from Alnylam, AstraZeneca, Abbott, Bristol-Myers Squibb, NovoNordisk, and Roche; Rudolf de Boer has had speaker engagements with and/or received fees from and/or served on an advisory board for Abbott, AstraZeneca, Bristol Myers Squibb, NovoNordisk, Roche, and Zoll; Rudolf de Boer received travel support from Abbott and NovoNordisk. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Milton Packer has declared to have potential conflicts of interest to report: 89bio, Abbvie, Actavis, Altimmune, Alnylam, Amarin, Amgen, Ardelyx, ARMGO, AstraZeneca, Attralus, Biopeutics, Boehringer Ingelheim, Caladrius, Casana, CSL Behring, Cytokinetics, Daiichi Sankyo, Imara, Lilly, Medtronic, Moderna, Novartis, NovoNordisk, Pharmacocosmos, Regeneron, Roche, Salamandra. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Zenas has made a $2 billion bet on autoimmune diseases with Chinese firm InnoCare, focusing on the development of orelabrutinib for multiple sclerosis. Former FDA director Peter Marks has joined Eli Lilly, marking the company's continued push in China. Sanofi's advancements in radiopharma, Boehringer Ingelheim's breakthrough in idiopathic pulmonary fibrosis, and Takeda's exit from cell therapy are also top stories. Cytiva filtration is highlighted as a solution for maintaining product integrity in biopharma.Biospace profiles the five most powerful women leading smaller biopharmaceutical companies, as the industry sees a shift with the departure of GSK CEO Emma Walmsley. A survey by CRB reveals that most life sciences companies are not planning new investments after tariffs, with big pharma taking the lead in manufacturing initiatives. Drug pricing criticism often overlooks the dynamic nature of drug pricing over time. Takeda's journey in building a cell therapy portfolio, only to ultimately walk away, is explored. Pfizer wins the bid for Metsera, Amgen offers Repatha at a discounted rate, and Roche acquires Akero for $3.5 billion. Biospace also honors 40 under 40 winners making an impact in the industry.Peter Marks, former director of the FDA's Center for Biologics Evaluation and Research, has taken on a new role as Senior Vice President for molecule discovery and the head of infectious diseases at Eli Lilly. Marks' controversial exit from the FDA led to his hiring by Lilly, following in the footsteps of another former FDA official, Rachael Anatol. Marks confirmed his new role to Stat News and began his first day at Lilly Research Laboratories on Monday.Support the show

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.A new survey from CRB shows that most life sciences companies, particularly smaller biotechs, are not planning new investments in response to tariffs. The majority of manufacturing initiatives in the U.S. made in response to tariffs are coming from big pharma companies. Sky Bioscience's CB1 inhibitor, Nimacimab, showed promising weight-loss results when combined with Wegovy despite falling short of expectations in a mid-stage obesity trial. Amgen will offer its lipid-lowering drug Repatha directly to patients at a 60% discount. Biospace has honored 40 under 40 leaders in biopharma whose achievements reflect the industry's grit and impact. Pfizer beat out two other suitors for a takeover of Metsera. Maplight seeks a $227 million IPO for its neuropsych portfolio.AMT designation is taking its first steps amid uncertain benefits. Pharming's restructuring triggers a 20% reduction in its workforce. Experts are forging new paths to address scalability, cost, and other barriers surrounding cell therapy production.The CDC has adopted ACIP recommendations on chickenpox and COVID-19 vaccines. Stay tuned for upcoming events such as webinars on mRNA medicine, biopharma deregulation, and transforming digital sequences into mRNA.Various job opportunities in the life sciences industry include positions at Sonothera, Eli Lilly and Company, and Amgen.Support the show

The U.S. government is now in its second week of a shutdown—with the FDA having paused acceptance of all new drug applications for the duration. But it was business as usual at the CDC, which adopted the recent recommendations of its newly revamped advisory committee on chickenpox and COVID-19 vaccines. And another senior leader, National Institute of Allergy and Infectious Diseases Director Jeanne Marrazzo, was fired last week, after filing a whistleblower report.  Across the country, cell and gene therapy leaders arrived in Phoenix for the annual Meeting on the Mesa, as the space remains in a state of flux—with regulatory and M&A momentum being stalled by commercial and market challenges. Takeda, for one, is looking to offload its cell therapy platform after years of hefty investment.  President Donald Trump's long-awaited tariffs did not hit on Oct. 1 as promised. But in the face of the looming levies, Pfizer signed a drug pricing deal with the White House that provides a three-year exemption. Amgen appears to be climbing onboard as well, announcing that its lipid-lowering drug Repatha will be available at a steep discount. These moves are all well and good for Big Pharma players, but a recent report from CRB reveals most smaller biopharma companies are not planning any investments to offset tariffs.  In our weekly weight loss segment, Skye Bioscience's cannabinoid receptor 1-targeting candidate nimacimab failed to outpace placebo in reducing body weight but elicited “intriguing synergy” in combination with Novo Nordisk's Wegovy, according to William Blair analysts. And regulatory documents shed further light on Pfizer's $4.9 billion takeover of Metsera, in which the New York pharma beat out two higher bidders for the promising obesity startup.  Finally, make sure to check out The 5 Most Powerful Women in Biopharma and BioSpace's inaugural 40 Under 40, highlighting 40 young leaders who have made an impact on the biopharma industry.  

