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Patients can’t benefit from what they don’t understand. Don’t let poor communication keep your solution from reaching the right patients. 🩺 Rheumatology innovators Patiently’s engagement solution ensures your innovative treatment connects with the patients who need it most. 💡 Drop the name of your solution and the disease you’re solving in the comments, and let’s make sure the right patients find your breakthrough. 🚀 #Rheumatology #HealthTech #PatientEngagement #RightPatientRightCare #InnovativeHealthcare #MedTech #DigitalHealth #HealthcareInnovation #Patiently

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# Only put off until tomorrow what you are willing to die having left undone. ## The HIFI Study: New Breakthrough in Prostate Cancer Treatment Prostate cancer has long been a concern for many individuals and their families. However, a recent study, known as the HIFI Study, has shed new light on the treatment options available for localized prostate cancer. EDAP TMS SA, a leading healthcare company, announced the publication of the HIFI Study results in the prestigious journal European Urology. This groundbreaking study highlights the efficacy of the Focal One Robotic High Intensity Focused Ultrasound \(HIFU\) treatment. The HIFI Study provides compelling evidence that HIFU offers comparable effectiveness and improved functional outcomes when compared to radical prostatectomy, a traditional surgical procedure for prostate cancer. This innovative robotic treatment proves to be a game-changer, offering patients a less invasive option with promising results. As an experienced Investment Advisor, I encourage you to take action and explore the potential investment opportunities in companies like EDAP TMS SA that are at the forefront of cutting-edge healthcare technologies. By investing in your health savings account \(HSA\), you not only secure financial growth but also contribute to the advancement of groundbreaking medical treatments. Don't miss out on the chance to be part of this transformative journey in healthcare and make a positive impact on your own well-being, your family, and the world. Empower yourself with knowledge, invest wisely, and seize the opportunities that arise. #hsa #investing #healthcare #health #family #wellness 💪💰🏥

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📢 #Ariceum is pleased to announce that it presented outstanding data on its proprietary radiolabelled peptide SS0110 (#satoreotide) in a Top-Rated Oral Presentation at European Association of Nuclear Medicine (EANM) Annual Conference. ²²⁵Ac-Satoreotide is a first-in-class somatostatin receptor 2 antagonist targeting extensive stage small cell lung cancer (#SCLC).   Highlights: 🔎 Satoreotide expressed a superior pharmacokinetic profile relative to DOTA-TATE with a higher pre-clinical anti-tumour efficacy, irrespective of radionuclide used 💡 100% survival with a single dose of 30 kBq ²²⁵Ac-satoreotide but not with ²²⁵Ac-DOTA-TATE   Learn more about Ariceum's presentation and ²²⁵Ac-Satoreotide, the first antagonist labelled with ²²⁵Ac to enter clinical development, in the press release linked in the comments 👇 #EANM #EANM24 #EANM2024 #biotech #oncology #lifesciences #oncology #cancer

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EvlaBio AG is a life science startup dedicated to the development of first-in-class therapeutics in the cardiovascular and cardiorenal space. The lead asset is a therapeutic monoclonal antibody (mAb) targeting the FGF23/FGFR4 pathway for the treatment of left ventricular hypertrophy (LVH) and heart failure with preserved ejection fraction (HFpEF) in the setting of chronic kidney disease (CKD). LVH and HFpEF occur in CKD patients as a consequence of FGF23/FGFR4 overdrive. Hence, blocking the FGF23/FGFR4 interaction has the potential to prevent cardiac hypertrophy and ameliorate heart failure in patients with CKD. The serviceable obtainable market of patients with LVH due to FGF23/FGFR4 overdrive ranges between 5 and 6 M in the seven major markets, representing a substantial commercial opportunity. Based on its underlying mechanism of action, the EvlaBio approach is expected to be hemodynamically neutral. This is a critical differentiating feature from currently available treatment options. With respect to modality, the EvlaBio will be the first biologic developed for this indication, and it has the potential to be a first in class and first in indication therapy. We also have a biomarker strategy leveraging specific features of target biology in place, ensuring effective clinical trial design. Meet EvlaBio @ #Sachs_BEF More Info @ https://lnkd.in/d7zEuKym #BigPharma #Dealmakers #PharmaIndustry #BiotechInEuropeForum #LifeSciences #Biotech #BioPharma #Partnering #Investment #Startups #Oncology #Neurology #Genomics #Immunotherapy #CNS #Autoimmune #Cardiovascular #BiotechIndustry #BioTechInvestment #Innovation #InvestmentForum #BiotechConference #EuropeanBiotech #SachsAutumnLifeSciencesWeek #SALSW

