This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.

开始日期2024-10-01

申办/合作机构

Idorsia Pharmaceuticals Ltd.

[+1]

NL-OMON52180 / Suspended临床4期

Prospective evaluation of potential effects of repeated gadoliniumbased contrast agent (GBCA) administrations of the same GBCA on motor and cognitive functions in neurologically normal adults in comparison to a non-GBCA exposed control group*ODYSSEY - Longterm study of GBCAs on motor, cognitive function after repeated CE-MRI

开始日期2022-03-31

申办/合作机构

IQVIA, Inc.

NCT05264506 / Terminated临床3期

A Phase 3, Open-label, Multi-center, Single-arm Study to Assess Contraceptive Efficacy and Safety of the Nomegestrol Acetate + 17β-estradiol Combined Oral Contraceptive (OG-8175A) in Premenopausal Females Aged 14 to 35 Years (Inclusive)

The purpose of this study is evaluating Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive in Premenopausal Females Aged 14 to 35 Years (Inclusive).

开始日期2022-02-17

申办/合作机构

Organon & Co.

[+1]

100 项与 IQVIA, Inc. 相关的临床结果

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0 项与 IQVIA, Inc. 相关的专利（医药）

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1,492

项与 IQVIA, Inc. 相关的文献（医药）

2024-09-01·Journal of Managed Care & Specialty Pharmacy

Treatment patterns and hospitalizations following rejection, reversal, or payment of the initial once-monthly paliperidone palmitate long-acting injectable antipsychotic claim among patients with schizophrenia or schizoaffective disorder

Article

作者: Lee, Inyoung ; Patel, Charmi ; Wang, Yi ; Benson, Carmela ; Shaikh, Nazneen Fatima ; Zhao, Xiaohui ; Near, Aimee M.

BACKGROUNDOnce-monthly paliperidone palmitate (PP1M) is a long-acting injectable antipsychotic approved for the treatment of schizophrenia and schizoaffective disorder (SCA) in adults.OBJECTIVETo assess treatment patterns and schizophrenia/SCA-related hospitalization following payer rejection, patient reversal, or payment of an initial PP1M claim.METHODSThis was a retrospective cohort study using the IQVIA Formulary Impact Analyzer database linked to the Medical Claims, Hospital Charge Detail Master, and Experian consumer databases. Patients with schizophrenia/SCA and ≥1 PP1M pharmacy claim from January 1, 2018, to February 28, 2022, were identified and stratified into 3 cohorts based on the transaction status of the initial PP1M claim (index date): rejected (payer not approved), reversed (payer approved, patient abandoned), and paid (payer approved, patient filled). Patient characteristics during the 12 months before the index date, subsequent treatment patterns, and schizophrenia/SCA-related hospitalization for patients with >6 months of follow-up were assessed by cohort.RESULTSThe rejected, reversed, and paid cohorts included 1,260, 1,046, and 1,686 patients, respectively. Across these cohorts, the mean ages ranged between 39.2 and 44.5 years; more than half were male (50.8%-51.6%) and White (50.6%-58.3%); 19.8%-24.6% of patients had a Quan-Charlson Comorbidity Index score of ≥2. Rates of prior atypical oral and long-acting injectable antipsychotic use ranged between 76.4%-80.3% and 7.8%-12.7%, respectively. Among patients with ≥6 months of follow-up, 52.2% in the rejected and 53.1% in the reversed cohorts had a subsequent paid PP1M claim during the study period; the median (quartile 1-quartile 3) time to the first paid PP1M claim was 22 (5-74) days for rejection and 11 (1-41) days for reversal. In the rejected and reversed cohorts, 10.2% (n = 111) and 9.8% (n = 90) of patients, respectively, did not receive any paid claim for an antipsychotic after the initial PP1M rejection/reversal. The prevalence of schizophrenia/SCA-related hospitalization during follow-up was similar between patients with a paid (7.4%) and rejected PP1M claim (7.0%; P = 0.689) but higher among patients with a reversed claim (10.8%; P = 0.004). After adjusting for confounders, patients in the reversed cohort were 39% more likely to have a schizophrenia/SCA-related hospitalization than those in the paid cohort (odds ratio = 1.39; 95% CI = 1.03-1.87).CONCLUSIONSPayer rejection and patient reversal of initial PP1M claims is a form of primary nonadherence and may influence patient trajectory. Data from this study suggest that patient reversal of PP1M may lead to an increased risk of schizophrenia/SCA-related hospitalizations, potentially caused by missed or delayed treatment. Policy initiatives that remove barriers to primary adherence or fulfillment may help improve patients' clinical outcomes.

