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Kevzara® (sarilumab) Approved by FDA for the Treatment of Active Polyarticular Juvenile Idiopathic Arthritis (pJIA)
Newsfilter· 2024-06-11 19:00
Approval in patients with pJIA weighing 63kg or greater adds to Kevzara's position in treating adult chronic inflammatory conditions of moderately to severely active rheumatoid arthritis and polymyalgia rheumatica TARRYTOWN, N.Y. and CAMBRIDGE, MA, June 11, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi today announced that the U.S. Food and Drug Administration has approved Kevzara® (sarilumab) for the treatment of patients weighing 63 kg or greater with active polyarticul ...
Kevzara® (sarilumab) Approved by FDA for the Treatment of Active Polyarticular Juvenile Idiopathic Arthritis (pJIA)
GlobeNewswire News Room· 2024-06-11 19:00
Approval in patients with pJIA weighing 63kg or greater adds to Kevzara's position in treating adult chronic inflammatory conditions of moderately to severely active rheumatoid arthritis and polymyalgia rheumatica TARRYTOWN, N.Y. and CAMBRIDGE, MA, June 11, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi today announced that the U.S. Food and Drug Administration has approved Kevzara® (sarilumab) for the treatment of patients weighing 63 kg or greater with active polyarticul ...
Regeneron Pharmaceuticals, Inc. (REGN) Management presents at Jefferies 2024 Global Healthcare Conference (Transcript)
2024-06-06 00:43
会议主要讨论的核心内容 - 公司在固体肿瘤和血液肿瘤领域的研发进展,包括PD-1/LAG-3联合疗法在黑色素瘤和非小细胞肺癌中的表现 [7][8][9][10][11][13][14][15][16][17][18][19][20][21][22][23][24] - 公司的CD28 co-stimulatory bispecific抗体在前列腺癌等实体瘤中的潜力 [25][26][27][28][29] - 公司在地理萎缩性黄斑变性(GA)和血友病 IX 因子抑制剂领域的新药研发进展 [31][32][33][34] 问答环节重要的提问和回答 问题1 **Akash Tewari 提问** 询问公司PD-1/LAG-3联合疗法在非小细胞肺癌一线治疗中的表现,是否只针对特定生物标志物阳性的亚群,还是可以应用于更广泛的人群 [7][10][11][13] **Israel Lowy 回答** 公司的PD-1/LAG-3联合疗法在黑色素瘤中表现出良好的疗效,不受PD-L1表达水平的影响,公司正在进一步探索在肺癌一线治疗中的应用前景 [8][9][12][13] 问题2 **Akash Tewari 提问** 询问公司PD-1/LAG-3联合疗法在黑色素瘤中的疗效数据,尤其是在无进展生存期和总生存期方面的表现 [14][15][16][17] **Israel Lowy 回答** 公司的PD-1/LAG-3联合疗法在黑色素瘤中不仅显示出良好的客观缓解率,而且在无进展生存期和完全缓解率方面也有优异的表现,公司正在进行头对头的临床试验与竞品进行比较 [16][17][18][19] 问题3 **Akash Tewari 提问** 询问公司CD28 co-stimulatory bispecific抗体在前列腺癌等实体瘤中的潜力,以及与CD3 bispecific的差异 [27][28] **Israel Lowy 回答** 公司的CD28 bispecific抗体在前列腺癌等实体瘤中展现出良好的疗效潜力,可以通过激活T细胞的共刺激通路来增强抗肿瘤免疫反应。公司正在探索将CD28和CD3 bispecific联合应用的方法,以期在提高疗效的同时降低毒性反应 [29]
Health Care Stocks Show Relative Strength as S&P 500 Stalls
ZACKS· 2024-06-05 03:45
The U.S. economy has begun to show signs of weakness as we head into the summer months. This morning, the Bureau of Labor Statistics reported that job openings fell in April to their lowest level in more than three years. The new data revealed that there were 8.06 million jobs open at the end of the month, a decrease from the 8.35 million openings in March. Coming off the heels of a weak April jobs report, it’s yet another sign that the hiring boom following the pandemic is cooling off. We’ll get more in th ...
Dupixent® (dupilumab) Recommended for EU Approval by the CHMP to Treat Patients with COPD
Newsfilter· 2024-05-31 13:05
Recommendation for adults with uncontrolled COPD with raised blood eosinophils based on data from two landmark Phase 3 trials demonstrating Dupixent significantly reduced exacerbations and improved lung function If approved, Dupixent would be the first-ever targeted therapy for COPD in the EU and the first new treatment approach for this disease in more than a decade TARRYTOWN, N.Y. and PARIS, May 31, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the ...
Dupixent® (dupilumab) Recommended for EU Approval by the CHMP to Treat Patients with COPD
GlobeNewswire News Room· 2024-05-31 13:05
Recommendation for adults with uncontrolled COPD with raised blood eosinophils based on data from two landmark Phase 3 trials demonstrating Dupixent significantly reduced exacerbations and improved lung function If approved, Dupixent would be the first-ever targeted therapy for COPD in the EU and the first new treatment approach for this disease in more than a decade TARRYTOWN, N.Y. and PARIS, May 31, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the ...
Press Release: Dupixent recommended for EU approval by the CHMP to treat patients with COPD
GlobeNewswire News Room· 2024-05-31 13:05
Dupixent recommended for EU approval by the CHMP to treat patients with COPD Recommendation for adults with uncontrolled COPD with raised blood eosinophils based on data from two landmark Phase 3 trials demonstrating Dupixent significantly reduced exacerbations and improved lung function If approved, Dupixent would be the first-ever targeted therapy for COPD in the EU and the first new treatment approach for this disease in more than a decade Paris and Tarrytown, N.Y. May 31, 2024. The European Medicines Ag ...
Press Release: Update on FDA priority review of Dupixent for the treatment of COPD patients with type 2 inflammation
Newsfilter· 2024-05-31 13:00
Update on FDA priority review of Dupixent for the treatment of COPD patients with type 2 inflammation Paris and Tarrytown, NY May 31, 2024. The US Food and Drug Administration (FDA) has extended by three months the target action date of its priority review of the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The revised target action date is September 27, ...
Update on FDA Priority Review of Dupixent® (dupilumab) for the Treatment of COPD Patients with Type 2 Inflammation
Newsfilter· 2024-05-31 13:00
TARRYTOWN, N.Y. and PARIS, May 31, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the U.S. Food and Drug Administration (FDA) has extended by three months the target action date of its priority review of the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The revised target action date is September 27, 202 ...
Update on FDA Priority Review of Dupixent® (dupilumab) for the Treatment of COPD Patients with Type 2 Inflammation
GlobeNewswire News Room· 2024-05-31 13:00
TARRYTOWN, N.Y. and PARIS, May 31, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the U.S. Food and Drug Administration (FDA) has extended by three months the target action date of its priority review of the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The revised target action date is September 27, 202 ...