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Sciwind Biosciences to Highlight Positive Results for Injectable Ecnoglutide (Phase 3), Oral Ecnoglutide (Phase 1), and Novel Amylin Analogs at the American Diabetes Association (ADA) 84th Annual Conference

A Phase 1 study of oral ecnoglutide (1871-LB) showed it to be safe and well tolerated and result in pronounced weight loss (up to -6.76% after 6 weeks of dosing). Improved oral bioavailability enables a 15 to 30 mg daily dose of oral ecnoglutide to match or exceed the plasma exposure of weekly subcutaneous GLP-1 analogs for weight loss. In a Phase 3 study in participants with type 2 diabetes (T2DM) (742-P, 793-P), weekly subcutaneous ecnoglutide resulted in robust HbA1c declines of up to -2.43% from baseline after 24 weeks of treatment, with up to 35.2% of participants reaching normoglycemia (HbA1c <5.7%) and 43.7% with weight reductions ≥5%. Novel amylin analogs (788-P, 789-P) were identified that showed potent in vitro activity. In preclinical models, combination of amylin analogs with ecnoglutide demonstrated a synergistic effect on body weight reduction, with improved efficacy compared to combination of cagrilintide and semaglutide. Moreover, a novel amylin development candidate was identified that is stable at neutral pH, providing the opportunity to co-formulate with ecnoglutide or other GLP-1 analogs to improve ease of use for patients and reduce costs. HANGZHOU, China and SAN FRANCISCO, June 22, 2024 /PRNewswire/ -- Sciwind Biosciences Co., Ltd., a clinical-stage biopharmaceutical company focusing on discovering and developing innovative therapies to treat metabolic disease, today announced that the company will present positive results from a Phase 3 clinical study of injectable ecnoglutide (XW003) in T2DM patients and from a Phase 1 study for oral ecnoglutide (XW004) in healthy and healthy obese participants, as well as preclinical data for novel amylin analog programs, at the American Diabetes Association (ADA) 84th Annual Conference. Five posters, including one late-breaking poster, will be presented. The ADA conference is being held in Orlando, FL June 21-24, 2024.  Late Breaking Poster Presentation (1871-LB): Saturday June 22, 12:30 PM - 1:30 PM"Phase 1 Topline Safety, Efficacy, and Pharmacokinetics of Oral Ecnoglutide" Poster Presentation (742-P): Sunday June 23, 12:30 PM - 1:30 PM"A Phase 3 Evaluation of cAMP Signaling Biased GLP-1 Analog Ecnoglutide (XW003) in Adults with Type 2 Diabetes" Poster Presentation (793-P): Sunday June 23, 12:30 PM - 1:30 PM"Biased GLP-1 analog ecnoglutide (XW003) has improved efficacy relative to unbiased peptides" Poster Presentation (789-P): Sunday June 23, 12:30 PM - 1:30 PM"Discovery of a Novel, Long-Acting Amylin Receptor Agonist for Body Weight Control" Poster Presentation (788-P): Sunday June 23, 12:30 PM - 1:30 PM"Synergistic Body Weight Reduction of GLP-1 Analog Ecnoglutide and Amylin Analogs in Preclinical Animal Models" About ecnoglutide Glucagon-like peptide-1 (GLP-1) analogs are effective therapies in managing type 2 diabetes, obesity, and have demonstrated clinical potential as a treatment for MASH.  Ecnoglutide is a novel, biased, long-acting GLP-1 peptide analog optimized for improved biological activity, cost-effective manufacturing, and once weekly subcutaneous dosing. Ecnoglutide has demonstrated treatment benefits for patients with type 2 diabetes and obesity and is safe and well tolerated in Phase 1 through Phase 3 clinical studies. About Sciwind Sciwind Biosciences is a clinical stage biopharmaceutical company focusing on discovering and developing innovative therapies to treat metabolic disease. Its product pipeline consists of potentially first-in-class and best-in-class drug candidates, including the long-acting GLP-1 peptide analog XW003 (Phase 3), oral GLP-1 peptide analog XW004 (Phase 1), an oral small molecule GLP-1 receptor agonist XW014 (Phase 1), and novel amylin analogs (preclinical). Sciwind has developed multiple proprietary technologies, including oral peptide and inhaled protein therapeutic delivery platforms and identified a series of drug candidates based on these core platform technologies. For more information, visit www.sciwindbio.com. 

