https://www.bms.com/news/details/2024/Bristol-Myers-Squibb-Announces-Opdivo-nivolumab-Plus-Yervoy-ipilimumab-Significantly-Improved-Overall-Survival-Compared-to-Lenvatinib-or-Sorafenib-as-First-Line-Treatment-for-Patients-with-Advanced-Hepatocellular-Carcinoma-in-CheckMate--9DW-Trial/default.aspx
Median OS was 23.7 months (95% CI: 18.8–29.4) for Opdivo plus Yervoy compared to 20.6 months (95% CI: 17.5–22.5) with lenvatinib or sorafenib (HR: 0.79 (0.65–0.96); p = 0.018).
Median OS was 23.7 months (95% CI: 18.8–29.4) for Opdivo plus Yervoy compared to 20.6 months (95% CI: 17.5–22.5) with lenvatinib or sorafenib (HR: 0.79 (0.65–0.96); p = 0.018).
Bms
News and media - Bristol Myers Squibb
Visit the Bristol Myers Squibb newsroom & stay up to date with our most current news as we continue to make a difference in the lives of our patients.
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I-Mab Announces Collaboration with Bristol Myers Squibb to Evaluate Givastomig in a Combination Study for Newly Diagnosed Gastric and Esophageal Cancers
I-Mab enters clinical collaboration with Bristol Myers Squibb to evaluate Claudin 18.2 x 4-1BB bispecific antibody givastomig in combination with nivolumab and chemotherapy for the treatment of gastric and esophageal cancer.
Collaboration builds on promising safety and efficacy data from the givastomig monotherapy study reported at the European Society of Medical Oncology Congress 2023.
에이비엘바이오 협력사 IMAB에서 ABL111(CLDN18.2)의 개발에서 BMS가 옵디보 무상지원
I-Mab enters clinical collaboration with Bristol Myers Squibb to evaluate Claudin 18.2 x 4-1BB bispecific antibody givastomig in combination with nivolumab and chemotherapy for the treatment of gastric and esophageal cancer.
Collaboration builds on promising safety and efficacy data from the givastomig monotherapy study reported at the European Society of Medical Oncology Congress 2023.
에이비엘바이오 협력사 IMAB에서 ABL111(CLDN18.2)의 개발에서 BMS가 옵디보 무상지원
Forwarded from 바이바이바이오🤡DS 제약/바이오 김민정
일라이 릴리 Tirzepatide, MASH Phase 2b SYNERGY-NASH 초록 공개
Fibrosis 1stage 이상 개선(헛..!)
15mg 51.0%, 10mg 51.3%, 5mg 54.9% (vs. placebo 29.7%)
모든 용량에서 p<0.05
primary end point (MASH resolution without worsening of fibrosis at 52 weeks)
15mg 73.3%, 10mg 62.8%, 5mg 51.8% (vs. placebo 29.7%)
모든 용량에서 p<0.001
3가지 용량 모두 71.7%~78.3% 환자가 NAS point 2점이상 감소
(vs. placebo 36.7%, p<0.001)
이에 MASH 관련 기업 전부 하락세
Madrigal -9.89%
89bio -4.10%
Akero -0.75%
https://events-distribution.easl.eu/from.storage?image=mIoM6rsplpmkPbT9D4cRMhCdB962jqqPLI0ekg3BGloLb0klBbYoN9dNVhvU-7Oz0
Fibrosis 1stage 이상 개선(헛..!)
15mg 51.0%, 10mg 51.3%, 5mg 54.9% (vs. placebo 29.7%)
모든 용량에서 p<0.05
primary end point (MASH resolution without worsening of fibrosis at 52 weeks)
15mg 73.3%, 10mg 62.8%, 5mg 51.8% (vs. placebo 29.7%)
모든 용량에서 p<0.001
3가지 용량 모두 71.7%~78.3% 환자가 NAS point 2점이상 감소
(vs. placebo 36.7%, p<0.001)
이에 MASH 관련 기업 전부 하락세
Madrigal -9.89%
89bio -4.10%
Akero -0.75%
https://events-distribution.easl.eu/from.storage?image=mIoM6rsplpmkPbT9D4cRMhCdB962jqqPLI0ekg3BGloLb0klBbYoN9dNVhvU-7Oz0
I-Mab Appoints Phillip Dennis, MD, PhD, as Chief Medical Officer
https://ir.i-mabbiopharma.com/news-releases/news-release-details/i-mab-appoints-phillip-dennis-md-phd-chief-medical-officer
Dr. Dennis는 사노피에서 ADC 프로젝트 총책임자(사노피가 ADC도 했었냐?) 겸 폐암 전략 부사장. AZ에서 폐암 전략 부사장(임핀지 개발 주도자) 출신임.
