IDE275 (GSK959) development is progressing into First-in-Human Phase 1 clinical trial(s) for the treatment of MSI-High solid tumors, representing IDEAYA's 5th potential first-in-class clinical program MSI-High prevalence in endometrial, colorectal, and gastric cancers is ~31%, 20%, and 19%, respectively, highlighting the market potential of IDE275 (GSK959) IDEAYA to receive a $7 million payment for IND acceptance, and potential future aggregate milestones of up to $950 million. IDEAYA has a 50/50 US Profit ...

GSK plc (NYSE: GSK ) is a biopharmaceutical company with a long history of driving innovation in developing vaccines, specialty medicines, and general healthcare. The company has important products such as Shingrix and Arexvy in its vaccine segment. GSK also presents a strong My name is Myriam Hernandez Alvarez. I received the Electronics and Telecommunication Engineering degree from the Escuela Politecnica Nacional, Quito, Ecuador, the M.Sc. degree in computer science from Ohio University, Athens, OH, USA, ...

GSK plc (GSK) announced that the FDA has accepted its new drug application (NDA) seeking approval for its investigational, first-in-class oral antibiotic, gepotidacin for treating uncomplicated urinary tract infections (uUTIs) in female adults and adolescents. With the FDA granting a priority review to the NDA, a decision from the regulatory body is expected on March 26, 2025. If approved, gepotidacin could become the first in a new class of oral antibiotic medicines to be approved for treating uUTIs in mor ...

Flu season is almost here, and there is a respiratory syncytial virus (RSV) vaccine update worth monitoring. Earlier today, the Food and Drug Administration (FDA) put a clinical hold on the combination and standalone influenza shot developed by Novavax Inc (NASDAQ:NVAX). NVAX Testing Chart Support NVAX is down 17.7% to trade at $10.36 in response, on track for its lowest close since mid May. The shares are still up 115% in 2024 though, and the round-number $10 level -- an area that coincides with its 160-da ...

文章核心观点 - GSK公司宣布其管线候选药物depemokimab在治疗慢性鼻窦炎伴有鼻息肉(CRSwNP)的成人患者的III期ANCHOR-1和ANCHOR-2研究中取得积极数据 [1] - 研究结果显示,与安慰剂加标准护理相比,depemokimab治疗可显著减少鼻息肉大小和鼻塞,达到共同主要终点 [1] - Depemokimab是一种IL-5抑制剂,IL-5在II型炎症中起关键作用,在鼻息肉组织中水平较高 [2] - Depemokimab正在进行严重哮喘、嗜酸性粒细胞性肉芽肿性血管炎和高嗜酸性粒细胞综合征的III期研究 [3][4] 公司相关 - GSK的呼吸系统产品组合目前由其生物制品Nucala(抗IL-5)为主,Nucala在2024年上半年销售增长15% [5] - GSK正在扩大Nucala的适应症,包括慢性阻塞性肺疾病(COPD) [5] 行业竞争 - 赛诺菲和再生元的Dupixent(IL-4和IL-13抑制剂)已获批多种II型炎症性疾病,包括COPD [6][7] - 阿斯利康的Fasenra(IL-5抑制剂)也获批治疗严重嗜酸性粒细胞性哮喘,并正在研究鼻息肉和COPD适应症 [7]

文章核心观点 - GSK公司宣布其管线候选药物depemokimab在治疗成人慢性鼻窦炎伴有鼻息肉(CRSwNP)的两项III期临床试验ANCHOR-1和ANCHOR-2中取得积极数据 [1] - Depemokimab是一种IL-5抑制剂,可以减少II型炎症,从而减小鼻息肉和缓解鼻塞 [2] - Depemokimab还在治疗严重哮喘的SWIFT-1和SWIFT-2两项III期临床试验中达到主要终点 [3] - 这些积极数据将支持depemokimab的全球监管申报 [4] 公司概况 - GSK的呼吸系统产品组合目前由其重磅生物制品Nucala驱动 [5] - Nucala在2024年上半年销售增长15%,达到8.56亿英镑 [5] - GSK还在研究Nucala用于治疗慢性阻塞性肺疾病(COPD) [5] 行业竞争 - Sanofi和Regeneron的Dupixent是另一款重要的II型炎症抑制剂,已获批多种适应症 [6] - 包括Dupixent在内,Nucala还面临来自AstraZeneca的Fasenra的竞争 [6][7] - Fasenra也获批用于治疗嗜酸性粒细胞性肉芽肿性血管炎 [7]

GAITHERSBURG, Md., Oct. 15, 2024 (GLOBE NEWSWIRE) -- BullFrog AI, Inc. (NASDAQ: BFRG; BFRGW) ("BullFrog AI" or the "Company"), a technology-enabled drug development company using artificial intelligence (AI) and machine learning to enable the successful development of pharmaceuticals and biologics, today announced the appointment of John Baldoni, Ph.D., to its Scientific Advisory Board. Dr. Baldoni brings over four decades of experience in the pharmaceutical industry, including leadership roles in scientifi ...

文章核心观点 - GSK公司的RSV疫苗Arexvy在60岁及以上成人中预防下呼吸道疾病的累计疗效在三个RSV季度中达到62.9%,预防严重下呼吸道疾病的疗效为67.4% [1] - Arexvy在第三个RSV季度的预防下呼吸道疾病的疗效为48% [1] - Arexvy是目前唯一拥有三个完整RSV季度的疗效和安全性数据的RSV疫苗 [1] 根据目录分别总结 Arexvy的市场表现 - Arexvy已获得美国、欧洲、日本等多个国家60岁及以上成人预防下呼吸道疾病的批准 [2] - Arexvy已获得美国和欧盟50-59岁成人的批准,正在其他国家申请同样适应症的扩展 [2] - Arexvy在2023年实现了12亿英镑的销售,2024年上半年销售额为2.44亿英镑 [2] - Arexvy上半年销售表现符合预期的季节性模式,下半年销售有望大幅提升 [3] 其他RSV疫苗竞争对手 - 辉瑞的RSV疫苗Abrysvo已在美国和欧盟获批用于预防老年人和通过孕妇免疫预防婴儿,2024年上半年销售2.01亿美元 [4] - 辉瑞正在评估Abrysvo用于18-59岁成人的III期临床试验,计划向FDA申请扩大适应症 [4] - moderna的mRNA疫苗mResvia已于2024年5月获得FDA批准,并在8月获得欧盟上市许可 [4] - moderna正在评估mResvia用于高危成人以及孕妇和儿童的早期临床试验 [5]

Share price of the British pharmaceutical company GSK (NYSE: GSK ) has gone nowhere since I last wrote about at the end of July. Until yesterday, that is, when it spiked by ~6% following news that the company had Manika is a macroeconomist with over 20 years of experience in industries including investment management, stock broking, investment banking. She also runs the profile Long Term Tips [LTT], which focuses on the generational opportunity in the green economy. Her investing group, Green Growth Giants ...

KEY TAKEAWAYS GSK shares in London jumped 5% Thursday after the British pharmaceutical giant said it has resolved most of the U.S. lawsuits it faced around claims that its discontinued heartburn medicine Zantac causes cancer. The London-listed firm said it had struck agreements to resolve 93%, or about 80,000, of the pending Zantac lawsuits in the U.S. and will make a total payment of up to $2.2 billion to settle them. GSK said the plaintiffs are unanimously recommending their clients accept the settlement. ...