Search Results for “FDA” – Page 86 – media

Junshi Biosciences’ PD-1 Approved in the EU, Achieving Market Launch in China, the US, and Europe

As a result, Toripalimab has become the first and only PD-1 approved for the treatment of nasopharyngeal carcinoma in Europe, as well as the only first-line treatment drug for advanced or metastatic esophageal squamous cell carcinoma regardless of PD-L1 expression. Prior to this, Toripalimab had already been approved in China and the US. On July 28, Junshi Biosciences announced that Toripalimab’s marketing authorization application received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), recommending its approval for the aforementioned indications. Toripalimab injection (Chinese trade name: Tuoyi®) is the first domestically approved PD-1 monoclonal antibody in China. In December 2018, the National Medical Products Administration conditionally approved Toripalimab for the treatment of unresectable or metastatic melanoma in patients who had failed prior systemic therapy. As of now, Toripalimab has received approval for seven indications in China, covering the treatment of melanoma, nasopharyngeal carcinoma, ...
- Source: drugdu
- 77
- September 25, 2024
Wealth myth” of GLP-1

Recently, the Lasker Award, an important award in the field of biomedicine known as the “vane” of the Nobel Prize, was announced. Among them, the “Clinical Medical Research Award” was awarded to Joel Habener (Massachusetts General Hospital), Lotte Bjerre Knudsen (Novo Nordisk) ) and Svetlana Mojsov (Rockefeller University). The reason for the award is that they discovered and developed GLP-1-based drugs, which revolutionized the treatment of obesity. GLP-1, glucagon-like peptide-1, is a peptide hormone encoded by the human glucagon gene and secreted by intestinal L cells. It can promote the synthesis and secretion of insulin and suppress appetite. Delaying the emptying of gastric contents, etc. Representative products include Novo Nordisk’s semaglutide and Eli Lilly’s tilpotide. It is worth mentioning that the research on GLP-1 has not only received attention from academic awards, but also brought “vast wealth” to companies in the industrial chain due to the huge market demand. The ...
- Source: drugdu
- 76
- September 25, 2024
Edward Life Sciences launches global business layoffs

After Edward Life Sciences (hereinafter referred to as Edward) sold its intensive care business to Becton DickinsonMedical for $4.2 billion, a major global layoff has begun. Approximately 3% of employees will be affected by this layoff, and according to proportional calculations, about 540 employees will be laid off. Edward CEO Bernard Zovighian stated that employees affected by the global layoffs have received notice today that some employees may temporarily stay to assist with the transformation of the intensive care business, while others may find other jobs within the company. 30.4 billion yuan sale, 4500 employees join Becton Dickinson Edward is deeply engaged in the fields of global structural heart disease, intensive care, and surgical monitoring. Currently, he has multiple advanced products such as heart valves, cardiac intervention therapy equipment, cardiac monitoring equipment, and surgical tools. Among them, with the “world’s first successfully implanted artificial mitral valve”, Edward firmly occupies the ...
- Source: drugdu
- 66
- September 24, 2024
Yingsi Intelligent’s world’s first TNIK inhibitor ISM001-055 has achieved positive results in phase IIa clinical trials

·ISM001-055 is an innovative drug driven by generative artificial intelligence and fully developed independently by Insilicon Intelligence. It targets TNIK (Traf2/NCK interacting kinase) and has completed phase IIa clinical trials for the treatment of patients with idiopathic pulmonary fibrosis (IPF); ·This study lasted for 12 weeks, and its preliminary results showed that ISM001-055 exhibited good safety in IPF patients and showed a dose-dependent pharmacological trend in improving lung function indicators in patients; ·The positive clinical trial results of ISM001-055 also provide the first conceptual validation for AI driven drug development. Hong Kong, China, September 18, 2024- Yingsi Intelligent, a clinical stage biotechnology company driven by generative artificial intelligence (AI), announced that its pipeline ISM001-055 has achieved positive preliminary research results in a phase IIa clinical trial. ISM001-055 is a “first in class” small molecule inhibitor driven by generative AI for drug discovery and design, targeting TNIK (Traf2/NCK interacting kinase) for ...
- Source: drugdu
- 68
- September 23, 2024
Lepu Biotech’s Injection of Vebecotamab Aiming for Priority Review for Nasopharyngeal Carcinoma

