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符合「Medical/Pharmaceuticals」新聞搜尋結果, 共 116 篇 ,以下為 1 - 24 篇 訂閱此列表,掌握最新動態
Head-to-Head Real-World Data: Cadonilimab Outperforms PD-1 Inhibitors in First-Line PD-L1-Low Gastric Cancer

HONG KONG, Jan. 14, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) announced the presentation of a real-world study at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI), comparing cadonilimab plus chemotherapy against a PD-1 inhibitor plus chemotherapy for the first-line (1L) treatment for advanced gastric (G) or gastroesophageal junction (GEJ) cancer with PD-L1 CPS <5 (a propensity-matched, retrospective cohort study). The study results showed that the cadonilimab regimen, compared to the PD-1 monoclonal antibody regimen, significantly prolonged patients' overall survival (OS) and progression-free survival (PFS). Both OS (HR=0.49, P=0.025) and PFS (HR=0.43, P=0.006) demonstrated statistically significant improvements. The full study has been accepted for publication in the Journal of Gastrointestinal Oncology. These real-world findings are highly consistent with the "all-comer benefit" profile previously observed for cadonilimab in the Phase III registrational trial COMPASSION-15. This real-world, head-to-head comparison further underscores cadonilimab's potential to elevate the standard of cancer immunotherapy and address clinical challenges unresolved by single-target PD-1 inhibitors. Based on the data from the pivotal Phase III COMPASSION-15 study, cadonilimab received approval in China in September 2024 for the first-line treatment of advanced gastric cancer across all patient subgroups and this indication was added to cadonilimab's list of covered indication under National Reimbursement Drug List (NRDL), effective 2026. Anti-PD-1 antibodies combined with chemotherapy is the international standard of care for advanced gastric cancer. However, its efficacy is significantly limited in patients with PD-L1-low (CPS < 5) or negative (CPS < 1) expression, where these patients constitute nearly half of all advanced gastric cancer cases. As a result, the U.S. Food and Drug Administration (FDA) restricted all approved first-line PD-1 inhibitors for advanced gastric cancer to only PD-L1-positive patients in 2024. This aligns with recommendations from leading guidelines, such as those of the National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO), which prioritize PD-1-based regimens for patients with PD-L1 CPS ≥5. Consequently, PD-L1-low or -negative advanced gastric cancer remains a major unmet clinical need globally due to thelack of effective immunotherapy options. A recent real-world study provides new evidence addressing this challenge. In this retrospective analysis, patients with PD-L1-low (CPS < 5) advanced G/GEJ cancer received first-line therapy with either cadonilimab plus chemotherapy or a PD-1 inhibitor plus chemotherapy. With a median follow-up of 11.0 months as of February 28, 2025, the results showed that the cadonilimab-based regimen achieved statistically significant and clinically meaningful improvements in both PFS and OS compared to the PD-1 inhibitor-based regimen. Some Key Findings from the Study published at GI-ASCO: Significant PFS and OS Improvement: Among PD-L1-low patients, the cadonilimab group achieved a median OS of 14.3 months, significantly longer than the 10.3 months observed in the PD-1 inhibitor group (OS HR=0.49, p=0.025), representing a 51% reduction in the risk of death. The median PFS was also extended to 9.3 months compared to 5.8 months in the control group (PFS HR=0.43, p=0.006), corresponding to a 57% reduction in the risk of disease progression or death. Higher Objective Response Rate (ORR): The objective response rate was superior in the cadonilimab group compared to the PD-1 inhibitor group (73.3% vs. 57.1%) for PD-L1-low patients. Manageable Safety and Good Tolerability: The incidence of any-grade adverse events was comparable between the two groups, and no statistically significant difference observed in the rate of grade 3-4 adverse events between the two groups. Akeso is actively advancing several prospective head-to-head Phase III registration studies with cadonilimab, aiming to elevate current standard immunotherapies. Notably, the international multi-center Phase III registration study COMPASSION-37, evaluating cadonilimab plus chemotherapy versus the PD-1 inhibitor nivolumab plus chemotherapy for first-line treatment of advanced gastric cancer, received approval from the U.S. FDA to initiate at the end of 2025. This milestone marks a new phase in the global development of cadonilimab. Forward-Looking Statement of Akeso, Inc.This announcement by Akeso, Inc. (9926.HK, "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. About AkesoAkeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 26 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. For more information, please visit https://www.akesobio.com/en/about-us/corporate-profile/ and follow us on Linkedin.

