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Business Wire Health: Clinical Trials News

Get the latest updates from Business Wire Health: Clinical Trials News directly as they happen.

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Last updated about 9 hours ago

Europäische Kommission genehmigt TEVIMBRA® zur neoadjuvanten/adjuvanten Behandlung von NSCLC vor Präsentation von Late-Breaking-Daten bei der WCLC 2025

about 9 hours ago

SAN CARLOS, Kalifornien, USA--(BUSINESS WIRE)--BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE...

诺为泰助力安罗替尼新适应症获批,见证肿瘤治疗新突破

about 10 hours ago

澳大利亚悉尼--(BUSINESS WIRE)-- #AnlotinibHydrochlorideCapsules--(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

Novotech助力Anlotinib併用療法獲准用於晚期軟組織肉瘤治療,見證腫瘤治療新突破

about 10 hours ago

澳洲雪梨--(BUSINESS WIRE)-- #AnlotinibHydrochlorideCapsules--(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)...

Stoke Therapeutics to Present at Upcoming Investor Conferences in September 2025

about 10 hours ago

BEDFORD, Mass.--(BUSINESS WIRE)--Stoke Therapeutics, Inc. (Nasdaq: STOK) is a biotechnology company dedicated...

Novotech Supports Groundbreaking Approval of Anlotinib Combination Therapy for Advanced Soft Tissue Sarcoma

about 10 hours ago

SYDNEY--(BUSINESS WIRE)-- #AnlotinibHydrochlorideCapsules--Novotech, a globally recognized full-service clinical research organization (CRO), is...

Kezar Life Sciences to Participate in Two Upcoming Investor Conferences

about 10 hours ago

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage...

Prothena to Participate in the Cantor Fitzgerald Global Healthcare Conference

about 10 hours ago

DUBLIN--(BUSINESS WIRE)---- $PRTA #Prothena--Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company...

Contineum Therapeutics to Present at September Investor Conferences

about 10 hours ago

SAN DIEGO--(BUSINESS WIRE)--Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a...

James F. Young, Ph.D. Appointed Executive Chairman of TechImmune

about 17 hours ago

IRVINE, Calif.--(BUSINESS WIRE)--Dr. Young brings an extraordinary depth of experience in vaccine...

TNF Pharmaceuticals Announces Reverse Stock Split For Nasdaq Listing Compliance

about 17 hours ago

NEW YORK--(BUSINESS WIRE)---- $TNFA--TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNF” or the “Company”)...

Massive Bio Launches Oracle Cerner App to Simplify Patient Records and Speed Up Clinical Trial Matching

about 18 hours ago

BOCA RATON, Fla.--(BUSINESS WIRE)--Massive Bio, a leader in AI-powered oncology clinical trial...