A prospective, multicentre open-label clinical trial to evaluate the efficacy of the fixed-dose combination of Doxylamine and Pyridoxine 10/10 mg modified-release capsules on the quality of life of pregnant women presenting with nausea and vomiting of pregnancy (NVP). - RES-6131-C1

开始日期2023-12-07

申办/合作机构-

NCT06259747

/ CompletedN/AIIT

Potential Therapeutic Implications of Acutaping on Nausea and Vomiting During Pregnancy

This study will answer the following research question:
Is acutaping has therapeutic implications on symptoms of nausea and vomiting during pregnancy?

开始日期2023-02-03

申办/合作机构

Kafrelsheikh University

100 项与琥珀酸多西拉敏相关的临床结果

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100 项与琥珀酸多西拉敏相关的转化医学

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100 项与琥珀酸多西拉敏相关的专利（医药）

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项与琥珀酸多西拉敏相关的文献（医药）

2025-01-01·WATER RESEARCH

Unexpected increase in microalgal removal of doxylamine induced by bicarbonate addition: synergistic chem-/bio-degradation mechanisms

Article

作者: Xiong, Jiu-Qiang ; Yang, Yushuang ; Jeon, Byong-Hun ; Gong, Yufeng ; Hu, Zhen-Hu ; Zhang, Xiaona ; Liang, Ying ; Qi, Xin

Microalgae-based approaches serve as promising methods for the remediation of pharmaceutical contaminants (PCs) compared to conventional wastewater treatment processes. However, how to decrease hydraulic retention times of the microalgal system currently has been one of the main bottlenecks. This study constructed an unexpected synergistic extra-chemical/intra-biological degradation system by adding 5.95 mM bicarbonate to the microalgal system, which achieved complete removal (100%) of a representative PC, doxylamine (DOX) in 96 h, compared to that 192 h in the control. Removal capacities and mass balance analyses demonstrated that biodegradation rate per unit microalgal density was significantly increased by 207%. Further analyses using transcriptomic, enzymatic inhibiting tests, and high-resolution mass spectrometry revealed that after addition of bicarbonate for metabolism of DOX, a hydrolase (CYP97C1) and a primary amine oxidase (TynA) can transform DOX into doxylamine N-oxide and an intermediate (C₁₅H₁₇NO₂) with a m/z of 244.1335. Meanwhile, bicarbonate reacted with microalgae-excreted hydrogen peroxide to form more oxidative radicals such as superoxide and hydroxyl radicals extracellularly, which promised the extracellular degradation of DOX according to the oxidative radical inhibiting tests. Further investigation showed addiing bicarbonate to the microalgal system improved the removal rate of 17 PCs by up to 500.8%. Therefore, this study not only developed an approach to enhance treatment efficiencies of diverse PCs by microalgae within a shorter time, but also carried unique mechanistic insights into the underlying principles.

2024-08-21·JOURNAL OF ANALYTICAL TOXICOLOGY

Over-the-counter medications encountered in the postmortem pediatric population from 2010–2020

Article

作者: Swatek, Jennifer L ; Marco, Stephanie M ; Midthun, Kari M

Abstract:

In forensic toxicology, the pediatric population requires special focus when evaluating positive findings because of the many toxicokinetic and toxicodynamic differences (e.g., metabolic capabilities, body size, etc.) between the pediatric and adult populations. In particular, the administration of over-the-counter (OTC) medications needs careful consideration, as dosages given to the pediatric population (0 days–18 years), particularly those given to individuals <5 years of age, tend to be lower than those given to individuals closer to adulthood. Postmortem pediatric data from 11 years (2010–2020) was compiled. A total of 1413 positive cases contained one or more of the following common OTC medications: antihistamines (brompheniramine, chlorpheniramine, diphenhydramine, doxylamine and pheniramine), pain relievers (acetaminophen, naproxen, ibuprofen and salicylates), cold/flu medications (dextro/levomethorphan, guaifenesin, ephedrine and pseudoephedrine), gastrointestinal aids (dicyclomine and loperamide) and/or sleep aids (melatonin). Antihistamines, cold/flu medications and pain relievers are the most common classes of drugs encountered in the postmortem pediatric population. To evaluate trends, three main age groups were created: ≤5 years old (5 U, birth-5 years old), middle childhood (MC, 6–11 years old), and early adolescence (EA, 12–18 years old). When considering the data, it must be noted that many of these drugs may be co-administered in single and/or multi-drug formulations. In addition, some drugs may have a variety of uses, e.g. antihistamines may also be used as sleep aids. Of note, the prevalence of cases involving those aged 6–11 years old was far less than their younger and older pediatric counterparts. With the widespread availability of OTC medications, unintentional overdoses, recreational misuse and suicidal overdoses can occur in the vulnerable, pediatric population.