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 115 加入收藏 :
Enhanced Genetype colorectal cancer risk test released - supports earlier disease detection and ColoSTAT® targeting

MELBOURNE, Australia, Jan. 14, 2026 /PRNewswire/ -- Rhythm Biosciences Ltd ('RHY', the 'Company' or the 'Group') (ASX: RHY), a transformative, predictive cancer diagnostics technology company is pleased to announce the commercial launch of its updated geneTypeTM Colorectal Cancer (CRC) Risk Assessment clinical test ("geneTypeTM CRC"), a significant advancement in personalised cancer risk prediction. The updated test incorporates additional clinical and lifestyle risk factors alongside the established 140-SNP polygenic risk score (PRS), delivering improved predictive accuracy across both genders and a wider age range. The enhanced test is designed to support earlier identification of individuals at elevated risk of colorectal cancer, enabling more targeted screening pathways and complementing Rhythm's ColoSTAT® blood-based CRC detection test. Validation data for the updated model has been recently published in the peer-reviewed journal PLOS ONE (Dite GS, et al. 2025), demonstrating improved predictive performance compared to traditional approaches. Evidence suggests that approximately 50% of colorectal cancer cases could be prevented through healthy lifestyle modifications. By incorporating lifestyle risk factors known to contribute to disease risk, the enhanced geneTypeTM CRC test aims to identify a broader cohort of at-risk individuals who may benefit from earlier intervention and monitoring. Key Clinical Applications The enhanced geneTypeTM CRC Risk Assessment test has several important use-cases for this innovative new clinical test: Improved risk stratification across both genders, with particular benefits for identifying higher-risk women. Identification of younger adults at risk of early-onset colorectal cancer, supporting earlier screening interventions. Potential to encourage greater participation in bowel cancer screening programs by providing personalised risk insights. In Australia, compliance with recommended bowel cancer screening programs remains below 50%. Individuals classified as higher risk using the geneTypeTM CRC test may be candidates for closer clinical monitoring through colonoscopy, FIT testing, or Rhythm's blood-based CRC detection test, ColoSTAT®. "The enhanced geneTypeTM CRC test strengthens our ability to identify individuals at elevated risk earlier, supporting more targeted screening and complementing ColoSTAT's® role in colorectal cancer detection." said Dr Erika Spaeth, Director of Clinical Affairs at Rhythm. About Rhythm Biosciences Rhythm Biosciences Ltd (ASX: RHY) is an Australian innovative, medical diagnostics company aimed at delivering simple, affordable blood tests for accurate and early detection of cancers. Rhythm is focused on improving patient outcomes through detection at the earliest possible stage, reducing the global burden of cancer, and saving lives. Rhythm Biosciences is committed to working with likeminded global partners to achieve commercialisation and distribution of these simple solutions. The company was founded in 2017 and is headquartered in Melbourne, Australia. For more information, visit rhythmbio.com and follow the company on LinkedIn and X.

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 110 加入收藏 :
Celltrion presents innovative drug pipeline and U.S. manufacturing and R&D expansion strategy at the 44th Annual J.P. Morgan Healthcare Conference