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Are you ready for the future of digital health and AI regulation? Join the next RAPS Switzerland Chapter event in Bern on the 25th of September, where we will be discussing the extremely hot topic of regulatory for digital health and artificial intelligence. As these technologies transform healthcare, understanding their regulatory challenges and opportunities is crucial. Our panel of experts will provide a comprehensive overview, discussing how regulatory bodies are adapting to ensure safety, efficacy, and ethical standards. View the agenda below and register now - spaces are extremely limited and are filling up fast! Sign up now > https://lnkd.in/dEnw8Jwd #medtech #regulatoryaffairs #raps #digitalhealth #ai

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#TriggeringThursday ! 🔵 An interesting, useful, thinking-triggering and beautiful (great pics!) paper published yesterday in Molecular Cell (Cell Press), showing us some intriguing aspects of #innateimmunity control: 🔵 SOLID and LIQUID #intracellular structures are important regulators of that #immunity type, in health and in #disease 🔵 Of cours, the All-Mighty #GAS - #STING pathway has an important places and roles in all that! 🔴 Not Open Access but worth finding & reading : https://lnkd.in/d4TzYw2e - it may trigger a lot of new thinking and ideas in you! How does all that impacts the work of all of us in #cancer #immunology #research? And us in #spatialbiology? #cancerresearch #cellbiology #biomarkers #oncology #cancertreatment #cancertherapy #radiotherapy #immunotherapy #celldeath #immunology #innate #subcellular 🔵 🔵 🔵 #gotoyourpathologist

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🗞️Report on “Orbis” in The Lancet Oncology 🌐Swissmedic, the Swiss Agency for Therapeutic Products has participated in Project Orbis since 2020. The initiative started by the US Federal Drugs Administration’s Oncology Center of Excellence enables parallel assessment of marketing authorisation applications for oncology products by international partner authorities. The FDA is responsible for overall coordination. However, each participating country remains completely independent as regards the final authorisation decision. 🔎Swissmedic experts scientifically evaluated the impact of the programme on the submission and review processes for medicinal product authorisations in Switzerland. Their aim was to assess its effects from Swissmedic’s point of view. 📈Simultaneous assessment has made it possible to significantly reduce the submission gap (i.e. the difference between the submission dates to different authorities) and the duration of assessment for innovative cancer medicines. As a result, patients have rapid access to promising new cancer therapies. This successful international collaboration is set to continue. 👇Find out more!

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Join Valeria Grigoriev, MBA, our Senior Regulatory Affairs Specialist, along with presenter’s from Phortas and the Head of Scientific Advice from the #EMA.   RAPS Europe Euro Convergence   Tues May 7, 13:45 – 14:45 CEST Location: A 05 + A 06   Meeting EMA and FDA: Formal and informal pathways, in search of alignment   Why attend? • Enhance regulatory engagement: Understand how scientific advice and informal meetings can improve communication and collaboration with regulatory agencies, enabling participants to establish effective lines of communication throughout drug development. Evaluate whether alignment with EMA and FDA is an actually achievable Parallel SA (PSA) meeting goal. • Optimize development strategies: Establish suitable type of topics and questions to be raised during informal versus scientific advice meetings, as well as get the best practices for concluding an exhaustive briefing package. Learn how to tailor drug development plans based on insights gained from regulatory interactions, allowing participants to make informed decisions, mitigate risks, and expedite the development process. • Improve compliance and quality assurance: Discover best practices for maintaining compliance and ensuring high-quality standards throughout drug development by applying lessons learned from successful Scientific Advice and informal interactions with the #FDA and EMA.   A full description of the session follows:   As regulatory affairs professionals we are familiar with the official meetings offered by the regulatory authorities EMA and FDA and, their importance for adequate drug development. An example of optional meetings offered during various time points in the product life cycle to support the resolution of scientific and regulatory issues is Scientific Advice (SA). These meetings in the US are typically referred to, for example as Type, A, B or C meetings. SA is not legally binding on authorities regarding any future marketing authorization application for the medicine concerned. In this way, no pre-evaluation of the results of the studies or conclusions on benefit-risk assessments can be granted. And still, the increase in the number of scientific advice requests remains constant. Interestingly, few regulatory professionals are familiar with all types of interactions offered by both EMA and FDA. Rarely used authority interactions, namely EMA SME briefing meetings and FDA INTERACT or pre-breakthrough meetings, hold significant benefits for drug development. In this session, we will discuss the advantages and disadvantages of SA and informal meetings as well as best practices for the preparation of such meetings. A reflection from a 5-year Parallel (PSA) program review will be presented on whether alignment with EMA and FDA in a PSA meeting is an achievable goal. Besides identifying the best candidates and the most suitable development phase to apply, the most noteworthy findings will be emphasized. #regulatory #pharmaceuticals 

