• 최종편집 2024-05-20(월)

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    [단독외신] EUSA Pharma Announces FDA Approval of Phase 3 Clinical Trial for Siltuximab in Hospitalized Patients With COVID-19 Associated Acute Respiratory Distress Syndrome
    EUSA Pharma Announces FDA Approval of Phase 3 Clinical Trial for Siltuximab in Hospitalized Patients With COVID-19 Associated Acute Respiratory Distress Syndrome EUSA Pharma, a global biopharmaceutical company focused on oncology and rare disease, today announced that the U.S. Food & Drug Administration (FDA) has approved a randomized, double-blind, placebo-controlled Phase 3 clinical trial protocol to evaluate the safety and efficacy of intravenous siltuximab plus standard of care in hospitalized patients with COVID-19 associated Acute Respiratory Distress Syndrome (ARDS). Siltuximab is a monoclonal antibody that directly neutralizes interleukin (IL)-6, an inflammatory cytokine detected at elevated levels in multiple inflammatory conditions, including COVID-19. It specifically binds to IL-6, thereby inactivating IL-6 induced signalling. Lee Morley, Chief Executive Officer, EUSA Pharma, said: “Since the start of the pandemic, a growing body of evidence has been published highlighting that COVID-19 associated ARDS may exhibit features of systemic hyperinflammation, resulting from excessive cytokine production - the so-called ‘cytokine storm’ - with IL-6 recognized as a key driver of this severe condition. Treatment approaches neutralizing IL-6 could therefore play a key role in mitigating further detrimental inflammation and progression to respiratory failure, which can be fatal. We thank the FDA for recognizing the importance of this clinical trial and the quick approval we received. Our plan now is to initiate the study as quickly as possible with the hope of seeing improved clinical outcomes in these critically ill patients.” To date, several independent clinical trials have begun globally to explore the safety and efficacy of siltuximab for the treatment of severe COVID-19 patients. Final results from the Papa Giovanni XXIII Hospital sponsored SISCO[1] (Siltuximab In Serious COVID-19) Study, an observational cohort control trial investigating siltuximab plus standard of care in COVID-19 patients with serious respiratory complications, are available via pre-print summary here (https://bit.ly/3ioH9vW).[2] However, the newly approved confirmatory clinical trial is vital because these findings require validation in a well-controlled randomized study and there is limited published data on the safety and efficacy of siltuximab in COVID-19. Siltuximab is also not yet FDA-approved for complications associated with COVID-19.
    • Animal Rights
    2020-07-03
  • 아바타메드, 나노포커스레이와 ‘코로나19 진단용 이동형 CT’ 해외판매 협약 체결
    아바타메드, 나노포커스레이와 ‘코로나19 진단용 이동형 CT’ 해외판매 협약 체결
    • NEWS & ISSUE
    • Social
    2020-07-03
  • 속보Northern Data: SBI Becomes New Strategic Shareholder
    Northern Data: SBI Becomes New Strategic Shareholder Northern Data AG (XETRA: NB2, ISIN: DE000A0SMU87), one of the world's largest providers of high-performance computing (HPC) solutions, is now welcoming SBI Crypto as a new strategic shareholder. SBI Crypto Co., Ltd., is a wholly-owned subsidiary of SBI Holdings Inc. (Tokyo: 8473) engaging in the areas of cryptocurrency mining. SBI Crypto is one of the first enterprises hosted at Northern Data's new Texas facility and became a strategic partner for projects relating to blockchain technology infrastructure and joint software development and deployment. SBI Crypto was one of the holders of the convertible bond issued in November 2019. Together with other strategic partners, which represent the majority of the convertible bondholders, SBI Crypto converted into stock. The strategic shareholders have agreed to a lock-up of up to 36 months subject to customary exceptions. “There are a lot of synergies available between SBI Group and Northern Data. We look forward to increased cooperation. We have high expectations of them, including software development and producing a positive impact to the energy grid,” explains Carson Smith, CEO of SBI Crypto. Aroosh Thillainathan, CEO of Northern Data AG commented as follows: “The first half of 2020 can be seen as a breakthrough for our company, as we moved from the developing and testing phase of the past years into scaling our business with world-class customers and partners. Turning them into strategic shareholders feels like the best possible confirmation that we are on the right track. I am confident that we have everything in place to write an impressive and sustainable success story from where we stand today. We are grateful for the support of our shareholders and are looking forward to continuing our exciting journey with you.” SBI Crypto is one of Northern Data's first two major clients that are now live at the new Texas facility. These initial revenues will be detailed in the half-year figures to June 30, 2020, which will be released in September. In addition to the all-new facility in Texas, Northern Data is developing additional sites in Canada and Scandinavia in order to meet overwhelming customer demand. The innovative design of these new facilities is currently in its final stage and the company is planning to officially disclose the locations within the upcoming weeks. Construction will commence shortly after this announcement and the go-live date is targeted for Q1 2021.
    • Animal Rights
    2020-07-03
  • 속보[인사] 국가정보원장 박지원, 통일부장관 이인영, 안보실장 서훈···靑 인사단행
    [인사] 국가정보원장 박지원, 통일부장관 이인영, 안보실장 서훈···靑 인사단행 통령 외교안보특보에 임종석·정의용 문재인 대통령은 3일 신임 국가정보원장에 박지원 전 민생당 의원(78)을 내정했다. 통일부 장관엔 더불어민주당 이인영 의원(56)을, 국가안보실장에는 서훈 국가정보원장(66)을 내정했다. 이날 단행된 외교안보라인 인사는 위기에 처한 남북관계를 돌파하기 위한 문 대통령 의지가 반영된 것으로 풀이된다. 강민석 청와대 대변인은 이날 춘추관 브리핑에서 문 대통령이 이같은 내용의 인사를 단행했다고 밝혔다. 그리고 대통령 외교안보특별보좌관에 임종석 전 대통령 비서실장(54)과 정의용 국가안보실장(74)을 임명했다. 이날 단행된 외교안보라인 인사는 북한의 개성 남북공동연락사무소 폭파 등으로 위기에 처한 남북관계를 돌파하기 위한 문 대통령 의지가 반영된 것으로 풀이된다. 임종석 특보는 문재인 정부 첫 대통령 비서실장을 지냈으며, 문재인 정부에서 세 차례 남북정상회담 준비를 총괄한 경험, 그 과정에서 김여정 조선노동당 중앙위원회 제1부부장 등 북한 핵심부와 신뢰관계를 형성한 점 등이 강점으로 꼽혀왔다. 지난달 남북경제문화협력재단(경문협) 이사장으로 취임하며, 민간 분야에서 남북관계 진전에 기여하고 싶다는 뜻을 밝혔다. 정의용 특보는 대선 시기부터 문재인 캠프 외교·안보 정책 설계를 이끌었고, 문재인 정부 초대 국가안보실장으로 일했다. 강민석 청와대 대변인은 이날 춘추관 브리핑에서 “국가안보실장과 외교안보특별보좌관은 이르면 오는 6일 임명한다”고 밝혔다.
    • NEWS & ISSUE
    • Politics
    2020-07-03
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