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 119 加入收藏 :
New MiniMed™ 780G system data demonstrates ability to address persistent blood sugar challenges for people with type 1 diabetes

With its advanced algorithm that provides autocorrections every 5 minutes, the latest data demonstrated that the MiniMed™ 780G system decreased rates of early morning hyperglycemia, known as dawn phenomenon, and improved overnight sleep DUBLIN and ORLANDO, Fla., June 21, 2024 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, is presenting a comprehensive body of new data at the American Diabetes Association's (ADA) 84th Scientific Sessions that showcases the benefits of the MiniMed™ 780G system. New data shows how the system addresses hyperglycemia and nighttime burden, adding to the established body of evidence that demonstrates the system's ability to tackle unique and burdensome challenges of diabetes, such as managing highs and meal-time management or carb counting, while also mirroring outcomes across a wide-ranging patient population.  Tackling hyperglycemia to improve long-term health with type 1 diabetesAmong the burdens of living with diabetes, hyperglycemia can often be overshadowed by hypoglycemia. Yet, in the U.S., only 26% of people living with diabetes achieve HbA1c levels of <7.0%.1 Reducing the time spent with high blood sugars continues to be a significant unmet need as it can lead to serious health problems impacting multiple organs.2 For children, prolonged highs can have adverse effects on memory, IQ, executive functioning, and learning.3 One cause of high blood sugars is the dawn phenomenon, an increase in glucose levels in the early morning.4 This can be a common occurrence for those living with diabetes and may add to feelings of frustration with diabetes. An encouraging new retrospective analysis of real-world data (n= 6026) showed that this morning peak was nearly eliminated for users who upgraded from the MiniMed™ 770G system to the MiniMed™ 780G system. The data assessed the elevation of sensor glucose levels >20 mg/dL from 3 - 6 a.m. compared to 12 – 3 a.m. at least 30% of the nights. The transition from the MiniMed™ 770G system to the MiniMed™ 780G system decreased dawn phenomenon rates from 12.2% to 4.5%. Time in Range also increased from 87.7% to 91.4% from 12 – 6 a.m., which is consistent with dawn phenomenon trends. Early and consistent management of hyperglycemia is critical as it has protective effects on the body that can last for decades.5 "For those living with type 1 diabetes, dawn phenomenon can be a stressful occurrence that feels out of one's control," explained Robert Vigersky, MD, Chief Medical Officer, Medtronic Diabetes. "The introduction of the MiniMed™ 780G system has made it easier to maintain target glucose range with less effort to protect against hyperglycemia.6,7 It's been an absolute gift for my patients who have struggled with stubborn highs throughout their diabetes journey." Reducing nighttime burden  For individuals living with type 1 diabetes, CGM-generated alerts and the need to deliver manual boluses disrupt sleeping through the night adding to the burden of diabetes. The MiniMed™ 780G system is designed to reduce the burden of diabetes throughout the day and night. Additional real-world data from a retrospective analysis presented at ADA (n=8019; <7 y/o, previously on the MiniMed™ 770G system who had greater than 14 nights on both systems) demonstrated that users had fewer overnight sleep interruptions and Time in Range improvements as a result of the automatic adjustments in insulin and correction† of glucose levels every 5 minutes, including during sleep.§ With the MiniMed™ 780G system, nighttime alerts decreased 45% for all users and 55% for those who used recommended optimal settings. Additionally, uninterrupted sleep, a greatly desired outcome for those living with diabetes, increased by 30 and 36 minutes per night, respectively. These results add to the diabetes burden reduction that MiniMed™ 780G system users experience with an advanced algorithm with frequent, every 5-minute autocorrections. The continued evolution of the MiniMed™ 780G system to reduce burdenAlong with evidence on the currently available MiniMed™ 780G system, additional data will be presented on the next iteration of the system,* which aims to further reduce diabetes management burden through its design. The system is intended to be paired with the Simplera Sync™ sensor, a disposable, all-in-one