ANCHOR is a prospective, multi-center, phase IV, interventional, single-arm, open-label study of 2,000 adult participants with symptomatic asthma requiring the use of rescue therapy aimed to compare the asthma exacerbation rates before and after switching from albuterol or levalbuterol to albuterol plus budesonide inhalation aerosol as rescue therapy.

开始日期2024-05-10

申办/合作机构

AstraZeneca PLC

[+1]

NCT05679908

/ Completed临床2期

A Phase 2, Double-blind, Randomized, Multicenter, Placebo-controlled, Three Arm Parallel Study to Evaluate the Efficacy and Safety of TNX-1900 (Intranasal Oxytocin) in Patients With Chronic Migraine (PREVENTION Study)

This is a phase 2, double-blind, randomized, multicenter, placebo-controlled, three arm parallel study to evaluate the efficacy and safety of two different dosages (30 IU daily and 60 IU daily) of TNX-1900 in patients with chronic migraine.

开始日期2022-12-06

申办/合作机构

Tonix Pharmaceuticals, Inc.

[+1]

100 项与 Premier, Inc. 相关的临床结果

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0 项与 Premier, Inc. 相关的专利（医药）

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249

项与 Premier, Inc. 相关的文献（医药）

2025-05-01·Annals of Surgery

Disparities in Access to Outpatient Surgery Related to Removal of Procedures From Medicare’s Inpatient-only List

Article

作者: Frakt, Austin B. ; Brownlee, Sarah A. ; Orav, Endel J. ; Dai, Dannie ; Soto, Mark ; Figueroa, Jose F. ; Rosenthal, Ning ; Tsai, Thomas C.

Objective:To assess the shift from inpatient to outpatient surgical care related to changes to the inpatient-only list in 2020 and 2021 compared with 2019.Background:The extent to which procedures shift from the inpatient to outpatient setting after removal from Medicare’s inpatient-only (IPO) list is unknown. Many health systems also encouraged a shift from inpatient to outpatient surgery during the coronavirus disease 2019 (COVID-19) pandemic. Assessing the relative change in outpatient surgical utilization for procedures removed from the IPO list during COVID-19 would provide empirical data on whether reimbursement policy changes or inpatient capacity needs during the pandemic were more likely to shift care from the inpatient to the outpatient setting.Methods:We used administrative data from the PINC AI Healthcare Database across 723 hospitals to determine the within-facility relative change in outpatient versus inpatient procedural volume in 2020 and 2021 compared with 2019 using a multivariable conditional fixed-effect Poisson regression model. We also assessed whether outpatient surgical utilization varied by race and ethnicity. Using a multivariable linear probability model, we assessed the absolute change in risk-adjusted 30-day complication, readmission, and mortality rates for inpatient and outpatient surgical procedures.Results:In 2020 and 2021, compared with 2019 respectively, there was a 5.3% (95% CI: 1.4% to 9.5%) and 41.3% (95% CI: 33.1% to 50.0%) relative increase in outpatient elective procedural volume. Outpatient procedural volume increased most significantly for hip replacement which was removed from the IPO list in 2020 [increase in outpatient surgical utilization of 589.3% (95% CI: 524.9% to 660.3%)]. The shift to outpatient hip replacement procedures was concentrated among White patients; in 2021, hip replacement procedural volume increased by 271.1% (95% CI: 241.2% and 303.7%) for White patients and 29.5% (95% CI: 24.4% and 34.9%) for Black patients compared with 2019 levels. There were no consistent or large changes in 30-day complication, readmission, or mortality risk in 2020 and 2021 compared with 2019.Conclusions:There was a modest increase in elective outpatient surgeries and a pronounced increase in outpatient orthopedic surgeries which were removed from the IPO list during the COVID-19 pandemic. Utilization of outpatient surgical procedures was concentrated among White patients.

