Roche (RHHBY) announced positive results from the late-stage STARGLO on the blood cancer drug Columvi (glofitamab). The STARGLO study is a phase III, multicentre, open-label, randomized study evaluating the efficacy and safety of Columvi, in combination with gemcitabine plus oxaliplatin (GemOx), versus MabThera/Rituxan (rituximab), in combination with GemOx (R-GemOx), in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of therapy and ...

Clinical trial to test recent findings that show LIXTE's lead clinical compound, LB-100, increases recognition of colon cancer cells by the immune system PASADENA, CA, June 14, 2024 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. ("LIXTE" or the "Company") (NASDAQ:LIXT), a clinical stage pharmaceutical company, today announced a collaboration with Roche and the Netherlands Cancer Institute (NKI) to conduct a new clinical trial in immune therapy unresponsive (MSI Low) metastatic colon cancer. As part ...

Roche (RHHBY) obtains the European Commission’s (EC) approval for Alecensa (alectinib) monotherapy, as adjuvant treatment following tumor resection for adult patients with anaplastic lymphoma kinase (ALK)- positive non-small cell lung cancer (NSCLC) at high risk of recurrence. Approximately half of all patients with early-stage NSCLC experience disease recurrence following surgery, despite adjuvant chemotherapy. Hence, Alecensa can now address this patient population. Please note that Alecensa is already ap ...

Dublin, June 10, 2024 (GLOBE NEWSWIRE) -- The "Roche Diagnostics International Ltd - Product Pipeline Analysis, 2024 Update" company profile has been added to ResearchAndMarkets.com's offering. This report is a source for data, analysis, and actionable intelligence on the company's portfolio of pipeline products. The report provides key information about the company, its major products and brands. The report enhances decision making capabilities and help to create effective counter strategies to gain compet ...

The test uses highly sensitive PCR technology, requiring only a single nasal-swab sample to provide rapid, accurate qualitative detection and differentiation among four of the most prevalent respiratory viruses for which differential diagnosis can drive appropriate treatment. Enables healthcare professionals to make confident clinical decisions and promptly determine appropriate treatment, with definitive results reported in just 20 minutes. Expands Roche’s extensive molecular point of care testing portfoli ...

文章核心观点 - 欧洲委员会批准罗氏公司的Alecensa作为ALK阳性早期肺癌患者的首个和唯一的靶向辅助治疗药物 [1] - Alecensa在ALK阳性切除非小细胞肺癌患者中将疾病复发或死亡风险降低76%,这是前所未有的 [1] - Alecensa的批准填补了早期肺癌治疗的重大未满足需求,因为约一半的患者在手术后仍会复发,即使接受了辅助化疗 [1][6] - 早期诊断和治疗肺癌可以减轻疾病进展带来的负担,为患者提供最佳治愈机会 [6] 公司相关 - 罗氏公司是全球最大的生物技术公司和体外诊断行业的领导者,致力于开发改善和拯救全球人民生命的创新药物和诊断产品 [8][9] - 肺癌是罗氏的重点关注领域和投资方向,公司致力于开发新的治疗方法、药物和检测手段,为每一位肺癌患者提供有效的治疗选择 [7] - Alecensa已在100多个国家获批用于晚期ALK阳性非小细胞肺癌的一线和二线治疗,已有超过94,000名晚期患者接受过Alecensa治疗 [2] 行业相关 - 肺癌是全球主要的癌症死因之一,每年有180万人死于此病,相当于每天有4,900人死于肺癌 [6] - 非小细胞肺癌占所有肺癌病例的约85% [6] - 即使接受手术和辅助化疗,约一半的早期肺癌患者仍会复发 [6] - 国际指南建议在早期和晚期非小细胞肺癌患者中常规检测ALK、EGFR和PD-L1生物标志物,以支持临床决策 [3]

After five years of treatment, 91% of children were alive — without treatment, children with Type 1 SMA would not be expected to live past two years of age 96% of Evrysdi-treated children could swallow, 80% could feed without a feeding tube and 59% could sit without support for at least 30 seconds Evrysdi is now approved in more than 100 countries with over 15,000 patients treated globally Basel, 07 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new five-year data confirming the sustained ef ...

Roche Holding AG (RHHBY) announced that the FDA has accepted its new drug application (NDA) seeking approval for its investigational oral therapy inavolisib for treating adult patients with breast cancer. The NDA is seeking approval for inavolisib in combination with Pfizer’s (PFE) Ibrance (palbociclib) and AstraZeneca’s (AZN) Faslodex (fulvestrant) to treat adult patients with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER)-negative, locally advanced/metastati ...

Priority Review recognises the best-in-class potential of the inavolisib-based regimen for patients in urgent need of new treatment options1,2 Additional analyses of INAVO120 will be presented in an oral abstract session at the 2024 American Society of Clinical Oncology Annual Meeting The target action date for the FDA decision is 27 November, 2024 Basel, 29 May 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Appl ...

文章核心观点 - 罗氏和日立高新科技宣布延长双方合作关系,将继续在体外诊断领域开展为期至少10年的合作[1][3] - 双方将通过结合各自在诊断创新、工程和制造方面的专业知识和往绩,推动行业变革性创新,为全球客户和患者提供新的解决方案[1][2] - 即将推出的新产品cobas® c703、ISE neo和cobas® Mass Spec solution体现了双方持续创新的决心[5] - 这次合作的重点是进一步加强双方的伙伴关系,为患者带来持续的变革性创新[3] 公司概况 - 罗氏成立于1896年,总部位于瑞士巴塞尔,是全球最大的生物技术公司和体外诊断行业的领导者[10] - 罗氏致力于通过科学卓越来发现和开发改善和拯救全球人民生命的药物和诊断产品[10] - 罗氏是个性化医疗的先驱,希望进一步改变医疗服务的交付方式,产生更大的影响[10] - 罗氏连续13年被道琼斯可持续发展指数评为制药行业最可持续公司之一,反映了其与当地合作伙伴共同提高医疗可及性的努力[11] 合作历史 - 罗氏和日立高新科技自1978年起就开始合作,致力于为需要的人带来创新的新诊断产品[7] - 双方合作已经在全球范围内安装了超过84,000台诊断设备,覆盖面广且影响力大[7] - 双方合作推出了多项体外诊断领域的创新,包括集成临床化学、电解质和免疫化学的"血清工作区"概念[8] - 双方还致力于提高诊断领域的可持续性,新一代系统可将塑料废弃物减少高达80%[8]