어쩌다가 다음 행선지로 동네 구멍가게 바이오텍으로 합류를 했는지... ㄷㄷ
https://ir.i-mabbiopharma.com/news-releases/news-release-details/i-mab-appoints-phillip-dennis-md-phd-chief-medical-officer
Dr. Dennis는 사노피에서 ADC 프로젝트 총책임자(사노피가 ADC도 했었냐?) 겸 폐암 전략 부사장. AZ에서 폐암 전략 부사장(임핀지 개발 주도자) 출신임.
어쩌다가 다음 행선지로 동네 구멍가게 바이오텍으로 합류를 했는지... ㄷㄷ
I-Mab
I-Mab | I-Mab Appoints Phillip Dennis, MD, PhD, as Chief Medical Officer
ROCKVILLE, Md. , June 6, 2024 /PRNewswire/ -- I-Mab (NASDAQ: IMAB ) (the "Company"), a U.S. -based, global biotech company, exclusively focused on the development and potential commercialization of highly differentiated immunotherapies for the treatment…
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Forwarded from 이혁수의 xRNA
Vir Biotechnology, Inc.(Nasdaq: VIR)는 만성 D형간염 환자의 치료를 위해 시험용 단일클론 항체인 토베비바르트와 시험용 소형 간섭 리보핵산인 엘렙시란을 평가하는 임상2상 SOLSTICE 시험의 새로운 예비 데이터를 오늘 발표했습니다. 2상 시험의 예비 데이터에 따르면 토베비바트 단독 또는 엘렙시란 병용 요법은 일반적으로 내약성이 양호했으며 참가자들은 12주와 24주차에 높은 바이러스 반응률, 48주 동안 지속되는 바이러스 반응, 높은 ALT 정상화율을 달성했습니다.
회사는 6월 5일 오전 6시(ET) / 오후 12시에 투자자 컨퍼런스 콜을 개최할 예정입니다. CEST를 통해 이러한 데이터를 논의합니다. 원래는 최신 포스터로 받아들여졌던 이 데이터는 2024년 EASL™ 콩그레스 2024의 유럽 간 연구 협회에서 6월 8일 구두 프레젠테이션을 통해 더 자세히 발표될 예정입니다.
회사는 6월 5일 오전 6시(ET) / 오후 12시에 투자자 컨퍼런스 콜을 개최할 예정입니다. CEST를 통해 이러한 데이터를 논의합니다. 원래는 최신 포스터로 받아들여졌던 이 데이터는 2024년 EASL™ 콩그레스 2024의 유럽 간 연구 협회에서 6월 8일 구두 프레젠테이션을 통해 더 자세히 발표될 예정입니다.
FDA cracks down on China's Hengrui in scathing manufacturing write-up
https://www.fiercepharma.com/pharma/fda-cracks-down-chinas-hengrui-scathing-manufacturing-write
https://www.fiercepharma.com/pharma/fda-cracks-down-chinas-hengrui-scathing-manufacturing-write
Chief among Hengrui’s slights, the company failed to make production records readily available for FDA inspectors, according to the agency.
In the Form 483 document, FDA staff said they were led down a longer route to stall their arrival at the location where Hengrui discarded office waste. Once the party reached the waste bins, the FDA staffers saw an employee “in a rapid-like manner placing documents in the waste bin,” while other individuals watched her—one of whom appeared to have torn documents in hand.
The FDA outlined the contents of those documents in a separate observation, noting that discarded batch records, validation reports and change controls did not always match archived official records.
This attempt at obfuscation by Hengrui ultimately delayed the FDA’s inspection, according to the manufacturing write-up.
Fierce Pharma
FDA cracks down on China's Hengrui in scathing manufacturing write-up
When the FDA comes knocking at your drug manufacturing facility, it’s best to play along. | In an eight-observation Form 483, the FDA chided Hengrui for a laundry list of manufacturing missteps, including poor contamination controls, subpar cleaning protocols…
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