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Chiesi has entered a $2.1 billion collaboration with Arbor to develop a gene therapy for primary hyperoxaluria type 1. AstraZeneca continues to invest in AI partnerships, FDA lifts clinical hold on Neurizon's ALS drug, and the cell and gene therapy field faces challenges and opportunities at the Meeting on the Mesa event. CDC adopts ACIP recommendations, FDA's manufacturing initiatives progress, and Mythic cuts staff.Industry leaders in the cell and gene therapy space are gathering in Phoenix for a meeting on the mesa, where the market is experiencing mixed signals. While M&A activity and regulatory support are showing momentum, challenges with commercialization are still hindering investor interest. The focus on next-generation multiple sclerosis treatments beyond BTK inhibitors is gaining attention, with companies like Immunic Therapeutics exploring neuroprotective targets and remyelination.The future of gene therapy depends on improving safety through targeted delivery and human-relevant testing to avoid costly failures. The FDA has released new guidance to streamline regulatory pathways for cell and gene therapies for small populations, which is receiving a warmer welcome compared to previous issuances. In other news, the US government shut down, leading to the FDA closing for new applications, while Amgen presents late-stage data for Repatha in preventing heart disease.Additionally, Metsera's obesity drug shows promising efficacy in mid-stage trials. Cybersecurity is highlighted as a crucial challenge in the pharmaceutical industry, with a focus on protecting manufacturing integrity and innovation. Upcoming events include webinars on mRNA medicine and biopharma deregulation, while job opportunities in various biopharma companies are also available.Support the show

Send us a textDr. Michael Koren joins Kevin Geddings to discuss the positive headline results from a clinical study on the cholesterol medication Repatha. Dr. Koren explains what "headline results" are and how they differ from results presented in a full scientific format. He talks about how these findings are being released due to market regulations to keep the parent company of Repatha, Amgen, from violating financial laws. Dr. Koren also explains that these results are encouraging for people with high cholesterol. The study was using Repatha as a potential preventative medication and preliminary results are looking good!Be a part of advancing science by participating in clinical research.Have a question for Dr. Koren? Email him at askDrKoren@MedEvidence.comListen on SpotifyListen on Apple PodcastsWatch on YouTubeShare with a friend. Rate, Review, and Subscribe to the MedEvidence! podcast to be notified when new episodes are released.Follow us on Social Media:FacebookInstagramX (Formerly Twitter)LinkedInWant to learn more? Checkout our entire library of podcasts, videos, articles and presentations at www.MedEvidence.comMusic: Storyblocks - Corporate InspiredThank you for listening!

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Former NIAID director Jeanne Marrazzo was fired after filing a whistleblower report, alleging retaliation. The FDA's new cell and gene therapy guidances have been well-received for streamlining therapies. In other news, CMS has finalized stronger protections for orphan drugs, and Amgen's Repatha has shown positive results in preventing heart disease. Lotte Biologics is highlighted as a multinational CDMO partner, and layoffs at CSL Vifor and Takeda are noted. Trump has delayed pharma tariffs, Pfizer's drug pricing deal with Trump raises questions, and GSK CEO Emma Walmsley's departure is discussed. Thank you for listening to the latest updates in the Pharma and Biotech industry. Stay tuned for more essential news in our next episode.Support the show