On September 19, the National Medical Products Administration (NMPA) released a public notice on its drug evaluation center’s official website, announcing that Lepu Biotech’s injection of Vebecotamab is proposed for priority review. This treatment is intended for patients with recurrent or metastatic nasopharyngeal carcinoma who have previously failed at least two lines of systemic chemotherapy and PD-1/PD-L1 inhibitor therapies. This drug, developed by Lepu Biotech, is an antibody-drug conjugate (ADC) targeting EGFR, with the development code MRG003. It is composed of an EGFR-targeted monoclonal antibody linked to a potent microtubule inhibitor, MMAE, through a vc linker. The molecular design of this drug has the potential to extend its application to a broader range of cancers that overexpress EGFR and may overcome various types of resistance caused by common mutations. In its previously published semi-annual report, Lepu Biotech indicated plans to submit a new drug application (NDA) for MRG003 to the ...
- Source: drugdu
- 66
- September 23, 2024
全球及中国在长效术后镇痛制剂领域的市场需求不断增长

近期，科伦药业发布公告，其子公司湖南科伦制药的化学药品“布比卡因脂质体注射液”获得国家药监局批准上市（商品名布瑞科®），按照化药3类获批，视同通过仿制药质量和疗效一致性评价。科伦药业的布瑞科®是我国第二个上市的布比卡因脂质体注射液产品。恒瑞医药的布比卡因脂质体注射液仿制药（商品名：艾恒平）已于2022年11月获批，为全球首仿药，同时也为国内首个上市的长效术后镇痛药物。今年7月，艾恒平获FDA批准上市，成为全球首家在美国获得该品种仿制药批准的厂家。国产药企接连成功突围背后，是全球及中国在长效术后镇痛制剂领域不断增长的市场需求。中国术后疼痛发生率仍然较高术后疼痛（postoperative pain）指手术操作引起的急性创伤和内脏器官的损伤以及神经末梢周围炎性刺激引起的疼痛。术后疼痛自麻醉清醒后出现，疼痛高峰期为术后24至48小时，持续时间一般不超过3到7天。术后疼痛短期内会对病人的心血管功能、呼吸功能、神经内分泌及免疫和心理情绪等方面造成不利影响，如术后疼痛在急性期没有得到有效控制，将有可能发展为慢性术后疼痛，持续时间可达半年甚至数十年。术后疼痛管理是保证术后镇痛效果的重要环节。术后疼痛管理的目标包括在安全的前提下，持续、有效镇痛。目前虽然非药物治疗，如理疗、音乐、分散注意力等方法有不同的治疗效果的研究报道，但手术后急性疼痛治疗仍以药物治疗为主。当前临床术后镇痛使用的主要药物包括：阿片类镇痛药、非甾体类抗炎药和局部麻醉药。其中局部麻醉药通过局部神经阻滞发挥区域镇痛作用，相比其他类型镇痛药物全身系统性不良反应少，但往往作用时间和强度不够，神经阻滞持续时间通常少于8小时，而术后疼痛的管理通常需要数天，临床可应用非连续多次注射局部麻醉药、硬膜外腔或外周神经插入导管连续输注药物、一次性泵等方法实现持续数天的术后镇痛。持续局部麻醉药输注可有效控制疼痛并减少术后阿片类药物的使用，但需要相对昂贵的设备和连续监测，且长期留置导管易引起导管移位和并发症。