Arnaud Muller

Bladder EpiCheck®, now also available in France,provides physicians and their patients with a simple, objective urine test for recurrent bladder cancer. The test analyzes subtle disease-specific changes in DNA methylation markers, with high sensitivity and specificity. Bladder EpiCheck is intended for use as a non-invasive method for detection of NMIBC recurrence in conjunction with standard of care methods. Bladder EpiCheck is CE-marked and available in Europe for primary and recurrent bladder cancer and upper tract urinary cancer, and FDA 510(k) cleared for bladder cancer recurrence in the United States. It is commercially available in Europe and soon in the United States. A.Menarini Diagnostics INOVIE (Groupe) Association Francaise Urologie

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Good article to revisit the role of Platinum based Chemo in mUC, again, always wonder if it is the time chemo phases out from bladder cancer treatment landscape?

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🔎 𝗔𝗿𝗲 𝘆𝗼𝘂 𝗮 #𝗗𝗧𝘅 𝗼𝗿 #𝗿𝗲𝗺𝗼𝘁𝗲𝗺𝗼𝗻𝗶𝘁𝗼𝗿𝗶𝗻𝗴 𝘀𝘁𝗮𝗿𝘁𝘂𝗽 𝘄𝗮𝗻𝘁𝗶𝗻𝗴 𝘁𝗼 𝗴𝗲𝘁 𝗿𝗲𝗶𝗺𝗯𝘂𝗿𝘀𝗲𝗺𝗲𝗻𝘁 𝗶𝗻 𝗙𝗿𝗮𝗻𝗰𝗲? 🗓 Join us this 10th and 11th of June for a unique workshop with the Délégation au numérique en santé (DNS), Haute Autorité de Santé, France Biotech, and Nextep Health to deeply understand #PECAN and other reimbursement paths, including legislation, regulation, and its key stakeholders. Our deep dive will break down how digital medical products can use their clinical data, review their commercialization strategy, and prepare to succeed in the French healthcare market. Our speakers will provide guidance and advice to understand regulatory frameworks, review and strengthen clinical evidence, and how to be fit for PECAN and other reimbursement paths. Join us to meet: 🎤 Corinne Collignon: As the head of the digital health mission department (Haute Autorité de Santé), she has worked for many years in the medical device evaluation department and will provide her experience around the HAS' expectations (clinical evidence, validation, and evaluation of medical devices). 🎤 Pascal Sellier: As the Vice-Chairman of the National Commission for the Evaluation of Medical Devices and Health Technologies at Haute Autorité de Santé, he represents the voice of patients and users in the French healthcare system. 🎤 Stephane Tholander: Currently he is the coordinator of the digital health commission and vice-president of France Biotech. As a serial entrepreneur and Co-Founder/co-CEO of Agora Health and AppThera, he is focused on innovation in healthcare and facilitating the acceleration and adoption of digital medical devices from all angles. 🎤 Vincent Vercamer: With extensive expertise in regulation and market access, he is currently the project director at the French Ministerial Delegation for Digital Health (DNS/Ministère de la Santé) and works closely with the Agence du numérique en santé, responsible for issues relating to #marketaccess and #PECAN. Additionally, he coordinates the G_NIUS platform, supporting innovators in preparing for their reimbursement applications. 🎤 Helene Viatge: With extensive expertise in medical device development and commercialization in France and Europe and founder of AppThera, a clinician platform supporting the prescription of digital therapeutics and enabling patient access. ✅ 𝘙𝘦𝘨𝘪𝘴𝘵𝘦𝘳 𝘯𝘰𝘸 𝘣𝘺 𝘤𝘰𝘯𝘵𝘢𝘤𝘵𝘪𝘯𝘨 𝘰𝘶𝘳 𝘵𝘦𝘢𝘮 𝘰𝘳 𝘴𝘦𝘯𝘥𝘪𝘯𝘨 𝘶𝘴 𝘢 𝘮𝘦𝘴𝘴𝘢𝘨𝘦 𝘷𝘪𝘢 𝘓𝘪𝘯𝘬𝘦𝘥𝘪𝘯 𝘵𝘰 𝘴𝘦𝘤𝘶𝘳𝘦 𝘺𝘰𝘶𝘳 𝘴𝘱𝘰𝘵! #Healthcare #Startups #PECAN #MarketEntry #Regulation #ClinicalEvidence #Workshop #Networking