Listen in as we discuss considerations, challenges, and strategies related to the use and switching of biosimilars in clinical practice.  You'll hear communication tips to address patient and prescriber concerns as well as operational considerations for integrating biosimilars into practice.  Special guests:Bharati Bhardwaja, PharmD, BCPS, LSSBBRheumatology Clinical Pharmacy SpecialistKaiser Permanente ColoradoMegan May, PharmD, BCOP, FHOPA, FAPOClinical Oncology Pharmacy SpecialistBaptist Health Lexington/Hamburg Cancer Care CenterYou'll also hear practical advice from TRC's Editorial Advisory Board member:Craig D. Williams, PharmD, FNLA, BCPSClinical Professor of Pharmacy PracticeOregon Health and Science UniversityFor the purposes of disclosure, Dr. Megan May reports relevant financial relationships [lung cancer] with Amgen, AstraZeneca, Pharmacosmos (speakers bureau). The other speakers have nothing to disclose.  All relevant financial relationships have been mitigated.This podcast is an excerpt from one of TRC's monthly live CE webinars, the full webinar originally aired in August 2025.TRC Healthcare offers CE credit for this podcast. Log in to your Pharmacist's Letter, Pharmacy Technician's Letter,or Prescriber Insights account and look for the title of this podcast in the list of available CE courses.Claim CreditThe clinical resources mentioned during the podcast are part of a subscription to Pharmacist's Letter, Pharmacy Technician's Letter, and Prescriber Insights: FAQ: Facts About BiosimilarsChart: Comparison of Insulins (United States)Chart: Biologics for Rheumatoid ArthritisChart: Biologics for Crohn's DiseaseUse code mt1025 at checkout for 10% off a new subscription.Send us a text****