Celltrion outlines a blueprint for innovative drug development built on its antibody expertise The company highlights its business strategy to scale U.S. manufacturing and R&D capabilities, strengthening its global supply chain, production and operations INCHEON, South Korea, Jan. 14, 2026 /PRNewswire/ -- Celltrion, Inc. (068270.KS), a leading global biopharmaceutical company, today presented key strategic priorities and clinical development updates for its innovative drug pipelines including antibody-drug conjugates (ADCs) and multi-specific antibodies (msAbs) at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, California. The company also highlighted plans to expand its manufacturing and R&D capabilities to support long-term growth, enhance supply resilience and reinforce its long-term commitment to the U.S. market. The presentation, composed of two sections— 'From Biosimilar Excellence to Next-Gen Innovative Therapeutics' and 'Scaling Our U.S. Presence with a Next-Gen Manufacturing and R&D Hub'—was delivered on the conference's Main Track. Celltrion's Chief Executive Officer Jin-Seok Seo and Senior Executive Vice President Hyuk-Jae Lee outlined the company's innovative drug pipeline, with plans to submit up to 16 investigational new drug (IND) applications by 2028, including up to 10 ADCs, 4 msAbs, 1 recombinant protein, and 1 peptide. In its biosimilar business, Celltrion aims to commercialize up to 18 products by 2030 and 41 products by 2038. The company's ADC candidates are designed to target solid tumor cancers; with IND applications for CT-P70, CT-P71 and CT-P73 accepted by the U.S. Food and Drug Administration (FDA) in 2025. CT-P70, a novel ADC candidate being developed for the treatment of non-small cell lung cancer (NSCLC), recently received Fast Track designation from the U.S. FDA, enabling expedited interactions throughout the development process and the potential for accelerated regulatory review. Celltrion is advancing a portfolio of msAbs that are designed to selectively target cancer cells or are activated only under specific conditions. Celltrion received an IND approval from the U.S. FDA for CT-P72, a tetravalent bispecific antibody being developed to target human epithelial growth factor receptor 2 (HER2) and cluster of differentiation 3 (CD3). "We have made significant progress and see compelling opportunities ahead. Building on our company's global footprint in biosimilar excellence, Celltrion is accelerating its transition toward next-generation innovative therapeutics," said Jin-Seok Seo, Chief Executive Officer at Celltrion. "Our expanding pipeline of ADCs and msAbs, grounded in deep antibody expertise, underscores our commitment to delivering meaningful value to patients worldwide. We aim to redefine the standard of care in oncology and beyond, while creating long-term sustainable value through scientific excellence and bold innovation." To reinforce the company's U.S. manufacturing capabilities, Celltrion recently completed the strategic acquisition of a former Eli Lilly manufacturing facility located in Branchburg, New Jersey, securing 66,000L of drug substance (DS) capacity.  The company plans to sequentially increase capacity to a total of 132,000L by 2030, while also extending its capabilities to include drug product (DP) facilities. Through this acquisition, Celltrion plans to ensure long-term supply chain resilience eliminating the tariff and trade risks, ultimately strengthening its competitiveness in the U.S. market. "The acquisition of the U.S. manufacturing facility represents a pivotal step in strengthening our global supply chain and solidifying our presence in the U.S. market," said Hyuk-Jae Lee, Senior Executive Vice President at Celltrion. "By securing large-scale DS capacity in the U.S., we are enhancing supply stability, mitigating trade and tariff risks, and establishing a solid foundation for expanded R&D collaboration and innovation in the region." About Celltrion, Inc. Celltrion, Inc. is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion, Inc. is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Built on trust through our fully integrated capabilities – from advanced R&D and in-house manufacturing to a reliable global supply network – we continue moving toward innovation as we work to ensure consistent availability of affordable, trusted, and high-quality biosimilars and biologics for patients and healthcare systems across the globe. For more information, please visit our website www.celltrion.com/en-us. and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook. FORWARD-LOOKING STATEMENT Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion, Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", "anticipates", the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion, Inc. and its subsidiaries' management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements. Celltrion, Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. US--26-00001 For further information please contact: Global PR Teamglobalpr@celltrion.com

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 27 加入收藏 :
DNV SUPPORTS NOUL IN IVDR CERTIFICATION FOR AI-BASED MEDICAL DIAGNOSTIC PRODUCTS