2024-06-18·Proceedings of the 28th International Conference on Evaluation and Assessment in Software Engineering

Using Large Language Models to Generate JUnit Tests: An Empirical Study

作者: Siddiq, Mohammed Latif ; Tanvir, Ridwanul Hasan ; Al Rifat, Fahmid ; Da Silva Santos, Joanna Cecilia ; Carvalho Lopes, Vinícius ; Ulfat, Noshin

2024-06-02·Current Medical Research and Opinion

Awareness, attitudes, and practices regarding meningococcal serogroup B vaccination in the United States among parents of older adolescents and among young adults: a plain language summary

Article

作者: Clements, Diana E. ; Tuly, Rifat ; Zhou, Zifan ; Preiss, Scott ; Oladele, Eni ; Multani, Jasjit K. ; Herrera-Restrepo, Oscar ; Krishnan, Annie ; Shi, Liucheng ; Chen, Chi-Chang ; Conley, Wanda J.

MenB disease, a type of meningitis, is a serious and life-threatening illness.The US Centers for Disease Control and Prevention recommends that 16-23-yr-olds get a MenB vaccine after talking with their healthcare provider and deciding it is the right choice.As of 2021, only about 3 in 10 17-yr-olds had received a MenB vaccine.We used an online survey to learn about parents of older teens & prime; (16-18 years) and young adults & prime; (19-23 years) awareness, and practices related to meningitis and the MenB vaccine.Parents of non-vaccinated teens, and non-vaccinated young adults, had a lower awareness of the causes, risks, and symptoms of meningitis, and the MenB vaccine.Most parents thought the impact of meningitis would be severe, compared with young adults who thought it would be less severe.Most participants were also not aware of their role in deciding if they or their child should be vaccinated against MenB.However, most showed a high interest in learning more about meningitis and the MenB vaccine.We also found, most teens and young adults who received the MenB vaccine right after talking about it with their healthcare provider.These findings show awareness and thoughts about meningitis and MenB vaccination.Providing education and resources to parents, young adults, and healthcare providers could create more opportunities to discuss MenB vaccination and lead to more teens and young adults accessing vaccination and being protected against meningitis.