频繁给药也会增加血药浓度波动、降低患者依从性，给患者造成疼痛和不方便、导致严重的副作用。尽管国内术后疼痛管理开展已有二十余年的历史，国内术后疼痛患者人群数量仍然较大。国家统计局数据显示：2022年，我国医疗卫生机构住院病人手术人次达到8271.75万人。而2023年一项对中国大陆百余医疗中心的横断面研究显示，手术后中重度疼痛的发生率达48.7%，包括32.2%的患者患有严重术后疼痛。这意味着国内不同程度的术后疼痛患者总数可能达到四千万人以上。布比卡因脂质体如何治疗术后疼痛？布比卡因（bupivacaine）是一种酰胺类的局部麻醉药，通过可逆地阻断快速电压门控钠离子通道来阻断神经脉冲的传递，从而达到镇痛效果。其盐酸盐即盐酸布比卡因早在1972年就已经在美国作为局部麻醉药上市，商品名包括Marcain、Marcaine（麻卡因）、Sensorcaine及Vivacaine，主要用于局部浸润麻醉、外周神经阻滞和椎管内阻滞。短效布比卡因制剂麻醉效果能维持3-6小时或更长时间，无法覆盖术后三至四天的疼痛高峰期。在此背景下，2011，FDA批准了Pacira BioSciences公司研制的布比卡因脂质体注射液用于直接注射至手术部位以帮助控制术后疼痛，商品名Exparel，是首个在美国上市的长效术后镇痛药物。2018年，FDA批准其扩大使用范围，包括围术期或术后通过肌间沟臂丛神经阻滞给药以产生手术后局部镇痛。公开数据显示，2023年Exparel全球销售额达到4.8亿美元，折合人民币约34亿，从2012年以来的复合增长率为40%，具体销售额趋势如下图。 Exparel在仅有两个适应症的情况下，产品销售额仍能接近5亿美元，原因主要在于产品独特的作用机制和高昂的价格。多囊脂质体(multivesicular liposomes,MVL)是以储库泡沫技术为基础的非同心脂质体，其内部由许多水性腔室以非同心圆的形式紧密填充构成，在注射部位能够蓄积形成药物储库，通过脂质腔室溶蚀实现药物缓释效果，各个水性腔室之间以脂质双分子层相隔，具有较高的药物包封率和回收率，可以用于小分子药物和蛋白、多肽等高分子药物的包封。多囊脂质体的囊泡较大，载药量大，包封率高，具有较好的生物相容性，目前用于开发长效缓释制剂。布比卡因脂质注射液通过多个囊泡结构的脂质体包裹药物缓释释放，不仅将镇痛效果延长至72小时，还可以减少布比卡因带来的副作用。长效镇痛制剂需要平衡药品的安全性与长效性、起效速度与起效平稳性。作为全球首个获批的长效局麻药，Exparel相关100多项临床试验涉及拇囊炎切除术、痔切除术、前列腺切除术、膝关节置换术、胸腔手术等的术中术后镇痛，以及儿科用药临床试验，临床结果支持Exparel应用于几乎所有手术的局部浸润麻醉以及术后镇痛；对不同手术，可避免使用或减少使用45%～78%阿片类药物；且与普通注射液相比能够在72小时内维持有效血药浓度的同时始终低于CNS毒性限度且没有药物突释行为，没有CNS不良反应病例报道。此外有研究显示布比卡因脂质体的血药浓度峰值低于盐酸布比卡因，或可一定程度上降低中枢及心脏相关毒性风险。 Exparel在美国的用药费用高昂，一瓶20毫升的Exparel售价约为376美元，而相同尺寸的盐酸布比卡因每瓶售价为38美元。未来长效术后镇痛制剂的发展方向长效术后镇痛制剂仍属于有待开拓的药物领域。在Exparel上市后，FDA相继批准上市了四款非阿片类术后长效镇痛药，均为布比卡因的改良制剂。改良型长效局部麻醉药已成为国内术后镇痛药的研发热点。目前恒瑞制药和科伦制药的布比卡因脂质体分别于2022年11月和2024年8月获批上市，另有2个布比卡因活性成分和5个罗哌卡因活性成分长效注射制剂药物进入申报或开展临床阶段。长效术后镇痛制剂这一品类仍有很大的发展空间，布比卡因脂质体作为长效术后镇痛制剂品类中上市的首个药物，相比原研药在美国的高昂用药费用，国产布比卡因脂质体注射液每支价格为382元，并且已成功通过国谈纳入医保药品目录。国内手术数量不断增长驱动布比卡因脂质体需求提升，新适应症的上市将持续推动这一品种的市场空间，且研发壁垒决定了其良好的竞争格局，具有可观的市场潜力。来源：https://news.yaozh.com/archive/44217.html
- Source: drugdu
- 83
- September 21, 2024
Former President of Johnson & Johnson Orthopedics jumps to orthopedic giant!

