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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 Degrees Pharmaceuticals社は、ARAKODA(タフェノキン)の新薬承認申請に対するUniversity of Kentuckyの参照権の付与を発表しました。この参照権により、FDAは、University of KentuckyのP. vivaxマラリアの治療のためのPhase IIbプログラムであるInvestigational SJ733のデータを検討するにあたり、60 Degrees Pharmaceuticals社のARAKODAのデータをレビューすることができます。Phase IIb研究は、全セクターを標的にした治療法の開発を目指すE...すべて展開
2024年8月12日、60 Degrees Pharmaceuticals社は、ARAKODA(タフェノキン)の新薬承認申請に対するUniversity of Kentuckyの参照権の付与を発表しました。この参照権により、FDAは、University of KentuckyのP. vivaxマラリアの治療のためのPhase IIbプログラムであるInvestigational SJ733のデータを検討するにあたり、60 Degrees Pharmaceuticals社のARAKODAのデータをレビューすることができます。Phase IIb研究は、全セクターを標的にした治療法の開発を目指すEisai Co. Ltd.と協力して実施され、SJ733とタフェノキンの単回投与を組み合わせて、安全性、耐性、薬物動態を評価します。試験では、60 Degrees Pharmaceuticals社がタフェノキンと偽薬を供給します。ARAKODAは、2018年にFDAによってマラリアの予防に承認され、最長6か月間の試験で評価されました。感染症治療に特化した同社は、ARAKODAの承認を2018年に受け、世界中の様々な研究機関と協力しています。
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