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符合「Pharmaceuticals」新聞搜尋結果, 共 122 篇 ,以下為 1 - 24 篇 訂閱此列表,掌握最新動態
Lynk Pharmaceuticals Announces Positive Phase III Topline Data of Zemprocitinib (LNK01001) in Rheumatoid Arthritis

HANGZHOU, China, SHANGHAI and BOSTON, Jan. 12, 2026 /PRNewswire/ -- Lynk Pharmaceuticals Co., Ltd. (hereinafter referred to as "Lynk Pharmaceuticals"), a clinical stage innovative drug development company focused on developing innovative therapies for immune and inflammatory diseases, today announced positive topline results from its Phase III clinical trial evaluating zemprocitinib (LNK01001) in patients with moderate to severe active rheumatoid arthritis (RA). The study met its primary and key secondary efficacy endpoints, demonstrating statistically significant improvements versus placebo (P < 0.0001), with a favorable safety and tolerability profile. This randomized, double-blind, placebo-controlled Phase III study (CTR20232969, NCT06276998) evaluated the efficacy and safety of zemprocitinib in patients with moderate to severe active RA who had an inadequate response to biologic disease-modifying antirheumatic drugs (bDMARDs). The trial was led by Professor Xiaofeng Zeng from Peking Union Medical College Hospital and Chinese Academy of Medical Sciences, and enrolled a total of 430 patients, who were randomized 1:1 to receive zemprocitinib 12 mg twice daily or placebo (PBO) twice daily. The primary endpoint was the proportion of patients achieving an ACR20 response at Week 24, with key secondary endpoints including the proportion of patients achieving ACR50 and DAS28 (CRP) ≤ 3.2 at Week 24. The study results showed that response rates in the zemprocitinib treatment group were significantly higher than those in the placebo group across all primary and key secondary efficacy endpoints, with the differences reaching statistical significance. Specifically, the ACR20 response rates at Week 12 and Week 24 vs. PBO were 74.0% versus 29.9% (P < 0.0001) and 79.1% versus 39.7% (P < 0.0001), respectively. The ACR50 response rates at Week 12 and Week 24 vs. PBO were 41.4% versus 9.3% (P < 0.0001) and 55.8% versus 22.0% (P < 0.0001), respectively. The proportion of patients achieving DAS28 (CRP) ≤ 3.2 at Week 12 and Week 24 vs. PBO were 51.2% versus 15.0% (P < 0.0001) and 67.0% versus 23.4% (P < 0.0001), respectively. In terms of safety, zemprocitinib was generally well tolerated. The majority of treatment emergent adverse events (TEAEs) were mild to moderate in severity (Grade 1–2). The incidence of serious adverse events was comparable between the zemprocitinib and placebo groups, and no new safety signals were observed. The overall safety profile was consistent with previous studies. The primary results of this study are planned to be formally presented at an upcoming international scientific conference. Professor Xiaofeng Zeng, the principal investigator of this study from Peking Union Medical College Hospital and Chinese Academy of Medical Sciences, said: "Rheumatoid arthritis is a chronic, progressive autoimmune disease that can severely impact patients' quality of life and physical health. In this Phase III study, zemprocitinib demonstrated strong efficacy, showing statistically significant improvements across the primary and key secondary efficacy endpoints, while maintaining a favorable safety and tolerability profile. These results suggest that zemprocitinib has the potential to offer a new treatment option for this patient population." Dr. Zhao-Kui (ZK) Wan, Founder and Chief Executive Officer of Lynk Pharmaceuticals, said: "We are very encouraged by the positive topline results from this Phase III trial of zemprocitinib. This represents the first disclosed trial results in China for a selective JAK1 inhibitor in patients with moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to prior biologic therapies. We believe that zemprocitinib, as a promising oral therapy, has the potential to offer a meaningful new treatment option for patients with rheumatoid arthritis. We would also like to express our sincere gratitude to the patients, investigators, and all teams involved for their dedication and contributions in achieving this important milestone." Gaobo Zhou, Chief Investment Officer of Simcere, said: "As the commercialization partner of zemprocitinib, we are pleased to see the strong performance of this Phase III study in rheumatoid arthritis. These results further highlight the therapeutic potential of zemprocitinib. We will continue to support its subsequent development and remain committed to bringing improved oral treatment options to patients with rheumatoid arthritis." About Zemprocitinib (LNK01001): Zemprocitinib (LNK01001) is a highly selective, next generation JAK1 inhibitor with best in class potential, being developed for the treatment of rheumatoid arthritis, ankylosing spondylitis, atopic dermatitis, and vitiligo. Compared with first-generation JAK inhibitors with lower selectivity, zemprocitinib exhibits significantly greater selectivity for JAK1, which may enhance efficacy while reducing off-target adverse effects. Zemprocitinib potently and dose-dependently inhibits multiple inflammation-related signaling pathways mediated by JAK1. In March 2022, Lynk Pharmaceuticals entered into a commercialization collaboration with Simcere to jointly advance the development and commercialization of zemprocitinib for rheumatoid arthritis and ankylosing spondylitis in Greater China. About Lynk Pharmaceuticals: Lynk Pharmaceuticals, a clinical stage company, was founded by senior drug R&D experts and executives from Pfizer, Merck, and Johnson & Johnson. Lynk Pharmaceuticals is dedicated to the discovery and development of innovative drugs for the treatment of immune and inflammatory diseases. Driven by a higher goal, Lynk Pharmaceuticals aims to be a market leader to address unmet medical demands by the development of innovative therapies. We thrive to provide differentiated innovative therapies to benefit patients globally. To date, Lynk Pharmaceuticals has independently developed several innovative new drug candidates and successfully completed a number of clinical studies. About Simcere: Simcere Pharmaceutical Group Limited (2096.HK) is a pharmaceutical company driven by innovation and focusing on four therapeutic areas including Neuroscience, Oncology, Autoimmune Diseases and Anti-infection. We proactively explore areas with significant unmet needs, and our mission is For patients, for life. Driven by our in-house R&D efforts and synergistic innovation, Simcere has established strategic cooperation partnerships with many innovative companies and research institutes.

