Roche, in collaboration with KlinRisk, Inc, has received CE-mark for the first AI-based risk stratification tool for assessment of progressive decline in kidney function.This tool will be launched as part of Roche’s new chronic kidney disease (CKD) algorithm panel to support care across the stages of the disease which affects 700 million people globally.Clinicians can use the CKD panel (Kidney Klinrisk Algorithm and Kidney KFRE Algorithm) to evaluate a patient’s risk of kidney function decline, including in ...

Roche, in collaboration with KlinRisk, Inc, has received CE-mark for the first AI-based risk stratification tool for assessment of progressive decline in kidney function.This tool will be launched as part of Roche’s new chronic kidney disease (CKD) algorithm panel to support care across the stages of the disease which affects 700 million people globally.Clinicians can use the CKD panel (Kidney Klinrisk Algorithm and Kidney KFRE Algorithm) to evaluate a patient’s risk of kidney function decline, including in ...

Core Insights - Roche announced FDA approval for Tecentriq® and Tecentriq Hybreza® in combination with lurbinectedin for maintenance treatment of extensive-stage small cell lung cancer (ES-SCLC) [1][3] - This marks the first and only combination therapy approved for first-line maintenance treatment of ES-SCLC, addressing a significant unmet need in a highly aggressive disease [1][3] - The approval is based on the phase III IMforte study, demonstrating a 46% reduction in the risk of disease progression or death and a 27% reduction in the risk of death compared to Tecentriq alone [1][2] FDA Approval Details - The FDA approved the combination therapy for adult patients with ES-SCLC whose disease has not progressed after first-line induction therapy [1] - The National Comprehensive Cancer Network (NCCN) has updated its guidelines to include this regimen as a category 2A preferred option for maintenance treatment [1][3] Study Findings - The IMforte study involved 660 patients in the induction phase, with 483 patients randomized for maintenance therapy [2] - Median overall survival for the combination therapy was 13.2 months compared to 10.6 months for Tecentriq alone, with a stratified hazard ratio of 0.73 [1][2] - Median progression-free survival was 5.4 months for the combination versus 2.1 months for Tecentriq alone, with a stratified hazard ratio of 0.54 [1][2] Company Commitment - Roche emphasizes its commitment to improving outcomes in difficult-to-treat cancers through innovative therapies [1][3] - The company has a history of developing treatments for aggressive cancer types, including various formulations of Tecentriq [5]

Core Viewpoint - Roche's Tecentriq and Tecentriq Hybreza have received FDA approval for maintenance treatment in extensive-stage small cell lung cancer (ES-SCLC), marking a significant advancement in treatment options for this aggressive disease [1][2]. Group 1: FDA Approval and Treatment Significance - The FDA approved Tecentriq and Tecentriq Hybreza in combination with lurbinectedin for adult patients with ES-SCLC whose disease has not progressed after first-line induction therapy [1]. - This approval represents the first and only combination therapy for first-line maintenance treatment of ES-SCLC, addressing a critical need in a disease with limited treatment options [1][6]. - The National Comprehensive Cancer Network (NCCN) has updated its guidelines to include this regimen as a category 2A preferred option for maintenance treatment [1]. Group 2: Clinical Study Results - The approval is based on the phase III IMforte study, which demonstrated that the combination therapy reduced the risk of disease progression or death by 46% and the risk of death by 27% compared to Tecentriq alone [2][4]. - The median overall survival for the combination therapy was 13.2 months, compared to 10.6 months for Tecentriq alone, with a stratified hazard ratio of 0.73 [2][4]. - Median progression-free survival was 5.4 months for the combination versus 2.1 months for Tecentriq alone, with a stratified hazard ratio of 0.54 [2][4]. Group 3: Background and Previous Approvals - Tecentriq was previously approved in 2019 in combination with chemotherapy for first-line treatment of adults with ES-SCLC, based on the IMpower133 study [3]. - The IMforte study enrolled 660 patients in the induction phase and randomized 483 patients in the maintenance phase, focusing on the efficacy and safety of the combination therapy [4][5].

Core Points - Dr. Claudia Süssmuth Dyckerhoff will not seek re-election to Roche's Board of Directors in 2026 and will be nominated for another healthcare company board [1] - Dr. Süssmuth Dyckerhoff has been a board member since March 2016 and has made significant contributions to Roche's success, particularly in understanding international market dynamics [2] Company Overview - Roche, founded in 1896 in Basel, Switzerland, is the world's largest biotechnology company and a leader in in-vitro diagnostics [2] - The company focuses on developing innovative medicines and diagnostics to improve global health and is a pioneer in personalized healthcare [2][3] - Roche is committed to sustainability and aims to achieve net zero by 2045 through initiatives like the Science Based Targets initiative [3]

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) in combination with lurbinectedin (Zepzelca®) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy wit. ...