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It is very important to inform the population, and decision makers about Sepsis. The aproximation or old term of “septicemia”, “cytokine storm” should be avoided. But what is sepsis? 🔥Sepsis is the body's "desperate" response to an infection it considers threatening. All organs fail to a greater or lesser extent. 🔥Sepsis is often very sudde going from a banal infection to "something else" without realizing it at first. It's an emergency => intensive care (ICU), often life-saving (20-50% mortality). But there is no specific treatment for sepsis. Sepsis is one of the leading causes of mortality, suffering (of families, loved ones, recovering) and healthcare cost. (20% of worldwide mortality, 0.5% of US GDP, 0.3% linked to hospitalization in intensive care and convalescence for long months/weeks). The incredible pain of recovery was highlighted by a very brave survivor 🔥Furthermore, sepsis let you with long months of recovery and many sequelae are common. https://lnkd.in/eqsKy3_S Sites : https://www.sepsis.org/, https://lnkd.in/etZnq9hh or https://lnkd.in/eRgJyFG8 Tusts like global sepsis alliance https://lnkd.in/ex8Z3sAK , Rory Staunton association https://lnkd.in/ekJxhfxq ; European sepsis alliance https://lnkd.in/eFUimaan ; Sepsis Trust https://lnkd.in/eBF9iWy2, Deutch sepsis Geselchaft https://lnkd.in/eBF9iWy2 France sepsis association https://lnkd.in/ezP_XfBk ; surviving sepsis campaign survivingsepsis.org ….. explain the importance of sepsis to the public, decision-makers and funders so that we can reduce this largely avoidable mortality, find one or more diagnoses and an effective treatment. There is a need for financing. Review articles in Antiox and Redox Signal - Forceville X, Van Antwerpen P, and Preiser JC https://lnkd.in/epdMBYx5 - Forceville X, Van Antwerpen P, Annane D, and Vincent JL, 2022. https://lnkd.in/dtTivdrv both beta version freely available on pubmed via HAL (select « pubmed » then « Forceville, selenocompounds » and that’s it. #Sepsis = #cancers =#cardiovasculardisease in term of mortality, quality of life suffering and cost #sepsis is an #emmergency such as # infarct #stroke #esicm #sscm #surviving-sepsis #WeAreICU #CriticalCare #IntensiveCare #WorldSepsisDay #SepsisAwareness #ResearchMatters #Healthcare #sepsiseducation #sepsisinnovation #curesepsis #sepsisawareness What is ICU https://lnkd.in/e4cfygbx Beginning of ICU (origins) https://lnkd.in/eV46-gxP. Sepsis team https://lnkd.in/eSD8kEfU Jacqueline Duda @Julia Kaye Fraser https://lnkd.in/ePGMKZqpShahrzad Kiavash Katy Grainger Davy Cotting Jamila Hedjal Sandra K Mary Millard M.Ed. Aaron Speer Idelette Nutma Ilse Malfait @ Simon Seyfarth James Corcoran Angels for Kids, The Angelica Garcia Foundation Mariah McKimbrough Marianne Haverkamp Kim’s 2nd Chance @Julie M Kimberly Emanuel Ed.D and Voices of Sepsis European Sepsis Alliance Amputee Coalition END SEPSIS, the Legacy of Rory Staunton and many other