377

项与 IQVIA, Inc. 相关的新闻（医药）

2024-10-31

·普利制药300630

【新品上市】普利抗过敏赛道新增重磅产品-普利制药富马酸卢帕他定片获国家药品监督管理局批准上市！

喜讯普利制药富马酸卢帕他定片获国家药品监督管理局批准上市！ ——新品上市—— 海南普利制药股份有限公司旗下的全资子公司浙江普利药业有限公司于近日收到国家药品监督管理局（以下简称“NMPA”）所签发的富马酸卢帕他定片的药品注册批件，视为通过一致性评价批准上市，将为拓展国内市场带来积极影响。该产品的获批丰富了我公司在抗过敏治疗药物中的产品管线，更好地满足临床用药需求，为广大患者提供更多更优的用药选择。 01 普利抗过敏赛道的布局普利制药在抗过敏领域深耕已久，其芙必叮®地氯雷他定系列产品为公司的抗过敏线领导品牌，也是公司的王牌品牌，芙必叮系列产品在同通用名地氯雷他定市场国内市占率将近7成，占有率全国第一，是全国使用最广泛的抗组胺药物之一，上市至今在临床使用近20年，受到了临床医生和患者的广泛认可。 ▲数据源于米内网普利芙必叮®地氯雷他定系列产品为国家级火炬项目，均过一致性评价。有三种剂型，分别为地氯雷他定片、地氯雷他定分散片及地氯雷他定干混悬剂，三种剂型全方位覆盖全年龄段不同患者，充分满足市场的不同需求。芙必叮®地氯雷他定片于2002年在国内首仿上市，并于2019年通过仿制药一致性评价，第三批国家集采中标，目前已出口德国、荷兰、马来西亚。芙必叮®地氯雷他定分散片于2004年国内独家上市，其分散剂型为全国独家剂型，并于2021年通过一致性评价。作为普利独家产品，已获批OTC，成为新一代的抗过敏非处方药物芙必叮®地氯雷他定干混悬剂于2004年国内独家上市，其干混剂型为全国独家剂型，为儿童的专属剂型，并于2021年通过一致性评价。普利制药此次获批的抗过敏药富马酸卢帕他定片商品名为芙必叮®，为抗过敏赛道新增重磅产品，代表了普利医学底蕴与专业支撑。普利将以此为契机，进一步提升并打造抗过敏领域普利芙必叮的品牌影响力和知名度。除了此次获批的富马酸卢帕他定片，普利制药在抗过敏赛道还布局有地氯雷他定口服溶液、比拉斯汀片、盐酸非索非那定口服混悬液等抗过敏药物，以此丰富抗过敏产品线，为荨麻疹及其他过敏性皮肤病提供新的用药选择！ 02 卢帕他定—新型二代抗组胺药富马酸卢帕他定片在2001年首次在西班牙上市，批准适应症为季节性和常年性过敏性鼻炎，商品名为Rupafin。目前，本品除在西班牙上市之外，还在巴西、葡萄牙、希腊、俄罗斯、日本和韩国等国家上市。双重作用机制富马酸卢帕他定片为第二代抗组胺药物，是一种长效、选择性外周H1受体拮抗剂。具有抗组胺和血小板拮抗活化因子（PAF）双重作用，通过选择性拮抗组胺H1受体发挥作用，能抑制致敏细胞脱颗粒及炎性细胞因子的释放，发挥抗过敏作用。并且药物在体内的一些代谢产物（地氯雷他定及其羟基代谢物）仍然具有抗组胺活性，有利于增强整体药效。组胺与PAF在过敏反应中的作用研究表明，过敏和炎症性疾病是由多种不同介质的生成和释放产生的多因素复杂过程。组胺即是在变态反应早期和这类疾病症状出现时含有的最多炎性介质。它是被抗原激活的肥大细胞和嗜碱细胞释放而产生的。这类疾病症状如打喷嚏、鼻痒、含泪和流涕大多数都是由组胺 H1 受体所导致的。[1]而 PAF 则是气道炎症中又一重要炎性介质。像组胺一样，PAF 也可以引起支气管的收缩和血管通透性的增强。从而导致流涕和鼻充血。同时，它还能引起支气管敏感度的上升，支气管敏感度的上升是诱发哮喘的主要原因。有研究表明 66%的哮喘因鼻炎诱发，鼻部疾病是哮喘、慢性肺阻塞、支气管扩张等气管疾病的起始点。[2-3] PAF 和组胺的作用是互补的，组胺是从肥大细胞贮藏器中释放出的早期应答介质，而 PAF 则是从头合成的。目前，临床上使用的抗过敏药均只有抗组胺活性，而没有 PAF 拮抗作用。很显然，同时阻断组胺和 PAF 的药物将会比仅阻断其中一种具有更好的临床效果。富马酸卢帕他定是目前唯一上市的既具有抗阻胺作用又拮抗 PAF 活性的抗过敏药。