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 221 加入收藏 :
Alamar Biosciences Announces Launch of NULISAqpcr™ AD 5-plex Assay, Advancing Blood Based Biomarker Detection in Alzheimer's Disease Research

FREMONT, Calif., Jan. 13, 2026 /PRNewswire/ -- Alamar Biosciences, Inc. ("Alamar"), a leader in precision proteomics dedicated to advancing the early detection of disease, is proud to announce the launch of its Research Use Only (RUO) NULISAqpcr™ AD 5-plex Assay. This innovative solution enables simultaneous quantitative measurement of five critical blood-based biomarkers relevant to the Alzheimer's Association recommended guidelines: brain-derived phosphorylated tau 217 (BD-pTau217), neurofilament light chain (NfL), amyloid-beta 42 (Aβ42), glial fibrillary acidic protein (GFAP), and APOE4 (carrier status), all from a single blood or plasma sample. NULISAqpcr AD 5-plex Assay includes BD-pTau217, GFAP, NfL, AB42 and APOE4. The NULISAqpcr AD 5-plex Assay consolidates key biomarkers into a single multiplexed format, delivering unmatched sensitivity, specificity, and ease of use. By incorporating BD-pTau217, Aβ42, NfL, and GFAP, the assay enables robust monitoring of amyloid and tau pathology, neurodegeneration, and inflammation, while accurately determining APOE4 carrier status—the strongest genetic risk factor for Alzheimer's disease. Together, these capabilities create a powerful tool for both translational and clinical research, and its relevance extends beyond Alzheimer's disease to other neurodegenerative and cognitive disorders. "The launch of the NULISAqpcr AD 5-plex Assay marks a significant milestone in our efforts to deliver precision proteomics solutions for neurodegenerative disease," said Dr. Yuling Luo, founder, chairman and chief executive officer of Alamar. "By combining these critical protein targets into a single assay with a streamlined workflow, we are empowering the neuroscience community to advance screening, early detection and precision diagnoses for Alzheimer's disease." "Blood-based biomarkers are redefining Alzheimer's research, providing an accurate, cheaper and more accessible means of establishing early diagnosis and aiding determination of eligibility for therapies," said Dr. Steven Williams, chief scientific officer of Alamar. "Traditional single-plex assays can measure these biomarkers individually, but require multiple tests to provide a comprehensive view of the disease. With NULISA™ it is now possible to measure multiple Alzheimer's-related proteins in blood, each offering unique insights into the underlying pathophysiology." Alamar is dedicated to collaborating with researchers, clinicians, and industry partners to unlock precision proteomics and improve outcomes for patients affected by Alzheimer's disease and other neurodegenerative conditions. The NULISAqpcr AD 5-plex Assay is available today as a service through our Technology Access Program. For more information about the NULISAqpcr AD 5-plex Assay and Alamar's full portfolio of precision proteomic solutions, visit www.alamarbio.com. About Alamar Biosciences, Inc. Alamar Biosciences is a privately held life sciences company dedicated to powering precision proteomics to enable the earliest detection of disease. Leveraging its proprietary NULISA™ technology and the ARGO™ HT System, Alamar's platform is designed to deliver ultra-high sensitivity and addresses key limitations of existing technologies to deliver precision proteomics. For more information, please visit alamarbio.com.   