2024-08-01·JOURNAL OF HAZARDOUS MATERIALS

Recovery mechanism of a microalgal species, Chlorella sp. from toxicity of doxylamine: Physiological and biochemical changes, and transcriptomics

Article

作者: Chen, Zhuo ; Xiong, Jiu-Qiang

Ubiquitous distribution of pharmaceutical contaminants in environment has caused unexpected adverse effects on ecological organisms; however, how microorganisms recover from their toxicities remains largely unknown. In this study, we comprehensively investigated the effect of a representative pollutant, doxylamine (DOX) on a freshwater microalgal species, Chlorella sp. by analyzing the growth patterns, biochemical changes (total chlorophyll, carotenoid, carbohydrate, protein, and antioxidant enzymes), and transcriptomics. We found toxicity of DOX on Chlorella sp. was mainly caused by disrupting synthesis of ribosomes in nucleolus, and r/t RNA binding and processing. Intriguingly, additional bicarbonate enhanced the toxicity of DOX with decreasing the half-maximum effective concentrations from 15.34 mg L^-1 to 4.63 mg L^-1, which can be caused by inhibiting fatty acid oxidation and amino acid metabolism. Microalgal cells can recover from this stress via upregulating antioxidant enzymatic activities to neutralize oxidative stresses, and photosynthetic pathways and nitrogen metabolism to supply more energies and cellular signaling molecules. This study extended our understanding on how microalgae can recover from chemical toxicity, and also emphasized the effect of environmental factors on the toxicity of these contaminants on aquatic microorganisms.

项与琥珀酸多西拉敏相关的新闻（医药）

2024-10-10

·PRNewswire

Duchesnay Pharmaceutical Group celebrates expansion of its treatment portfolio for nausea and vomiting of pregnancy to 40 countries around the world

Achievement highlights continued growth of Quebec-based business BLAINVILLE, QC, Oct. 10, 2024 /PRNewswire/ - Duchesnay Pharmaceutical Group (DPG), one of the eight companies across the country chosen to participate in the Government of Canada's Global Hypergrowth Project, is very proud to announce that its treatment portfolio for nausea and vomiting of pregnancy (NVP) global footprint has now expanded to include additional regulatory approvals in over 40 countries around the world. Continue Reading DPG celebrates expansion of its NVP treatment portfolio to 40 countries around the world (CNW Group/Duchesnay Pharmaceutical Group (DPG)) Developed, patented and manufactured locally at DPG's state-of-the-art facility in Blainville, Quebec, this unique product portfolio consists of the combination of doxylamine succinate and pyridoxine hydrochloride, available in different strengths and formulations under different trade names (such as Xonvea® and Bonjesta®) around the world. "This portfolio has a 40-year history of safe use by pregnant women to manage and treat NVP, often referred to as 'morning sickness,'" said Michael Gallo, Vice-President, Regulatory & Medical Affairs, Duchesnay Pharmaceutical Group. "In fact, the recognition of nausea and vomiting of pregnancy as a medical condition is a result of the efforts of the Duchesnay team, who have pioneered the scientific landscape around this serious condition since the early 2000s." This combination of doxylamine succinate and pyridoxine hydrochloride has already received market authorization in an additional 13 countries in 2024 with new approvals expected in the short term and for several years to come. "We are very proud of this accomplishment, and it would not be possible without the commitment of our teams and the collaboration and dedication of our international partners,'' said Suzanne Paszkiewicz, Vice-President, Global Partnerships & Business Development, Duchesnay Pharmaceutical Group. "The issue of NVP and the lack of approved treatment options is a universal one, therefore we are committed to continuing to address this medical need around the world." ABOUT DUCHESNAY PHARMACEUTICAL GROUP Duchesnay Pharmaceutical Group (DPG), with its affiliated companies, is headquartered in Blainville, Quebec. The Group consists of six pharmaceutical companies to meet the needs of patients in Canada, the U.S. and abroad. The companies are Duchesnay (Canada) and Duchesnay USA, both dedicated to women's health; Medunik Canada and Medunik USA, which provide treatments for rare and debilitating diseases; and Analog Pharma Canada and Analog Pharma, specializing in generic medications. From its state-of-the-art manufacturing plant, DPG exports its innovative treatments to more than 50 countries. DPG is one of the eight companies across the country chosen to participate in the Government of Canada's Global Hypergrowth Project. This appointment offers exclusive and personalized support for at least two years, in order to accelerate its growth to become an anchor firm in the Canadian economy. DPG, through its proprietary research and development, and through exclusive partnerships, offers innovative treatments for a variety of medical conditions in women's health, urology, oncology and for rare and debilitating diseases, plus lower-cost generic medications. DPG recognizes the dedication and professionalism of its employees and promotes a positive culture and flexible work environment. It is deeply committed to environmental responsibility and to giving back to the community through the support of various charitable organizations. For more information, please visit . SOURCE Duchesnay Pharmaceutical Group (DPG) WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准