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Very proud to announce that InSphero and partners have received €12 million for a pivotal initiative within the European UNLOOC Project, aiming to revolutionize drug discovery and safety testing through comprehensive end-to-end solutions. The focus of this work package, led by our fantastic VP of Technology and Platforms, Olivier Frey, encompasses every stage—from 3D microtissue engineering and production to assay execution, raw data generation, and automated data analysis—ensuring reliable information for informed decision-making.   By integrating microfluidics, bioengineering, microelectronics, big data, and AI, we strive to industrialize scalable and robust organ-on-chip systems with advanced readouts. This holistic approach is essential for addressing patient diversity and heterogeneity in drug efficacy and safety testing, ultimately leading to more personalized and effective treatments.   Our commitment to developing off-the-shelf 3D in vitro microtissues panels that reflect human diversity is a significant step toward this goal. Leveraging innovative cryopreservation techniques, we aim to create extensive biobanks of 3D in vitro models. Coupled with advanced readout methods—including 3D microscopy, RNA sequencing, lipidomics, and Raman spectroscopy—and multi-parametric data analysis using AI/ML, we are poised to deliver economically viable solutions with high-resolution data acquisition.   Olivier, who is a member of the UNLOOC executive board and leads the project at InSphero, puts it in a nutshell like this: “Addressing diversity in in vitro testing requires a next generation of production and analysis techniques allowing for economically viable solutions and high-resolution data acquisition to resolve patient and population-related differences of drug effects.”   We are proud to collaborate with 51 organizations across 10 European countries in this €68 million project, supported by the Chips Joint Undertaking and national agencies. Together, we are paving the way for a new era in drug development and personalized medicine. PS: Some of our excellent partners are ZEISS Microscopy, microfluidic ChipShop GmbH, CSEM, and Core Life Analytics just to name a few.   #InSphero #UNLOOC #DrugDiscovery #3DCellCulture #OrganOnChip #PersonalizedMedicine #AI #Biotechnology

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BIOVIIIx has been recognized as the 𝐇𝐞𝐦𝐨𝐩𝐡𝐢𝐥𝐢𝐚 𝐂𝐨𝐦𝐩𝐚𝐧𝐲 𝐨𝐟 𝐭𝐡𝐞 𝐘𝐞𝐚𝐫 In Europe by Life Sciences Review "𝐵𝐼𝑂𝑉𝐼𝐼𝐼𝑥 𝑖𝑠 𝑔𝑟𝑜𝑢𝑛𝑑𝑒𝑑 𝑖𝑛 𝑒𝑡ℎ𝑖𝑐𝑎𝑙 𝑎𝑛𝑑 ℎ𝑢𝑚𝑎𝑛-𝑐𝑒𝑛𝑡𝑟𝑖𝑐 𝑣𝑎𝑙𝑢𝑒𝑠. 𝐼𝑡𝑠 𝑑𝑒𝑐𝑖𝑠𝑖𝑜𝑛-𝑚𝑎𝑘𝑖𝑛𝑔 𝑝𝑟𝑜𝑐𝑒𝑠𝑠 𝑓𝑜𝑐𝑢𝑠𝑒𝑠 𝑜𝑛 𝑝𝑟𝑜𝑗𝑒𝑐𝑡𝑠 𝑡ℎ𝑎𝑡 𝑑𝑖𝑟𝑒𝑐𝑡𝑙𝑦 𝑏𝑒𝑛𝑒𝑓𝑖𝑡 𝑝𝑎𝑡𝑖𝑒𝑛𝑡𝑠, 𝑜𝑓𝑡𝑒𝑛 𝑓𝑜𝑟𝑒𝑔𝑜𝑖𝑛𝑔 𝑖𝑚𝑚𝑒𝑑𝑖𝑎𝑡𝑒 𝑓𝑖𝑛𝑎𝑛𝑐𝑖𝑎𝑙 𝑔𝑎𝑖𝑛𝑠. 𝑇ℎ𝑖𝑠 𝑝𝑎𝑡𝑖𝑒𝑛𝑡-𝑐𝑒𝑛𝑡𝑟𝑖𝑐 𝑎𝑝𝑝𝑟𝑜𝑎𝑐ℎ 𝑙𝑒𝑎𝑑𝑠 𝑡ℎ𝑒 𝑐𝑜𝑚𝑝𝑎𝑛𝑦 𝑡𝑜 𝑔𝑜 𝑎𝑏𝑜𝑣𝑒 𝑎𝑛𝑑 𝑏𝑒𝑦𝑜𝑛𝑑 𝑠𝑡𝑎𝑛𝑑𝑎𝑟𝑑 𝑝𝑟𝑎𝑐𝑡𝑖𝑐𝑒𝑠." - Davide Rosiello, Chief Executive Officer of BIOVIIIx The article will also be featured in the forthcoming special print edition of Hemophilia 2024. Read More: https://lnkd.in/gRB9nJiH #BIOVIIIx #LifeSciencesReview #Coagulation #Hemophilia #BiotechInnovation #ScientificResearch #HealthcareInnovation #InnovativeTherapies #PharmaResearch #EmployeeTraining