2025-02-06·The Oncologist

Resource utilization and inpatient hospitalization costs associated with thromboembolic events among patients with polycythemia vera

Article

作者: Yu, Jingbo ; Pemmaraju, Naveen ; Rosenthal, Ning ; Braunstein, Evan ; Gayle, Julie ; Brown, Harold

AbstractBackgroundHealthcare resource utilization (HCRU) and costs are often elevated in patients with polycythemia vera (PV), and this patient population has an increased risk of developing thromboembolic events (TEs). This study describes HCRU, costs, and mortality during TE-related hospitalizations among patients with PV in a contemporary real-world setting in the United States.Patients and MethodsThis retrospective cohort study included adult inpatients with PV and TE discharged from 623 hospitals between January 1, 2017, and June 30, 2020 with a 2-year follow-up period after the first TE-related (index) hospitalization. Data were abstracted from the PINC AI Healthcare database, which includes 25% of US inpatient discharges.ResultsAmong 3494 patients (index TE: arterial, 69.1%; venous, 27.1%; both, 3.7%), mean (SD) age was 70.7 (14) years, and most patients were male (58.6%), White (81.2%), with Medicare insurance (72.6%). Mean (SD) Charlson Comorbidity Index score was 3.2 (2.3). Mean total hospitalization costs were $24 403 during the index hospitalization (mean [SD] hospital length of stay [LOS], 7 [9] days). A third (n = 1150) of patients were admitted to the intensive care unit (mean cost, $29 342; mean [SD] LOS, 5 [7] days). During 30 days and 2 years of follow-up, the TE-related readmission rate was 6.4% and 20.0%, respectively. All-cause mortality was 6.2% during index hospitalization; an additional 4.7% occurred during the 2-year follow-up period.ConclusionAmong patients with PV and TE, inpatient hospitalization HCRU, costs, and mortality were substantial. These findings highlight the importance of preventing TEs in the management of PV.

2025-01-01·Journal of Perinatology

Acute kidney injury associated with increased costs in the neonatal intensive care unit: analysis of Pediatric Health Information System database

Article

作者: Selewski, David T ; Steflik, Heidi J ; Corrigan, Corinne ; Brinton, Daniel L

AbstractObjectiveCompare neonatal intensive care unit hospitalization costs between neonates with and without AKI; identify predictors of AKI-associated costs. We hypothesized neonates with AKI would amass more costs than those without AKI.Study designRetrospective, multicenter cohort study of surviving neonates cared for 2015–2021 in Pediatric Health Information System database. The primary outcome was estimated hospitalization costs.ResultsData from 304,725 neonates were evaluated, 8774 (3%) with AKI and 295,951 (97%) without AKI. Neonates with AKI had $58,807 greater adjusted costs than those without AKI. AKI-associated costs were most strongly driven by Feudtner Pediatric Complex Chronic Conditions Classifications (cardiovascaular, congenital/genetic, gastrointestinal, medical technology) and gestational age. Adjusted costs decreased with increasing gestational age, regardless of AKI status.ConclusionsAKI is independently associated with increased hospital costs. Knowledge of these drivers can help in identifying high-value practices for cost mitigation strategies.

项与 Premier, Inc. 相关的新闻（医药）

2024-12-17

·PRNewswire

BRIJ Medical, Inc. Awarded Breakthrough Technology Agreement in the Non-Invasive Skin Closure Category with Premier, Inc.