2024-05-13

·信狐药迅

杭东中美华东突破性品种迈华替尼和四川科伦博泰塔戈利单抗提交上市申请| 新受理（5.6-5.12）

本周药品注册受理数据，分门别类呈现，一目了然。(5.6-5.12）小编收到有些用户反应，不想收到咱们每周文章的推送提醒，而有些用户又特别需要这个提醒，在小编强烈要求下，我们给力的程序员终于实现了可以关闭提醒的功能，这个绝对全网独一家喔，不想收到提醒的，只要在信狐药迅对话框内回复关键词“拒收文章提醒”，那么就可以不受推送的打扰啦!新药上市申请药品名称企业注册分类受理号迈华替尼片杭州中美华东制药有限公司1CXHS2400041迈华替尼片杭州中美华东制药有限公司1CXHS2400040塔戈利单抗注射液四川科伦博泰生物医药股份有限公司1CXSS2400049新药临床申请药品名称企业注册分类受理号HRS-4508片江苏恒瑞医药股份有限公司1CXHL2400465HRS-4508片江苏恒瑞医药股份有限公司1CXHL2400464TJ0113胶囊杭州天玑济世生物科技有限公司1CXHL2400459TJ0113胶囊杭州天玑济世生物科技有限公司1CXHL2400458注射用DN022150江西科睿药业有限公司1CXHL2400461注射用PLAT001海南普利制药股份有限公司1CXHL2400457AL2846胶囊正大天晴药业集团股份有限公司1CXHL2400463HRS-6209胶囊江苏恒瑞医药股份有限公司1CXHL2400447HRS-8080片山东盛迪医药有限公司1CXHL2400446HRS-8080片山东盛迪医药有限公司1CXHL2400445HRS-8080片山东盛迪医药有限公司1CXHL2400444HRS-8080片山东盛迪医药有限公司1CXHL2400443注射用盐酸ORIC-1940成都奥睿药业有限公司1CXHL2400442HS-10380片江苏豪森药业集团有限公司1CXHL2400441HS-10380片江苏豪森药业集团有限公司1CXHL2400440HRS-1358片山东盛迪医药有限公司1CXHL2400452HRS-1358片山东盛迪医药有限公司1CXHL2400451HRS-6209胶囊江苏恒瑞医药股份有限公司1CXHL2400450HRS-6209胶囊江苏恒瑞医药股份有限公司1CXHL2400449HRS-6209胶囊江苏恒瑞医药股份有限公司1CXHL2400448LPM787000048马来酸盐缓释片山东绿叶制药有限公司1CXHL2400456LPM787000048马来酸盐缓释片山东绿叶制药有限公司1CXHL2400455LPM787000048马来酸盐缓释片山东绿叶制药有限公司1CXHL2400454LPM787000048马来酸盐缓释片山东绿叶制药有限公司1CXHL2400453HP-001胶囊上海超阳药业有限公司1CXHL2400439HP-001胶囊上海超阳药业有限公司1CXHL2400438HP-001胶囊上海超阳药业有限公司1CXHL2400437HRN01胶囊北京华睿鼎信科技有限公司1CXHL2400436HRN01胶囊北京华睿鼎信科技有限公司1CXHL2400435LW347片上海长森药业有限公司1CXHL2400434LW347片上海长森药业有限公司1CXHL2400433NTQ3617片南京正大天晴制药有限公司1CXHL2400432NTQ3617片南京正大天晴制药有限公司1CXHL2400431NTQ3617片南京正大天晴制药有限公司1CXHL2400430SJP-0132滴眼液千寿制药科技(北京)有限公司1CXHL2400429HP560片海创药业股份有限公司1CXHL2400428HP560片海创药业股份有限公司1CXHL2400427B0123广州帝奇医药技术有限公司2.2CXHL2400460枸橼酸舒芬太尼注射液宜昌人福药业有限责任公司2.4CXHL2400470枸橼酸舒芬太尼注射液宜昌人福药业有限责任公司2.4CXHL2400469枸橼酸舒芬太尼注射液宜昌人福药业有限责任公司2.4CXHL2400468枸橼酸舒芬太尼注射液宜昌人福药业有限责任公司2.4CXHL2400467枸橼酸舒芬太尼注射液宜昌人福药业有限责任公司2.4CXHL2400466西达本胺片深圳微芯生物科技股份有限公司2.4CXHL2400462利多卡因丙胺卡因气雾剂山东华铂凯盛生物科技有限公司3CYHL2400089琥珀酸多西拉敏片江西新赣江药业股份有限公司3CYHL2400088盐酸毛果芸香碱滴眼液湖北远大天天明制药有限公司3CYHL2400087盐酸多塞平片南京泽恒医药技术开发有限公司3CYHL2400086盐酸多塞平片南京泽恒医药技术开发有限公司3CYHL2400085复方硫酸钠片北京韩美药品有限公司3CYHL2400084注射用多黏菌素E甲磺酸钠齐鲁制药(海南)有限公司3CYHL2400083铜[64Cu]氧奥曲肽注射液北京先通国际医药科技股份有限公司3CYHL2400082匹可硫酸钠口服溶液北京柏雅联合药物研究所有限公司3CYHL2400081洛索洛芬钠贴剂四川科伦药业股份有限公司4CYHL2400091洛索洛芬钠贴剂四川科伦药业股份有限公司4CYHL2400090带状疱疹IN001 