关键词: Food and Drug Administration drug approval clinical trials drug approval process investigational drugs medication development new drug approvals

Mesh : Humans Drug Approval United States United States Food and Drug Administration Pharmacists / organization & administration Antineoplastic Agents / therapeutic use

来  源:   DOI:10.1093/ajhp/zxae046

Abstract:
OBJECTIVE: 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 providing periodic updates on new and anticipated novel drug approvals.
CONCLUSIONS: Selected drug approvals anticipated in the 12-month period covering the first quarter of 2024 through the fourth quarter of 2024 are reviewed. The analysis emphasizes drugs expected to have significant clinical and financial impact in hospitals and clinics, as selected from 59 novel drugs awaiting US Food and Drug Administration approval. This year\'s pipeline includes recently added drugs with various indications including oncology, infectious diseases, genetic disorders, and rare diseases. New cellular and gene therapies are rapidly evolving and being studied for several rare diseases and cancers.
CONCLUSIONS: More oncology agents, including gene therapies, oral agents, and monoclonal antibodies, are in the pipeline this year. Additional diseases targeted by new novel drugs, including cellular and gene therapies, are hemophilia, nonalcoholic steatohepatitis, Alzheimer\'s disease, and rare diseases such as galactosemia and epidermolysis bullosa.
摘要:
结论:为了加快文章的发表,AJHP在接受后尽快在线发布手稿。接受的手稿经过同行评审和复制编辑,但在技术格式化和作者打样之前在线发布。这些手稿不是记录的最终版本,将在以后替换为最终文章(按照AJHP样式格式化并由作者证明)。
目的:卫生系统药师在监控药品管道管理处方中起着至关重要的作用,分配资源,并优化新疗法的临床计划。本文旨在通过提供有关新药和预期新药批准的定期更新来支持药剂师。
结论:审查了2024年第一季度至2024年第四季度的12个月内预期的部分药物批准。该分析强调了预计会在医院和诊所产生重大临床和财务影响的药物,从等待美国食品和药物管理局批准的59种新药中选出。今年的管道包括最近添加的具有各种适应症的药物,包括肿瘤学,传染病,遗传性疾病,和罕见的疾病。新的细胞和基因疗法正在迅速发展,并正在研究几种罕见的疾病和癌症。
结论:更多肿瘤药物,包括基因疗法,口服药物,和单克隆抗体,今年正在筹备中。新新药针对的其他疾病,包括细胞和基因疗法,是血友病,非酒精性脂肪性肝炎,老年痴呆症,和罕见的疾病,如半乳糖血症和大疱性表皮松解症。
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