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The Enterome Team will attend the ESMO IO Meeting 2024 from December 11 to 13, 2024, in Geneva. We’re excited to share new clinical data findings from the Phase 1/2 ‘AUDREY’ trial of EO4010 in Colorectal Cancer, one poster presentation will feature promising efficacy data from Cohort 2 and 3 of the AUDREY study. If you're attending ESMO - European Society for Medical Oncology Immuno-Oncology (I/O) Meeting 2024, join us to learn more: 📅 Poster presentation details:   Abstract #457 - Title: EO4010 (EO) + nivolumab (N) ± bevacizumab (B) in patients (pts) with microsatellite stable (MSS) metastatic colorectal carcinoma (mCRC) - Presenting Author: Dr. Romain Cohen, Department of medical oncology, Saint-Antoine hospital, AP-HP, Assistance Publique - Hôpitaux de Paris, and Assistant Professor of Oncology at Sorbonne Université, Paris - Poster Session: presentation time December 12, 12:00 PM-13:00 PM CET A special thank you to our presenting authors, the investigators in this international, multicenter study, and the patients and their families who make this research possible. #ESMOIO2024 #Enterome #Oncology #Immunotherapy #ClinicalTrials #CancerResearch #Colorectalcancer #CancerInnovation

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🔬 𝗘𝘅𝗽𝗹𝗼𝗿𝗶𝗻𝗴 𝘁𝗵𝗲 𝗥𝗼𝗹𝗲 𝗼𝗳 𝗣𝘀𝗲𝘂𝗱𝗼𝘃𝗶𝗿𝘂𝘀 𝗣𝗹𝗮𝘁𝗳𝗼𝗿𝗺𝘀 𝗶𝗻 𝗩𝗮𝗰𝗰𝗶𝗻𝗲 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 🔍 At Microbe Investigations Switzerland, we understand the critical role that innovative technologies play in advancing medical research and public health. Pseudovirus platforms offer numerous advantages in the field of vaccine development: 🌐 𝗦𝗮𝗳𝗲 & 𝗡𝗼𝗻-𝗶𝗻𝗳𝗲𝗰𝘁𝗶𝗼𝘂𝘀 - Mimics virus entry without the risk. 🧪 𝗣𝗿𝗲𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗥𝗲𝘀𝗲𝗮𝗿𝗰𝗵 - Enables detailed study of viral mechanisms. 💉 𝗩𝗮𝗰𝗰𝗶𝗻𝗲 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 - Supports the creation of effective vaccines. 📊 𝗥𝗮𝗽𝗶𝗱 𝗣𝗿𝗼𝗱𝘂𝗰𝘁𝗶𝗼𝗻 & 𝗦𝗰𝗮𝗹𝗮𝗯𝗶𝗹𝗶𝘁𝘆 - Meets demands swiftly and efficiently. 🧬 𝗩𝗲𝗿𝘀𝗮𝘁𝗶𝗹𝗲 𝗗𝗲𝗹𝗶𝘃𝗲𝗿𝘆 𝗩𝗲𝗵𝗶𝗰𝗹𝗲 - Adaptable to various therapeutic needs. Our state-of-the-art testing services include evaluating these platforms to ensure they are optimized for both safety and efficacy. Dive deeper into how pseudovirus platforms are revolutionizing vaccine development, and discover why they are essential tools in our ongoing fight against infectious diseases. 👉 Learn more : The Role of Pseudovirus Platforms in Rapid Vaccine Development https://lnkd.in/gm6-FrEe 🌟 At MIS, we're committed to pioneering research that leads to real-world solutions. Let's innovate together for a healthier tomorrow! #VaccineDevelopment #Pseudovirus #Biotechnology #PublicHealth #Innovation #MISwitzerland