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 160 加入收藏 :
diaTribe Convenes International Consensus to Guide Diabetes Technology Use During Pregnancy

Expert recommendations provide crucial guidance to leverage CGM and AID during pregnancy. SAN FRANCISCO, Jan. 13, 2026 /PRNewswire/ -- The diaTribe Foundation announces the publication of the first international consensus statement on the use of continuous glucose monitoring (CGM) and automated insulin delivery (AID) during pregnancy. Published in The Lancet Diabetes & Endocrinology, the document aims to standardize care, improve outcomes, and ease the daily burden of managing type 1 (T1D), type 2 (T2D), and gestational diabetes (GDM) during pregnancy. Managing diabetes is exceptionally challenging during pregnancy due to hormonal shifts and narrow glucose targets. As CGM and AID become standard of care in diabetes for their ability to improve management, many enter pregnancy already relying on these technologies or adopt them to help navigate this demanding time. Despite growing use, application of technology has remained disjointed in pregnancy due to a lack of detailed clinical guidance, particularly for T2D and GDM. "Application of Continuous Glucose Monitoring and Automated Insulin Delivery Technologies for Pregnant Women with Type 1 Diabetes, Type 2 Diabetes or Gestational Diabetes Mellitus" was developed by experts across six continents to address this gap. "It is absolutely possible to have a safe and healthy pregnancy with diabetes, and technologies can help—but these tools are often underutilized due to limited research, few devices approved for use in pregnancy, and a lack of clear guidance," said Dr. Katrien Benhalima, endocrinologist and chair of the expert author group. "Publishing this consensus is a key step to ensuring that maternal healthcare for people with diabetes continues to improve as technologies evolve." The paper provides 14 specific recommendations, including: Guidance on picking AID systems and adapting settings to meet pregnancy-specific physiological needs, including detailed charts with device-specific recommendations Considerations for technology use during preconception, pregnancy, labor and delivery, and the immediate postpartum period CGM time in range targets specifically for T2D and GDM, expanding upon previous standards set for T1D. The consensus aims to support key members of the pregnancy care team who may be less familiar with diabetes technologies, including primary care and obstetrics providers, through recommendations based on the latest evidence and clinical experience. By confirming these technologies can be safely used during pregnancy, the authors also hope to increase device access and user confidence. This initiative was led by The diaTribe Foundation and strengthened by input from 25 leading global bodies, including the American College of Obstetricians and Gynecologists, Breakthrough T1D, European Association for the Study of Diabetes, and World Organization of Family Doctors. The diaTribe Foundation is dedicated to improving the lives of people with diabetes and advocating for action. We ensure that people have the resources and education needed to thrive with diabetes, bring people with diabetes to the conversation on regulatory issues, connect the field and the diabetes community, and change the narrative around diabetes. Endorsing organizations:ADJ Diabetes BrazilAdvanced Technologies & Treatments for DiabetesAmerican Association of Clinical EndocrinologyAmerican College of DiabetologyAmerican Pharmacists AssociationAssociation of Diabetes Care & Education SpecialistsAustralasian Diabetes in Pregnancy SocietyAustralian Diabetes SocietyAustralian Diabetes Educators AssociationBrazilian Diabetes SocietyBreakthrough T1DCentre for Chronic Disease Control (India)Diabetes AustraliaDiabetes IndiaEuropean Association for the Study of DiabetesEuropean Board and College of Obstetrics and GynaecologyIndian College of Obstetricians and GynaecologistsInternational Association of Diabetes and Pregnancy Study GroupsInternational Diabetes FederationInternational Federation of Gynaecology and ObstetricsJapan Diabetes SocietyResearch Society for the Study of Diabetes IndiaSociety for Obstetric Medicine IndiaWorld Organization of Family Doctors Supported by the American College of Obstetricians and Gynecologists