MARIETTA, Ga., Dec. 17, 2024 /PRNewswire/ -- BRIJ Medical, Inc. has been awarded a breakthrough technology national group purchasing agreement in the "non-invasive skin closure" category with Premier, Inc. Effective December 15, 2024, the new agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for the Brijjit® BP-100 and BP-75 Force Modulating Tissues Bridges. Premier offers Breakthrough Technology designations to innovations that offer a major advantage in terms of patient safety, clinical outcomes and operational efficiencies. Continue Reading BRIJ Medical, Inc. Awarded Breakthrough Technology Agreement in the Non-Invasive Skin Closure Category with Premier, Inc. "Being awarded a national group purchasing agreement with Premier is a transformative milestone for BRIJ Medical," said Tim Gleeson, CEO. "This marks a significant step forward in our mission to improve the lives of both patients and surgeons post-surgery. Our product suite is designed to drastically improve patient healing while reducing the time required for final closure. As a team, we couldn't be more excited about the opportunity to collaborate with Premier's membership." The Brijjit Force Modulating Tissue Bridge offers a non-invasive solution for relieving tension during incision closure, wound support, and scar therapy. It is cost-effective, replacing the final suture layer (sutures, glues, staples, and tapes) and also reducing the need for expensive dressings. Additionally, it reduces operative time, being up to 9x faster than suture placement. Data supports a 90% reduction in wound breakdown,* lowering complications such as open wounds, and mitigating risk factors for surgical site infection. Furthermore, its hypoallergenic adhesive minimizes allergic skin reactions and is proven to reduce scar area by 38%.* Premier is a leading technology-driven healthcare improvement company, providing solutions to two-thirds of all healthcare providers in the U.S. Playing a critical role in the rapidly evolving healthcare industry, Premier unites providers, suppliers, payers and policymakers to make healthcare better with national scale, smarter with actionable intelligence and faster with novel technologies. With integrated data and analytics, collaboratives, supply chain solutions, consulting and other services, Premier enables better care and outcomes at a lower cost. ABOUT SUPPLIER At BRIJ Medical, our flagship product, the Brijjit® Force Modulating Tissue Bridge, is clinically proven in multiple studies, including a randomized clinical trial, to reduce wound breakdown by 90%* and reduce scar area by 38%.* It eliminates up to 100% of tension on incisions and healing wounds, while also saving surgeons time (up to 9x faster than sutures), and is a cost-effective solution for practices, ASCs and hospitals alike. At BRIJ Medical, we provide enhanced control and confidence at every step of the healing journey. For more information, visit BRIJmedical.com. *Clinical evidence in two breast studies. SOURCE BRIJ Medical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2024-12-05