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Tribun Health, a major player in software solutions for digital pathology, has announced its selection among the winners of the i-Nov Wave 11 competition organized by Bpifrance, as part of the France 2030 plan. This competition aims to support the accelerated emergence of innovative companies that are leaders in their field. Tribun Health’s image management software CaloPix® represents a significant advancement in anatomopathology. Tribun Health’s project, “Pathomix®,” strives to broaden diagnostic product offerings, fostering a seamless integration between healthcare services and advancements in research and pharmaceutical development. The project's aim is to empower pathology’s role in precision diagnostics by providing advanced tools for the consolidation, enhancement, and exploitation of real-world data. At the heart of this initiative is the development of an advanced data query module, allowing healthcare facilities to pinpoint specific data for secondary use while adhering to GDPR and HIPAA regulations. #digitalpathology #pathologynews

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An exciting talk is on the way from Jérôme Caron, Head of the Orakl Oncology Lab 🙌 The development of new biologics is accelerated by technological innovation, and Medicen Paris Region, together with ACROBiosystems, has brought together some key players in the field. Anticipating drug efficacy and clinical benefits remains a significant bottleneck in drug development, especially for cancer—a highly heterogeneous disease. Jérôme will share how we are addressing this challenge by leveraging our tumor avatars and drug screening techniques to better predict patient responses to therapies in the clinic 🔮 #drugscreening #drugdevelopment

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Timing plays a key role in the success of any partnership, with CDMOs no exception. However, contrary to popular belief, it's never too early to partner with a CDMO. Whilst some will only support clinical trial or commercial manufacturing, others, like evitria, are equipped to support the preclinical stages of development. For small startups and organisations, this support can be a lifeline. By assisting with research and preclinical manufacturing, CDMOs can help accelerate developmental timelines and enhance the efficiency of drug discovery. If you have any questions about how a CDMO might fit into your strategy, please get in touch or explore what services we offer: https://lnkd.in/eWXRWDac #CDMOs #AntibodyManufacturing #PreclinicalDevelopment #Partnerships

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In Wallonia, innovation in the fight against cancer is at the top of the world, thanks to the presence of leading companies in ATMPs, nuclear medicine, immunotherapy, precision medicine, and proton therapy, supported by exceptional academics and clinicians. Great news for patients—and a prime opportunity for investors to align impact with profit. 👉 Read this interesting article mentioning PDC*line Pharma : https://lnkd.in/ev6nhjUg

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Collaboration driving “Better Human Disease Models” Pushing the bounds of science can only be achieved through collaborations like this and we are proud to have partnered with Bi/ond in achieving this significant milestone in cardiac tissue engineering. By leveraging our axoCells™ Ventricular Cardiomyocytes and the Bi/ond MUSbit™ platform, they were able to successfully establish protocols to generate and characterize human 3D cardiac muscle tissues that closely mirror human heart tissue. This opens up new doors for cardiac research, drug discovery, and cardiac toxicology studies. #organoid #cellculture #cardiacdisease #cardiotox #3Dtissue #heartdisease #3Rs #regenerativemedicine #tissueengineering #research #humancells #organonachip

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BioNTech's acquisition of Biotheus for $800 million is a significant step forward in cancer treatment innovation 💫 Here's what this means for healthcare: • Enhanced development of bispecific antibodies • Access to advanced manufacturing facilities • Multiple clinical trials starting in 2024-2025 • Integration of promising oncology pipelines • Stronger presence in the Chinese market • Expanded global research capabilities The partnership brings together two innovative companies with a shared vision for advancing cancer treatments. With registrational trials on the horizon and potential milestone payments of $150 million, this collaboration sets the stage for breakthrough therapies. Success in biotechnology comes from strategic partnerships and bold moves. https://lnkd.in/eXznysSW