In this JCO Article Insights episode, Dr. Ece Cal interviews Dr. Martin Wermke, author of the JCO article, "Phase I Dose-Escalation Results for the Delta-Like Ligand 3/CD3 IgG-Like T-Cell Engager Obrixtamig (BI 764532) in Patients With Delta-Like Ligand 3+ Small Cell Lung Cancer or Neuroendocrine Carcinomas." TRANSCRIPT The disclosures for guests on this podcast can be found in the transcript. Dr. Ece Cali: Welcome to this episode of JCO Article Insights. This is Dr. Ece Cali, JCO editorial fellow, and today I am joined by Dr. Martin Wermke, Professor for Experimental Cancer Therapy at Dresden University of Technology, to discuss the manuscript “Phase 1 Dose-Escalation Results for the Delta-Like Ligand 3/CD3 IgG-like T-Cell Engager Obrixtamig in Patients with DLL3+ Small Cell Lung Cancer or Neuroendocrine Carcinomas.” Obrixtamig is a bispecific T-cell engager that binds to DLL3 on tumor cells and CD3 on T-cells. This manuscript presents the phase 1A dose escalation results of Obrixtamig in patients with DLL3+ small cell lung cancer and neuroendocrine carcinomas. In this study, 168 patients were treated with Obrixtamig across four different dosing regimens. 49% of the patients had small cell lung cancer, 42% had extrapulmonary neuroendocrine carcinoma, and 8% had large cell neuroendocrine carcinoma of the lung. Patients received a median of two prior lines of therapy. 33% of the patients had brain metastases at baseline. Of note, this trial did not mandate baseline brain imaging. Maximum tolerated dose was not reached. 88% of the patients experienced a treatment-related adverse event, however, only 3.6% of the patients had to discontinue treatment due to treatment-related AEs, and dose reduction due to treatment-related AEs was documented in 2.4% of the patient population. Similar to the other DLL3-targeted bi-therapies, the most common adverse events included CRS in 57%, dysgeusia in 23%, and pyrexia in 21% of the patients. CRS events were mostly mild. They occurred more frequently in the first two to three doses. 9% of the patients experienced ICANS, of which 3% were graded as Grade 3 or higher. And let's review the efficacy results. Responses were only seen in patients who received 90 microgram per kg or more once weekly or once every three weeks dosing. The objective response rate in patients who received an effective dose was 28%. If we review by tumor type, 21% of the small cell lung cancer patients, 27% of the extrapulmonary neuroendocrine carcinoma patients, and 70% of the large cell neuroendocrine carcinoma patients had objective response. Median duration of response was 8.5 months, though this data is immature due to short follow-up. Dr. Wermke, DLL3-targeted bispecific T-cell engagers are reshaping the treatment landscape of small cell lung cancer. This trial investigates Obrixtamig in other high-grade neuroendocrine tumors as well. Can you put this trial into context for us and explain why it may represent an important step forward? Dr. Martin Wermke: Yeah, thank you for providing me with the opportunity to discuss our data today. I think the data with Obrixtamig in small cell lung cancer are largely similar to what has been observed with other bispecific T-cell engagers such as tarlatamab with respect to the response rate and duration. It has, however, been to be mentioned that BI 1438001 had a bit more liberal inclusion criteria than other trials around. You already mentioned the fact that we allowed the inclusion of patients without mandatory brain imaging, which led to some patients having their brain mets been diagnosed during the treatment with obrixtamig and then adding to the progressive disease patients. That is something which was not the case with the tarlatamab trials where you really had to have a brain imaging before, and in the Phase 1 trial you were even required to treat the brain mets before you included the patient. So it is a bit different, more poorest patient population. I think the trial adds on existing data by being the first trial to also include non-SCLC neuroendocrine carcinoma of other origin, for example from the gastrointestinal tract, and also by including large cell neuroendocrine carcinoma of the lung, which is a really hard to treat pulmonary neoplasm which currently lacks any standardized treatment. So that is really a step forward which we will build on in the future. Dr. Ece Cali: And one thing I would note in this trial, only patients with tumor expressing DLL3 were enrolled. Can you tell us a little bit more about this target, DLL3 in the context of neuroendocrine tumors, and does DLL3 expression predict clinical outcomes after treatment with DLL3 BiTEs, or do we actually need other predictive biomarkers for these novel agents? Dr. Martin Wermke: Yeah, thank you. That's a pretty interesting question. First of all, DLL3 is an atypical notch ligand, which is expressed by the majority of neuroendocrine carcinomas, virtually absent on healthy adult tissues. Therefore, turning it really into a bona fide target for T-cell engaging therapies, pretty low risk for on-target off-tumor side effects. We found that in all the patients we screened, we had an expression rate of about 94% in small cell lung cancer, 80% of large cell neuroendocrine carcinoma of the lung were positive, and also about 80% of the extrapulmonary neuroendocrine carcinoma. So it's really a high prevalence. So the fact that we only included DLL3+ tumors still means we included most of the patients that presented with these diseases. I think at the moment there are no data suggesting a clear-cut association between DLL3 expression levels and outcome on DLL3 CD3 T-cell engagers. There's also not a lot published. If you want to find this out for tarlatamab, you have to look into their patent to really see the data, but it's not clear-cut and I'm sure we need other markers to complement that. And I think what probably plays a major role is intrinsic T-cell fitness. So the question how really diseased your T-cells are, how old you are, because age also correlates with the fitness of the immune system, and other patient characteristics such as tumor burden, we've seen all across the board that the higher the tumor burden, the lower the rate of prolonged response is in such trials. And I also think we need to focus on other components of the tumor microenvironment. So see how high the T-cell infiltration with obrixtamig is and how abundant suppressive elements like regulatory T-cells or myeloid-derived suppressive cells are. That is work which is currently being done. Data are emerging, but I don't think that at the moment we have any clear biomarker helping us to select who should not receive DLL3 T-cell engagers. Dr. Ece Cali: Those are great points and there is a lot we need to learn about how to use these novel agents in the future. I'd like to highlight the results in large cell neuroendocrine carcinoma of the lung. The response rate in this group was remarkably high at 70%. Though we should note the small sample size of only 14 patients in this trial. After first line chemoimmunotherapy, current approved options for this population have very modest clinical activity. Given these trial results, how do you envision the field moving forward for patients with large cell neuroendocrine carcinoma? Dr. Martin Wermke: Yeah, I think LCNEC is really an area which urgently needs further improvement of therapeutic standards. At the moment, as I said, there is no real standard. We are usually extrapolating from results we have in small cell lung cancer or non-small cell lung cancer, but I don't think we have too many prospective trials really informing this. Of course, 14 patients is a small sample size, but I think it's still fair to say that we can claim that DLL3 T-cell engagers are not doing worse in LCNEC than they do in SCLC. And that's why I think we really need to move forward clinical trials that are specifically targeting this population. Although I fear a bit that, given the rareness of this disease and the aggressiveness of its phenotype, that this is probably not the main focus of the pharmaceutical industry. So I think it's up to us academic investigators to really come up with investigator-initiated trials trying to fill the knowledge gaps we have here. Dr. Ece Cali: And one more thing that I want to talk about is the accessibility for these drugs. These novel agents are showing real promise in improving outcomes for patients with high-grade neuroendocrine tumors, an area where progress has been limited until very recently. However, as DLL3 BiTEs become more widely used, issues of logistics and access come into sharper focus. With unique toxicities and the specialized monitoring, their use is restricted to certain centers. Looking ahead, what kinds of strategies could help mitigate some of these adverse events or make these treatments more broadly available? Dr. Martin Wermke: Yeah, I think if you look at countries like the United States where tarlatamab has already been approved, we can see how the management strategies are evolving. I've heard about a colleague equipping their patients with thermometers and a pill of Dexamethasone, alongside with a temperature control protocol and clearly instructing them, "If you measure a temperature above a certain level then start taking the Dexamethasone and come back to our office and we're going to take care of you." I think that's one way to move forward. I think we are lucky in a way that CRS usually manifests within the first 24 hours. This was the same in our study, like in the tarlatamab studies. So we really know when the time of trouble is for our patients. And in this time, I think we need to instruct the patients to stay close to the hospital. I don't think we need to hospitalize all of them, but we probably need them to stay in a nearby hotel to be able to reach the emergency room if needed in a short period of time. And I think we can also learn in this strategy how to manage bispecific antibodies from the experience our colleagues in hematology had because they have been using bispecific T-cell engagers for quite some years right now and they developed strategies and networks that were able to successfully treat these patients also on an outpatient basis. And I think that is clearly an experience we need to follow, acknowledging that we are talking about diseases which are much more frequent than the standard hematology indications. Dr. Ece Cali: Thank you so much, Dr. Wermke, for this informative discussion and for sharing your perspective on this evolving field. Dr. Martin Wermke: Yeah, thank you for providing me with the opportunity to talk about data. It was really great being able to share that, and I really think that we are just at the beginning of a new exciting area for the treatment of neuroendocrine carcinomas, and I think much improvement is yet to come for our patients. Dr. Ece Cali: Yes, that's really exciting. And thank you everyone for listening to JCO Article Insights. Please come back for more interviews and article summaries and be sure to leave us a rating and review so others can find our show. For more podcasts and episodes from ASCO, please visit asco.org/podcasts. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on this podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Dr. Martin Wermke's Disclosures Honoraria: Lilly, Boehringer Ingelheim, SYNLAB, Janssen, Merck Serono, GWT, Amgen, Novartis, Pfizer,  BMS GmbH & Co. KG, Regeneron, MJH/PER, Takeda Consulting or Advisory Role: Bristol-Myers Squib, Novartis, Lilly, Boehringer Ingelheim, ISA Pharmaceuticals, Amgen, immatics, Bayer, ImCheck therapeutics, AstraZeneca, Tacalyx, Regeneron, Daiichi Sankyo Europe GmbH, Zymeworks, PharmaMar, Iovance Biotherapeutics, T-Knife, Genentech Research Funding: Roche Patents, Royalties, Other Intellectual Property Travel, Accommodations, Expenses: Pfizer, Bristol-Myers Squibb, AstraZeneca,  Amgen,  GEMoaB, Sanofi/Aventis, immatics,  Merck Serono, Janssen Oncology, Iovance Biotherapeutics, Daiichi Sankyo Europe GmbH"