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 151 加入收藏 :
Field Medical to Present at the 44th Annual J.P. Morgan Healthcare Conference

CARDIFF-BY-THE-SEA, Calif., Jan. 12, 2026 /PRNewswire/ -- Field Medical Inc., a clinical-stage medical technology company advancing a versatile, next-generation pulsed field ablation (PFA) platform designed to support both ventricular tachycardia (VT) and atrial fibrillation (AF) ablation, today announced that its founder, Steven Mickelsen, MD, will present at the 44th annual J.P. Morgan Healthcare Conference on Thursday, Jan. 15, 2026, at 10 a.m. PT at The Westin St. Francis in San Francisco. The FieldForce™ Ablation System by Field Medical: This next-generation PFA system is designed for transmural lesion creation, offering a novel approach to VT ablation. The presentation will feature a company overview, including the FieldForce™ PFA platform, clinical progress in VT, the Field-PULSE AF study, and plans for the upcoming pivotal VT trial. Field Medical's leadership team will be available for meetings during the conference. To request a meeting, please email ir@fieldmedicalinc.com. About Field Medical® Inc.Founded in 2022, Field Medical is a clinical-stage medical technology company committed to advancing pulsed field ablation (PFA) solutions for complex cardiac arrhythmias. Its FieldForce™ Ablation System integrates a focal catheter design with proprietary FieldBending™ energy designed to safely deliver efficient, precise ablation with the goal of improving outcomes in ventricular and atrial arrhythmia treatment. In 2024, Field Medical earned Breakthrough Device Designation and gained entry into the FDA TAP Pilot Program for its ventricular tachycardia indication. In October 2025, the VCAS trial was published in Circulation. For more information, visit www.fieldmedicalinc.com and follow us on LinkedIn, X and YouTube. The FieldForce™ Ablation System is an investigational device and is limited by federal (or U.S.) law to investigational use. ContactsMediaHolly Windler619.929.1275media@fieldmedicalinc.com Investor Relationsir@fieldmedicalinc.com  

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 131 加入收藏 :
Suvoda sets new standard for streamlined patient and site experience in clinical trials