SEOUL, South Korea, Jan. 14, 2026 /PRNewswire/ -- DNV, the independent global assurance and risk management provider, is partnering with Korean AI-driven blood and cancer diagnostics company Noul to certify their malaria diagnosis, blood cell morphology and cervical cancer testing solutions, under the European Union's In Vitro Diagnostic Medical Device Regulation (IVDR). The EU's IVDR provides a regulatory basis for establishing the safety and effectiveness of new in-vitro diagnostic (IVD) devices. Most  IVD devices require a certificate of compliance with the IVDR to receive a CE mark that allows their sale in the EU. However, many other countries also recognize the CE mark as sufficient to market IVD devices, making IVDR compliance a gateway to global market access. As an IVDR Notified Body, DNV will carry out certification on three Noul solutions: the miLab™ MAL cartridge for malaria diagnosis, miLab™ BCM cartridge for blood cell analysis and miLab™ CER cartridge for cervical cancer testing. The solutions are based on Noul's innovative miLab™ point-of-care diagnostic platform. Combining integrated sample preparation, digital imaging and AI analysis, the miLab ensures consistently high-quality testing and efficient workflows in any setting – from state-of-the-art urban hospitals to remote rural clinics. "Noul's AI-powered diagnostic lab, miLab™, combines accuracy and efficiency, and healthcare bodies around the world are interested in how miLab can help them deliver better care. Timely certification against appropriate standards is essential to our global expansion plans. Working with DNV's local team of medical device certification experts here in Korea will help us take a big step in those plans," said Taehwan (TH) Kim, Chief Business Officer and Head of Europe Regional Office at Noul. "The world needs innovative diagnostic solutions like Noul's miLab to be delivered to market with full confidence in their safety and accuracy while minimizing unnecessary delays. As one of the top 5 notified bodies globally – and thanks to our global team of auditors, technical assessors and clinicians – DNV offers efficient certification with the flexibility to adjust to manufacturers timelines and business goals," said Cecilie Gudesen Torp, Global Director Medical Services at DNV.

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 206 加入收藏 :
Rakuten Medical and LOTTE Biologics Sign Manufacturing Agreement to Support Biopharmaceuticals in Global Oncology Program