mRNA疫苗深圳深信生物科技有限公司1.2CXSL240028723价肺炎球菌多糖疫苗复星安特金(成都)生物制药有限公司3.3CXSL2400290CM512注射液康诺亚生物医药科技(成都)有限公司1CXSL2400309重组I型单纯疱疹病毒R130注射液(Vero细胞)上海允英生物医药科技有限公司1CXSL2400308RC148注射液荣昌生物制药(烟台)股份有限公司1CXSL2400305TQB2868注射液正大天晴药业集团南京顺欣制药有限公司1CXSL2400307注射用MK-2870默沙东研发(中国)有限公司1CXSL2400304KAL-003成都厌氧君生物科技有限公司1CXSL2400303KAL-003成都厌氧君生物科技有限公司1CXSL2400302注射用BG-C9074广州百济神州生物制药有限公司1CXSL2400301RC1416注射液南京融捷康生物科技有限公司1CXSL2400300RC1416注射液南京融捷康生物科技有限公司1CXSL2400299IBI354信达生物制药(苏州)有限公司1CXSL2400298注射用CB-002上海麦科思生物医药有限公司1CXSL2400297LM-299注射液礼新医药科技(上海)有限公司1CXSL2400296KN069注射液苏州康宁杰瑞生物科技有限公司1CXSL24002949MW2821迈威(上海)生物科技股份有限公司1CXSL2400292注射用BL-M14D1成都百利多特生物药业有限责任公司1CXSL2400291HBM9027注射液和铂医药(上海)有限责任公司1CXSL2400289AFN0328注射液合肥阿法纳生物科技有限公司1CXSL2400288注射用QLS4131齐鲁制药有限公司1CXSL2400286TAL-T细胞注射液广州泛恩生物科技有限公司1CXSL2400285注射用维迪西妥单抗荣昌生物制药(烟台)股份有限公司2.2CXSL2400306德谷胰岛素注射液山东新时代药业有限公司3.3CXSL2400293泰它西普注射液荣昌生物制药(烟台)股份有限公司2.1;2.2CXSL2400295仿制药申请药品名称企业注册分类受理号盐酸多巴胺注射液海南普利制药股份有限公司3CYHS2401431盐酸溴己新口服溶液南京海纳制药有限公司3CYHS2401419盐酸溴己新口服溶液南京海纳制药有限公司3CYHS2401416注射用尼可地尔湖南赛隆药业(长沙)有限公司3CYHS2401411注射用尼可地尔湖南赛隆药业(长沙)有限公司3CYHS2401410注射用尼可地尔湖南赛隆药业(长沙)有限公司3CYHS2401409生理氯化钠溶液重庆药谷制药有限公司3CYHS2401405马来酸依那普利口服溶液成都倍特得诺药业有限公司3CYHS2401404盐酸多西环素片浙江赛默制药有限公司3CYHS2401422盐酸多西环素片浙江赛默制药有限公司3CYHS2401421盐酸曲唑酮片华益药业科技(安徽)有限公司3CYHS2401400吲哚布芬片湖南方盛制药股份有限公司3CYHS2401392依托泊苷注射液四川汇宇制药股份有限公司3CYHS2401384注射用吲哚菁绿海南紫程众投生物科技有限公司3CYHS2401375马来酸曲美布汀片湖南诺纳医药科技有限公司3CYHS2401370门冬氨酸钾镁注射液海南紫程众投生物科技有限公司3CYHS2401369葡萄糖酸钙氯化钠注射液江苏亚尧生物科技有限公司3CYHS2401383葡萄糖酸钙氯化钠注射液江苏亚尧生物科技有限公司3CYHS2401382盐酸纳美芬注射液福建新迪医药科技有限公司3CYHS2401361西咪替丁注射液云南药科院生物医药股份有限公司3CYHS2401360盐酸洛美沙星滴眼液江苏广承药业有限公司3CYHS2401352盐酸甲氧氯普胺注射液南京康发生物科技有限公司3CYHS2401351头孢地尼干混悬剂浙江巨泰药业有限公司3CYHS2401349头孢地尼干混悬剂浙江巨泰药业有限公司3CYHS2401348盐酸奥普力农注射液遂成药业股份有限公司3CYHS2401340利多卡因凝胶贴膏浙江赛默制药有限公司3CYHS2401368米诺地尔搽剂西安德立生物化工有