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At the 4th Digital Health Conference in Lisbon, the presentation "Innovation in Clinical Drug Development - Digital Measures Integration as a Coordination Challenge" by Julia Chernova, PhD, Director, Biostatistics - Cytel, Digital Biomarkers Expert Stat (SME) | Digital Health for Sanofi, will explore how digital tools are transforming the clinical drug development process. The session will focus on the integration of digital measures and the coordination hurdles that come with this evolution, highlighting the challenges, best practices, and potential solutions for successful implementation. The talk aims to shed light on the role of digital innovations in enhancing clinical trials and improving overall outcomes in drug development. The Lineup: 🎤Atif Elahi, Digital Health Business Leader - Roche 🎤 Ghaith Sankari, Head of Global Digital Health Data Science - Bayer 🎤 Paula Salme Sandrak, Product Strategist (dHealth & Health AI) - Bayer 🎤 Ricardo Sáinz Fuertes, Global Director Digital Health Solutions, NEURii Program Director - Eisai EMEA 🎤 Lu Zheng, Head of Value-Based Partnerships & Digital Health, Europe & Canada - Takeda 🎤 Leslie Anne Fendt, Integrated Solutions Program Lead - Roche 🎤 Dan Ma, Head of Innovation & New Commercial Partnerships - Sandoz 🎤 Ayaka Yanagisawa, Former Head of Data Analytics, Digital Health Solutions - Biogen 🎤 Miguel Amador, Partner & Chief Innovation Officer - Complear 🎤 Charlotte S., Senior Digital Health Scientist - Lundbeck 🎤 Julia Chernova, Director, Biostatistics - Cytel 🎤 Pete Brockmeier, Global Associate Director, Digital Health - Novo Nordisk 🎤 Mohamed-Ramzi, Senior Director, Johnson & Johnson Innovative Medicine 🎤 Dr. Friderike Bruchmann, Co-Founder & CEO - XO Life 🎤 Katherine Ossenkopp, Country Manager Germany - Future4Care 🎤 Farnaz Behroozi, Ph.D., Head of Pharma, Huma 🎤 Yulia Koinak, CEO/Founder - LAB325 - Digital Products Engineering 🎤Charles Vivien, Vice President of Global Sales, Wegrow 🎤Dr Bonnie Cheuk, Global Capability Development Leader - Digital, Data, AI and Learning Agility, AstraZeneca 🎤Marcos Oliveira, Senior Business Developer, Tonic App 🥇Gold Sponsor - Tonic App 🥉Bronze Sponsors - SpotMe, Wegrow, LAB325 - Digital Products Engineering Only a few seats are still available! Register Here: https://lnkd.in/dnGCCigv Hope to see you in Lisbon! #dhubiq #digitalhealth

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The Glioblastoma Foundation is excited to announce that we have acquired lisavanbulin, a promising glioblastoma drug candidate from the Swiss drug manufacturer Basilea Pharmaceutica! The acquisition and further development of Lisavanbulin highlights our commitment to transforming glioblastoma from terminal to treatable with personalized therapies. Lisavanbulin’s success in clinical studies, combined with our expertise in genomic testing, will help us identify the subset of glioblastoma patients for which Lisavanbulin will be effective. We look forward to initiating clinical trials and making strides in glioblastoma treatment. ✨ Learn more about Lisavanbulin and how we are transforming the future of glioblastoma treatment: bit.ly/3NFTPQ6 #GlioblastomaFoundation #AdvancingResearch #GlioblastomaTreatment #GenomicTesting #Glioblastoma #BrainCancer

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Join us and other experts at this upcoming event with the RAPS Switzerland Chapter for an exploration of the regulatory landscape surrounding digital health and artificial intelligence in healthcare. Elena Lucano from Veranex will speak about "The Role of Data in Healthcare," providing insights on the new regulatory scheme's impact on digital medtech companies. Learn more and register: https://hubs.la/Q02QnMt10

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Are you curious to learn more about the different #ResearchProjects tackling the biggest questions in #GastricCancer diagnostics and treatment around Europe? Follow the link to read one of our blogs featuring Professor Tamara Matysiak-Budnik from CHU de Nantes #NantesUniversityHospital, as she delves into this topic, and explores the ideal screening strategy with GastroPanel® to revolutionise care pathways for #precancerous conditions. Take a look: https://ow.ly/Ao6B50R48UZ #MedicalResearch #HealthcareInsights