SEOUL, South Korea, Jan. 14, 2026 /PRNewswire/ -- Rakuten Medical, Inc. and LOTTE Biologics today announced that they have signed a biopharmaceutical contract manufacturing agreement during the J.P. Morgan Healthcare Conference in San Francisco to strengthen Rakuten Medical's production capabilities for its innovative oncology therapy, Alluminox® platform-based photoimmunotherapy. Signing ceremony held during the J.P. Morgan Healthcare Conference Under the agreement, LOTTE Biologics will provide advanced manufacturing services for monoclonal antibody intermediates and their conjugates, supporting Rakuten Medical's global clinical development and future commercialization. Rakuten Medical's proprietary photoimmunotherapy technology is designed to selectively target cells in solid tumors, by combining cell-targeting moieties, such as antibodies, with light-activatable agents, enabling focal and selective destruction of solid tumor cells upon light exposure. In Japan, the therapy is approved for recurrent head and neck cancer, and its footprint has expanded steadily, through broader site adoption and sustained year–over–year growth in treatment numbers. In parallel, a global Phase 3 clinical trial is underway in the United States, Taiwan region and Japan, with plans to start treatment in Ukraine and Poland soon. Rakuten Medical also plans to initiate a Phase 1 clinical trial in Japan for other solid tumors beyond head and neck cancer this year. These clinical and commercial dynamics are driving increased demand for Rakuten Medical's bioconjugates. LOTTE Biologics has been expanding its capabilities as a global contract development and manufacturing organization (CDMO), particularly in the field of monoclonal and multispecific antibodies, antibody-drug conjugates (ADCs), and advanced bioconjugation services. LOTTE Biologics will support the production of monoclonal antibody intermediates and their conjugates for Rakuten Medical's programs, through its specialized ADC manufacturing facility at the Syracuse Bio Campus in New York. The facility is equipped with dedicated ADC production capabilities and advanced bioconjugation technologies, enabling the company to deliver high-quality manufacturing services while meeting global regulatory requirements and ensuring stable supply for customers worldwide. About LOTTE Biologics Founded in 2022 and headquartered in Seoul, South Korea, LOTTE Biologics operates integrated biologics facilities in the United States and South Korea. Through a unified Dual Hub Service model, LOTTE Biologics enhances supply security, supports manufacturing scalability, and maintains consistent quality standards across regions. LOTTE Biologics provides modular, phase-appropriate manufacturing solutions spanning preclinical through commercial stages, with proven capability in producing mammalian-cell-based biologics, including monoclonal antibodies, fusion proteins, and multispecific modalities. At the Syracuse Bio Campus in New York, LOTTE Biologics delivers high-quality GMP drug substance manufacturing supported by more than 62 global regulatory approvals. The site offers 40,000 L of total capacity across eight 5,000 L stainless steel bioreactors and includes analytical and warehouse infrastructure. In addition, the company has expanded into Antibody-Drug Conjugates (ADCs) through strategic investment in onsite conjugation suites, enabling a streamlined, end-to-end pathway from biologic drug substance production to ADC manufacturing within a single campus. In South Korea, LOTTE Biologics is constructing three advanced bio plants at the Songdo Bio Campus. With the first facility already underway and scheduled for operation in 2027, each plant will include eight 15,000 L stainless steel bioreactors for commercial production, supported by multiple 3,000 L bioreactors for clinical-scale needs. Collectively, these plants will provide a manufacturing volume exceeding 360,000L in bioreactor capacity. Guided by the vision "Possibilities Beyond Limits," LOTTE Biologics is committed to serving as a long-term, trusted partner, supporting efficient scale-up, dependable manufacturing execution, and the continuous advancement of clients' therapeutic programs. More information about LOTTE Biologics, please visit: www.lottebiologics.com  About Rakuten Medical, Inc. Rakuten Medical, Inc. is a global biotechnology company developing and commercializing its Alluminox® platform-based photoimmunotherapy, which has been shown to induce rapid and selective cell killing. Rakuten Medical's photoimmunotherapy is currently investigational outside Japan. Rakuten Medical is committed to its mission to conquer cancer by developing its pioneering treatments as quickly as possible to as many patients as possible all over the world. The company has offices in five countries/regions, including the United States, where it is headquartered, Japan, Taiwan region, Switzerland and India. For more information, visit www.rakuten-med.com. About the Alluminox® Platform The Alluminox® platform is Rakuten Medical's investigational technology that combines pharmaceuticals, medical devices, medical technology and other peripheral technologies. Rakuten Medical is developing Alluminox platform-based photoimmunotherapy, which involves two key steps: 1) drug administration, and 2) targeted illumination using medical devices. The drug component consists of a cell-targeting moiety conjugated to a light-activatable dye, such as IRDye® 700DX (IR700), that selectively binds to the surface of targeted cells, such as tumor cells. The device component consists of a light source that locally illuminates the targeted cells with red light (690 nm) to transiently activate the drug. Rakuten Medical's preclinical data have shown that this activation elicits rapid and selective necrosis of targeted cells through a biophysical process that compromises the membrane integrity of the targeted cells. Therapies developed on the Alluminox platform may also result in local and systemic innate and adaptive immune activation due to immunogenic cell death of the targeted tumor cells and/or the removal of targeted immunosuppressive cells within the tumor microenvironment. Photoimmunotherapy was originally developed by Dr. Hisataka Kobayashi and his team at the National Cancer Institute in the United States. Outside Japan, Rakuten Medical's Alluminox platform-based photoimmunotherapy is investigational.