continuous glucose monitor (CGM) designed to require no overtape. A 24-site, single arm study evaluated the use of the next iteration of the MiniMed™ 780G system algorithm paired with the Simplera Sync™ sensor. Results were promising across all clinical outcomes metrics including Time in Range (TIR), Time in Tight Range (TITR) and Time Above Range (TAR), compared to the run-in group where hybrid closed loop (auto basal only) or open-loop delivery was used. The study included the use of recommended optimal settings (ROS) (100 mg/dL set target with an active insulin time of 2 hours) related to TIR, TITR, and TAR. "The MiniMed™ 780G system has firmly established itself as a proven automated insulin delivery system," said study investigator Gregory Forlenza, MD, professor and pediatric endocrinologist at the Barbara Davis Center. "With the next iteration of the system and this next-generation Simplera Sync™ sensor, the overall experience for people living with type 1 diabetes could be enhanced and may prove to be a compelling option for diabetes management — particularly when leveraged in combination with recommended optimal settings." The MiniMed™ 780G system** is currently available for ages 7 and above in over 100 countries globally and will be launching with the Simplera Sync™ sensor in parts of Europe in late July. Currently, Simplera Sync™ is investigational and not approved for commercial use in the U.S.* Safety and Glycemic Outcomes Using the MiniMed™ 780G system with an All-in-OneDisposable Sensor with Transmitter3-month study period (n=109, ages 7-17; n=107, ages 18-80) Youths (ages 7-17) Adults (ages 18-80) Run-in(N=112) Study(N=109) ROS(N=41) Run-in(N=110) Study(N=107) ROS(N=44) Time in Smart Guard,% 14.5±31.3 93.5±11.3 96.9±3.1 33.2±40.3 96.6±6.6 97.5±3.7 Mean SG, mg/dL 180.4±27.1 154.4±17.6 149.0±15.3 161.0±18.7 142.2±12.8 136.5±12.0 Percentage of time spent at glucose ranges <70 mg/dL (% TBR) 1.6±1.7 1.9±1.4 1.9±1.2 1.7±1.9 1.5±1.4 1.7±1.4 70-140 mg/dL (% TITR) 32.1±14.1 49.2±9.7 52.7±9.2 39.2±13.0 56.1±10.5 61.6±9.9 70-180 mg/dL (% TIR) 54.4±15.7 71.4±9.9 74.7±9.3 66.5±12.6 80.2±8.1 83.8±7.4 >180 mg/dL (% TAR) 44.0±16.1 26.7±10.1 23.3±9.4 31.8±13.1 18.2±8.4 14.5±7.7   Caption: Glycemic metrics and insulin delivered during youth and adult MiniMed™ 780G system investigational use with the disposable all-in-one Simplera Sync™ sensor To view this data at the 84th American Diabetes Association (ADA) Scientific Sessions in Orlando, Florida, view the company's previous announcement here for presentation times. About MedtronicBold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow Medtronic on LinkedIn. About Medtronic Diabetes (www.medtronicdiabetes.com) Medtronic Diabetes is on a mission to alleviate the burden of diabetes by empowering individuals to live life on their terms, with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. *Investigational. Not approved by the FDA for any use and not commercially available in the US. **MiniMed™ 780G system is for type 1 ages 7 and over. Prescription required. WARNING: Do not use SmartGuard™ feature for people who require less than 8 units or more than 250 units of insulin/day. For details, see https://bit.ly/780gRisks † Refers to auto correct, which provides bolus assistance. Can deliver all auto correction doses automatically without user interaction, feature can be turned on and off. § Refers to SmartGuard™ feature. Individual results may vary. Ebekozien O, Mungmode A, Sanchez J, Rompicherla S, Demeterco-Berggren C, Weinstock RS, Jacobsen LM, Davis G, McKee A, Akturk HK, Maahs DM, Kamboj MK. Longitudinal Trends in Glycemic Outcomes and Technology Use for Over 48,000 People with Type 1 Diabetes (2016-2022) from the T1D Exchange Quality Improvement Collaborative. Diabetes Technol Ther. 2023 Nov;25(11):765-773. doi: 10.1089/dia.2023.0320. Epub 2023 Oct 16. PMID: 37768677. The Diabetes Control and Complications Trial Research Group. The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long-Term Complications in Insulin-Dependent Diabetes Mellitus. N Engl J Med 1993; 329:977-986 Mauras N, Buckingham B, White NH, Tsalikian E, Weinzimer SA, Jo B, Cato A, Fox LA, Aye T, Arbelaez AM, Hershey T, Tansey M, Tamborlane W, Foland-Ross LC, Shen H, Englert K, Mazaika P, Marzelli M, Reiss AL; Diabetes Research in Children Network (DirecNet). Impact of Type 1 Diabetes in the Developing Brain in Children: A Longitudinal Study. Diabetes Care. 2021 Apr;44(4):983-992.  