因此，将会有较好的临床应用前景。[2,4] 03 卢帕他定市场数据全球根据IQVIA数据，富马酸卢帕他定片2023年全球销售额达到约2.28亿美元，其中中国市场销售占比17%，全球排名第二，中国为卢帕他定主要市场之一。 ▲数据源于IQVIA数据库中国据米内网数据显示，中国抗组胺药市场整体规模庞大，总体市场容量约为46亿元，其中，口服常释剂型占据主导地位，市场规模达到约34.2亿元人民币，占比高达74%。由此可见，抗组胺药口服市场拥有极为可观的总体规模。 ▲数据源于米内网据米内网数据显示，富马酸卢帕他定片在国内城市公立医院2023年的销售额达3.1亿元，呈稳定增长趋势，是全身用抗组胺化药TOP3产品。未来，卢帕他定有望进一步拓展其市场份额，成为抗组胺药市场中的重要力量。 ▲数据源于米内网过敏性鼻炎和荨麻疹为常见的过敏性疾病。其中据报告全球至少有5亿过敏性鼻炎患者，我国进行的多中心流行病学调查显示成人过敏性鼻炎患病率在2005~2011年的六年间从11.1%上升至17.6%，有些地区（如北京、杭州等）甚至翻倍。另外慢性荨麻疹全球的发病率约为0.05%~3%，中国CU的发病率约为2.6~4.2%。[5-9]过敏性疾病严重的影响了国民的身体健康和生活质量，普利的抗过敏药物将为众多过敏患者带来福音！ 04 关于普利制药普利制药 1992 年成立于海口，是中国医药制剂国际化先导企业和国家工信部智能制造示范企业，已被国家工信部纳入工业转型升级中国制造 2025 年儿童药重点项目企业，2023年海南普利通过海关“AEO”高级认证。海南普利及其子公司浙江普利、安徽普利已多次顺利通过美国FDA、欧盟EMA现场审计。作为中国医药制剂国际化先导企业，普利制药多年来一直恪守全球较高质量标准，是国内为数不多的原料药和注射剂研发和生产平台，也是为数不多的同时获得美国、中国、欧盟等药监部门批准的原料药、关键辅料、药物药剂和GMP中间体CMO/CDMO的优质供应商。普利制药培育的全身用抗过敏药领导品牌芙必叮®，临床使用已有20年，深受医生、药师、患儿、家长的一致好评，被评为“2021年中国自主创新品牌日活动-创新之星”，并于2021年上榜“中国家庭常备药”，同时荣获“网络最佳人气奖”。并于2016年、2019年、2020年、2021年、2022年之后，2023年六次荣列“中国医药-品牌榜”。未来，普利将继续深耕抗过敏赛道，更好的服务于中国及全球患者。高品质好药，普利智造！文献来源 1.Kuby IMMNOLOGY，Sixth Edition 2007 W.H. Freeman and Company 2.严慧娟. 治疗变应性鼻炎新药——卢帕他定[J]. 医药导报, 2010, 29 (07): 895-897. 3.Mullol J, et al. Allergy. 2015 Jan;70 Suppl 100:1-24. 4.CHRISTEPEHENDERSONWR.Lipid iflam matorymed iators,leukotrienes pmstaglandins plateletactivatingfactor [J]，Clin Allergy Imunol 200216:233-254. 5.World Allergy Organ J, 2008,1(6 Suppl):S4-4S17. 6.WAO White Book on Allergy 2013 Update. J Allergy Clin Immunol, 2020,146(4):721-767. 7.GINA. Global Strategy for Asthma Management and Prevention. 8.Allergy, 2008,63 Suppl 86:8-160. 9.中华医学会皮肤性病学分会荨麻疹研究中心. 抗IgE疗法——奥马珠单抗治疗慢性荨麻疹专家共识 [J] . 中华皮肤科杂志, 2021, 54(12) : 1057-1062. DOI: 10.35541/cjd.20210568.