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🎄 🚨 7 Days of Christmas Discounts!!🚨 🎄 For the next 7 days only, Proventa is offering 𝟐𝟎% 𝐨𝐟𝐟 on all our 𝟐𝟎𝟐𝟓 𝐋𝐢𝐟𝐞 𝐒𝐜𝐢𝐞𝐧𝐜𝐞𝐬 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐲 𝐌𝐞𝐞𝐭𝐢𝐧𝐠𝐬! 𝐖𝐡𝐲 𝐂𝐡𝐨𝐨𝐬𝐞 𝐏𝐫𝐨𝐯𝐞𝐧𝐭𝐚? ✔️ 𝐅𝐨𝐜𝐮𝐬𝐞𝐝 & 𝐓𝐚𝐫𝐠𝐞𝐭𝐞𝐝: Intimate meetings specifically attracting senior pharma and biotech decision-makers. ✔️𝐂𝐥𝐨𝐬𝐞𝐝-𝐃𝐨𝐨𝐫 𝐃𝐢𝐬𝐜𝐮𝐬𝐬𝐢𝐨𝐧𝐬: Engage in uninterrupted roundtable sessions with industry elite leaders and biotech innovators addressing their key challenges. ✔️𝐏𝐫𝐞-𝐐𝐮𝐚𝐥𝐢𝐟𝐢𝐞𝐝 𝐂𝐨𝐧𝐧𝐞𝐜𝐭𝐢𝐨𝐧𝐬: Build meaningful relationships through pre-arranged one-to-one meetings with companies that have clear needs, budgets, and challenges. 🔔 𝐃𝐨𝐧’𝐭 𝐌𝐢𝐬𝐬 𝐎𝐮𝐭! This is your best opportunity to secure unmatched value for your 2025 strategy. Act now to lock in your discount and elevate your business connections. 📩Contact us today to learn more!

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"When To License vs. Buy the Whole Pig" - BioSpace opinion piece by Annalee Armstrong. A very nicely written perspective on Pharma : Biotech transactions. It is better for pharma to commit to smaller upfronts and load larger backend milestones, especially when therapeutics are novel and potentially risky. With regards to upfronts Armstrong writes - " The back-loaded nature of these deals “shift[s] all the risk back [to] the person innovating,” Spoor said, making these types of deals attractive for pharma companies looking to access early candidates that have yet to show commercial success. When a licensing deal is announced, Spoor said he eyes the upfront payment to see “how much is real, how much is future potential.” According to GlobalData, upfront payments are slowly getting bigger, growing 137%, or $55 million on average from 2021 to 2024, or 22% ($17 million) per year. " However an acquisition may be better to eliminate competition from the field, an example cited is Pfizer buying Seagen to establish a massive footprint in the ADC space. Nice short read on the current practices of biotech economics. BioSpace article here - https://lnkd.in/eMc7qDW9