Core Viewpoint - Roche has initiated a tender offer to acquire all outstanding shares of 89bio, Inc. at a price of $14.50 per share, along with a contingent value right (CVR) for potential milestone payments totaling up to $6.00 per share in cash, as part of a merger agreement announced on September 17, 2025 [1][3]. Tender Offer Details - The tender offer will expire on October 29, 2025, unless extended [2]. - Roche has filed a tender offer statement with the SEC, and Bluefin Merger Subsidiary, Inc. is the acquirer in this offer [2]. - 89bio's board of directors has unanimously recommended that stockholders tender their shares in the offer [3]. Conditions and Next Steps - The closing of the tender offer is subject to customary conditions, including regulatory approvals and a majority of shares being tendered [3]. - If the tender offer is successful, any remaining shares will be acquired in a second-step merger at the same price of $14.50 per share, plus the CVR [3]. - The transaction is expected to close in the fourth quarter of 2025 [3]. Company Background - 89bio is a clinical-stage biopharmaceutical company focused on developing therapies for liver and cardiometabolic diseases, currently in Phase 3 trials for its lead candidate, pegozafermin [6]. - Roche, founded in 1896, is the world's largest biotechnology company and a leader in in-vitro diagnostics, committed to scientific excellence and personalized healthcare [7].

(Reuters) -Global drugmakers are scrambling to shore up their U.S. manufacturing capacity and domestic inventory as the Trump administration moves ahead with a 100% tariff on imported branded and patented drugs, starting October 1. The sweeping measure has triggered a flurry of activity across the industry, including fast-tracking U.S. manufacturing projects, price cuts and direct-to-consumer sales. Here's what drugmakers are doing to mitigate supply-chain risks and reassure investors: Pfizer Pfizer re ...

Core Insights - Roche announced primary results from the TSIX Study Program, demonstrating the effectiveness of its sixth-generation high-sensitivity Troponin T test for diagnosing heart attacks, which enhances patient triage in emergency departments [1][3][7] Company Overview - Roche has a 30-year legacy in troponin innovation and was the first to introduce high-sensitivity troponin tests, with the new test being the first in a series of anticipated approvals aimed at improving coronary artery disease management [4][9] - The company aims to standardize care globally, as evidenced by the comprehensive TSIX study program involving over 13,000 participants across multiple countries [5][7] Study Findings - The TSIX study program established standard upper reference limits for troponin levels, with a 99th percentile URL of 27 ng/L for the overall population, and sex-specific URLs of 18 ng/L for females and 32 ng/L for males, confirming the test's accuracy [6][8] - The study demonstrated a negative predictive value of 99.7%, allowing 56.6% of patients to be discharged shortly after presentation, highlighting the test's clinical performance [8] Industry Context - Chest pain is a leading cause of emergency care visits, with only 10% of patients actually experiencing a heart attack, emphasizing the need for reliable diagnostic tools to alleviate pressure on healthcare services [2][3] - The ability to quickly identify acute myocardial infarction is crucial for effective resource allocation in overcrowded emergency departments, which frequently report overcrowding [2][6]

今年荣获"上海市荣誉市民"称号的李曦萌是中国丹麦商会全国创始会长及特雷通集团创始人兼首席 执行官，为促进中丹经贸领域的交流合作、推动上海发展和对外友好交往作出卓越贡献。施万是罗氏集 团董事会主席，他长期关注中国和上海的发展，推动罗氏上海创新中心、罗氏中国加速器项目在沪落 地，于2009年起连续16年参加上海市市长国际企业家咨询会议，并于2024年起担任会议主席。 此次荣获"白玉兰荣誉奖"的28位外籍人士来自美国、英国、法国、德国、澳大利亚、荷兰、新加 坡、日本等国家，在经贸、金融、科技、航运、医疗、教育、文化等领域为上海经济社会发展作出了突 出贡献。他们是：埃里克·科尼埃尔、安南、戴光辉、德里克·迪恩、范睿思、福斯特、葛思越、古睿 智、顾宇韶、贺朗瑞纳、菅匡彦、简思华、杰夫、康思大、柯曼、孔康瑞、朗智文、楼剑锋、马溯·斯 特贝尔、米歇尔·欧斯莱、诺伯特、彭振科、申安迪、肖松、谢伟博、杨葆焱、虞晶怡、约根·博乐。 记者 吴頔 洪俊杰 上海市政府昨天举行2025年"上海市荣誉市民""白玉兰荣誉奖"颁授仪式。丹麦籍人士李曦萌、瑞士 籍人士施万获"上海市荣誉市民"称号，法国籍人士埃里克·科尼埃尔等28人获"白玉兰荣誉 ...