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SAN CARLOS, Californie--(BUSINESS WIRE)--BeOne Medicines Ltd. (Nasdaq : ONC ; HKEX : 06160 ; SSE : 688235), une société internationale spécialisée dans l’oncologie, a annoncé aujourd’hui que la Commission européenne (CE) a approuvé TEVIMBRA (tislelizumab), en association avec une chimiothérapie à base de platine en tant que traitement néoadjuvant suivi d’une monothérapie par TEVIMBRA en tant que traitement adjuvant, pour les patients adultes atteints d’un cancer du poumon non à petites cellules...

SAN CARLOS, Kalifornien, USA--(BUSINESS WIRE)--BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), ein globales Onkologieunternehmen, teilte heute mit, dass die Europäische Kommission die Kombinationstherapie mit TEVIMBRA (Tislelizumab) und einer platinhaltigen Chemotherapie als neoadjuvante Behandlung, gefolgt von einer Monotherapie mit TEVIMBRA als adjuvante Behandlung, bei erwachsenen Patienten mit resektablem, nicht-kleinzelligem Lungenkrebs (NSCLC) und hohem Rezidivrisiko zugelas...

澳洲雪梨--(BUSINESS WIRE)--(美國商業資訊)-- Novotech作為一家可提供全方位服務的國際性受託研究機構 (CRO)，很榮幸能助力正大天晴藥業集團，推動Anlotinib鹽酸鹽膠囊獲准新增適應症，作為不可切除的局部晚期或轉移性軟組織肉瘤 (STS) 的第一線治療，與化療合併使用。這是Anlotinib在中國獲准的第九項適應症，也是正式核准Anlotinib合併化療用於晚期或轉移性STS第一線治療。 此前，Anlotinib已被中國臨床腫瘤學會 (CSCO) 指引推薦為軟組織肉瘤的第二線單方療法。此次新增適應症，對於此前未接受過全身治療的患者而言意義重大，為他們提供了新的第一線治療選擇。 在此過程中，Novotech提供了一套全面且符合監管要求的生物統計服務，涵蓋試驗計畫書審核與設計、統計分析計畫、CDISC資料集產生以及資料庫鎖定後的表格、圖表和清單 (TFL) 輸出等。這些舉措提高了資料的透明度，增強了結果的解讀性，為新藥申請 (NDA) 的成功申報發揮了重要作用。 Novotech擁有經驗豐富的資深生物統計學家和程式設計人員，提供從試驗計畫書設計、統計諮詢到...

澳大利亚悉尼--(BUSINESS WIRE)--(美国商业资讯)-- Novotech（诺为泰）作为一家可提供全方位服务的国际性临床合同研究组织 (CRO)，很荣幸能助力正大天晴的1类新药安罗替尼又一新适应症近期获批，联合化疗用于既往未接受过系统性治疗的不可切除局部晚期或转移性软组织肉瘤患者的一线治疗。这是盐酸安罗替尼胶囊在中国获批的第九个适应症，也标志着全球首个联合化疗的组合疗法正式获批用于晚期或转移性软组织肉瘤的一线治疗。此前，安罗替尼单药已被中国临床肿瘤学会（CSCO）指南推荐用于二线晚期或转移性软组织肉瘤治疗，且为唯一I级推荐的靶向治疗药物。（来源：正大天晴药业集团） 在这一重大研发项目中， Novotech（诺为泰）通过提供全面，高质量，监管机构认可的方案审阅设计，统计分析计划，CDISC数据集以及锁库后的TFL（Tables, Figures, and Listings）报告等统计编程服务，提升了临床数据的透明度并简化了数据解读，为该药物的NDA递交工作提供了有力支持，从而为患者带来了新的治疗希望。 诺为泰拥有经验丰富的生物统计学家和统计程序员团队，提供包括方案设计，统计...

BEDFORD, Mass.--(BUSINESS WIRE)--Stoke Therapeutics, Inc. (Nasdaq: STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine and has a lead investigational medicine, zorevunersen, in development as a first-in-class potential disease-modifying treatment for Dravet syndrome. The Company today announced that Interim Chief Executive Officer Ian F. Smith will present at the following upcoming investor conferences: Cantor Global He...

SYDNEY--(BUSINESS WIRE)--Novotech, a globally recognized full-service clinical research organization (CRO), is proud to have partnered with Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ Pharma) in achieving a significant regulatory milestone: the approval of Anlotinib Hydrochloride Capsules for a new indication as a first-line treatment for unresectable locally advanced or metastatic soft tissue sarcoma (STS) in combination with chemotherapy. This approval marks the ninth indication fo...

SAN DIEGO--(BUSINESS WIRE)--Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical-stage biopharmaceutical company pioneering differentiated therapies for the treatment of neuroscience, inflammation and immunology (NI&I) indications, today announced that management is scheduled to present at the following investor conferences in September. Cantor Global Healthcare Conference 2025 – fireside chat on Thursday, September 4, 2025, at 9:10 a.m. ET. Morgan Stanley 23rd...

DUBLIN--(BUSINESS WIRE)--Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, today announced that members of its senior management team will participate in a fireside chat at the Cantor Fitzgerald Global Healthcare Conference on Thursday, September 4, 2025 at 10:55 a.m. ET in New York, NY. A live webcast of the fireside chat can be accessed through the investor relati...

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases, today announced that Chris Kirk, Chief Executive Officer and Co-founder, will participate in two upcoming investor conferences taking place in September: Event: 2025 Wells Fargo Healthcare Conference Location: Boston, MA Date/Time: Friday, September 5, 2025, at 11:00 am ET Form...

IRVINE, Calif.--(BUSINESS WIRE)--Dr. Young brings an extraordinary depth of experience in vaccine science, immunology, and pharmaceutical development, with more than 40 years of leadership across academia, government initiatives, and the biotechnology industry. He has been a driving force in advancing vaccine innovation, regulatory strategy, and global health impact. He was involved in the Operation Warp Speed effort, the U.S. government’s coordinated initiative to accelerate the development, m...