Johnson & Johnson has had frequent executive changes in recent years, not only in the innovative pharmaceutical industry, but also in the medical technology department. At least nine executive changes have been reported since 2023. Recently, Enovis, a global orthopedic giant, announced the appointment of Tim Czartoski as president of its U.S. surgical and global products and supporting technologies business. Tim Czartoski previously worked in the DePuy Synthes orthopedic business unit of Johnson & Johnson Medical Technology. Tim Czartoski is a very experienced veteran in the medical field. He has more than 20 years of experience in the medical technology industry, especially in the orthopedic business. Tim Czartoski has held several key positions at Johnson & Johnson, leading the growth of Johnson & Johnson’s business. Looking back at Tim Czartoski’s career at Johnson & Johnson, he has held several positions in the DePuy Synthes orthopedic business unit of Johnson & ...
- Source: drugdu
- 65
- September 21, 2024
Novo Nordisk’s new anchor

In the first half of 2024, Novo Nordisk achieved revenue of 133.4 billion Danish kroner, a year-on-year increase of 24%, and its performance continued to grow. The increase in the volume of semaglutide is a key factor in the growth of performance. Ozempic, a semaglutide hypoglycemic injection, achieved revenue of 56.7 billion Danish kroner, Rybelsus, a semaglutide hypoglycemic oral agent, achieved revenue of 10.9 billion Danish kroner, and Wegovy, a semaglutide weight loss injection, achieved revenue of 21 billion Danish kroner. The total sales of semaglutide were 88.7 billion Danish kroner, a year-on-year increase of 43%, accounting for 2/3 of Novo Nordisk’s total revenue. While semaglutide is selling well around the world, Novo Nordisk is also constantly adjusting and optimizing its R&D strategy and business layout. By enriching its product portfolio, it will further strengthen its dominant position in the field of blood sugar and fat reduction. At the same ...
- Source: drugdu
- 53
- September 20, 2024
How many drugs does Biotech need to sell to avoid losing money?

Looking around the world, biotech is a group with extremely high “metabolism”. According to statistics from GF Securities, since 1990, more than 600 biotech companies have IPOed on Nasdaq. However, as of June 30, 2020, only 12 biotechs have relatively stable income and positive cash flow. Extending the timeline, from the rise of the concept of biotech in the 1980s to the present, in 40 years, there are only a few who have entered the pharma camp by buying on their own. Why is it difficult for biotech to survive for a long time? This is determined by the business model. Compared with large pharmaceutical companies with average growth but strong certainty, biotech is a divergent innovation model, and the growth process is full of uncertainty. In other words, due to the high risk of R&D and the uncertainty of sales, most biotechs can’t run the business model at all, ...
- Source: drugdu
- 52
- September 20, 2024
Clinical study of innovative gene therapy drug LY-M003 injection launched

LY-M003 Disclaimer: Due to limited proficiency, errors are inevitable, or some information may not be timely. Please feel free to leave a message to indicate. This article only provides an introduction to medical and health-related drugs, and does not recommend treatment plans (if applicable); This article does not constitute any investment advice. Recently, a prospective, single center, open label, single arm, single dose clinical study evaluating the safety, tolerability, and efficacy of LY-M003 injection in the treatment of adult patients with Wilson’s disease was launched at the First Affiliated Hospital of Zhejiang University School of Medicine (hereinafter referred to as “Zhejiang First Hospital”). The project was led by Professor Yu Chaohui, the leader of the Gastroenterology Department, as the main researcher. LY-M003 injection is an innovative gene therapy drug developed by Lingyi (Hangzhou) Biotechnology Co., Ltd. (hereinafter referred to as “Lingyi Biotechnology”). The Department of Gastroenterology at Zhejiang First Hospital ...
- Source: drugdu
- 82
- September 19, 2024

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.