文章核心观点 - 欧洲药品管理局(EMA)委员会(CHMP)对Roche公司的新药PiaSky(crovalimab)给出了积极的评价,建议批准其用于治疗成人和青少年(12岁及以上,体重40kg及以上)的阵发性睡眠性血红蛋白尿症(PNH)[1][3] - 如果获批,PiaSky将成为欧盟首个用于PNH的每月皮下注射(SC)治疗,并可选择自我注射,为患者提供一种替代现有静脉注射(IV)C5抑制剂的选择,有助于减轻治疗负担[1][2] - PiaSky的推荐是基于COMMODORE 2研究结果,每4周给予SC PiaSky可实现与每2周给予静脉注射依鲁单抗相当的疾病控制和安全性[3][9] 公司相关 - Roche是全球最大的生物技术公司和体外诊断领域的全球领导者,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[5][6] - Roche正在开展广泛的PiaSky临床开发计划,包括5项正在进行的III期临床试验和3项早期临床试验,涉及补体介导性疾病,如PNH、非典型溶血性尿毒综合征和镰状细胞病[3][9][13][14][16][17][18][20][21] 行业相关 - PNH是一种罕见且危及生命的血液疾病,全球约有20,000人患有该病,C5抑制剂已被证明在治疗PNH方面有效[3][4][5][11] - PiaSky是一种新型C5抑制剂,可在体内循环利用,使药物能够多次结合和抑制C5蛋白,从而实现每4周一次的皮下给药,这为PNH患者和照顾者提供了更多日常生活自由[3][4]

The World Health Organization (WHO) has awarded Roche's human papillomavirus (HPV) test prequalification designations for use on the cobas 5800 System and for self-collected samples on the cobas 5800, 6800 and 8800 Systems. These designations build upon last June's WHO prequalification that included the cobas HPV test for use on the cobas 6800 and 8800 Systems. WHO prequalification enables low- and middle-income countries (LMICs) to use Roche HPV screening solutions, including self-collection, in their nati ...

Roche (RHHBY) announced that the European Commission has granted marketing authorization to the subcutaneous (SC) formulation of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) drug Ocrevus (ocrelizumab). The approval is based on pivotal data from the late-stage OCARINA II trial, which showed non-inferior levels of the drug in the blood when administered subcutaneously, and a safety and efficacy profile comparable to the intravenous (IV) formulation in patients with RMS ...

OCREVUS® subcutaneous (SC) injection offers a new 10-minute administration with comparable efficacy and safety to intravenous (IV) infusion Provides an additional treatment option without the need for IV facilities, expanding accessibility for patients SAN DIEGO, June 25, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Roche received European Commission (EC) marketing authorization of OCREVUS® (ocrelizumab) SC co-formulated with ENHANZE®, Halozyme's propriet ...

文章核心观点 - 欧洲委员会批准OCREVUS皮下注射剂,为多发性硬化症患者提供了一种新的10分钟给药方式,与静脉输注具有可比的疗效和安全性 [1][2][3] - OCREVUS皮下注射剂为患者提供了一种无需静脉输注设施的新治疗选择,扩大了患者的可及性 [1][2][3] - 罗氏正在与欧洲各国卫生系统密切合作,尽快让多发性硬化症患者获得OCREVUS皮下注射剂 [1] 关于OCREVUS SC - OCREVUS SC是将OCREVUS与Halozyme Therapeutics的ENHANZE®给药技术结合而成 [4][6] - ENHANZE®技术可以暂时降解皮下组织中的透明质酸,增加皮下组织的渗透性,使OCREVUS能够快速分散和吸收进入血液 [6] - OCREVUS是首个获批治疗复发性多发性硬化症(RMS)和原发性进行性多发性硬化症(PPMS)的药物 [7] OCARINA II临床试验 - OCARINA II是一项III期全球多中心随机对照试验,评估OCREVUS皮下注射剂与静脉输注剂在药代动力学、安全性和疗效方面的比较 [8][9] - 该试验达到了主要和次要终点,结果显示皮下注射剂与静脉输注剂在OCREVUS血药浓度、临床(复发)和影像学(MRI病灶)疾病活动控制方面具有可比性 [9] - OCREVUS皮下注射剂的安全性与静脉输注剂一致 [9] 多发性硬化症概况 - 多发性硬化症是一种慢性疾病,全球影响超过290万人 [10] - 多发性硬化症是年轻成人非创伤性残疾的主要原因,大多数患者在20-40岁发病 [10] - 所有类型的多发性硬化症患者从发病初期就会出现神经元永久性损害和疾病进展,延迟诊断和治疗会对患者的身心健康和社会经济造成负面影响 [11][12] - 复发缓解型多发性硬化症(RRMS)是最常见的类型,约占85%,大部分最终会转为继发进行型 [12] - 原发进行型多发性硬化症(PPMS)是一种严重的类型,约占15%,在OCREVUS获批前一直没有获批的治疗方法 [12] 罗氏在神经科学领域 - 神经科学是罗氏研发的重点领域,公司正在研究超过12种治疗神经系统疾病的药物 [13][14] - 罗氏致力于推动科学理解的边界,解决神经科学领域最棘手的挑战 [14] - 罗氏被连续15年评为制药行业最可持续公司之一,反映了公司在提高医疗可及性方面的努力 [16]

