Promethazine Hydrochloride

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.

扫描二维码即可下载《数图药讯》2024年第18期目   录政策解读1. 四部门联合发文：关于开展2024年医疗保障基金飞行检查工作的通知2. 国家药典委员会：关于举办药品微生物检验和生物负载监测实操培训班的通知3. 上海阳光医药采购网：关于公布全国药品集中采购（胰岛素专项接续）（GY-YD2024-1）中选结果的通知4. 上海阳光医药采购网：关于调整部分国家组织药品集中采购品种中选结果的公告5. 江苏省公共资源交易中心：关于调整部分药品供应价格的通知（苏易药发〔2024〕133号）行业动态1. 药讯动态：重磅获批和重磅临床2. 药企动态：市场动态零售品类数据洞见1. 抗组胺药零售市场趋势分析2. 苯海拉明零售（放大市场）销售分析3. 苯海拉明零售（放大市场）企业销售分析政策解读1、四部门联合发文：关于开展2024年医疗保障基金飞行检查工作的通知按照《国务院办公厅关于加强医疗保障基金使用常态化监管的实施意见》（国办发〔2023〕17号）要求，国家医保局、财政部、国家卫生健康委、国家中医药局决定在全国范围开展2024年医疗保障基金飞行检查工作。现印发《2024年医疗保障基金飞行检查工作方案》，请遵照执行。相关文件请扫描上方二维码查看2、国家药典委员会：关于举办药品微生物检验和生物负载监测实操培训班的通知为进一步强化质量风险管控理念，加强药品生产全过程控制要求，提升药品微生物检验和生物负载监测的规范性，保障药品安全性，国家药典委员会定于2024年5月28日至30日在杭州举办“药品微生物检验和生物负载监测实操培训班”。具体课程安排见附件。附件：药品微生物检验和生物负载监测实操培训班课程安排.docx关于举办药品微生物检验和生物负载监测实操培训班的通知.pdf相关文件请扫描上方二维码查看3、上海阳光医药采购网：关于公布全国药品集中采购（胰岛素专项接续）（GY-YD2024-1）中选结果的通知根据《全国药品集中采购文件（胰岛素专项接续）（GY-YD2024-1）》规定，国家组织药品联合采购办公室开展了胰岛素专项接续采购工作，现公布中选结果（详见附件）。本次集采中选结果将于2024年5月起实施，请各地做好与上一采购周期的衔接，具体执行日期以各地发布通知为准。附件1：全国药品集中采购（胰岛素专项接续）中选结果表（GY-YD2024-1)附件2：全国药品集中采购（胰岛素专项接续）中选品种供应清单相关文件请扫描上方二维码查看4、上海阳光医药采购网：关于调整部分国家组织药品集中采购品种中选结果的公告近日，国家组织药品联合采购办公室收到国家组织药品集中采购部分中选企业自主降价承诺函，涉及溴己新注射剂、奥曲肽注射剂、哌拉西林他唑巴坦注射剂、甘油果糖氯化钠注射剂型4个品种。按照《全国药品集中采购文件》有关规定，现对上述4个品种的中选价格予以调整，请国家组织药品联合采购办公室各成员单位于2024年5月1日起执行新的中选价格。附件：1.部分品种调整后中选结果2.部分品种调整后可供应清单相关文件请扫描上方二维码查看5、江苏省公共资源交易中心：关于调整部分药品供应价格的通知（苏易药发〔2024〕133号）根据《江苏省医疗保障局关于深入推进药品阳光采购的实施意见》（苏医保发〔2021〕64号）的要求和企业申请，对部分药品的供应价格进行了调整，现予以公布（详见附件）。附件：部分药品供应价格调整表.pdf相关文件请扫描上方二维码查看行业动态01药讯动态：重磅获批和重磅临床最近重磅获批正大天晴自主研发的1类创新药富马酸安奈克替尼胶囊（研发代号：TQ-B3101）获中国国家药品监督管理局（NMPA）批准上市，用于ROS1阳性的局部晚期或转移性非小细胞肺癌成人患者。 罗氏（Roche）旗下中外制药株式会社（Chugai Pharmaceutical）及其中国全资子公司日健中外制药联合申报的5.1类新药注射用尼可地尔上市申请已正式获得中国国家药监局（NMPA）批准。 齐鲁制药的靶向抗肿瘤药物鲁达欣®（地舒单抗注射液）正式获得上市许可批准，用于治疗不可手术切除或者手术切除可能导致严重功能障碍的骨巨细胞瘤，包括成人和骨骼发育成熟的青少年患者。 