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強生/拜耳Xarelto(拜瑞妥)顯著降低高危群體主要不良心臟事件風險

來源:生物谷 時間:2017.2.142017年02月14日訊,德國制藥巨頭拜耳(Bayer)與合作伙伴美國醫藥巨頭強生(JNJ)近日聯合宣布,評估...

2017-02-24

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CFDA發布一致性評價臨床有效性試驗一般考慮的通告

來源:藥研發 時間:2017.2.8為規范仿制藥質量和療效一致性評價工作,CFDA發布了《關于落實〈國務院辦公廳關于開展仿制藥質量和療效一致性評價的意見〉有關事項的公告》(2016年第1...

2017-02-24

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亞寶藥業1類新藥獲批臨床

來源:藥研發 時間:2017.2.15亞寶藥業宣布其1類新藥鹽酸亞格拉汀原料藥和膠囊劑獲CFDA授予《藥物臨床試驗批件》和《審批意見通知件》。該藥是亞寶與禮來制藥合作開發的用于治療2型...

2017-02-24

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默沙東艾滋新藥III期臨床成功

來源:藥研發 時間:2017.2.17默沙東(MSD)宣布其非核苷逆轉錄酶抑制劑(NNRTI)doravirine(MK-1439)治療HIV-1感染的一項關鍵性III期臨床試驗達到了主要研究終點:部分受試者在...

2017-02-24

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肝癌重磅消息!衛材新型靶向抗癌藥Lenvima一線治療肝細胞癌III期臨床獲得成功

來源:生物谷 2017-02-032017年2月3日訊 ,日本藥企衛材(Eisai)近日宣布,該公司自主研發的新型靶向抗癌藥Lenvima(lenvatinib)一線治療晚期肝細胞癌在一項III期臨床研究(Study 304...

2017-02-24

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Therakind抗炎藥Jylamvo(甲氨蝶呤,2mg/mL口服液)獲歐盟CHMP支持批準

來源:生物谷 2017-02-032017年2月3日訊 ,歐洲制藥公司Therakind開發一款抗炎藥Jylamvo(甲氨蝶呤,2毫克/毫升口服液)近日獲得了歐洲藥品管理局(EMA)人用醫藥產品委員會(CHMP)的...

2017-02-24

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