·医药健闻

阿斯利康任命中国区业务新负责人；美国最大健康保险商CEO街头遇刺身亡；诺华29亿美元引进PTC亨廷顿病项目 | 日报

全球医疗行业每日重点资讯文 | 苏丁企业动态阿斯利康(AstraZeneca)12月4日宣布任命Iskra Reic为全球执行副总裁、国际业务负责人，全面负责包括中国、亚洲和欧亚市场、中东和非洲、拉丁美洲、澳大利亚和新西兰在内的地区整体战略。近期，Iskra负责新成立的阿斯利康疫苗和免疫疗法业务部。Iskra Reic发布内部信宣布，林骁出任阿斯利康中国总经理，关冬梅出任阿斯利康中国肿瘤业务总经理。林骁和关冬梅将分别成为生物制药业务部和肿瘤业务部全球管理团队成员。美国最大健康保险商CEO街头遇刺身亡。当地时间12月4日早晨6点46分左右，在美国纽约曼哈顿中城的希尔顿酒店门口发生枪击事件，一名50岁男子胸部中枪。中枪的男子为美国联合健康集团(UnitedHealth Group)旗下的联合健康保险公司CEO布莱恩·汤普森(Brian Thompson)。汤普森遭遇枪击后被紧急送往医院，经抢救无效死亡。联合健康集团随即取消了其投资者日活动。 Novavax已签署最终协议，以2亿美元的价格将其位于捷克的生产设施出售给诺和诺德(Novo Nordisk)。包括一个15万平方英尺的最先进的重组蛋白生产设施和建筑，以及现有的劳动力和所有相关和必要的基础设施。除了2024年1.9亿美元的现金支付和2025年额外的1000万美元外，Novavax预计出售该设施将使每年的运营成本降低约8000万美元。预计在2024年12月30日协议完成后，生产设施的全部责任将转移给诺和诺德。由于含有红麹原料的保健品引发健康危害问题，小林制药被香港投资基金要求对前会长等人提起诉讼，进行索赔。要求创始人家族出身的前会长小林一雅等7人赔偿超过100亿日元。持有小林制药7%以上股份的Oasis Management于11月下旬提出了这一要求。小林制药在2024年1月～9月期间因红麹问题产生的费用等计入了超过100亿日元的特别损失。如果监事不代表公司提起诉讼，Oasis Management可以在2025年1月下旬提起股东代表诉讼。费森尤斯医疗(FME)宣布，其心肺业务集团已与美国的Premier, Inc.达成了一项关于Novalung ECMO系统的全国性集团采购协议。通过该采购协议，费森尤斯将获得Premier联盟会员共4350家美国医院及卫生系统的访问权，大大增加了潜在的市场覆盖。Novalung系统用于超过6小时的ECMO支持，治疗急性呼吸衰竭或心肺衰竭。羚锐制药公告，拟使用自有资金收购银谷制药有限责任公司100%的股权。根据初步评估，银谷制药综合估值暂定为不超过人民币7.82亿元。银谷制药是一家以化学药品研发为核心、集创新药物研究、原料合成、制剂生产和药品销售为一体的创新型制药企业。最终交易能否达成存在不确定性。产业动态 PTC Therapeutics宣布，与诺华(Novartis)签署了一项关于亨廷顿病项目PTC518及其相关分子的独家全球许可与合作协议。根据协议，PTC将获得10亿美元的预付款，以及高达19亿美元的开发、监管和销售里程碑款项。PTC518是一种可口服的小分子药物，能够有效减少引发神经元损伤和死亡的突变型亨廷顿蛋白的生成，从而延缓疾病进展。两家公司预计该交易将在2025年第一季度完成。待PIVOT-HD试验的安慰剂对照部分（预计于2025年上半年）结束后，诺华将接手PTC518的开发、生产和商业化工作。吉利德科学（Gilead Sciences）与Tubulis签署一项独家选择权和许可协议，旨在共同发现并开发针对实体瘤靶点的抗体偶联药物（ADC）。吉利德将获得Tubulis专有技术平台Tubutecan和Alco5的使用权。Tubulis将主导候选药物的发现和开发工作，设计一种基于拓扑异构酶I抑制剂的ADC候选药物。Tubulis将获得2000万美元的预付款；若吉利德行使选择权，则需支付额外3000万美元的选择权费用。此外，Tubulis还可获得最高达4.15亿美元的开发与商业化里程碑等款项。 Keros Therapeutics与武田（Takeda）达成一项独家全球开发和商业化许可协议，以推进Elritercept的开发。Elritercept目前正在进行两项2期临床试验，一项针对患有极低风险、低风险或中等风险骨髓增生异常综合征（MDS）的患者，另一项针对骨髓纤维化（MF）患者。武田将获得全球进一步开发、生产和商业化Elritercept的独家许可（不包括中国内地，中国香港和澳门地区）。Keros将收到2亿美元的预付款，并有资格获得超过11亿美元的开发、监管及商业里程碑付款。 COUR Pharmaceuticals与罗氏（Roche）旗下基因泰克（Genentech）达成战略合作与许可协议，双方将共同开发和商业化COUR的专有免疫耐受纳米颗粒（tolerogenic nanoparticle）疗法，用于治疗自身免疫性疾病。