勃林格殷格翰（BI）阿达木单抗可互换生物类似药Cyltezo（adalimumab-adbm）的高浓度版本（100mg/mL）获FDA批准上市，用于治疗多种慢性炎症性疾病。 百济神州的PD-1抗体替雷利珠单抗第13项适应症获药监局批准上市，联合氟尿嘧啶类和铂类药物化疗用于局部晚期不可切除的或转移性的胃或胃食管结合部（G/GEJ）腺癌的一线治疗。最近重磅临床启德医药GQ1010注射液获得中国国家药监局药品审评中心（CDE）临床试验默示许可，拟开发治疗晚期实体瘤成年患者。 普米斯自主研发的抗PD-L1/VEGF双特异性抗体新药PM8002注射液获中国国家药品监督管理局药品审评中心（CDE）批准开展一项多中心、随机、双盲注册性3期临床试验，针对的适应症为——PM8002注射液或安慰剂联合注射用白蛋白结合型紫杉醇一线治疗不可手术的局部晚期/复发转移性三阴性乳腺癌。 加科思药业自主研发的KRAS G12C抑制剂戈来雷塞（glecirasib）的2期注册性临床数据达到主要研究终点。 康诺亚研发的司普奇拜单抗治疗季节性过敏性鼻炎（SAR）的III期临床研究完成双盲治疗期数据揭盲及统计分析，临床数据达到主要终点。 阿斯利康宣布，III期ECHO研究中期分析结果显示，相较于标准化疗免疫疗法，BTK抑制剂Calquence（阿可替尼）与标准化疗免疫疗法（苯达莫司汀和利妥昔单抗）联合治疗使套细胞淋巴瘤（MCL）患者的无进展生存期（PFS）实现显著的统计学意义和临床意义改善。 02药企动态：市场动态4月29日，Repertoire®Immune Medicines宣布，该公司已与百时美施贵宝（BMS）达成多年战略合作，共同开发针对多达三种自身免疫性疾病的耐受性疫苗（tolerizing vaccines）。该合作旨在通过重置免疫系统，为患有自身免疫性疾病的患者开发有效、有选择性和持久的治疗方法。根据协议条款，除了获得分级版税外，Repertoire将获得6500万美元的预付款，以及高达18亿美元的开发、监管和商业里程碑付款。Repertoire将领导所有活动直至候选药物被BMS选中，而BMS将获得耐受性疫苗的全球独家开发和商业化权益。此外，在临床开发期间，该公司将部署DECODE来监测患者对疫苗的免疫反应，为疫苗的药效学效应提供关键见解。 4月30日，苏州星核迪赛生物技术有限公司宣布完成近亿元天使轮融资。本轮融资由复星医药旗下复健资本新药创新基金领投，创瑞投资杭实创盈基金参与投资。根据星核迪赛新闻稿，本轮融资将用于DSL101和DSL201等核心管线的持续推进、继续开发新型脂质化合物及LNP递送系统，进一步拓展核酸药物管线布局等。零售品类数据洞见01抗组胺药零售市场趋势分析图1：2020-2023抗组胺药零售（放大市场）销售额数据来源： 中国药品零售数据库RPDB药店数据中国医药工业信息中心抗组胺药是组胺受体的阻断药，分为第一代抗组胺药物苯海拉明、扑尔敏和异丙嗪等，第二代抗组胺药物特非那丁、阿司米唑等，第三代抗组胺药物左旋西替利嗪、地氯雷他定等。抗组胺药最主要的作用是抗过敏，同时还有松弛消化道平滑肌的作用，用于治疗晕车恶心和呕吐等症状，还可扩张支气管治疗哮喘，临床应用较为广泛。 02苯海拉明零售放大市场销售分析图2: 2021-2023年苯海拉明零售（放大市场）销售额数据来源： 中国药品零售数据库RPDB药店数据中国医药工业信息中心苯海拉明具有很好的止痒效果，能够快速改善过敏的症状，还可用于预防晕船、晕车、晕飞机等晕动病。由于其方便使用、疗效明显等特点，销量自2021年起逐渐增加。 03苯海拉明零售放大市场销售分析图3: 2023年Q1-Q3苯海拉明零售端销售额Top 10企业数据来源： 中国药品零售数据库RPDB药店数据中国医药工业信息中心统计了苯海拉明全国销售额TOP 10的企业，山东新华制药股份有限公司、吉林省博大制药股份有限公司位列苯海拉明零售端销售额榜单TOP2，销售额分别为752.51万元、628.33万元。来源：医药地理、国家药监局、腾讯、新浪等。END如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001