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爱科百发宣布呼吸道合胞病毒新药爱司韦®的上市许可申请获国家药品监督管理局正式受理并纳入优先审评审批程序
December 08, 2022 20:00 ET | Shanghai Ark Biopharmaceutical Co., Ltd.
中国上海, Dec. 09, 2022 (GLOBE NEWSWIRE) -- 上海爱科百发生物医药技术股份有限公司(以下简称“ 爱科百发”),一家致力于儿科及呼吸疾病领域创新药研发的生物制药企业,今日宣布中国国家药品监督管理局正式受理治疗呼吸道合胞病毒(RSV)感染新药爱司韦®(通用名:齐瑞索韦/ziresovir)的上市许可申请(NDA),并且纳入“优先审评审批”程序。 ...
Statement on the Pediatric Surge From Federally Funded Pediatric Groups
November 09, 2022 09:00 ET | Pediatric Pandemic Network
NEW HAVEN, Conn., Nov. 09, 2022 (GLOBE NEWSWIRE) -- Amid the wave of severe respiratory illnesses among children that is pushing hospitals past capacity, multiple federally funded programs - the...
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Ark Biopharmaceutical Presents Positive Results in Phase 3 AIRFLO Study of Ziresovir in RSV-Infected Hospitalized Infants at 12th International RSV Symposium
October 06, 2022 23:39 ET | Shanghai Ark Biopharmaceutical Co., Ltd.
SHANGHAI, China, Oct. 07, 2022 (GLOBE NEWSWIRE) -- Results from Shanghai Ark Biopharmaceutical Co., Ltd. (Ark Biopharmaceutical)’s successful Phase 3 study (AIRFLO) with the respiratory syncytial...
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Icosavax Reports Second Quarter 2022 Financial Results and Provides Corporate Update
August 15, 2022 16:05 ET | Icosavax, Inc.
– Announced positive topline interim Phase 1/1b results for VLP vaccine candidate IVX-121 against respiratory syncytial virus (RSV) - – Icosavax plans to file an IND and initiate a Phase 1 trial...
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爱科百发宣布爱司韦™在治疗呼吸道合胞病毒(RSV)感染的住院婴幼儿中的临床三期试验达到主要终点
April 07, 2022 03:50 ET | Shanghai Ark Biopharmaceutical Co., Ltd.
在临床三期AirFLO试验中,爱司韦™与安慰剂相比显著降低症状评分(p=0.002)及病毒载量(p=0.006),达到试验主要终点和关键次要终点 RSV感染是五岁以下儿童因病毒感染而住院及死亡的首要因素爱司韦™是全球首个成功在儿童患者人群中完成关键性三期临床研究的RSV抗病毒药物爱司韦™计划于2022年年中向中国监管机构提交新药上市申请 上海, April 07, 2022 (GLOBE...
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愛科百發宣佈愛司韋™在治療呼吸道合胞病毒(RSV)感染的住院嬰幼兒中的臨床三期試驗達到主要終點
April 07, 2022 03:50 ET | Shanghai Ark Biopharmaceutical Co., Ltd.
在臨床三期AirFLO試驗中,愛司韋™與安慰劑相比顯著降低症狀評分(p=0.002)及病毒載量(p=0.006),達到試驗主要終點和關鍵次要終點 RSV感染是五歲以下兒童因病毒感染而住院及死亡的首要因素愛司韋™是全球首個成功在兒童患者人群中完成關鍵性三期臨床研究的RSV抗病毒藥物愛司韋™計畫於2022年年中向中國監管機構提交新藥上市申請 上海, April 07, 2022 ...
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ArkBio Announces Positive Results of Phase 3 Study with Ziresovir in Infants and Children Hospitalized with Respiratory Syncytial Virus Infection
April 07, 2022 03:50 ET | Shanghai Ark Biopharmaceutical Co., Ltd.
Phase 3 AirFLO study with ziresovir met primary and key secondary endpoints of significant reduction of sign-and-symptom score (p=0.002) and viral load (p=0.006) respectively, compared with...
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Icosavax Announces Topline Interim Phase 1/2 Results for IVX-411 Against SARS-CoV-2
March 25, 2022 08:00 ET | Icosavax, Inc.
- Immunologic response observed in both SARS-CoV-2 naive and previously vaccinated subjects, but lower than expected and inconsistent with known data on company’s platform and VLP technology;...