CONSHOHOCKEN, Pa., Jan. 12, 2026 /PRNewswire/ -- Suvoda, a clinical trial technology company, took decisive steps in 2025 toward a more connected and streamlined clinical trial experience for both patients and sites. The company's merger with Greenphire marked a pivotal moment in that journey, strengthening Suvoda's ability to tackle persistent trial operational challenges with a more unified approach. Together with continued product innovation and deployment of AI tools, Suvoda closed the year with growing momentum toward a single, cohesive ecosystem that reduces complexity across the clinical trial lifecycle. "The last twelve months marked an important step forward for Suvoda," said Jagath Wanninayake, CEO of Suvoda. "Our teams worked with care and intention as we brought two strong companies together and delivered new capabilities that reflect what patients and sites actually need. As we enter 2026, we're focused on helping sponsors and sites navigate their trials with clarity while giving patients a smoother, more supportive experience." Making the patient journey easier A defining milestone of the year was the launch of Suvoda's patient app, a clear demonstration of how a unified platform can meaningfully improve the clinical trial experience for patients. The app brings eCOA questionnaires, patient payments, reminders, and visit scheduling into one consumer-grade interface that patients can use on their own devices. This advancement helps participants stay engaged while easing the administrative load for busy sites. Harnessing AI to alleviate administrative burden in clinical trials Suvoda also simplified how study teams access critical information with Sofia, an AI assistant currently deployed in Suvoda IRT with platform expansion in the future. Sofia helps users ask questions and get answers with a generative AI tool, replacing multi-step navigation with quick, clear responses. Built with strong privacy and role-based controls, Sofia supports everyday decision making for study teams without compromising data security or the integrity of the study blind. Recognized for innovation Suvoda's approach earned continued recognition in 2025, including a new patent for its platform architecture, bringing its total to five. Everest Group also named Suvoda a Leader in its RTSM PEAK Matrix® assessment. Across its portfolio, Suvoda released enhancements that improve transparency, data quality, and ease of use, reflecting its ongoing focus on practical innovation that supports real-world trial operations. Positioned for continued growth in 2026 The company anticipates continuing its strong growth in 2026 as pharmaceutical sponsors and CROs increasingly look for unified platforms that reduce trial complexity while supporting exceptional patient and site experiences. "We spent 2025 not only merging two companies, but unifying our technologies, our people, and our mission," Wanninayake said. "That foundation positions us to deliver even greater value in 2026 and beyond. We're ready to support sponsors and sites to meet more of their clinical trial needs and help patients move through their studies with ease and confidence." About Suvoda Suvoda is a global clinical trial technology company with a market-leading, real-time software platform that empowers sponsors and CROs to make confident decisions and sites and patients to take calm, controlled action. Suvoda delivers interconnected, action-driven software solutions and industry-leading services and support, so that even in the most time-sensitive, mission-critical moments, life-changing studies keep moving forward. Headquartered outside Philadelphia, Suvoda also maintains offices in Portland, OR, Barcelona, Spain, Bucharest and Iasi, Romania, and Tokyo, Japan. The company maintains customer satisfaction scores that consistently exceed the technology industry average, contributing to the company being selected by trial sponsors and CROs to support more than 2000 trials across more than 95 countries. Suvoda recently merged with Greenphire, a leading provider of clinical trial financial management and patient support tools. To learn more, visit suvoda.com and follow Suvoda on LinkedIn. CONTACT:  Robin Abadía  Director, External Communications  marketing@suvoda.com Logo - https://mma.prnasia.com/media2/1759317/Suvoda_updated_Logo.jpg?p=medium600

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 115 加入收藏 :
Basecamp Research launches world-first AI models for programmable gene insertion

