NEW TAIPEI CITY, Dec. 24, 2025 /PRNewswire/ -- Caliway Biopharmaceuticals (TWSE: 6919) today announced that it has completed the submission of an Investigational New Drug (IND) application to the U.S. FDA for a Phase 2 clinical study of its world's first large-area localized fat reduction drug candidate, CBL-514, for the weight management indication. This submission accelerates the clinical development of CBL-514 in combination with GLP-1R agonist (GLP-1RA) therapies and expands the Company's R&D footprint ...

Core Viewpoint - The FDA has approved Agios Pharmaceuticals' drug, mitapivat (brand name: Aqvesme), for the treatment of certain blood disorders, leading to an 18.63% increase in the company's stock price [1]. Group 1: Drug Approval and Market Impact - The drug Aqvesme is the first oral therapy approved for non-transfusion-dependent and transfusion-dependent alpha or beta thalassemia patients [3]. - The approval is based on a late-stage study showing statistically significant improvements in hemoglobin response compared to the placebo group [7]. - The company targets approximately 6,000 adult thalassemia patients in the U.S., with about 4,000 expected to have access to treatment at launch [7]. Group 2: Financial Aspects and Analyst Insights - The annual treatment cost for Aqvesme is approximately $425,000 per patient, which is a premium over the wholesale acquisition cost of $335,000 for another drug, Pyrukynd [6]. - Analysts estimate that the approval unlocks an additional peak revenue opportunity of about $320 million for the existing mitapivat product line [6]. - The drug will come with a black box warning regarding hepatocellular injury and will require liver function tests every four weeks during the first 24 weeks of treatment [5].

坚决扛好经济大省挑大梁的省会担当 ——市委经济工作会议侧记 □ 南京日报/紫金山新闻记者 以推动科技创新和产业创新融合为主线，着力培育壮大新动能。今年以来，全市获批34家全国重点实验 室，占全省77%，全年科技中小型企业突破2.38万家，加快建设42家概念验证中心、57家中试平台、30 家公共技术服务平台，滚动培育40家高水平新型研发机构。市科技局党组书记、局长赵成军表示，他们 将重点围绕"谋长远、促转化、建平台、育主体、优创新"五个方面抓好科技创新工作，突出科技创新和 产业创新融合，紧盯成果转化需求开展高效对接服务，高标准打造重点转化平台，不断提升重大科创平 台原始创新策源能力，"量质并举"培育科技型企业，营造开放创新生态，力争在国家创新体系中体 现"新地位"、在供给与需求侧双向奔赴中激发"新活力"、在提升创新策源能力上实现"新突破"、在壮大 创新型企业集群上迈上"新台阶"、在营造产业科技创新生态中争取"新优势"。 "稳"的基础更加巩固、"进"的态势持续增强、"新"的动能加速壮大……收官之年的亮眼表现，成为我 市"十四五"以来，面对错综复杂的外部形势和艰巨繁重的改革发展稳定任务，团结奋进、砥砺前行，保 持G ...

至少有两位分析师表示，药品标签内容和相关要求符合预期。 地中海贫血是一种遗传性血液疾病，影响人体产生血红蛋白和健康红细胞的能力。 在实施一项必需的安全计划后，Aqvesme预计将于下个月晚些时候上市。 该药物将附带关于肝细胞损伤的黑框警告，并要求在治疗的前24周内每四周进行一次肝功能检测。药品 标签还将建议肝硬化患者不要使用。 美国食品药品监督管理局(FDA)批准了Agios Pharmaceuticals(AGIO.US)药物用于治疗某种血液疾病的扩 大适应症，该股股价周三大幅上涨18.63%。 该公司周二晚间宣布，其化学名为米他匹伐(商品名：Aqvesme)的药物获批准，成为针对非输血依赖性 和输血依赖性α或β地中海贫血患者的首个口服疗法。 该公司首席财务官塞西莉亚.琼斯在周三的分析师电话会议上表示，该药物每位患者的年治疗费用约为 42.5万美元。 该公司针对的是美国约6000名成人地中海贫血患者群体，其中约4000名患者在药物上市初期即有机会获 得治疗。 此次最新批准是基于一项后期研究，在该研究中，与安慰剂组相比，接受该药物治疗的患者在血红蛋白 反应方面显示出统计学上的显著改善。 Cantor公司分析师 ...