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 196 加入收藏 :
ArisGlobal Accelerates Growth and AI Adoption Following Strong 2025 Performance

More than 100 new and expanded LifeSphere customers, 34 global go-lives, and rapid enterprise adoption of NavaX signal strong momentum BOSTON, Jan. 14, 2026 /PRNewswire/ -- ArisGlobal, an AI-first technology company at the forefront of life sciences and creator of LifeSphere® , today announced strong results for 2025, marked by sustained customer growth, successful global implementations, and accelerated adoption of its NavaX AI-powered capabilities. Throughout the year, ArisGlobal helped pharmaceutical and life sciences organizations modernize Safety, Regulatory, and R&D IT operations – moving AI from pilot programs into live, production environments at enterprise scale. Customer Growth & Expansion Demand for AI-enabled modernization continued to rise in 2025 as life sciences organization sought to address growing data volumes, operational complexity, and regulatory pressure. Key highlights include: Over 100 combined net new customers and customer expansions across LifeSphere; 125% year-over-year increase in NavaX customers, driven by enterprise adoption in Safety and Regulatory This growth reflects increasing customer confidence in ArisGlobal's ability to deliver measurable outcomes, with many organizations expanding beyond initial deployments to broader, multi-domain use cases. "Customers are no longer experimenting with AI – they're operationalizing it," said Steve Nuckols, Chief Customer Officer. "What we're seeing is clear momentum: larger deployments, faster expansions, and a growing focus on results like cycle time reduction, consistency, and inspection readiness." Global Implementations and Delivery at Scale In 2025, ArisGlobal completed 38 global go-lives, reinforcing its reputation for delivering complex, enterprise-scale programs: 22 Safety go-lives 11 Regulatory go-lives 5 NavaX go-lives These programs included deployments for three of the world's top 10 pharmaceutical companies, as well as some of the industry's earliest production implementations of advanced AI capabilities. "Our teams operate with the same sense of urgency our customers live with every day," said Raj Hattarki, Chief Operating Officer. "These were complex, global programs, yet we helped customers go live faster without compromising compliance and the foundation needed for long-term success. With NavaX in particular, our focus has been unwavering: accelerating time to value. Every day saved matters, because every day lost is a missed opportunity to create impact for our customers." Product Innovation: From AI Features to Intelligent Orchestration ArisGlobal made significant product advances in 2025, shifting LifeSphere from isolated AI features to a more connected, intelligence-driven operating model. Key launches included: Unify, a data orchestration layer that connects Safety, Regulatory, Quality, and Medical data – providing a shared foundation for cross-domain visibility, reporting, and decision-making; NavaX Insights, which transforms operational and safety data into actionable intelligence through real-time analytics, trend identification, and performance monitoring; NavaX Agents, introducing agentic AI to Safety and Regulatory Today, NavaX supports customers and collectively processes 700,000 cases annually; that number is expected to expand to 2.5 million cases by mid-2026. ArisGlobal's innovation leadership was recognized with the Frost & Sullivan 2025 New Product Innovation Award. The company also continued active participation in the EU AI Pact, reinforcing its commitment to responsible AI in regulated environments. "2025 marked a turning point where AI stopped being theoretical and started delivering results," said Ann-Marie Orange, CIO and Global Head of R&D. "With NavaX and Unify, customers aren't just automating tasks – they're orchestrating data and decisions across the enterprise." Looking Ahead Building on strong momentum in 2025, ArisGlobal enters 2026 focused on scaling enterprise AI adopting and expanding its role as a data intelligence and technology partner to global life sciences organizations. "This year proved what's possible when AI is deployed responsibly and designed for real-world operations," said Aman Wasan, CEO of ArisGlobal. "As AI enters its enterprise phase, our focus is clear: intelligent orchestration, trust by design, and outcomes that matter for patients, regulators, and teams who support them." About ArisGlobal  ArisGlobal, an AI-first technology company and creator of LifeSphere®, is transforming the way today's most successful life sciences companies develop breakthroughs and bring new products to market. Headquartered in the United States, ArisGlobal has regional offices in Europe, India, Japan, and China. For more updates, follow ArisGlobal on LinkedIn or by visiting www.arisglobal.com.  Logo - https://mma.prnasia.com/media2/1510670/ArisGlobal_Logo.jpg?p=medium600 

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 15 日 (星期四) 農曆十一月廿七日
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