06 February 2024, Baden-Württemberg, Mannheim: Claudia Fleischer, Managing Director of Roche ... [+] Diagnostics GmbH, stands on a staircase at Roche Pharma's annual press conference. The business results for 2023, the development of employee numbers and Roche's investments in Germany are presented. Photo: Uwe Anspach/dpa (Photo by Uwe Anspach/picture alliance via Getty Images) dpa/picture alliance via Getty Images The stock price of Roche (OTCMKTS: RHHBY) trades at $35 per share, about 33% below its peak l ...

The cobas® c 703 and cobas® ISE neo analytical units, deliver higher testing capacity and increased automation helping to improve laboratory workflows and advance patient care. The new cobas c 703 analytical unit offers industry-leading high throughput clinical chemistry testing1 with up to 2,000 tests per hour and 70 reagent positions, doubling the existing clinical chemistry throughput on cobas pro integrated solutions. The new cobas ISE neo analytical unit delivers more efficient ISE testing, reducing ha ...

文章核心观点 - 该公司推出了首个获得临床批准的高灵敏度原位杂交(ISH)检测试剂盒,可以帮助鉴别B细胞恶性肿瘤和正常免疫反应 [1][2][3][4] - 该检测试剂盒可以评估60多种B细胞淋巴瘤亚型和浆细胞肿瘤,并可以使用小样本和固定组织,减少额外活检的需求 [4] - 这是该公司业内领先的血液病理学产品组合的重要补充 [5] 行业概况 - B细胞淋巴瘤占非霍奇金淋巴瘤(NHL)约85%,NHL是全球第10常见的癌症,每年有超过25万人死于此病 [2] - 在NHL早期,患者可能出现淋巴结肿大、发烧、疲劳、食欲下降或红疹等症状 [2] 公司概况 - 该公司成立于1896年,是世界最大的生物技术公司和体外诊断领域的全球领导者 [6] - 该公司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 [6] - 该公司连续15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努力改善医疗可及性的努力 [7] - 该公司在美国的子公司Genentech是其全资成员,在日本的Chugai Pharmaceutical是其控股公司 [8]

Swiss pharma giant Roche Holdings (RHHBY) entered into a research collaboration and licensing agreement with a biotechnology company, Ascidian Therapeutics, for the discovery and development of RNA exon editing therapeutics targeting neurological diseases. Ascidian’s exon editing technology is designed to provide the durability of gene therapy by rewriting RNA, while sharply reducing the risks associated with direct DNA editing and gene replacement. This approach has the potential to treat patients with one ...

The solution, which includes the VENTANA DP 200 slide scanner, Roche's digital pathology workflow software and a display, is now cleared to aid in clinical diagnosis, enabling pathologists to diagnose patients using digital images. Primary diagnosis for digital pathology enhances healthcare efficiency and helps ensure effective and timely patient care, especially in areas where access to pathologists is limited. This clearance is a foundational step in Roche's commitment to enable routine clinical diagnosis ...