To ensure this doesn’t happen in the future, please enable Javascript and cookies in your browser.If you have an ad-blocker enabled you may be blocked from proceeding. Please disable your ad-blocker and refresh. ...

分组1: Bristol Myers Squibb - Bristol Myers Squibb offers an attractive dividend yield of 4.6% with a payout ratio of around 85%, indicating a balance of risk and reward for investors [4][6][12] - The company faces potential patent cliffs, with its cancer drugs Revlimid and Pomalyst facing generic competition in 2026, and cardiovascular drug Eliquis losing patent protections in 2028 [6][4] - Despite these challenges, Bristol Myers Squibb has been investing in its drug pipeline through acquisitions, suggesting a likelihood of sustaining its dividend [6][4] 分组2: Medtronic - Medtronic has a dividend yield of 2.9% and has experienced a slowdown in dividend growth, which has dropped from mid to high single digits to low single digits [8][11] - The company is undergoing a restructuring to refocus on growth, including exiting certain businesses and investing in new products, with a notable spinoff of its diabetes division planned [9][11] - Medtronic has increased its dividend for 48 consecutive years, indicating strong potential for future growth and a payout ratio of around 75%, positioning it well for long-term investors [11][12]

Core Viewpoint - Agios Pharmaceuticals has received FDA approval for mitapivat, a treatment for anemia in adults with alpha or beta thalassemia, which will be marketed as AQVESME in the United States [2]. Group 1: FDA Approval - The FDA has approved mitapivat for treating anemia in adults with alpha or beta thalassemia [2]. - The drug will be marketed under the brand name AQVESME in the United States [2]. Group 2: Investor Relations - Morgan Sanford, Vice President of Investor Relations, is leading the conference call to discuss the approval and its implications [2]. - The company has provided access to presentation slides on its website for investors [2].

| | | 12月22日，据NMPA官网显示，海南合瑞制药提交的4类仿制药布地奈德肠溶胶囊获批上市，斩获国内首仿，打破云顶新耀在igAN对因治疗市场的独占局 面，重塑该领域竞争格局。 截图来源：NMPA 布地奈德肠溶胶囊是一款布地奈德的创新口服靶向迟释制剂，用于治疗具有进展风险的原发性IgA肾病成人患者。作为全球首个IgA肾病的对因治疗药物， 布地奈德肠溶胶囊不仅填补了国内从疾病源头治疗IgA肾病的空白，更为患者提供了创新的治疗选择。 大涨1581%重磅品种，云顶新耀独占鳌头 布地奈德肠溶胶囊原研公司为Calliditas，作为重磅药物，2019年，云顶新耀从Calliditas公司引进了该产品在大中华地区和新加坡的商业化权益，2023年11 月21日在国内获批上市，商品名为耐赋康，用于治疗具有进展风险的原发性免疫球蛋白A（IgA）肾病成人患者，以降低蛋白尿水平。2025年1月1日起布地 奈德肠溶胶囊正式纳入医保报销。 | 药品名称 | 通用名 | 医保目录剂型 ( | 注册剂型 0 | 医保类别 | 医保编号 | 药品分类(功能) | 区域 | 增补情况 | | --- | --- | --- | --- ...

The S&P 500 hit a record high on Wednesday, with broad gains across sectors supporting the main indexes during a shortened Christmas Eve session. The benchmark S&P 500 touched an intraday record high of 6,921.42 points, surpassing its previous peak in October, as investors continued to bet on more interest rate cuts from the Federal Reserve next year following mixed economic data. The U.S. economy grew at its fastest pace in two years in the third quarter, government data showed on Tuesday, after the releas ...

Stocks stocks closed higher on Wednesday, as the Dow Industrials and S&P 500 registered record closing highs in a broad rally during a holiday-shortened session.The blue-chip Dow rose 288.75 points, or 0.60%, to 48,731.16. The S&P 500 gained 0.3% to end at 6,932.05 points, while the Nasdaq climbed 0.2%.Indexes have been climbing in recent days, buoyed in part by a rebound in AI-related names after last week’s selloff that was triggered by concerns about inflated valuations and high capital expenditures dent ...