Plus: Pharma company Amgen announces a $650 million expansion of its U.S. manufacturing network. And federal regulators ease restrictions on Boeing aircraft deliveries. Alex Ossola hosts. Sign up for WSJ's free What's News newsletter. An artificial-intelligence tool assisted in the making of this episode by creating summaries that were based on Wall Street Journal reporting and reviewed and adapted by an editor. Learn more about your ad choices. Visit megaphone.fm/adchoices

This episode covers: Cardiology This Week: A concise summary of recent studies Strategic decisions in valvular heart disease Optimising drug therapy in chronic coronary syndromes Mythbusters: Does wearing a white coat make you smarter? Host: Susanna Price Guests: John-Paul Carpenter, Fabien Praz, Robert Storey Want to watch that episode? Go to: https://esc365.escardio.org/event/2092 Want to watch that extended interview on Optimising drug therapy in chronic coronary syndromes ? Go to: https://esc365.escardio.org/event/2092?resource=interview Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsors. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English-language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Nicolle Kraenkel, Fabien Praz and Susanna Price have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder Mycardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Robert Storey has declared to have potential conflicts of interest to report: research grants and personal fees from AstraZeneca and Cytosorbents, and personal fees from Abbott, Afortiori Development/Thrombolytic Science, Boehringer Ingelheim/Lilly, Bristol Myers Squibb/Johnson & Johnson, Chiesi, Idorsia/Viatris, Novo Nordisk, PhaseBio and Tabuk. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Host: Susanna Price Guest: Robert Storey Want to watch that extended interview? Go to: https://esc365.escardio.org/event/2092?resource=interview Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsors. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English-language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Nicolle Kraenkel and Susanna Price have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder Mycardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi.  Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Robert Storey has declared to have potential conflicts of interest to report: research grants and personal fees from AstraZeneca and Cytosorbents, and personal fees from Abbott, Afortiori Development/Thrombolytic Science, Boehringer Ingelheim/Lilly, Bristol Myers Squibb/Johnson & Johnson, Chiesi, Idorsia/Viatris, Novo Nordisk, PhaseBio and Tabuk. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Cardiovascular expert Colleen Walsh-Irwin returns to NP Pulse for an in-depth look at hyperlipidemia and the importance of controlling LDL-C levels. Walsh-Irwin also walks us through lipid panels, risk scoring and the many tools NPs have at their disposal to keep patients healthy and informed.  This podcast is made possible by Amgen.