O'Neal, Teri B. "Dawn Phenomenon." U.S. National Library of Medicine, 16 May 2023, www.ncbi.nlm.nih.gov/books/NBK430893/.  Lachin JM, Bebu I, Nathan DM; DCCT/EDIC Research Group. The Beneficial Effects of Earlier Versus Later Implementation of Intensive Therapy in Type 1 Diabetes. Diabetes Care. 2021 Aug 11;44(10):2225–30. Arrieta A, Battelino T, Scaramuzza AE, Da Silva J, Castañeda J, Cordero TL, Shin J, Cohen O. Comparison of MiniMed™ 780G system performance in users aged younger and older than 15 years: Evidence from 12 870 real-world users. Diabetes Obes Metab. 2022 Jul;24(7):1370-1379. Beck RW, Bergenstal RM, Riddlesworth TD, Kollman C, Li Z, Brown AS, Close KL. Validation of Time in Range as an Outcome Measure for Diabetes Clinical Trials. Diabetes Care. 2019 Mar;42(3):400-405. doi: 10.2337/dc18-1444. Epub 2018 Oct 23. PMID: 30352896; PMCID: PMC6905478. Contacts: Ashley Patterson Ryan Weispfenning Public Relations Investor Relations +1 (818) 576-3025 +1 (763) 505-4626    

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Pierre Fabre Laboratories receives the Galien International Prize for EBVALLO®, the first allogeneic immunotherapy for patients with a rare cancer

CASTRES, France, June 21, 2024 /PRNewswire/ -- Pierre Fabre Laboratories has been awarded the "Prix Galien International" Prize in the "Best Product for a Rare/Orphan Disease" category for EBVALLO® (tabelecleucel), indicated as monotherapy for the treatment of patients with post-transplant lymphoproliferative disorder positive for Epstein-Barr virus (EBV+ PTLD) who have received at least one prior treatment.  During the same ceremony, EBVALLO® received the "Prix Galien" Italy Award in the Advanced Therapy Medicinal Product category. These two exceptional recognitions follow the awarding of EBVALLO® for the "Prix Galien France" on December 2023 As a symbol of scientific rigor, excellence, and innovation, the "Prix Galien International" awards remarkable recent health innovations available to the public, following an evaluation done by an independent committee of experts. Today this prize exists in fifteen countries, its reputation and influence have made it the most prestigious distinction in the medical field. Through this prize, the jury honors EBVALLO®, thanks to its innovative manufacturing process and mechanism of action. It offers rapid and lasting clinical results in over 50% of cases, in a rare disease with a particularly unfavorable prognosis, leading to significant morbidity and mortality. This award highlights the innovation capacity of Pierre Fabre Laboratories in oncology, one of its priority areas of development, and its ability to establish successful collaborations, such as the one with Atara Biotherapeutics (ATARA), an American biotech company. A global agreement was signed in December 2023, providing Pierre Fabre Laboratories with the EBVALLO® development, manufacturing, and commercialization rights all over the world. EBVALLO® was approved by the European Medicines Agency (EMA) in December 2022, and to date, this promising new treatment is marketed in Germany and Austria. In Europe, EBVALLO® is available to patients as part of an Early Access Program since July 2023. "We are very proud to receive this award, which we dedicate to the patients. It is a recognition of the major therapeutic advancement that EBVALLO® represents for patients with a rare cancer and a very unfavorable prognosis, who until now had significant unmet needs. This cancer, which affects a few hundred people worldwide each year, resonates perfectly with our purpose: every time we take care for a single person, we make the whole world better." said Éric Ducournau, CEO of the Pierre Fabre Laboratories. CONTACT: Laurence MARCHAL, laurence.marchal@pierre-fabre.com PDF - https://mma.prnewswire.com/media/2444819/PR_PRIX_GALIEN_INTERNATIONAL_PRO_EN.pdf From the left : Núria Perez-Cullell, Director of Medical, Patient, and Consumer Affairs at Pierre Fabre Laboratories, Clémentine Sergeant, Cell Therapy Corporate Lead, Pr. Pier Luigi Canonico, Chair of the Prix Galien Italy and Prix Galien International Awards Committee,    

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Biocytogen Awarded U.S. Patent for RenLite® Common Light Chain Mouse Platform