一致性评价上市批准

2024-10-25

·IQVIA艾昆纬

精彩回顾丨 “赋能重塑，向新前行” 2024 IQVIA艾昆纬医疗科技峰会成功举办

10月22日，由IQVIA艾昆纬主办，复旦大学管理学院学术支持的2024 IQVIA艾昆纬医疗科技峰会在上海顺利召开。峰会吸引超两百位跨国及本土医疗器械企业负责人、行业专家、投资机构等业内同仁参加，共同探讨国内外形势变化加速下，中国医疗器械企业如何练内功，求创新。 IQVIA艾昆纬中国管理咨询和市场洞察业务负责人陈劲豪在开幕致辞中表示，IQVIA入华30年来，见证并参与了中国医疗行业的磅礴发展，中国现已成为全球第二大医疗器械市场。在国内外形势加速变化的背景下，医疗器械企业的机遇与挑战并存。在临床需求和医改政策的新形势下，企业需要深入了解政策和趋势。在评估医疗器械的价值及全球创新医疗技术发展的背景下，企业需要从源头创新，更高效地管理产品的全生命周期。另外，不管是收购、自主创新还是国际化，医疗器械企业也需要关注多元化的增长手段和渠道。国家医疗保障局原副局长陈金甫以“中国医保政策和医药发展”为主题发表演讲，他表示，医保在支持医药创新中发挥了关键作用并拓宽了市场的发展驱动能力。医保筹资成为医药发展的基石，医保支付范围和价格机制也对医药市场具有调节作用；医保在医药生态性营造中的战略性购买不仅关注价格的降低，更注重药品和医疗器械的质量提升和供应稳定性。企业应在了解政策趋势的基础上，夯实核心价值并从源头创新。面对人口老龄化加剧和医疗服务需求增加的现实，医疗器械企业在战略前瞻性、管理效率、决策执行力和成本控制力等方面都面临着更高要求。而随着医疗控费政策的频频出台，医改在采购、临床术式和医保报销等环节全面推进，也使得行业增速面临挑战。峰会演讲中，IQVIA艾昆纬医疗器械解决方案负责人杨凯，北京大学公共政策研究中心副主任、研究员，北京大学医学技术发展与研究中心常务副主任江滨博士，IQVIA艾昆纬医疗器械市场准入咨询经理张书培，IQVIA艾昆纬卫生经济与真实世界洞察高级咨询顾问艾亚萍，IQVIA艾昆纬医疗器械数据库负责人沈柳怿，IQVIA艾昆纬商业技术解决方案执行总监孙玮珉就相关话题带来精彩演讲，从行业格局，政策和趋势解读，产品全生命周期的管理，以及数字化战略创新等方面展开分析，赋能医疗器械企业顺应趋势，把握市场机遇。中国(上海)自由贸易试验区临港新片区管理委员会高新产业和科技创新处副处长傅张杰在会中介绍了临港片区支持医疗器械企业落地的相关政策。 <<左滑查看更多精彩瞬间>> IQVIA艾昆纬管理咨询部企业战略负责人徐莹、江远投资合伙人李佳安、中伦律师事务所合伙人李雷以“出海与并购，中国医疗器械行业的战略性增长策略”为主题展开圆桌讨论，并就本土医疗器械公司当前融资趋势，成功出海的法规和运营要素，以及进军海外市场的战略重要性进行了精彩分析。面对行业的国内外形势及市场格局的不断变化，医疗科技行业应密切关注政策趋势，注重技术创新和市场需求，优化产品从研发到商业化的策略，IQVIA也将持续通过自身的数据、技术和解决方案优势，助力医疗科技企业应对市场变数，实现稳步增长和长青发展。声明原创内容的最终解释权以及版权归IQVIA艾昆纬中国所有。如需转载文章，请发送邮件至iqviagcmarketing@iqvia.com。

