最近和预期的新药批准情况(2024 年第 3 季度至 2025 年第 2 季度)。

IF 2.1 4区 医学 Q3 PHARMACOLOGY & PHARMACY American Journal of Health-System Pharmacy Pub Date : 2024-11-07 DOI:10.1093/ajhp/zxae242
Matthew H Rim, Collin Dean, Enela Aliaj, Brittany L Karas, Farah Barada, Andrew M Levitsky
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引用次数: 0

摘要

免责声明:为了加快文章的发表,AJHP在接受稿件后会尽快将其发布到网上。被录用的稿件已经过同行评审和校对,但在进行技术格式化和作者校对之前会在网上发布。目的:医疗系统的药剂师在监控药品流水线以管理处方、分配资源和优化新疗法临床项目方面发挥着至关重要的作用。本文旨在通过分享新药和预期新药的批准情况来为药剂师提供支持。摘要:本文回顾了 2024 年第三季度至 2025 年第二季度这 12 个月期间预期批准的部分药物。分析强调了从 54 种等待美国食品药品管理局批准的新药中选出的预计将对医院和诊所产生重大临床和财务影响的药物。治疗癌症的新型细胞疗法不断进入药物管线,而治疗胆道癌、胃癌、胰腺癌和乳腺癌的新型靶向疗法,以及 3 种已获批准的静脉注射药物的皮下注射版正在等待审批。此外,许多治疗罕见和超罕见疾病(如遗传性血管性水肿、黄斑毛细血管扩张症、先天性肾上腺皮质增生症和巴特综合征)的新药也在开发中。此外,还有两种治疗血友病的新型皮下注射药物、一种治疗遗传性血管性水肿的新型口服药物、一种治疗特应性皮炎的新型单克隆抗体和第一种口服 penem 抗生素也在研发过程中:结论:针对癌症和罕见病的各种适应症的新药将继续增强药物管线。
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Recent and anticipated novel drug approvals (3Q 2024 through 2Q 2025).

Purpose: Health-system pharmacists play a crucial role in monitoring the pharmaceutical pipeline to manage formularies, allocate resources, and optimize clinical programs for new therapies. This article aims to support pharmacists by sharing new and anticipated novel drug approvals.

Summary: Selected drug approvals anticipated in the 12-month period covering the third quarter of 2024 through the second quarter of 2025 are reviewed. The analysis emphasizes drugs expected to have significant clinical and financial impact in hospitals and clinics selected from 54 novel drugs awaiting US Food and Drug Administration approval. New cell therapies for treating cancers continue to enter the drug pipeline, while novel targeted therapies for biliary tract, gastric, pancreatic, and breast cancers, as well as 3 subcutaneous versions of already approved drugs given intravenously, are awaiting approval. Additionally, many novel drugs are being developed for treatment of rare and ultra-rare diseases such as hereditary angioedema, macular telangiectasia, congenital adrenal hyperplasia, and Barth syndrome. Two new subcutaneous drugs for hemophilia, a new oral medication for hereditary angioedema, a novel monoclonal antibody for atopic dermatitis, and the first oral penem antibiotic are also in the pipeline.

Conclusion: New drugs with various indications for cancers and rare diseases continue to strengthen the drug pipeline.

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来源期刊
CiteScore
2.90
自引率
18.50%
发文量
341
审稿时长
3-8 weeks
期刊介绍: The American Journal of Health-System Pharmacy (AJHP) is the official publication of the American Society of Health-System Pharmacists (ASHP). It publishes peer-reviewed scientific papers on contemporary drug therapy and pharmacy practice innovations in hospitals and health systems. With a circulation of more than 43,000, AJHP is the most widely recognized and respected clinical pharmacy journal in the world.
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