The breakthrough tackles a longstanding challenge in genetic medicine with the goal of developing a new generation of curative cell and gene therapies. Developed in collaboration with NVIDIA by training the largest evolutionary AI models on a new, globally collected dataset, accelerated by NVIDIA BioNeMo. The same versatile model also helped design novel antimicrobial peptide molecules with a 97% lab-confirmed success rate, including candidates that appeared highly potent against multidrug-resistant "superbugs." Basecamp Research also adds NVentures as an investor ahead of Series C round following deep technical collaboration on EDEN models. LONDON and CAMBRIDGE, Mass., Jan. 12, 2026 /PRNewswire/ -- Basecamp Research, a frontier AI lab harnessing evolution to design new medicines, today announced the first AI models capable of programmable gene insertion, offering a new way to replace faulty genes and reprogram cells for therapeutic use. Trained in collaboration with NVIDIA, these models are driving the development of a new generation of treatments for cancer and inherited diseases. In parallel, Basecamp Research secured an investment from NVentures (NVIDIA's venture capital arm) in its pre-Series C round following years of close technical collaboration, which will help the company to accelerate its research and development efforts. "We believe we are at the start of a major expansion of what's possible for patients with cancer and genetic disease," said John Finn, Chief Scientific Officer at Basecamp Research. "By using AI to design the therapeutic enzyme, we hope to accelerate the development of cures for thousands of untreatable diseases, potentially transforming millions of lives." Programmable Gene Insertion Programmable gene insertion - placing large therapeutic DNA sequences at precise locations in the human genome - has been a central goal in genetic medicine for decades. Existing CRISPR-based approaches can only make small edits and must damage DNA to do so, limiting where and how they can be used. Basecamp Research is the first to demonstrate that AI can design enzymes capable of performing large gene insertion at defined sites in the human genome, opening a long-sought path toward programmable therapies. Basecamp Research's AI-Programmable Gene Insertion (aiPGI™) platform is powered by EDEN, a new family of evolutionary AI models developed with NVIDIA, trained on BaseData™, the company's proprietary genomics dataset - the largest of its kind. The models learn the language of DNA and patterns of evolution, allowing the algorithms to design new, programmable therapies for cancer and genetic disease. In lab results published today in a paper co-authored by NVIDIA, Microsoft and leading academics, [link], the EDEN models designed multiple active insertion proteins for 100% of tested disease-relevant target sites in the human genome, requiring only the genomic target site as a prompt and marking a significant step forward in AI model capability. Basecamp Research has already demonstrated insertion at over 10,000 disease-related locations in the human genome, including therapeutically relevant integration of cancer-fighting DNA into primary human T cells at novel safe-harbour sites. This produced CAR-T cells that show strong killing of cancer cells, showing over 90% tumour-cell clearance in laboratory assays. AI-Designed Molecules To Fight "Superbugs" In another key frontier therapeutic design task targeting the global drug-resistance crisis, the same model proved its versatility by designing a focused library of novel antimicrobial peptides (AMPs) – small proteins with the potential to kill harmful bacteria – with 97% of candidates demonstrating confirmed activity in laboratory tests. In a collaboration with University of Pennsylvania scientists led by Prof. César de la Fuente, the top-performing AMPs showed high potency against critical-priority, multidrug-resistant pathogens, offering a powerful new tool in the fight against dangerous "superbugs." Breakthrough powered by unique data & frontier AI models The EDEN models that power aiPGI™ were trained on over 10 trillion tokens of evolutionary DNA from more than one million newly-discovered species. This data was collected over five years from over 150 locations across 28 countries and five continents as part of a novel data collection strategy pioneered by the company, published in June 2025. The largest EDEN model was trained on 1.95x1024 FLOPS of compute on a cluster of 1,008 NVIDIA Hopper GPUs and accelerated with libraries from NVIDIA BioNeMo, making it comparable in scale to GPT-4 class models and placing it among the most computationally intensive biological models ever reported. Therapeutic assets in development These capabilities underpin Basecamp Research's emerging pipeline of cell and gene therapies, opening the path to treatments that are more precise, predictable and personalised than those available today. The company's goal is to develop potentially curative therapies across a range of cancer and genetic disease indications, powered by continued improvements to BaseData™, the EDEN models and aiPGI™. About Basecamp ResearchBasecamp Research is dedicated to solving major challenges in the life sciences by exploring Beyond Known Biology™. The company builds frontier AI models using BaseData, the world's largest ethically-sourced and globally representative biological dataset. Basecamp Research collects and curates its own biological data through partnerships with more than 152 organizations in 28 countries, giving its AI access to genetic diversity that doesn't exist for models trained on public database sources. This allows Basecamp Research to design novel protein sequences and biological systems that can accelerate therapeutic research and development. Basecamp Research partners with biopharma companies and academic institutions worldwide, and its work has been recognized with honors including Fast Company's Top 10 Most Innovative Companies in Biotech and the FT-backed Sifted AI100 list of Europe's leading AI startups. Learn more at basecamp-research.com.BaseData™, Beyond Known Biology™, EDEN-GLM™ and aiPGI™ are brand names and technologies of Basecamp Research.

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 139 加入收藏 :
2026 年 1 月 13 日 (星期二) 農曆十一月廿五日
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