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[GRIP NEWS] Reminder for Clinical Trial Professionals: Changes to Swiss Human Research Act Ordinances  On 1 November 2024, significant amendments to Switzerland’s Human Research Act (HRA) ordinances came into effect, marking a pivotal shift in the regulatory landscape for clinical trials and research projects. These updates are designed to strengthen participant protection, improve transparency, and modernize the regulatory framework for clinical trials and research projects.  For those navigating these changes, a comprehensive explanatory report and a detailed presentation are available. These resources cover: Approval and Implementation: Key timelines, including phased entry into force and supporting links. HRA Ordinances Overview: A summary of updated regulations and their scope. Detailed Amendments: Specific changes to OrgO-HRA, ClinO, ClinO-MD, HRO, and SCRO ordinances. Transitional Provisions: Guidance to ensure compliance during the transition period.   All updates related to the implementation of these ordinances can be accessed through official resources (resources in the comments).  If you want to stay ahead of regulatory changes like this and explore how these updates may impact your work, check out our GRIP (Global Regulatory Intelligence Platform) service. GRIP delivers curated insights, detailed analyses, and tailored support to help you navigate evolving regulatory requirements in clinical research and pharmacovigilance. For more information please visit https://lnkd.in/dZ5K-Jxc or contact us directly at [email protected]. #GRIPnews #thedrugsafetyexperts

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Today Christophe Girardey, presented on "Requirements for Laboratory Equipment: Interfaces and Data Formats" at the #GAMP DACH Post Conference in Mannheim on Data Integrity. This session addressed the challenges of following data integrity guidelines, particularly due to the continued use of paper in today's laboratories.   Key takeaways: 💡 Data integrity warning letters have increased, especially for lab-related aspects 💡 Paper-based methods struggle to meet ALCOA data integrity guidelines 💡 Electronic systems such as LIMS, LES, and ELN offer superior data management capabilities 💡 Learn how open standards like SiLA and AnIML could facilitate lab instrument integration 💡 Don't miss this opportunity to deepen your understanding of communication standards that simplify instrument and system integration.   For those not attending the conference, read the article here 👉https://lnkd.in/enh5pGGe or contact us for more insights https://lnkd.in/eWVdNqzW !   #GAMP5Conference #DataIntegrity #PharmaInnovation #GxPCompliance #LabAutomation

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We are thrilled to announce the release of our latest case study: "Intelligent Inventory Management of Clinical Samples and Reagents from +4°C to -196°C" Discover how the world's leading pharmaceutical companies are using Bluechiip to manage their critical sample inventories and chemical assets. Dive into the full case study here https://lnkd.in/gsjNpJFt #Pharmaceuticals #DrugDiscovery #SampleManagement #Innovation #Bluechiip

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📢 Exciting news for medical device innovators and rare disease patients in the EU! 🇪🇺 The European Medicines Agency (EMA) has launched a pilot programme to support the development and assessment of orphan medical devices. This initiative aims to accelerate innovation for devices treating rare diseases affecting fewer than 12,000 individuals annually in the EU. Key highlights: 🔬 Free expert advice for manufacturers and notified bodies 🎯 Focus on devices for life-threatening conditions, paediatric use, and novel technologies. 🗓️ Pilot runs until the end of 2025, with plans for long-term implementation. 👥 Supports small and medium-sized enterprises. 🤝 Aligns with new EU guidance on clinical evaluation of orphan devices (June 2024). This program is a game-changer for addressing unmet medical needs in rare diseases. The EMA is paving the way for faster development of crucial medical technologies by providing early guidance on clinical strategies and data requirements. Are you working on innovative medical devices for rare conditions? This could be your opportunity to fast-track your project and make a real difference in patients' lives. https://lnkd.in/dcsvryJu #MedicalDevices #RareDiseases #HealthcareInnovation #EuropeanUnion #EMA

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We are happy to share with you a short video describing clearly and quickly what the SG-OCRA Technology is all about and how 1 minute of testing can help counter the often underestimated problem of Oral Cancer. OPEN VIDEO > https://lc.cx/rGqvfo #studiumgenetics #oralcarcinoma #oralcancer #headandneckcancer #oralcancerday

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