限公司3CYHS2401338吸入用盐酸丙卡特罗溶液海南金瑞宝医药科技有限公司3CYHS2401337吸入用盐酸丙卡特罗溶液海南金瑞宝医药科技有限公司3CYHS2401336阿仑膦酸钠口服溶液山东如至生物医药科技有限公司3CYHS2401335氯化钙注射液广西铭磊维生制药有限公司3CYHS2401334阿伐那非片昆明积大制药股份有限公司3CYHS2401333阿伐那非片昆明积大制药股份有限公司3CYHS2401332吸入用布地奈德混悬液浙江赛默制药有限公司4CYHS2401432盐酸特比萘芬喷雾剂浙江寰领医药科技有限公司4CYHS2401430布洛芬缓释胶囊山东丹红制药有限公司4CYHS2401429沙库巴曲缬沙坦钠片山东新华制药股份有限公司4CYHS2401428盐酸贝尼地平片深圳大佛药业股份有限公司4CYHS2401427盐酸贝尼地平片深圳大佛药业股份有限公司4CYHS2401426单硝酸异山梨酯片珠海润都制药股份有限公司4CYHS2401415枸橼酸西地那非片南京正科医药股份有限公司4CYHS2401420枸橼酸西地那非片南京正科医药股份有限公司4CYHS2401418枸橼酸西地那非片南京正科医药股份有限公司4CYHS2401417克唑替尼胶囊重庆华森制药股份有限公司4CYHS2401414非布司他片四川依科制药有限公司4CYHS2401413非布司他片四川依科制药有限公司4CYHS2401412盐酸贝尼地平片石家庄四药有限公司4CYHS2401408克立硼罗软膏广东华润顺峰药业有限公司4CYHS2401407结构脂肪乳注射液(C6-24)江苏盈科生物制药有限公司4CYHS2401406硫酸氨基葡萄糖胶囊恒昌(广州)新药研究有限公司4CYHS2401425氧海东市平安区永安气体有限公司4CYHS2401424瑞巴派特片浙江赛默制药有限公司4CYHS2401423盐酸奥布卡因滴眼液浙江视方极医药科技有限公司4CYHS2401399甲硝唑凝胶浙江寰领医药科技有限公司4CYHS2401398硫酸特布他林雾化吸入用溶液浙江莎普爱思药业股份有限公司4CYHS2401397蔗糖羟基氧化铁咀嚼片南京恒生制药有限公司4CYHS2401396马来酸氟伏沙明片重庆赛维药业有限公司4CYHS2401395马来酸氟伏沙明片重庆赛维药业有限公司4CYHS2401394西格列汀二甲双胍片(II)湖南威特制药股份有限公司4CYHS2401393富马酸伏诺拉生片海口市制药厂有限公司4CYHS2401391富马酸伏诺拉生片海口市制药厂有限公司4CYHS2401390非诺贝特酸胆碱缓释胶囊湖南九典制药股份有限公司4CYHS2401389聚乙二醇钠钾散重庆希尔安药业有限公司4CYHS2401388聚乙二醇钠钾散四川信拓医药技术有限公司4CYHS2401387马来酸氟伏沙明片辰欣药业股份有限公司4CYHS2401386依折麦布阿托伐他汀钙片(I)江苏万高药业股份有限公司4CYHS2401385氧(液态)侨源(金堂)气体有限公司4CYHS2401403腺苷注射液大道隆达(北京)医药科技发展有限公司4CYHS2401402双醋瑞因胶囊赛灵药业科技集团股份有限公司4CYHS2401401左卡尼汀口服溶液广州一品红制药有限公司4CYHS2401381瑞格列奈片成都恒瑞制药有限公司4CYHS2401380恩格列净片浙江宏元药业股份有限公司4CYHS2401379氘丁苯那嗪片南京正大天晴制药有限公司4CYHS2401378氘丁苯那嗪片南京正大天晴制药有限公司4CYHS2401377氘丁苯那嗪片南京正大天晴制药有限公司4CYHS2401376富马酸伏诺拉生片天方药业有限公司4CYHS2401374富马酸伏诺拉生片天方药业有限公司4CYHS2401373二甲硅油乳剂成都倍特得诺药业有限公司4CYHS2401372二甲硅油乳剂成都倍特得诺药业有限公司4CYHS2401371碳酸司维拉姆片江苏天士力帝益药业有限公司4CYHS2401359马来酸非尼拉敏盐酸萘甲唑啉滴眼液浙江视方极医药科技有限公司4CYHS2401358中长链脂肪乳/氨基酸(16)/葡萄糖(16%)注射液瑞阳制药股份有限公司4CYHS2401357阿司匹林肠溶片浙江易泽达医药科技有限公司4CYHS2401356乙磺酸尼达尼布软胶囊瑞阳制药股份有限公司4CYHS2401355骨化三醇软胶囊浙江浙北药业有限公司4CYHS2401354富马酸卢帕他定片浙江赛默制药有限公司4CYHS2401353盐酸阿莫罗芬搽剂浙江寰领医药科技有限公司4CYHS2401350吡仑帕奈片成都苑东生物制药股份有限公司4CYHS2401347吡仑帕奈片成都苑东生物制药股份有限公司4CYHS2401346贝前列素钠片山