To read more of Derek's reporting on GLP-1 drugs, you can subscribe to his Substack here. GLP-1 drugs like Ozempic and Zepbound don't just help with Type 2 diabetes and weight loss. They seem to curb alcohol, cocaine, and tobacco use among addicts. In some studies, they prevent strokes, heart attacks, chronic kidney disease, sleep apnea, and Parkinson's disease. They're associated with a lower risk of several cancers, including pancreatic cancer and multiple myeloma. Arthritic patients on the drugs experienced relief from knee pain that was “on par with opioid drugs.” A small study found that they reduce migraine headaches by 50 percent. And emerging research suggests they might even slow the rate of memory loss among people diagnosed with Alzheimer's. Is all of this real? And if it's real, how is one drug doing so many different things? And if it is doing all those things, why shouldn't we be developing versions of the drug for just about everyone? Today we have two guests: David D'Alessio, chief of endocrinology and metabolism at the Duke University School of Medicine; and Randy Seeley, a professor of surgery, internal medicine, and nutritional sciences at the University of Michigan. We talk about how these drugs work—why they seem to do everything—and how our understanding of them could make them better, more effective, more broadly useful. If you have questions, observations, or ideas for future episodes, email us at PlainEnglish@Spotify.com. Host: Derek Thompson Guests: David D'Alessio and Randy Seeley Producer: Devon Baroldi Disclosure: Dr. Seeley has received research support from several pharmaceutical companies, including Eli Lilly, Diasome, and Amgen. Learn more about your ad choices. Visit podcastchoices.com/adchoices

In der heutigen Folge sprechen die Finanzjournalisten Daniel Eckert und Philipp Vetter über Rückenwind für die Hannover Rück, den erfolgreichen Börsengang der Kryptobörse Gemini und fehlende Friedensfantasie bei Heidelberg Materials. Außerdem geht es um Warner Bros Discovery, Tesla, Micron Technology, Palantir, Advanced Micro Devices, Microsoft, Strategy, Trade Republic, EQT, Apollo Global Management, Merck & Co., Amgen, Boeing, Nike, Coinshares Physical XRP (WKN: A3GRUE), Bitwise Physical XRP (WKN: A3GYNB) und Invesco Physical Bitcoin (WKN: A3GU8J). Die Tickets zum Finance Summit am 17. September bekommt ihr 40 Euro günstiger – aber nur mit dem exklusiven Code AAA2025, der ihr unter dem folgenden Link eingeben müsst: https://veranstaltung.businessinsider.de/BN5aLV Außerdem könnt ihr unter diesem Link euer Depot hochladen – und mit etwas Glück wird kein Geringerer als Christian W. Röhl euer Depot beim Summit checken und optimieren. https://form.jotform.com/Product_Unit/formular-finance-summit-depot-check Wir freuen uns über Feedback an 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. Der Börsen-Podcast 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. +++ 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 e Biotech world.Novo Nordisk has cut 9,000 jobs worldwide and reduced its 2025 profit growth guidance. The new CEO is fulfilling a cost reallocation promise, leading to a decrease in operating profit growth projection from 10% to 16% down to 4% to 10%. The company's restructuring efforts are aimed at increasing efficiency and reducing costs. In other news, the ousted CDC director Susan Monarez will testify in front of the Senate, and a recent report from the Maha commission emphasizes chronic diseases and potential vaccine reform.Biotechs are using contingent value rights (CVRs) to close the gap between buyer and seller expectations in transactions amid a down market. Novartis is actively pursuing acquisitions, particularly in the cardiovascular space, while Novo Nordisk is restructuring and cutting costs, impacting profit growth projections. Amgen is looking beyond the scrutiny of one obesity asset to focus on a fuller portfolio. Trilink Biotechnologies offers process development services for nucleic acid therapeutic development. In other news, LB Neuroscience files for a $228 million IPO, Novartis acquires Tourmaline for $1.4 billion, and Hengrui licenses a heart disease drug to a US startup for up to $1 billion. The FDA debuts a consumer 'green list' instead of addressing the GLP-1 compounding fight. Thank you for tuning in to Pharma and Biotech daily.