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🚀 I’m pleased to announce the creation of the startup : AstraNICE AstraNICE aims to help surgeons seeing the invisible with a universal near infrared fluorescent coating. Created in March 2024 on the basis of a worldwide patented technology, the result of 5 years of academic research, Laboratoire de Bioimagerie et Pathologies Illkirch, UMR 7021 CNRS - Centre national de la recherche scientifique, Université de Strasbourg, supported by the SATT CONECTUS with the support of the Institut de Chirurgie guidée par l'Image (IHU Strasbourg) & IRCAD, AstraNICE responds to the need of patients and surgeons for safer surgical practice thanks to a fluorescence imaging modality. The startup is founded by a multidisciplinary Team, Michele Diana as Chief Medical Officer, Andrey Klymchenko as Chief Scientific Officer and me John Volke as Chief Executive Officer. AstraNICE offers surgical equipment manufacturers a unique fluorescent coating - versatile and easy to apply - which can give innovative additional functionality to their products and allow them to participate in the growing dynamic of Fluorescence Image Guided Surgery (#FIGS). Indeed, to improve the current state of the art of #FIGS and overcome current limitations, AstraNICE develops a new technology defined NICE (Near-Infrared Coating of Equipment), a fully biocompatible coating that exhibits strong fluorescent properties in the NIR range and makes real-time visualization possible in the operating room. The ultra-bright NICE coating can be directly applied onto a wide variety of surgical tools and substrates (fiducial & tumor markers, endoscopic clips, catheters, bougies, gauzes, implantable devices etc.…) to functionalize them and make them visible from underneath the tissues (up to 1 cm depth). #FIGS and NICE coating hold the promise to disrupt surgical practice with a positive impact on the entire value chain (surgeons, hospitals, medical device manufacturers…) for the benefit of patients. In the short term, AstraNICE portfolio will tackle current clinical problems by making medical devices visible using NIR imaging. In the long run, AstraNICE will leverage Artificial Intelligence and will develop digital solutions integrating the NICE technology. 🚀 This new company is part of a strategy of complementarity and market acceleration supported by Quest for health, BioValley France, Région Grand Est and Bpifrance. . ✔Let’s follow @AstraNICE to its LinkedIn page: https://lnkd.in/e-dDRgv9 ✔Discover the press release : https://bit.ly/45sL7wu #surgeons #surgery #FIGS #fluorescence #coating #nearinfrared #innovation

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Kudos to Debiopharm! But the problem of silos remains, certainly in big companies. IMHO, the root cause has to do with communication between different stakeholders, at the very basic level of the words that are being used. They are either imprecise and ambiguous ( e.g. "inflammation" ") and/or mean different things to different stakeholders (ask a clinical oncologist, a GP or a cancer biologist to give you a clear definition of "cancer"). When different experts meet to discuss, they may use the same words but the meaning is not the same. There is a disconnect.... and no one is truly aware of it... This leads to quid pro quos, silos and sometimes catastrophic outcomes. I have seen it over and over again in my 20 years of teaching biotech to all non-biologists... A standardized, controlled vocabulary, or ontology, is crucial to ensure clear communication and collaboration across all functions. I have nailed it down, at least version 1.0, thanks to my 3000 students representing all functions in the pharma industry. I'd love to publish what I have as an online interactive glossary where each term becomes an item of actionable knowledge. But I need help and some funding. Anyone out there interested?

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December 06 and 09, 2024 headlines from the Collabrity Report, a daily summary of financings for therapeutic biotechnology company executives and investors - www.collabrityreport.com New! Collabrity Report (CR) Analytics Janux’s $403 Million Public Offering Tharimmune’s $2 Million Private Placement Orphagen’s $2 Million Grant

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Important news about LuminoDx: CLIA Certification I am pleased to announce that LuminoDx has received its Clinical Laboratory Improvement Amendments (CLIA) certification. This certification allows us to begin testing patient samples with our first liver health-related test, the Factor V assay. Soon, we will also add a test to our CLIA menu that is predictive of liver rejection post-transplant. Having the ability to clinically validate Laboratory Developed Tests (LDTs) enables us to expand our portfolio and support biotech and pharmaceutical companies in developing therapeutic solutions with validated, indication-specific tests. Now, with CLIA validation of our GLP-compliant laboratory, we can analyze patient samples across multiple platforms and provide results to support patient decision-making as well as translational research support.

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With PPARs, more (isoforms) is better A great article by M. P. Cooreman, L. Vonghia, S. M. Francque: MASLD/MASH and type 2 diabetes: Two sides of the same coin? From single PPAR to pan-PPAR agonists - ScienceDirect "Single PPAR agonists are approved for hypertriglyceridemia (PPARα) and T2D (PPARγ), but these, as well as dual PPAR agonists, have shown mixed results as anti-MASH treatments in clinical trials. Agonists of all three PPAR isoforms have the potential to improve the full disease spectrum from insulin resistance to fibrosis, and correspondingly to improve cardiometabolic and hepatic health, as has been shown (phase II data) with the pan-PPAR agonist lanifibranor."

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