东百诺医药股份有限公司4CYHS2401345曲伏前列素滴眼液广州大光制药有限公司4CYHS2401344硫酸镁钠钾口服用浓溶液广西维威制药有限公司4CYHS2401343磷酸奥司他韦胶囊陕西步长高新制药有限公司4CYHS2401342盐酸氟西汀分散片山东达因海洋生物制药股份有限公司4CYHS2401339盐酸达泊西汀片浙江施强制药有限公司4CYHS2401367替米沙坦片河北山姆士药业有限公司4CYHS2401366注射用阿糖胞苷仁合熙德隆药业有限公司4CYHS2401365替米沙坦片河北山姆士药业有限公司4CYHS2401364注射用阿糖胞苷仁合熙德隆药业有限公司4CYHS2401363替米沙坦片河北山姆士药业有限公司4CYHS2401362盐酸多柔比星脂质体注射液河北天成药业股份有限公司4CYHS2401341达比加群酯胶囊天方药业有限公司4CYHS2401331达比加群酯胶囊天方药业有限公司4CYHS2401330乳果糖口服溶液湖南及正医药科技有限公司4CYHS2401329乳果糖口服溶液湖南及正医药科技有限公司4CYHS2401328乌司奴单抗注射液百奥泰生物制药股份有限公司3.3CXSS2400048乌司奴单抗注射液(静脉输注)百奥泰生物制药股份有限公司3.3CXSS2400047乌司奴单抗注射液百奥泰生物制药股份有限公司3.3CXSS2400046进口申请药品名称企业注册分类受理号Fitusiran注射液Genzyme Corporation1JXHS2400034Fitusiran注射液Genzyme Corporation1JXHS2400033盐酸氨酮戊酸己酯软膏光动力治疗系统ASIERIS MEDITEC (Hong Kong) CO., LIMITED2.2JXHS2400035地拉罗司片Annora Pharma Private Limited5.2JYHS2400025地拉罗司片Annora Pharma Private Limited5.2JYHS2400024地拉罗司片Annora Pharma Private Limited5.2JYHS2400023BI 690517片Boehringer Ingelheim International GmbH1JXHL2400106BI 690517片Boehringer Ingelheim International GmbH1JXHL2400105LOXO-435片Eli Lilly and Company1JXHL2400104LOXO-435片Eli Lilly and Company1JXHL2400103LOXO-435片Eli Lilly and Company1JXHL2400102BI 1810631 片Boehringer Ingelheim International GmbH1JXHL2400099RO7434656注射液F. Hoffmann-La Roche Ltd.1JXHL2400098马昔腾坦分散片Actelion Pharmaceuticals Ltd.2.2JXHL2400107Upadacitinib口服溶液AbbVie Inc.2.2JXHL2400097Upadacitinib口服溶液AbbVie Inc.2.2JXHL2400096Capivasertib片AstraZeneca AB2.4JXHL2400101Capivasertib片AstraZeneca AB2.4JXHL2400100BAY 3375968Bayer AG1JXSL2400088Relatlimab注射液Bristol-Myers Squibb Company1JXSL2400085DS-7300aDaiichi Sankyo, Inc.1JXSL2400087古塞奇尤单抗注射液Janssen Research & Development, LLC2.2JXSL2400091古塞奇尤单抗注射液Janssen Research & Development, LLC2.2JXSL2400090古塞奇尤单抗注射液Janssen Research & Development, LLC2.2JXSL2400089Ropeginterferon alfa-2b注射液PharmaEssentia Corporation2.2JXSL2400086中药相关申请药品名称企业注册分类受理号蒿平颗粒新奇康药业股份有限公司1.1CXZL2400024清血败毒丸江苏中雍红瑞制药有限公司1.1CXZL2400023不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市突破性疗法

