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 Celltrion’s monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59) becomes the first authorized COVID-19 treatment approved from the Korean Ministry of Food and Drug Safety (MFDS)
elltrion Group announced that the Korean Ministry of Food and Drug Safety (MFDS) approved regdanvimab (CT-P59), a monoclonal antibody treatment for COVID-19 for the extended use in elderly patients aged 50 years and over, or with at least one underlying medical condition (the obese, cardiovascular disease, chronic lung disease, diabetes, chronic kidney disease, chronic liver disease, and patients with immunosuppressive agents) with mild symptoms of COVID-19, and adult patients with moderate symptoms of COVID-19. This marks the first time a monoclonal antibody treatment for COVID-19 has received a full approval to treat patients with COVID-19 from the Korean MFDS.…　続きを読む
2021年09月18日　PM10:34
2021年09月18日
ENHERTU® Reduced the Risk of Disease Progression or Death by 72% Versus Trastuzumab Emtansine (T-DM1) in Patients with HER2 Positive Metastatic Breast Cancer
etailed positive results from the head-to-head DESTINY-Breast03 phase 3 trial showed that ENHERTU® (trastuzumab deruxtecan), the Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca HER2 directed antibody drug conjugate (ADC), demonstrated superior progression-free survival (PFS) versus trastuzumab emtansine (T-DM1), a HER2 directed ADC currently approved to treat patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane. Results were presented as the first late-breaking presentation (#LBA1) in the ESMO Presidential Symposium at the European Society for Medical Oncology (#ESMO21) 2021 Virtual Congress.…　続きを読む
2021年09月18日
ENHERTU® Demonstrated Clinically Meaningful and Durable Response in Patients with HER2 Positive Advanced Gastric Cancer in DESTINY-Gastric02 Phase 2 Trial
etailed results from the positive DESTINY-Gastric02 phase 2 trial showed that ENHERTU® (trastuzumab deruxtecan), the Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca HER2 directed antibody drug conjugate (ADC), provided a clinically meaningful and durable tumor response in patients with HER2 positive metastatic and/or unresectable gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with a trastuzumab-containing regimen. Results were presented during a late-breaking Mini Oral presentation at the European Society for Medical Oncology (#ESMO21) 2021 Virtual Congress (#LBA55).…　続きを読む
2021年09月18日
武田的EXKIVITY™ (mobocertinib)成为美国FDA首次核准的专为EGFR外显子20插入+ NSCLC患者设计的口服治疗药物
武田药品工业株式会社(Takeda Pharmaceutical Company Limited, TSE:4502/NYSE:TAK)（简称“武田”）今天宣布，美国食品药品管理局(FDA)已核准EXKIVITY (mobocertinib)用于治疗含铂化疗期间或之后疾病进展的伴表皮生长因子受体(EGFR)外显子20插入突变（经FDA核准的检测检出）的局部晚期或转移性非小细胞肺癌(NSCLC)成人患者。EXKIVITY获得FDA优先审理，并获得突破性疗法认定、快速通道审评资格认定和孤儿药资格认定，是首个也是唯一获批的专为EGFR外显子20插入突变设计的口服治疗药物。该适应证获批的依据是总缓解率(ORR)和DoR，走加速审批流程。该适应证的持续核准或取决于验证性试验对临床收益的验证和描述。…　続きを読む
2021年09月17日
Masimo上市单例患者使用的rainbow® SuperSensor™
Masimo (NASDAQ: MASI)今天宣布，单例患者使用的粘贴式rainbow® SuperSensor™获得CE认证并在欧洲上市，该产品兼容Masimo和内置Masimo rainbow®技术的第三方监护仪。全面、便捷的多功能SuperSensor属业界首创，采用12枚LED无创连续同步提供12种血液成分参数：SET®氧饱和度(SpO2)、总血红蛋白(SpHb®)、碳氧血红蛋白(SpCO®)、高铁血红蛋白(SpMet®)、氧储备指数(ORi™)、PVi®、RPVi™、脉率(PR)、呼吸率(RRp®)、灌注指数(Pi)、氧饱和度分数(SpfO2™)和氧含量(SpOC™)——全部集成于同一枚单例患者使用的粘贴式传感器。SuperSensor提供连续评估患者状态的功能，让临床工作者能够无创连续同步监测众多不同的生理指标。…　続きを読む

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