— All bodily sensations, including those visceral feelings from your chest and stomach, are relayed back to the brain through the pathways via the spinal cord. Your already anxious and highly alert brain then processes these signals at both conscious and unconscious levels. The insula is a part of the brain specifically involved in conscious awareness of your emotions, pain and bodily sensations. The prefrontal cortex also engages in self-awareness, especially by labeling and naming these physical sensations, like feeling tightness or pain in your stomach, and attributing cognitive value to them, like “this is fine and will go away” or “this is terrible, and I am dying.” These physical sensations can sometimes create a loop of increasing anxiety as they make the brain feel more scared of the situation because of the turmoil it senses in the body.  Although the feelings of fear and anxiety start in your brain, you also feel them in your body because your brain alters your bodily functions. Emotions take place in both your body and your brain, but you become aware of their existence with your brain. — by Arash Javanbakht, Associate Professor of Psychiatry, Wayne State University Valeria interviews Dr. Megan Plotkowski on the topic of The Neuroscience Of Anxiety — Dr. Megan is an EMDR-trained Associate Marriage and Family Therapist who brings a rare fusion of scientific precision, emotional depth, and intuitive clarity to her clinical work. She holds a PhD in molecular biology and biochemistry with an emphasis in neuroscience, as well as a master's degree in clinical psychology—bridging the world of hard science with the complexities of human experience.  Megan currently works in both private practice and community mental health, specializing in clients who feel overwhelmed, emotionally stuck, or disconnected—particularly those navigating anger, anxiety, addiction, trauma, or complex family dynamics. Before entering the field of psychotherapy, Megan worked as a research scientist at Amgen and UCLA, contributing to groundbreaking studies in molecular genetics and neural protein structure and function. She also taught at UCLA. Her academic background continues to inform a therapy style rooted in evidence-based practice, intellectual rigor, and deep compassion. In recent years, Megan has also come to recognize and trust a deep intuitive knowing that emerges both in her personal life and in the therapy room. This awareness led her to develop a dual-wisdom model of therapy that honors both the analytical and the unseen—a framework that bridges neuroscience and symbolism, logic and lived experience, insight and mystery. Whether drawing from hard science, depth psychology, or intuition, Megan's work is grounded in the belief that healing often begins where the visible ends—and that true transformation happens when the unspoken is finally brought into the light. To learn more about Megan Plotkowski and her work, please visit: https://www.thescientisttherapist.com/

The Amgen Irish Open 2025 is back at The K Club, September 3rd–7th, and this year it's more than just golf it's a full festival of sport, music, food, family fun, and world-class fan experiences.In this special preview episode, I break down everything you need to know before heading to Straffan:✅ The Golf: Rory McIlroy chasing another Irish Open title, Shane Lowry on home soil, and a star-studded field featuring Pádraig Harrington, Séamus Power, Luke Donald, Francesco Molinari, Danny Willett, Jhonattan Vegas and more.✅ Fan Experiences & Activations:The Academy – free PGA coachingThe Arcade – VR & gamingBeat the Pro – how to pre-register for your shot on the 12thRory's Q&A – Thursday in the Championship VillageGrand Slam Trophies on display all weekKids Zone – the biggest ever, and how to get kids' tickets free✅ Food, Drink & Music: Gourmet street food, the Summer House champagne bar by the 16th, craft drinks, and live music with The Stunning (Saturday) and Simple Things (Sunday).✅ Travel Tips:Free public parking & shuttle infoTicket+ priority parking & hospitality accessTrain + Expressway shuttle (€15 return)Local buses, walking routes, and taxi drop-offsAccessibility info: Blue Badge parking, mobility scooter hire✅ Paddy's Fan Checklist: 5 things you need to sort before leaving home to make your day hassle-free.Whether you're chasing Rory's autograph, bringing the family for a day out, or just want to soak up the atmosphere with a pint by the 16th, this episode is your ultimate guide to getting the best value and craic from your Irish Open experience.

Episode 368 - Steve Bamford @Bamfordgolf, Paul Williams @GolfBetting and Barry O'Hanrahan @AGoodTalkGolf discuss their selections for this week's Amgen Irish Open on the DP World Tour. Listeners should visit Golf Betting System for the best golf betting coverage. Read our new best bookmaker golf guide. Intro: 00:30; Bobsaid444 in the USA Listener Review: 01:42; Summer Break Update: 07:20; Ryder Cup Captain Picks Start: 21:45; Amgen Irish Open Start: 33:44. Paul's Amgen Irish Open Betting Preview: irish open betting tips We have a new set of Golf Betting System bookmaker guides, highlighting current 2025 sports accounts. boylesports offers betfred promo codes betfred sign up offer ladbrokes bet 10 get 40 ladbrokes new customer offer coral bonus code coral sign up offer bet365 bet 10 get 30 bet365 bonus code william hill bonus code 2025 william hill welcome offer unibet bonus code All offers are for new customers, 18+ Check out our new most golf each way places page Steve Bamford provides pga tips across the whole of 2025 Let us talk you through the bet365 each way extra + bet365 golf each way places X: Steve Bamford @Bamfordgolf; Barry O'Hanrahan @AGoodTalkGolf; Paul Williams @GolfBetting Most Viewed Pages https://www.golfbettingsystem.co.uk/bet365-sign-up-offer/ https://www.golfbettingsystem.co.uk/william-hill-promo-code-golf/ https://www.golfbettingsystem.co.uk/william-hill-sign-up-offer/ https://www.golfbettingsystem.co.uk/betfred-promo-code/ https://www.golfbettingsystem.co.uk/boylesports-promo-code/ https://www.golfbettingsystem.co.uk/ladbrokes-sign-up-offer/ https://www.golfbettingsystem.co.uk/bet365-bonus-code-2023/ https://www.golfbettingsystem.co.uk/ladbrokes-promo-code/ This podcast is for listeners of 18 and above. Please be Gambleaware, you can visit GambleAware.org for more information and of course please bet responsibly.  