2024-05-10

·FierceHealthcare

New specialty care provider Harmonia Healthcare opens clinic to treat extreme morning sickness

Harmonia Healthcare's chief scientific officer, Marlena Fejzo, Ph.D., will also leverage her groundbreaking discovery of the hormone associated with HG to drive innovations in prognostics, prevention and treatments. Harmonia Healthcare, a new provider focused on specialty women’s health, has opened a clinic in New Jersey to treat hyperemesis gravidarum (HG). HG can bring nausea and vomiting during pregnancy severe enough to prevent proper food intake and can lead to weight loss, dehydration and ultimately hospitalization. It can cause complications for mothers and their babies and is estimated to affect up to nearly 11% of pregnant women. Harmonia’s new clinic will offer evidence-based treatments and educate patients on the latest science around HG. Its offerings include medication and vitamin infusion, electrolyte replacement plans, prescription management, diagnostic bloodwork and telehealth. A second clinic is planned to open in New York City this fall. The clinic does not require referrals. Its chief scientific officer, Marlena Fejzo, Ph.D., a women’s health researcher with lived experience of HG, will also leverage her and colleagues' groundbreaking discovery of the hormone associated with the condition—GDF15—to drive innovations in prognostics, prevention and treatment. Fejzo was a 2023 Fiercest Women in Life Sciences awardee. “We really want to fix the broken care model in women’s health and improve care,” Fejzo told Fierce Healthcare. “We hope to expand this to be the future of care for these undertreated and underdiagnosed diseases.” Harmonia’s online platform will offer educational resources and eventually telehealth, though women should still ideally first come into the clinic in person. The current status quo for women with HG is unacceptable and costly, Fejzo says. If they end up in an emergency room, they are treated with fluids or antiemetic drugs and released. But because HG causes persistent nausea and vomiting, women need persistent medication management, Fejzo argues. If they are discharged without a prescription, many will inevitably wind up back in the hospital again; 60% of women have multiple hospital visits, per Fejzo. And, while HG is starting to be diagnosed properly more often, Fejzo said, it can still be misdiagnosed or not diagnosed at all. “A lot of people think that it’s just regular nausea and vomiting and that everything’s going to be fine … when actually there are really adverse outcomes associated with HG for the mother and the baby,” Fejzo said. During a recent conference, Fejzo said she discovered ER doctors affiliated with Harvard discharge HG patients without a prescription. Their justification for it was that the medications might make them tired, and then they would have to miss work. “That’s a real misunderstanding of HG,” Fejzo said, adding that if Harvard-affiliated docs are doing it, “I assume it is common.” RELATED: New study finds cause and potential treatment for dangerous morning sickness Part of the reason Fejzo believes this is happening is due to a famous historic incident known as the thalidomide disaster. After women being treated with thalidomide for nausea had babies with birth defects, it launched a widespread hesitancy to prescribe medications during pregnancy, Fejzo said. There also remains a misguided belief that HG is psychological or resolves on its own. And because HG typically starts early in pregnancy, many women see ER docs before even seeing their obstetrician, meaning many providers may not be aware of how sick their patients have really been. Obstetricians are also generally not trained to ask their patients about their levels of nausea and vomiting—and patients, too, may not talk about it, Fejzo explained. To address this, Harmonia will be monitoring women receiving medication management and coordinating with their other providers, like OB-GYNs, midwives and doulas. The goal is to intervene as early as possible with more aggressive treatment before the condition spirals out of control. The best medications for HG being prescribed off-label include Zofran, Phenergan and Reglan, according to Fejzo. Yet doctors usually begin with doxylamine and pyridoxine, as recommended by the American College of Obstetricians and Gynecologists, which Fejzo says are “pretty much a placebo for HG.” By serving patients with HG, Harmonia will have the infrastructure in place to run clinical trials on potential new treatments, Fejzo said. She is already advising NGM Bio, which recently announced it is interested in testing its drug NGM120 in HG patients. While Fejzo doesn’t anticipate challenges with patients getting their scripts filled, Harmonia providers will educate patients on how to have conversations with pharmacists in case they do run into pushback. In recent years, pharmacists have sometimes refused to fill opioid prescriptions with doses they perceived as too high or poorly monitored by the prescriber. One of the country’s only other clinics in this space, Alabama’s Morning Sickness Clinic, claims its model has led to a 95% reduction in ER visits and a 90% decrease in total cost of care. Its co-founder, an emergency medicine physician, is one of Harmonia’s clinical advisers. Harmonia eventually hopes to expand to serve other under-researched women’s health conditions. While the company does not currently plan to pursue formal health system partnerships, it hopes that its clinics will come to be known locally as the go-to expert for these conditions. And, while it isn’t yet, Harmonia plans to be working with commercial and Medicaid insurance plans by the end of this year.

