牛牛AI助理已提取核心訊息
On August 12, 2024, 60 Degrees Pharmaceuticals, Inc. announced the granting of a right of reference to the University of Kentucky for the company's new drug application for ARAKODA (tafenoquine). This right of reference enables the FDA to review the company's data on ARAKODA as it considers the University of Kentucky's investigational SJ733 Phase IIb program for the treatment of vivax malaria. The Phase IIb study, funded by the Global Health Innovative Technology Fund, will combine SJ733 with a single dose of tafenoquine to assess safety, tolerability, and pharmacokinetics. The University of Kentucky, in collaboration with Eisai Co. Ltd., aims to develop a treatment suitable for all patients with uncomplicated P. vivax malaria. 60 Degrees Pharmaceuticals will supply tafenoquine and placebos for the trial. ARAKODA, approved by the FDA in 2018 for malaria prophylaxis, has been evaluated in several trials for up to six months. The company, which specializes in infectious disease treatments, received FDA approval for ARAKODA in 2018 and collaborates with various research organizations globally.
On August 12, 2024, 60 Degrees Pharmaceuticals, Inc. announced the granting of a right of reference to the University of Kentucky for the company's new drug application for ARAKODA (tafenoquine). This right of reference enables the FDA to review the company's data on ARAKODA as it considers the University of Kentucky's investigational SJ733 Phase IIb program for the treatment of vivax malaria. The Phase IIb study, funded by the Global Health Innovative Technology Fund, will combine SJ733 with a single dose of tafenoquine to assess safety, tolerability, and pharmacokinetics. The University of Kentucky, in collaboration with Eisai Co. Ltd., aims to develop a treatment suitable for all patients with uncomplicated P. vivax malaria. 60 Degrees Pharmaceuticals will supply tafenoquine and placebos for the trial. ARAKODA, approved by the FDA in 2018 for malaria prophylaxis, has been evaluated in several trials for up to six months. The company, which specializes in infectious disease treatments, received FDA approval for ARAKODA in 2018 and collaborates with various research organizations globally.
2024年8月12日，60度製藥公司宣佈將授予肯塔基大學使用《ARAKODA (貪食親褐細胞瘧疾) 》新藥申請表的參考權。該參考權使FDA能夠在考慮肯塔基大學對未成熟P型瘧疾的SJ733 IIb期實驗計劃進行審查時，審查該公司關於ARAKODA的數據。該IIb期研究由全球健康創新科技基金會資助，將結合SJ733和一劑多青黴素來評估安全性，耐受性和藥代動力學。肯塔基大學與Eisai公司合作，旨在開發適用於所有未經複雜化的P型瘧疾患者的治療方法。60度製藥公司將爲試驗提供多青黴素和安慰劑。ARAKODA已於2018年獲得FDA批准用於瘧疾預防，並已在多項試驗中得到評估長達六個月。該公司專注於傳染病治療，在全球各種研究組織中與之合作。
2024年8月12日，60度製藥公司宣佈將授予肯塔基大學使用《ARAKODA (貪食親褐細胞瘧疾) 》新藥申請表的參考權。該參考權使FDA能夠在考慮肯塔基大學對未成熟P型瘧疾的SJ733 IIb期實驗計劃進行審查時，審查該公司關於ARAKODA的數據。該IIb期研究由全球健康創新科技基金會資助，將結合SJ733和一劑多青黴素來評估安全性，耐受性和藥代動力學。肯塔基大學與Eisai公司合作，旨在開發適用於所有未經複雜化的P型瘧疾患者的治療方法。60度製藥公司將爲試驗提供多青黴素和安慰劑。ARAKODA已於2018年獲得FDA批准用於瘧疾預防，並已在多項試驗中得到評估長達六個月。該公司專注於傳染病治療，在全球各種研究組織中與之合作。
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譯文內容由第三人軟體翻譯。
牛牛AI助手部分由第三方人工智慧模型基於資訊內容自動產生，只对除中国内地以外的地区提供。
以上內容僅用作資訊或教育之目的，不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
風險及免責聲明
牛牛AI助手部分由第三方人工智慧模型基於資訊內容自動產生，只对除中国内地以外的地区提供。
以上內容僅用作資訊或教育之目的，不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
我知道了
風險及免責聲明
牛牛AI助手部分由第三方人工智慧模型基於資訊內容自動產生，只对除中国内地以外的地区提供。
以上內容僅用作資訊或教育之目的，不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
我知道了