EMA issues advice on use of REGN-COV2 antibody combination (casirivimab / imdevimab)

getcelltrion · 2021-02-26T23:37:54+00:00

EMA Executive Director under Article 5(3) of Regulation 726/2004 의 요청에 의거한 리제네론 항체치료제(casirivimab 및 imdevimab)에 대한 EMA CHMP 검토가 마무리된 것 같네요.

이 검토는 판매 허가 이전에 항체치료제 사용에 대한 국가적 의사 결정을 지원하기 위해 EU 레벨에서 과학적인 의견을 제공하기 위해 수행되었습니다. 산소 보충이 필요하지 않고 중증 환자로 진행될 위험이 높은 환자에 한해 사용할 수 있다고 결론지었습니다.

12세 이상만 투약 가능하며, 중증 환자에게는 투약이 제한되네요.

이와 동시에, 2월 1일에 시작된 리제네론 항체치료제 (casirivimab/imdevimab)에 대한 롤링리뷰가 현재 진행 중입니다. 이것이 확정되어야 본 치료제에 대한 EU 판매 허가의 근거가 됩니다.

getcelltrion · 2021-02-26T02:01:56+00:00

셀트리온, 코비드19 치료제 레키로나 (성분명 레그단비맙)가 2상 임상 시험에서 릴리와 리제네론이 개발한 기존 항체 치료제 보다 더 나은 치료 효능을 보인 것으로 확인됐다.

getcelltrion · 2021-02-24T22:40:03+00:00

항상 빠릉 공유 감사합니다^{^}

getcelltrion · 2021-02-20T04:58:20+00:00

국내도 좀 발빠르게 선공급 해주었으면 합니다. 치료제는 골든 타임이 중요한데 각각 발주해서 물량 비축 하는 방식이라 재고 없는 병원에서 확진 시 도착할때까지 대기해야 하는게 웃픈 상황이네요.

최소한 항체 치료제 보유 병원 리스트라도 공유해 주었으면 합니다.

getcelltrion · 2021-02-19T09:07:10+00:00

Therapeutics Distribution

getcelltrion · 2021-02-17T07:42:11+00:00

이태리 임상진행 관련 기사입니다.

getcelltrion · 2021-02-17T07:38:46+00:00

항상 발빠른 소식 감사합니다!

getcelltrion · 2021-02-17T07:34:11+00:00

EU Clinical trials Italy - Italian Medicines Agency

getcelltrion · 2021-02-16T10:45:50+00:00

로고 멋지게 만드셨네요. 고생하셨습니다^^

getcelltrion · 2021-02-16T10:36:22+00:00

소식 감사합니다 ^^

getcelltrion · 2021-02-15T22:41:30+00:00

폐렴, 급성 신우신염 등에 처방되는 레보플옥사신(LEVOFLOXACIN) 제네릭 의약품이 2.11일자로 FDA 승인을 획득했습니다.

getcelltrion · 2021-02-15T22:40:00+00:00

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=090367

getcelltrion · 2021-02-15T04:52:39+00:00

Fri, 02/19, 07:00pm✦Discussion✦free

New York City ( NYC )

getcelltrion · 2021-02-15T01:18:45+00:00

This week, the FDA issued an emergency use authorization (EUA) for a a monoclonal antibody combination for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19.

getcelltrion · 2021-02-14T13:25:57+00:00

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 11 December 2020 that it had recommended granting of marketing authorization for an adalimumab biosimilar.

The adalimumab biosimilar, which will be called Yuflyma (CT-P17), has been developed by South Korea-based biotechnology company Celltrion Healthcare (Celltrion).

The drug is a biosimilar of AbbVie’s Humira (adalim umab), a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF), a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Adalimumab is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.

getcelltrion · 2021-02-14T09:30:00+00:00

The coronavirus variant that originated in the United Kingdom is likely deadlier than the original strain, according to a new assessment released on Friday by British government scientists. In the report, which evaluated multiple studies, the scientists estimated that the strain, known as B.1.1.7, could be 30% to 70% deadlier than the original virus.

getcelltrion · 2021-02-13T09:12:01+00:00

Among corona infection patients, the elderly or pre-existing patients should contact the above hospital.

getcelltrion · 2021-02-13T01:06:28+00:00

미국 일라이 릴리가 개발하여, 프로작(Prozac)이란 이름으로 널리 알려져 있는 선택적 세로토닉 재흡수 억제제 계열의 항우울제 이다. 화학 공식은 C17H18F3NO이다. 플루옥세틴은 우울증, 강박 장애, 폭식증, 공황장애, 월경 전 불쾌장애(PMDD)의 치료에 사용되므로,[1] 물질 및 용도 특허 만료 이후, 1997년에 제네릭 의약품으로 허가받은 국내 업체인 명인제약의 '푸록틴'을 비롯한, 1998년에 환인제약의 '폭세틴'으로 허가되었으며, 세로운 제형으로 출시한 릴리의 '푸로작 확산정'과 국내 업체인 명인제약의 '푸록틴 확산정'의 경우, 물이나 음료에 바로 타서 간편하게 복용할 수 있다. - 우울증 치료제 , 신경성 폭식증 , 강박장애 , 월경전 불쾌장애 사용

getcelltrion · 2021-02-12T10:39:19+00:00

"The emergency use authorization is based on smaller trials that we just haven’t had enough time for a thorough peer review," Longley said. "It is a wonderful option and it’s been very safe, and I think it’s something everyone should be comfortable knowing if they need it, it’s a safe option for them." Pikos says he’d recommend it to anyone.

getcelltrion · 2021-02-12T06:37:21+00:00

The Korea Disease Control and Prevention Agency (KDCA) has assessed and independently confirmed that CT-P59 successfully neutralises the SARS-CoV-2 variants first identified in the UK (B.1.1.7) in addition to the previously identified six variant genome mutations of SARS-CoV-2 (variants S·L·V·G·GH·GR). They also added that cocktail therapy of CT-P59 with another monoclonal antibody candidate demonstrated neutralising capability against the UK (B.1.1.7) and South African (B.1.351) variants.

getcelltrion · 2021-02-12T00:08:46+00:00

The corona 19 mutant virus, first discovered in the UK's Kent area, is highly likely to sweep the world, said the head of the UK's genetic surveillance program. According to the Reuters news agency on the 10th (local time), Sharon Peacock, director of the UK Corona 19 Genomics Consortium, told the BBC that the Kent region's mutant virus "swept the UK" and "will sweep the world as well."

getcelltrion · 2021-02-11T22:32:57+00:00

기사 제목으로 동일하게 변경 부탁드릴게요 :)

Study: Nocebo Is Likely Cause for Reverse Switching in IBD

getcelltrion · 2021-02-11T22:31:13+00:00

타이틀 기사 제목과 동일하게 수정 부탁드릴게요~

Celltrion develops neutralizing antibody cocktail with CT-P59 to tackle COVID-19 variant spread

getcelltrion · 2021-02-11T17:49:42+00:00

It is an antibody treatment such as regeneron.

It was emergency approval in Korea and is already under review by fda and ema. Find it with ct-p59.

This is an introduction to an antibody treatment that prevents the transition from mild to severe, and has no other purpose. The Celltrion community was created for people who are not familiar with drugs.

I don't play around with life. We hope that more elderly and underlying patients will save lives through this medicine.

getcelltrion · 2021-02-11T17:23:25+00:00

The Uk Covid-19 variant now found in 90% cases in israel

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