100 项与琥珀酸多西拉敏相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02327	琥珀酸多西拉敏	R06AA09	DB00366

研发状态

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适应症	国家/地区	公司	日期
超敏反应	美国	Sanofi-Aventis U.S. LLC	1948-04-07
早孕反应	美国	Sanofi-Aventis U.S. LLC	1948-04-07
入睡和睡眠障碍	美国	Sanofi-Aventis U.S. LLC	1948-04-07

未上市

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适应症	最高研发状态	国家/地区	公司	日期
妊娠剧吐	临床3期	加拿大	Duchesnay, Inc.	2006-02-01
恶心	临床3期	加拿大	Duchesnay, Inc.	2006-02-01
怀孕	临床3期	加拿大	Duchesnay, Inc.	2006-02-01
呕吐	临床3期	加拿大	Duchesnay, Inc.	2006-02-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00290732 (CTgov)	临床1期	浸润性乳腺癌	20	Doxil TM+Dox-SL (Intraductal Arm)	選夢夢選網願蓋餘觸構(齋夢觸觸夢淵顧衊範衊) = 齋選醖窪窪淵餘餘膚顧遞築餘顧構積醖積蓋簾 (餘獵夢築鏇顧夢構壓壓, 獵餘積齋遞襯廠憲衊廠 ~ 艱廠蓋鏇窪網壓願遞獵)	-	2013-09-26
				Intravenous arm (Intravenous Arm)	鏇蓋醖鹹廠積膚範顧範(鹽鑰鹹醖觸選鹹鬱餘鬱) = 膚積遞網積齋簾醖鬱簾鬱壓鏇鹹製衊艱夢膚構 (簾糧膚製範簾淵鹹簾鑰, 糧顧鹽艱觸鑰簾壓衊衊 ~ 廠構遞鹽鏇窪範憲艱齋) 更多
NCT00796315 (CTgov)	临床1期	过敏性鼻炎	41	Doxylamine Succinate (Subjects Aged 2-5 Years)	觸願齋積廠製淵淵鑰醖(齋選衊觸製網淵醖醖衊) = 鹹艱壓齋觸繭網鏇積構糧蓋構壓鹽壓觸顧艱廠 (觸簾觸鬱襯餘鬱製顧繭, 壓憲遞衊範齋鑰憲選選 ~ 築窪淵築鑰廠齋糧鏇窪) 更多	-	2013-01-25
				Doxylamine Succinate (Subjects Aged 6-11 Years)	觸願齋積廠製淵淵鑰醖(齋選衊觸製網淵醖醖衊) = 積顧鹽蓋繭獵鏇遞糧壓糧蓋構壓鹽壓觸顧艱廠 (觸簾觸鬱襯餘鬱製顧繭, 簾築遞鏇簾顧積鏇鑰鏇 ~ 蓋淵積築網遞獵築鏇獵) 更多