COUR将获得4000万美元的预付款和近期里程碑付款，此外，还可获得超过9亿美元的开发、商业化和销售里程碑款项。根据合作协议，COUR负责完成前期临床开发和生产技术转移，而基因泰克将承担临床开发、监管申报及商业化的相关工作。 Rgenta Therapeutics与葛兰素史克（GSK）签订一项多年期多靶点的战略研究合作协议，旨在推进新型靶向RNA小分子剪接调节剂在肿瘤等多个疾病领域的发现和开发。Rgenta将获得高达4600万美元的现金预付款和行权前里程碑款项，并且还可能从每个靶点中获得近5亿美元的选择权行使费用、研究、开发、监管和商业化里程碑付款，以及分级专利费和潜在的股权投资。GSK则拥有将合作范围扩展到其他靶点的选择权。礼来宣布，在对比试验中，其减肥药物Zepbound的减重效果优于诺和诺德的Wegovy。试验显示，使用Zepbound的患者体重平均减轻20.2%，而Wegovy患者体重减轻13.7%。礼来计划将结果发表在同行评审期刊，并在医学会议上发布。由于担心在印度这一潜力巨大的市场上落后于竞争对手礼来，诺和诺德印度团队一直在推动该公司在印度更早推出减肥药Wegovy，以保持其在全球范围减肥药市场中的领导地位。诺和诺德的印度团队提议将Wegovy在印度的上市时间提前到明年，而礼来预计也将在同一时间在印度推出旗下减肥药Mounjaro。默沙东宣布，美国FDA已授予在研抗体偶联药物sacituzumab tirumotecan(Sac-TMT)突破性疗法认定，用于治疗携带表皮生长因子受体(EGFR)突变的晚期或转移性非鳞状非小细胞肺癌(NSCLC)患者，这些患者的疾病在接受酪氨酸激酶抑制剂(TKI)和含铂化疗后出现进展。Sac-TMT是默沙东与科伦博泰合作开发的TROP2靶向在研ADC。优时比中国与浙江博锐生物制药有限公司就比奇珠单抗（倍捷乐）在中国市场的商业推广签署合作协议。今年7月，比奇珠单抗获得中国国家药监局（NMPA）批准，用于治疗常规疗法效果不佳或不耐受的活动性强直性脊柱炎（AS）成人患者，此后于9月获批治疗放射学阴性中轴型脊柱关节炎（nr-axSpA）成人患者。绿叶制药集团宣布，创新药注射用芦比替定（赞必佳，Zepzelca）作为纳入优先审评审批程序的品种，获得国家药品监督管理局的上市批准，适用于治疗含铂化疗中或化疗后疾病进展的转移性小细胞肺癌（SCLC）成人患者。赞必佳是一种选择性的致癌基因转录抑制剂，在抑制肿瘤基因转录、导致肿瘤细胞凋亡的同时，还可调节肿瘤微环境，进一步发挥抗肿瘤作用。和黄医药和信达生物联合宣布爱优特与达伯舒联合疗法用于治疗既往系统性抗肿瘤治疗后失败且不适合进行根治性手术治疗或根治性放疗的晚期错配修复完整（pMMR）的子宫内膜癌患者的新药上市申请在中国获附条件批准。此前，该联合疗法获中国国家药品监督管理局纳入优先评审及突破性治疗品种。此次获批标志着呋喹替尼与领先的免疫检查点抑制剂联合疗法的首个监管注册批准。和黄医药自主研发创新药物呋喹替尼获得中国国家药品监督管理局（NMPA）批准，联合信迪利单抗用于既往系统性抗肿瘤治疗后失败且不适合进行根治性手术治疗或根治性放疗的晚期错配修复完整（pMMR）子宫内膜癌（EMC）患者。复宏汉霖自主研发的创新型抗PD-1单抗H药汉斯状（斯鲁利单抗注射液）正式获得国家药品监督管理局（NMPA）批准，联合培美曲塞和卡铂适用于表皮生长因子受体（EGFR）基因突变阴性和间变性淋巴瘤激酶（ALK）阴性的不可手术切除的局部晚期或转移性非鳞状非小细胞肺癌（nsNSCLC）的一线治疗。益普生宣布BYLVAY, Odevixibat capsules（中文：蓓尔唯，奥德昔巴特胶囊）经中国国家药品监督管理局正式批准，用于治疗≥6月龄的进行性家族性肝内胆汁淤积症（PFIC）患者的瘙痒。此前，在先行先试政策下，奥德昔巴特在海南博鳌乐城医疗特区先行落地。深圳微灵医疗披露已开启的植入式脑机接口临床研究。目前该研究已在华北、华中、华南、西北和西南等地区的重点医疗机构有序开展。本轮临床研究采用微灵医疗自研成果，脑机接口系统的神经信号传感器“CORTEX-0型高密度网状超柔顺神经电极阵列”以及配套的便携式颅内脑电监测仪。国家医保局在江苏苏州正式启动全国医保个人账户跨省共济功能。在国家医保局统筹推动下，目前，江苏、河北等9个省（市）31个统筹区，已正式上线医保个人账户的跨省共济功能，打破个人账户原有地域限制，将其使用范围进一步扩大。香港中文大学医学院首次发现一系列与肠道炎症相关的肠道微生物标志物，有效区分常见的慢性肠道疾病包括功能性消化道疾病及炎症性肠病。研究结果最近于国际期刊《自然医学》发表。团队预期相关检测技术可于2027年在香港作临床应用。联系美通社 +86-10-5953 9500 info@prnasia.com