BEIJING, June 21, 2024 /PRNewswire/ -- Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", HKEX: 02315) announced United States Patent and Trademark Office (USPTO) patent grant for independently developed RenLite® fully human common light chain mouse platform. RenLite mice, developed using Biocytogen's proprietary Size-Unlimited and Precise Chromosome Engineering (SUPCETM) technology, feature the in situ replacement of the entire human antibody heavy chain variable region genes and a single light chain variable region gene. This enables the generation of highly diverse fully human antibodies that share a common light chain, effectively avoiding light-heavy chain mismatches during the assembly of bispecific antibodies, thereby significantly reducing the complexity of the CMC process. The molecular structures of these bispecific antibodies resemble monoclonal antibodies, exhibiting favorable physicochemical properties. Leveraging RenLite and RenLite KO mice, Biocytogen has generated a library of antibodies targeting over 200 TAA targets, enabling the rapid development of bispecific antibody and bispecific antibody-drug-conjugate (ADC) therapies. In addition to the RenLite platform, Biocytogen's independently developed RenMice® series includes RenMabTM, RenNano®, RenTCRTM and RenTCR-mimicTM platforms. These five fully human antibody/TCR mouse platforms cater to the diverse R&D needs of pharmaceutical companies globally. Since their debut in 2019, the RenMice platforms have garnered widespread recognition within the biotech and pharmaceutical industries. As of December 31, 2023, Biocytogen has established 47 target-nominated RenMice licensing projects with over 20 multinational corporations (MNCs) and biopharmaceutical/biotech companies, including Merck KGaA, Janssen, Xencor, BeiGene and Innovent. The RenMice platform has generated a library of over 400,000 fully human antibodies against thousands of targets and high-quality candidate antibodies, facilitating 103 projects encompassing co-development, out-licensing, and transfer agreements. The U.S. patent authorization for the RenLite platform technology demonstrates Biocytogen's exceptional innovation capabilities and global competitiveness. Biocytogen will continue to pursue global patent strategies and protect key technologies, offering advanced technology platforms and robust intellectual property protection for its partners. Besides the United States, patent applications for the RenLite platform have been submitted in China, Europe, Japan, South Korea, Canada, Singapore, Russia, Israel, Australia, and other countries and regions with authorizations in progress. About Biocytogen Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Founded on gene editing technology, Biocytogen leverages genetically engineered proprietary RenMice® (RenMabTM/RenLite®/RenNano®/RenTCR-mimicTM) platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, nanobody discovery and TCR-mimic antibody discovery, and has established a sub-brand, RenBiologicsTM, to explore global partnerships for an off-the-shelf library of >400,000 fully human antibody sequences against approximately 1000 targets for worldwide collaboration. As of December 31, 2023, 103 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and 47 target-nominated RenMice® licensing projects have been established around the globe, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen pioneered the generation of drug target knock-in humanized models for preclinical research, and currently provides a few thousand off-the-shelf animal and cell models under the company's sub-brand, BioMiceTM, along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in Beijing, Biocytogen has branches in China (Haimen Jiangsu, Shanghai), USA (Boston, San Francisco), and Germany (Heidelberg). For more information, please visit http://en.biocytogen.com.cn. Biocytogen Contacts Antibody assets and platforms: BD-Licensing@biocytogen.comPress Contact: pr@bbctg.com.cn

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ISTH announces launch of new global education initiative in factor XI/XIa inhibition

Leading international society embarks on multi-year initiative to increase clinician awareness of factor XI/XIa inhibition BANGKOK, June 21, 2024 /PRNewswire/ -- The International Society on Thrombosis and Haemostasis (ISTH), the leading worldwide not-for-profit organization dedicated to advancing the understanding, prevention, diagnosis, and treatment of conditions related to thrombosis and hemostasis, announces the official launch of new education titled "ISTH Emerging Therapies in Thrombosis—Factor XI/XIa Inhibitors". The organization is embarking on a comprehensive, globally relevant educational initiative to increase clinician awareness of factor XI (FXI) inhibition and how it might lead to the development of safer anticoagulation therapy. In early 2023, the ISTH organized the multi-disciplinary, international Factor XI/XIa Educational Steering Committee, a group of world-renowned experts led by Jeff Weitz, MD, to survey a sample of the multi-disciplinary target audiences for this education. By utilizing the results of the survey, with input from other educational sources, the committee designed a dynamic educational roadmap to guide the development of the factor XI/XIa multi-year initiative. The ISTH will develop a centralized and branded learning center called the "Learning Hub" that will be integrated within the ISTH Academy, an online platform providing Society members with premier access to educational resources. It will be launched in conjunction with an in-person learning experience on-site at the ISTH Academy booth at the ISTH's 2024 Congress in Bangkok, Thailand, from June 22-26, 2024. The in-person learning experience will focus on the topic The Promise of Factor XI/XIa Inhibitors: Anticoagulation Without the Risk of Bleeding. This 20-minute lecture will be recorded and broadcast in the ISTH Academy booth throughout the meeting and shared on the ISTH Academy after the Congress. "Launching the factor XI/XIa educational roadmap in Bangkok is an exciting opportunity to kick off this global education initiative," said Weitz, the ISTH's recently elected Secretary General for 2024-2028 term. "Our leadership in the steering committee and feedback from the greater thrombosis and hemostasis community has allowed us to understand the current needs and create meaningful education in factor XI/XIa inhibition." The offerings inside the Learning Hub on the ISTH Academy platform will include: The results of the survey and a factor XI/XIa educational roadmap A glossary of terms to aid learners in understanding current and evolving terminology related to FXI/XIa inhibition Educational content developed by the ISTH and links to external resources A research round-up, a collation of current trials and research for all FXI/XIa inhibitor indications under investigation Subscription-style updates, allowing the ISTH to provide new research and educational activities that will be released throughout the year ISTH Emerging Therapies in Thrombosis—Factor XI/XIa Inhibitors is supported by educational grants from Bayer, Anthos, and BMS/J&J. For more information, visit this link. About the International Society on Thrombosis and Haemostasis (ISTH)Founded in 1969, the ISTH is the leading worldwide not-for-profit organization dedicated to advancing the understanding, prevention, diagnosis, and treatment of conditions related to thrombosis and hemostasis. ISTH is an international medical-scientific professional membership organization with more than 7,500 clinicians, researchers, and educators working together to improve the lives of patients in more than 110 countries around the world. Among its highly regarded activities and initiatives are education and standardization programs, research activities, meetings and congresses, peer-reviewed publications, expert committees, and World Thrombosis Day on 13 October. Visit ISTH online at www.isth.org. Logo - https://mma.prnasia.com/media2/454627/4754468/ISTH_Logo.jpg?p=medium600

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ISTH Releases Evidence-Based Clinical Practice Guideline for Hemophilia Treatment

CHAPEL HILL, N.C., June 21, 2024 /PRNewswire/ -- The International Society on Thrombosis and Haemostasis (ISTH), the leading international professional medical-scientific organization dedicated to advancing the understanding, prevention, diagnosis, and treatment of conditions related to thrombosis and hemostasis, has published the first clinical practice guideline utilizing strict GRADE methodology for the treatment of congenital hemophilia A and B. Hemophilia, a rare bleeding disorder resulting from deficiencies in blood coagulation factors, affects hundreds of thousands individuals worldwide and demands intricate management strategies. As the first comprehensive guideline based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach it provides a rigorous and structured decision-making framework for clinicians, healthcare professionals, patients and their caregivers. The objective of this guideline is to offer a comprehensive overview of evidence in making informed treatment decisions. Developed over several years, the ISTH assembled a multidisciplinary panel comprising physicians and patient representatives with global representation, balanced to mitigate potential biases. This diverse panel prioritized key clinical questions and outcomes crucial for both clinicians and patients. The recommendations underwent rigorous analyses, including public commentary, ensuring comprehensiveness, transparency and inclusivity. The culmination of this endeavor is a set of 13 recommendations, addressing critical aspects of hemophilia A and B care. They are accompanied by extensive remarks providing additional context and guidance for interpretation and implementation. Among these recommendations, strong endorsements advocate for prophylactic treatment over episodic interventions for severe and moderately severe hemophilia A and B, underscoring a paradigm shift in clinical practice. Recognizing that hemophilia is a rare and complex disease that poses challenges for guideline development and implementation, the new guideline contributes valuable insights into the evolving hemophilia treatment landscape. It illustrates and emphasizes the importance of patient involvement and shared decision-making in treatment decisions and advocates for individual and situational therapeutic choices. Moreover, the guideline addresses important gaps in scientific data and identifies critical research priorities. "With hemophilia management being complex, our guideline provides clarity, guiding treatment decisions with evidence-based insight, yet highlighting the importance of making treatment decisions consistent with patients' individual risks, values, and preferences," stated Suely M. Rezende, M.D., Ph.D., Chair of the ISTH Hemophilia Guideline Panel. "Our collaborative effort has yielded a roadmap for optimizing patient care, setting a new standard in hemophilia treatment guidelines." To provide important context, commentaries have been published alongside the guideline to provide further guidance on its interpretation and implementation. The commentaries, authored by preeminent experts also address challenges for clinical practice and policy, discuss strengths and limitations of the GRADE methodology for rare diseases, share how observational data can add highly valuable information in the absence of RCT data and comment on the pros and cons of the guideline. Looking ahead as new and quality data becomes available in the dynamic and ever-evolving landscape of new hemophilia treatments that offer unprecedented improvements in treatment choices for clinicians and patients, the ISTH remains committed to advancing hemophilia research and ultimately improving the lives of people with hemophilia. Future updates to the guideline are expected to encompass emerging treatments such as novel high-sustained Factor VIII as well as new non-factor therapies and gene therapy. By continuously updating and complementing this guideline, the ISTH aims to drive innovation and enhance outcomes for individuals living with hemophilia worldwide. Additionally, it will provide further opportunities for working and collaborating with stakeholders globally to ensure that the latest advancements and best clinical practice guidance is provided and effectively disseminated and implemented, ultimately benefiting innovation in the global hemophilia community. For more information, to access the full guideline and read all three corresponding commentaries, please visit https://www.isth.org/page/hemophiliaguideline. About the International Society on Thrombosis and Haemostasis (ISTH)Founded in 1969, the ISTH is the leading worldwide not-for-profit organization dedicated to advancing the understanding, prevention, diagnosis, and treatment of conditions related to thrombosis and hemostasis. ISTH is an international medical-scientific professional membership organization with more than 7,000 clinicians, researchers, and educators working together to improve the lives of patients in more than 110 countries around the world. Among its highly regarded activities and initiatives are education and standardization programs, clinical and laboratory practice guidelines and guidance, research activities, meetings and congresses, peer-reviewed publications, expert committees, and World Thrombosis Day on 13 October. Visit ISTH online at www.isth.org. Logo - https://mma.prnasia.com/media2/454627/ISTH_Logo.jpg?p=medium600

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