Off The Ball's Golf Weekly podcast has a very special guest today as on tour at the Irish Open, they chat to five-time major champion, Rory McIlroy. Want access to the full podcast? Join Ireland's biggest, best (and possibly nerdiest) golf community!Become an Off The Ball member at http://offtheball.com/join and email golfweekly@offtheball.com with proof of your subscription to get access to the Golf Weekly Discord server!

Welcome to the Sweet Spot, sponsored by SBK. Get the latest golf betting tips for the upcoming Amgen Irish Open, as Dave Clark returns with Steve Palmer to take a look at this week's tournaments.   The team also take a look back at last week's Omega European Masters, where Thriston Lawrence took the win.  Steve gives us his predictions for the Amgen Irish Open, pinpointing the best value selections. The team also have a chat about the upcoming Ryder cup. Steve gives us his thoughts on both teams.

As September approaches, many families notice asthma symptoms getting worse. Ragweed pollen, viral infections, cooler nights, and the stress of back-to-school routines all combine to create Asthma Peak Week, a time when asthma attacks and ER visits spike across the country. Asthma mom, Sherrina Gibson, joins us to share how her family prepares her 11-year-old daughter for fall asthma challenges. She talks about cleaning routines, school planning, and teaching her daughter self-awareness and empowerment. Dr. Payel Gupta adds medical guidance on asthma action plans and seasonal medication adjustments. You'll learn how to spot asthma triggers, prepare your home and school, and teach children to recognize symptoms early so they can act before a flare gets worse. What we cover in our episode about preparing for asthma peak week: Parenting with asthma: Sherrina Gibson shares her family's journey and how they prepare their home and routines each fall. Asthma management strategies: Cleaning, decluttering, updating medications, and coordinating with schools and coaches. Asthma Peak Week explained: Why symptoms spike in September and how to get ahead of it. Asthma action plans: Why every family needs one and how to keep copies at home, school, and on the go. Empowering kids with asthma: Teaching children to recognize symptoms, use their inhaler properly, and advocate for themselves at school and in sports. More episodes about asthma Ep. 81: Why asthma attacks rise in September peak week Ep. 58: What is controlled Asthma? - Everything you need to know! Ep. 117: As-Needed Albuterol–Budesonide in Mild Asthma (BATURA Trial) Ep. 124: Asthma peak week and understanding triggers Made in partnership with The Allergy & Asthma Network. Thanks to AstraZeneca and Amgen for sponsoring today's episode.  This podcast is for informational purposes only and does not substitute professional medical advice. Always consult with your healthcare provider for any medical concerns.

There aren't many Ivy League professors as bold as Dave Collum. It's amazing he still has a job.  (00:00) How Collum Predicted the 2008 Financial Crisis (11:00) Collum's Mission to Uncover the Truth About Covid (19:36) Government Experiments Being Conducted on Foster Care Children (24:17) What's the Truth About Diddy? (34:07) What's the Truth About the Assassination Attempt on Donald Trump? (1:00:45) Are We Being Purposefully Distracted From Things That Actually Matter? (1:12:04) The Real Dangers of AI Dave Collum is a professor of organic chemistry at Cornell University, where he earned his BS in biology and later returned after completing his PhD in chemistry at Columbia. A former department chair and 20-year associate editor of The Journal of Organic Chemistry, Dave has also consulted for major pharmaceutical companies including Merck, Pfizer, and Amgen. Outside of academia, he's known for his sharp, contrarian takes on politics, economics, and culture—often shared via his unfiltered X account (@DavidBCollum), frequent podcast appearances, and his widely read annual “Year in Review” at Peak Prosperity. He's also coached collegiate gymnastics and taekwondo and has been featured in outlets like The Wall Street Journal, Rolling Stone, and The Federalist but usually on topics far removed from chemistry. Paid partnerships with: Dutch: Get $50 a year for vet care with Tucker50 at https://dutch.com/tucker Liberty Safe: Visit https://LibertySafe.com to find a dealer and learn more Beam: Get 30% off for a limited time using the code TUCKER at https://ShopBeam.com/Tucker Learn more about your ad choices. Visit megaphone.fm/adchoices

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