并购疫苗高管变更

2024-11-20

·Business Wire

CalmWave Raises $5.25 Million from Third Prime and Investor Syndicate to Fuel Expansion in Health Systems

SEATTLE--( BUSINESS WIRE )-- CalmWave , the creator of the Quiet ICU, today announced that it has closed a $5.25 million financing round led by Third Prime with participation from Catalyst by Wellstar, Silver Circle, Rebellion, Impulsum, and existing investors Bonfire Ventures, Tau Ventures, and Hike Ventures. CalmWave will use the new capital to accelerate market penetration and strengthen and expand its GPO channel partnerships, including Premier, Inc. and Partners Coop. CalmWave is the first effective solution to address the endemic problem of alarm fatigue in Intensive Care Units (ICUs). Non-actionable alarms are alerts triggered by monitoring systems that do not require immediate intervention or clinical response. Such alarms make up 80-99% of alarms in ICUs, which is a primary cause of alarm fatigue. Alarm fatigue occurs when the constant flood of alarms overwhelms both clinicians and patients. This constant barrage of alarms not only heightens the risk of negative outcomes like ICU delirium, but it also strains healthcare staff, impacting overall patient care. “We are dedicated to objectively improving healthcare, starting with eliminating non-actionable alarms in ICUs. We have demonstrated a 58% reduction in non-actionable alarms and increased safety in our retrospective analysis of one of our charter customer’s Cardiac Care units,” said Ophir Ronen, founder and CEO, CalmWave. “We have strong momentum, and now, with this new investment, we are moving quickly to rapidly expand to additional hospital systems.” The CalmWave Operations Platform uses "Transparent AI," which makes the reasoning and data behind its conclusions fully visible. This approach empowers healthcare organizations to optimize operations and confirm they are making well-informed, data-driven decisions. To feed its models, CalmWave uses a hospital’s retrospective and real-time patient data, such as vital signs, interventions, and medication administration, to provide objective recommendations for reducing alarm fatigue. Implementing these recommendations by nursing staff improves the clinical work environment and patient care. “CalmWave is driving rapid innovation in an industry that has long been seeking a solution but has been slow to evolve. Ophir is an accomplished leader and has assembled an outstanding team with unique expertise in deep technology and big data,” said Keith Hamlin, co-founder and General Partner of Third Prime. “CalmWave has built a world-class SaaS platform very quickly. The company’s vision to create the quiet ICU is a springboard towards highly optimized, data-driven hospital operations.” About CalmWave CalmWave's mission is to objectively improve healthcare, starting with safely eliminating non-actionable alarms. Alarms triggered by bedside monitoring systems that do not require immediate intervention or clinical response comprise 80-99% of all audible alarms in ICUs. These non-actionable alarms contribute to a well-recognized and widespread issue known as alarm fatigue. Alarm fatigue exists in every hospital and is rampant in the modern healthcare system. It is a great stressor for clinicians and patients, ultimately impacting patient outcomes and staff retention. Using Transparent AI, CalmWave outlines the rationale behind each optimized setting, empowering a hospital’s nursing staff to evaluate and implement optimized alarm limit recommendations in the monitor at the patient’s bedside. Implementing CalmWave remediates alarm fatigue and can improve staff retention and patient outcomes. Visit CalmWave.ai for more information, and follow us on LinkedIn and X .

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