并购

2024-10-23

·PRNewswire

Precision Medicine Group Announces Key Leadership Appointments

– Karl Deonanan appointed Chief Financial Officer – – Matt DeZee named to newly established role, Chief Transformation and Strategy Officer – BETHESDA, Md., Oct. 23, 2024 /PRNewswire/ -- Precision Medicine Group (Precision), a leading next-generation provider of drug development and commercialization services, today announced key leadership changes to support its next phase of growth. This includes the appointment of Karl Deonanan as Chief Financial Officer (CFO). Mr. Deonanan succeeds Matt DeZee, who has served as CFO of Precision since 2020 and will be transitioning to the newly created role of Chief Transformation and Strategy Officer (CTSO), effective immediately. Continue Reading Precision Medicine Group today announced key leadership changes to support its next phase of growth. Post this Precision Medicine Group is a leading next-generation provider of drug development and commercialization services. Karl Deonanan - Chief Financial Officer Matt DeZee - Chief Transformation and Strategy Officer "Since its inception in 2012, Precision's success has been enabled by its people – a global team of experts spanning the clinical through commercial continuum who are committed to delivering innovative, best-in-class services to support life science organizations from molecule to market," said Margaret Keegan, Chief Executive Officer of Precision. "With today's appointments, we are bolstering our executive leadership team – and welcoming an experienced financial leader with a proven track record of scaling high growth organizations. I look forward to Karl and Matt's contributions as we continue to grow Precision and strategically assimilate the next wave of technological advancements to improve the development, manufacture and launch of new life-changing medicines." In their new roles, Mr. Deonanan will be responsible for all finance and accounting functions, and Mr. DeZee will lead strategic growth and operational optimization, enhancing how Precision serves a global suite of clients. Both have oversight across Precision's two groups: Precision for Medicine, the premier provider of biomarker-driven clinical research and development, including integrated lab and clinical trial services; and Precision AQ, the foremost provider of commercialization services supporting life science organizations from launch through product maturity. Karl Deonanan, Chief Financial Officer Mr. Deonanan joins Precision with nearly 30 years of finance and accounting experience and over 20 years leading life science services organizations. Most recently, he was CFO at ProPharma Group, a multi-unit life science services organization and, before that, he held executive-level financial leadership roles at X-Chem, Inc., Synteract and IQVIA. In these roles, Mr. Deonanan led organizations ranging in size from $100 million to $3.5 billion in revenue with up to 30,000 employees across over 60 countries, partnered with both private and public investors and led complex systems implementations, innovative strategic partnering arrangements and initial public offerings. Mr. Deonanan holds an M.S. in Accounting from East Carolina University and a B.S. in Accounting from the University of North Carolina Wilmington. Mr. Deonanan commented, "I could not be more excited to join Precision at this inflection point in the company's history. Precision has built a truly unique platform pointed at the future of both drug development and commercialization. I look forward to contributing to the next generation of innovation for our clients and the patients they serve." Matt DeZee, Chief Transformation and Strategy Officer A member of Precision's founding team, Mr. DeZee served as Corporate Development Officer for eight years before becoming CFO in 2020. Prior to joining Precision, he held leadership roles at United BioSource Corporation (UBC,) a global team of 1,300 scientists, researchers, clinical data managers and reimbursement experts focused on generating real-world evidence in support of drug manufacturers and patients worldwide. Throughout his time at Precision, Mr. DeZee has played a key role in architecting the organization's growth, leading M&A, global geographic expansions and digital transformation. He holds a B.A. in Economics from the University of Maryland. Mr. DeZee added, "When we started this company in 2012, we knew there was an unmet need for innovators developing the next generation of treatments. Operational optimization and digital transformation help us provide the speed our clients are seeking. I'm excited to lead the adoption of new technologies to enhance and expand our solutions to accelerate the development and commercialization of new therapies." About Precision Medicine Group Formed in 2012, Precision Medicine Group is a specialized services company supporting next-generation approaches to drug development and commercialization. Precision provides an integrated infrastructure that supports pharmaceutical and life science companies as they develop new products in the age of precision medicine. The company is headquartered in Bethesda, Maryland, with offices throughout North America, Europe and Asia. For more information, visit precisionmedicinegrp.com. Media Contact: Contact Hannah Deresiewicz Precision AQ [email protected] SOURCE Precision Medicine Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED