This is an observational study to compare the utility of the novel aMRI approach in human brain to the standard of care imaging approach for diagnosing and assessing glioma. Tumor cells have altered metabolism compared to normal cells.This makes metabolic activity imaging useful for diagnosing and assessing neurological disease. However, current options for metabolic activity imaging are limited. Metabolic activity imaging is primarily conducted using positron emission tomography (PET) with a radioactive tracer called fludeoxyglucose F-18 (¹⁸FDG). A PET scan is a procedure in which a small amount of radioactive glucose (¹⁸FDG) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. PET imaging is very expensive and is usually much less available than other imaging techniques such as magnetic resonance imaging (MRI). MRI uses radiofrequency waves and a strong magnetic field to provide clear and detailed pictures of internal organs and tissues. While MRI is more available than PET, it isn't as useful in evaluating metabolic activity. Unlike standard MRI, the aMRI approach uses new ways of analyzing MRI images that provides information about tumor cell metabolic activity. Via direct comparison with a standard metabolic imaging approach, ¹⁸FDG PET, this clinical trial will assess the validity of aMRI as a metabolic imaging approach for evaluating neurological disease in patients with glioma.

开始日期2023-12-11

申办/合作机构

OHSU Knight Cancer Institute

[+1]

NCT05915702 / Recruiting临床3期

A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of the Central Nervous System (CNS), Compared to 0.1 mmol Gd/kg Approved Macrocyclic Gadolinium-based Contrast Agents (GBCAs)

Researchers are looking for a better way to help people with known or suspected brain or spinal cord-related problems scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI).
MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject a contrast agent into a patient's vein to perform a so called "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve the evaluation.
The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI.
The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work better than MRI scans without the use of a contrast agent (GBCA). The researchers will compare the ability to detect brain and spinal cord-related problems in gadoquatrane-MRI scans to plain-MRI scans without the use of a contrast agent.
The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein.
Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits.
At the start or during the study, the doctors and their study team will:
take blood and urine samples
do physical examinations
check blood pressure and heart rate
review the MRI scans obtained in the study and decide on the diagnosis
ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

开始日期2023-07-24

申办/合作机构

Bayer AG

NCT05915728 / Recruiting临床3期

A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of Any Body Region (Except CNS), Compared to 0.1 mmol Gd/kg Approved Macrocyclic Gadolinium-based Contrast Agents (GBCAs)

Researchers are looking for a better way to help people with any known or suspected problems (except brain or spinal cord-related problems) scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI).
MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject contrast agent into a patient's vein to perform a so called "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve the evaluation.
The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI.
The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work better than MRI scans without the use of a contrast agent (GBCA). The researchers will compare the ability to detect known or suspected problems (except brain or spinal cord-related problems) with gadoquatrane-MRI scans to plain-MRI scans without the use of a contrast agent.
The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein.
Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits.
At the start or during the study, the doctors and their study team will:
take blood and urine samples
do physical examinations
check blood pressure and heart rate
review the MRI scans obtained in the study and decide on the diagnosis
ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

开始日期2023-07-24

申办/合作机构

Bayer AG

100 项与钆特酸葡胺相关的临床结果

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100 项与钆特酸葡胺相关的转化医学

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100 项与钆特酸葡胺相关的专利（医药）

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项与钆特酸葡胺相关的文献（医药）

2024-02-24·Journal of magnetic resonance imaging : JMRI

Effects of Gadolinium Retention in the Brains of Type 2 Diabetic Rats after Repeated Administration of Gadolinium-Based MRI Contrast Agents on Neurobiology and NLRP3 Inflammasome Activation.

Article

作者: Xiang Yao ; Haoran Zhang ; Jingyi Hu ; Xiaoning Lin ; Jin Sun ; Junlong Kang ; Zhichun Huang ; Guangsong Wang ; Xinhua Tian ; E Chen ; Ke Ren

BACKGROUND:

The neurotoxic potential of gadolinium (Gd)-based contrast agents (GBCAs) retention in the brains of patients with type 2 diabetes mellitus (T2DM) is unclear.

PURPOSE:

To determine the deposition and clearance of GBCAs in T2DM rats and the mechanism by which Gd enhances nucleotide-binding oligomerization domain-3 (NLRP3) inflammasome activation.

STUDY TYPE:

Cross-sectional, prospective.

ANIMAL MODEL:

104 T2DM male Wistar rats.

FIELD STRENGTH/SEQUENCE:

9.4-T, T1-weighted fast spin echo sequence.

ASSESSMENT:

T2DM (male Wistar rats, n = 52) and control group (healthy, male Wistar rats, n = 52) rats received saline, gadodiamide, Gd-diethylenetriaminepentaacetic acid, and gadoterate meglumine for four consecutive days per week for 7 weeks. The distribution and clearance of Gd in the certain brain were assessed by MRI (T1 signal intensity and relaxation rate R1, on the last day of each week), inductively coupled plasma mass-spectroscopy, ultraperformance liquid chromatography mass spectrometry, and transmission electron microscopy. Behavioral tests, histopathological features, and the effects of GBCAs on neuroinflammation were also analyzed.

STATISTICAL TESTS:

One-way analysis of variance, bonferroni method, and unpaired t-test. A P-value <0.05 was considered statistically significant.

RESULTS:

The movement distance and appearance time in the open field test of the T2DM rats in the gadodiamide group were significantly shorter than in the other groups. Furthermore, the expression of NLRP3, Pro-Caspase-1, interleukin-1β (IL-1β), and apoptosis-associated speck-like protein containing a CARD protein in neurons was significantly higher in the gadodiamide group than in the saline group, as shown by Western blot. Gadodiamide also induced differentiation of microglia into M1 type, decreased the neuronal mitochondrial membrane potential, and significantly increased neuronal apoptosis from flow cytometry.

DATA CONCLUSION:

T2DM may affect both the deposition and clearance of GBCAs in the brain. Informed by the T2DM model, gadodiamide could mediate the neuroinflammatory response by NLRP3 inflammasome activation.

LEVEL OF EVIDENCE:

1 TECHNICAL EFFICACY: Stage 1.

2024-02-19·European journal of nuclear medicine and molecular imaging

Magnetic-optical dual-modality imaging monitoring chemotherapy efficacy of pancreatic ductal adenocarcinoma with a low-dose fibronectin-targeting Gd-based contrast agent.

Article

作者: Wenjia Zhang ; Xiaolong Liang ; Xinyu Zhang ; Wei Tong ; Guangyuan Shi ; Haozhuo Guo ; Zhengyu Jin ; Jie Tian ; Yang Du ; Huadan Xue

PURPOSE:

Pancreatic ductal adenocarcinoma (PDAC) is a lethal hypovascular tumor surrounded by dense fibrosis. Albumin-bound paclitaxel and gemcitabine (AG) chemotherapy is the mainstay of PDAC treatment through depleting peritumoral fibrosis and killing tumor cells; however, it remains challenging due to the lack of a noninvasive imaging method evaluating fibrotic changes during AG chemotherapy. In this study, we developed a dual-modality imaging platform that enables noninvasive, dynamic, and quantitative assessment of chemotherapy-induced fibrotic changes through near-infrared fluorescence molecular imaging (FMI) and magnetic resonance imaging (MRI) using an extradomain B fibronectin (EDB-FN)-targeted imaging probe (ZD2-Gd-DOTA-Cy7).

METHODS:

The ZD2-Gd-DOTA-Cy7 probe was constructed by conjugating a peptide (Cys-TVRTSAD) to Gd-DOTA and the near-infrared dye Cy7. PDAC murine xenograft models were intravenously injected with ZD2-Gd-DOTA-Cy7 at a Gd concentration of 0.05 mmol/kg or free Cy7 and Gd-DOTA as control. The normalized tumor background ratio (TBR) on FMI and the T1 reduction ratio on MRI were quantitatively analyzed. For models receiving AG chemotherapy or saline, MRI/FMI was performed before and after treatment. Histological analyses were performed for validation.

RESULTS:

The ZD2-Gd-DOTA-Cy7 concentration showed a linear correlation with the fluorescence intensity and T1 relaxation time in vitro. The optimal imaging time was 30 min after injection of the ZD2-Gd-DOTA-Cy7 (0.05 mmol/kg), only half of the clinic dosage of gadolinium. Additionally, ZD2-Gd-DOTA-Cy7 generated a 1.44-fold and 1.90-fold robust contrast enhancement compared with Cy7 (P < 0.05) and Gd-DOTA (P < 0.05), respectively. For AG chemotherapy monitoring, the T1 reduction ratio and normalized TBR in the fibrotic tumor areas were significantly increased by 1.99-fold (P < 0.05) and 1.78-fold (P < 0.05), respectively, in the control group compared with those in the AG group.

CONCLUSION:

MRI/FMI with a low dose of ZD2-Gd-DOTA-Cy7 enables sensitive imaging of PDAC and the quantitative assessment of fibrotic changes during AG chemotherapy, which shows potential clinical applications for precise diagnosis, post-treatment monitoring, and disease management.

2024-02-19·Dalton transactions (Cambridge, England : 2003)

Mapping the distribution of electronic states within the ⁵D₄ and ⁷F₆ levels of Tb³⁺ complexes with optical spectroscopy.

Article

作者: Nicolaj Kofod ; Margrete Juel Henrichsen ; Thomas Just Sørensen

The Tb(III) ion has the most intense luminescence of the trivalent lanthanide(III) ions. In contrast to Eu(III), where the two levels only include a single state, the high number of electronic states in the ground (⁷F₆) and emitting (⁵D₄) levels makes detailed interpretations of the electronic structure-the crystal field-difficult. Here, luminescence emission and excitation spectra of Tb(III) complexes with 1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid (DOTA, [Tb(DOTA)(H₂O)]^-), ethylenediaminetetraacetic acid (EDTA, [Tb(EDTA)(H₂O)₃]^-) and diethylenetriaminepentaacetic acid (DTPA, [Tb(DTPA)(H₂O)]^2-) as well as the Tb(III) aqua ion ([Tb(H₂O)₉]³⁺) were recorded at room temperature and in frozen solution. Using these data the electronic structure of the ⁵D₄ multiplets of Tb(III) was mapped by considering the transitions to the singly degenerate ⁷F₀ state. A detailed spectroscopic investigation was performed and it was found that the ⁵D₄ multiplet could accurately be described as a single band for [Tb(H₂O)₉]³⁺, [Tb(DOTA)(H₂O)]^- and [Tb(EDTA)(H₂O)₃]^-. In contrast, for [Tb(DTPA)(H₂O)]^2- two bands were needed. These results demonstrated the ability of describing the electronic structure of the emitting ⁵D₄ multiplet using emission spectra. This offers an avenue for investigating the relationship between molecular structure and luminescent properties in detailed photophysical studies of Tb(III) ion complexes.

项与钆特酸葡胺相关的新闻（医药）

2024-01-16

·药通社

全球超13亿重磅品种，国内竟无企业获批？

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。近日，据CDE官网显示，海南普利制药递交的4类仿制化药注射用卡非佐米的上市申请今日获受理。据药融云数据统计，目前该品种尚无本土药企获批生产销售。截图来源：CDE官网卡非佐米（carfilzomib）最初由Proteolix公司研发，2009年奥尼克斯（Onyx）收购Proteolix获得该品种，2013年8月，安进收购奥尼克斯制药公司，并获得卡非佐米的专利权。最早于2012年7月在美国获批上市，用于至少接受过两种（硼替佐米和免疫调节剂）先前的多发性骨髓瘤患者，是继硼替佐米后第二个被 FDA 批准的蛋白酶体抑制剂。全球超13亿重磅品种，首仿竞争进入白热化阶段目前卡非佐米已在全球多个国家上市。早在2020年，卡非佐米全球销售额已超10亿美元。据药融云数据统计，近三年（2020-2022年）卡非佐米全球销售额分别11.2、11.8和13.2亿美元。注射用卡非佐米在2022年院内市场上线以来，销售额直线上升，销售额超2956万元，同比增长达231.35%。截图来源：药融云全国医院销售数据库据药融云数据统计，卡非佐米注射品种国内尚无药企获批，豪森药业是最早进行卡非佐米仿制申报的企业，申报类别是3类仿制药。继豪森药业之后，上海创诺制药、齐鲁制药、四川汇宇制药、以及扬子江药业也相继报产，此次海南普利制药，是最新报产的企业，预计不久后将进入注射用卡非佐米首仿竞争的白热化阶段。纳入医保目录，多发性骨髓瘤患者又添有力武器2023年3月1日起，2022版医保目录正式实施，众多创新性强、临床价值高、疗效显著的药物被纳入新版目录，让更多中国患者能够及时获得有效治疗。对于多发性骨髓瘤（MM）患者来说，一个特别值得关注的好消息是，创新药物注射用卡非佐米首次被纳入医保，用于治疗复发或难治性多发性骨髓瘤成人患者。这一消息将大大提高新药的可及性，真正减轻患者的经济负担，为多发性骨髓瘤患者又添了一款有力武器。注射用卡非佐米作为年销10亿美元的重磅药物，在中国化合物专利即将于25年8月到期，仿制药企闻风而动，除11家国内仿制药企的争先布局，同时还有安进生物技术、杭州泰格医药科技等药企开展了临床试验，目前处于3期阶段。截图来源：药融云中国上市药品专利卡非佐米作为新一代的高度选择性不可逆蛋白酶体阻断药，属于环氧甲酮四肽蛋白酶体抑制剂类似物，主要抑制20S蛋白酶体的糜蛋白酶。它的结构和作用机理不同于二肽硼酸类似物硼替佐米，硼替佐米与蛋白酶体的催化β5亚组可逆性结合，而卡非佐米不可逆共价结合蛋白酶体的催化β5亚组和免疫蛋白酶体β5i(LMP7)亚组，相比于硼替佐米具有更好的效力和耐药性，业界预计其可能会取代硼替佐米，市场前景看好。除此次提交的注射用卡非佐米，目前海南普利制药还提交了钆特酸葡胺注射液、左亚叶酸钙注射液、硝普钠氯化钠注射液等26个品种的仿制申请，均在审评审批中。END本文为原创文章，转载请留言获取授权点击阅读原文，申请药融云企业版免费试用！

并购专利到期上市批准免疫疗法

2023-10-19

·GlobeNewswire-Health Care

GUERBET : Revenue at 30 September 2023.

Revenue at 30 September 2023 Activity 9-month revenue: €573.9 million, up 2.7% at CER1 Third-quarter sales remained very strong in Asia (+15.2% at CER), were stable in EMEA (+0.6%) and showed a smaller decline in the Americas (-5.2%)Expecting double-digit activity growth in the fourth quarter of 2023 thanks to the surge in sales of EluciremTM and strong momentum in Interventional Imaging Financial targets confirmed 2023 revenue up by more than 5% like-for-like and at CERRestated EBITDA margin2 of around 11% in 2023, before returning in 2024 to a higher level than in 2021 (14.4%) Villepinte, 19 October 2023: Guerbet (FR0000032526 GBT), a global specialist in contrast agents and solutions for medical imaging, is publishing its revenue for the period to 30 September 2023. Over the first nine months of the year, Group sales came to €573.9 million, up 0.8% on the same period in 2022. Business activity reflected a negative forex effect of €10.4 million. At CER1, revenue for the first nine months grew by 2.7%. Sales in the third quarter of 2023 came to €195.2 million, up 2.3% at CER, after rising by 2.8% during the first half of the financial year. Taking into account the expected ramp-up in EluciremTM sales in the fourth quarter, this scenario supports Guerbet’s financial targets for the full year and for next year. Geographical breakdown of consolidated Group revenue (IFRS) In millions of euros,at 30 September 20239 months 20229 months 2023At current exchange rates% change9 months 2023At CER1% changeSales in EMEA245.2258.5+5.4%258.6+5.5%Sales in the Americas182.5160.9-11.8%161.5-11.5%Sales in Asia141.4154.4+9.2%164.2+16.1%Total569.2573.9+0.8%584.3+2.7% 1Constant exchange rates: the exchange rate impact was eliminated by recalculating sales for the period on the basis of the exchange rates used for the previous financial year. In the EMEA region, the Group saw an increase in 9-month sales of 5.4% at current exchange rates and 5.5% at CER, driven by the increase in volumes and positive price effects. In the third quarter, revenue for the region came to €79.9 million, with moderate growth (+0.6% at CER) linked to a particularly high comparison base. In the Americas, sales for the period to end-September 2023 fell by 11.8% at current exchange rates and by 11.5% at CER. As expected, the decline in revenue slowed significantly in the third quarter to -5.2% at CER. After the complete normalisation of production rates during the first half of 2023, the Raleigh (North Carolina) site was again able to increase its production capacity with a view to increasing its sales - of EluciremTM in particular - in the fourth quarter. In Asia, sales growth over the 9-month period was +9.2%, incorporating a particularly substantial negative forex effect of -€9.8m (depreciation of Chinese, Japanese and Korean currencies) during the period; at CER, growth was +16.1%, a remarkable performance driven mainly by China (+39%), which continued to benefit from the introduction of direct distribution in 2022. In the third quarter alone, sales in Asia were up 15.2% at CER. Breakdown of consolidated Group revenue (IFRS) by activity In millions of euros,at 30 September 20239 months 20229 months 2023At current exchange rates% change9 months 2023At CER1% changeDiagnostic Imaging 502.2506.4+0.8%515.3+2.6%MRI192.4187.3-2.7%189.4-1.6%X-ray309.8319.0+3.0%325.8+5.2%Interventional Imaging67.067.5+0.7%69.0+3.0%Total569.2573.9+0.8%584.3+2.7% 1Constant exchange rates: the exchange rate impact was eliminated by recalculating sales for the period on the basis of the exchange rates used for the previous financial year. Revenue from Diagnostic Imaging at CER was up 2.6% at 30 September 2023 (+0.8% at current exchange rates) and up 1.2% in the third quarter. Note that the X-ray division now includes the revenue of Intrasense, consolidated since 1 January 2023. In MRI, sales for the 9-month period were down 1.6% at CER due to a contraction in activity in the third quarter of 2023. This reflects: A negative price effect linked to the price pressure exerted by the generic product for Dotarem® on the US market.Sales of EluciremTM which slowed in the third quarter due to longer-than-expected approval times (formulary process) in US hospitals, with a strong catch-up effect expected from the fourth quarter of 2023. In the X-ray division, revenue rose by 5.2% over the first nine months at CER, marked by a sharp acceleration in growth in the third quarter (+8.7%), again due to a sharp increase in sales of Xenetix®. In Interventional Imaging, sales at CER were up 3.0% compared with the first nine months of 2022. After a negative comparison base effect in the Asia-Pacific region in the first half of 2023, revenue for the third quarter rose by a sharp 10.3%, driven by strong sales of Lipiodol®. Financial targets for 2023 and 2024 confirmed Activity continues to be underpinned by robust volumes and broadly positive price effects (with the exception of Dotarem®), reflecting the Group’s ability to pass on cost increases to its customers (iodine in particular). In the fourth quarter of 2023, Guerbet expects double-digit sales growth driven by a very strong rebound in activity in the United States, linked in particular to the ramp-up of EluciremTM sales once the current approval processes are completed, and to continued favourable trends in Interventional Imaging. For the full year, Guerbet confirms that it is targeting revenue growth of more than 5% like-for-like and at CER. It still expects a restated EBITDA2 to revenue ratio of around 11% in 2023, before returning in 2024 to a higher level than in 2021 (14.4%). As a reminder, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a favourable opinion on the granting of marketing authorisation for Elucirem™ in the European Union for use in adults and children aged two and older for contrast-enhanced MRI. The European Commission is expected to make its decision by the end of 2023. Next event: Publication of full-year revenue8 February 2024 after market close About Guerbet At Guerbet, we build lasting relationships so that we enable people to live better. That is our purpose. We are a leader in medical imaging worldwide, offering a comprehensive range of pharmaceutical products, medical devices, and digital and AI solutions for diagnostic and interventional imaging. A pioneer in contrast media for 95 years, with more than 2,600 employees worldwide, we continuously innovate and devote 10% of our sales to research and development in four centres in France, Israel, and the United States. Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €753 million in revenue in 2022. Forward-looking statements Certain information contained in this press release does not reflect historical data but constitutes forward-looking statements. These forward-looking statements are based on estimates, forecasts, and assumptions, including but not limited to assumptions about the current and future strategy of the Group and the economic environment in which the Group operates. They involve known and unknown risks, uncertainties, and other factors that may result in a significant difference between the Group’s actual performance and results and those presented explicitly or implicitly by these forward-looking statements.These forward-looking statements are valid only as of the date of this press release, and the Group expressly disclaims any obligation or commitment to publish an update or revision of the forward-looking statements contained in this press release to reflect changes in their underlying assumptions, events, conditions, or circumstances. The forward-looking statements contained in this press release are for illustrative purposes only. Forward-looking statements and information are not guarantees of future performance and are subject to risks and uncertainties that are difficult to predict and are generally beyond the Group’s control.These risks and uncertainties include but are not limited to the uncertainties inherent in research and development, future clinical data and analyses (including after a marketing authorization is granted), decisions by regulatory authorities (such as the US Food and Drug Administration or the European Medicines Agency) regarding whether and when to approve any application for a drug, process, or biological product filed for any such product candidates, and their decisions regarding labeling and other factors that may affect the availability or commercial potential of such product candidates. A detailed description of the risks and uncertainties related to the Group’s activities can be found in Chapter 4.9 “Risk factors” of the Group’s Universal Registration Document filed with the AMF (French financial markets authority) under number D.23-0203 on March 31, 2023, available on the Group’s website (www.guerbet.com). 1 Constant exchange rates: the exchange rate impact was eliminated by recalculating sales for the period on the basis of the exchange rates used for the previous financial year.2 Excluding non-recurring costs related to the optimisation of the operating plan and changes in the sales model. 2 Excluding non-recurring costs related to the optimisation of the operating plan and changes in the sales model. Contacts : Guerbet Jérôme Estampes, Chief Financial Officer +33.1.45.91.50.00 / jerome.estampes@guerbet.comClaire Lauvernier, Communications Director +33.6.79.52.11.88 / claire.lauvernier@guerbet.com Actifin Marianne Py, Financial Communications +33.1.80.48.25.31 / mpy@actifin.frJennifer Jullia, Press +33.1.56.88.11.19 / jjullia@actifin.fr Attachment 23 1019 Guerbet_ CP CA T3 VA Vdef

财报生物类似药

2023-10-16

·PRNewswire

Bracco Diagnostics Showcases Innovation and Collaborative Vision at RSNA 2023 Annual Meeting

--Leaders in Radiology Will Share Insights on VUEWAY® (gadopiclenol) solution for injection After the First Year of Use in the U.S.-- --Applied Radiology to Announce Expansion of the Bracco-Supported "Leaders on the Horizon" Program-- MONROE TOWNSHIP, N.J., Oct. 16, 2023 /PRNewswire/ -- Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a pioneer in diagnostic imaging, is showcasing its commitment to innovation and purpose-driven partnership at the Radiological Society of North America (RSNA) 2023 Annual Meeting, to be held November 26-30 in Chicago, Illinois. This year, Bracco's activities at RSNA are captured by the theme, "Unlocking the Invisible." Through this overarching vision, Bracco is demonstrating its dedication to maximizing diagnostic accuracy and resource efficiency with the aim of improving people's lives. Engagement Opportunities Hosted by Bracco at RSNA 2023: MR Symposium: Bracco presents "The Future is Now: The Novel GBCA Gadopiclenol." This symposium will feature insights from leaders in radiology on how they have implemented VUEWAY injection into their practice since its FDA approval last year, using half the gadolinium (0.05 mmol/kg) compared to other macrocyclic GBCAs with approved doses of 0.1 mmol/kg in approved indications in the U.S.i-v The event will take place on Monday, November 27 at McCormick Place S101AB, South Building, from 9:00 AM – 10:00 AM CST. Please see Indications and Important Safety Information below, including Boxed Warning. "I am delighted to participate in this Bracco-sponsored symposium, as it will be a great opportunity for anyone interested in learning more about gadopiclenol and our initial experience with it for abdominal MR imaging at the University of Wisconsin to date," said Perry J. Pickhardt, MD, Professor of Radiology and Chief of Gastrointestinal Imaging at the University of Wisconsin School of Medicine and Public Health. Max Wintermark, MD, Professor and Chair of Neuroradiology at The University of Texas MD Anderson Cancer Center, said, "I am excited to participate in the Round Table Symposium sponsored by Bracco Diagnostics Inc. This will be a great opportunity for anyone interested in learning more about gadopiclenol and what our experience has been at MD Anderson Cancer Center to date." Supporting the Future of Diagnostic Imaging: The Applied Radiology "Leaders on the Horizon" Residency Program, which is supported by Bracco through an unrestricted educational grant, is expanding globally and will now include all diagnostic imaging modalities. Through this program, scholarships are bestowed upon six radiology resident applicants whose submitted research papers (three clinical research papers and three clinical review articles) are selected for publication by Applied Radiology. These individuals will be honored at a special evening reception hosted by Applied Radiology during RSNA 2023. Additionally, Bracco is thrilled to be entering the fourth year of its 10-year commitment to donate $450,000 to the RSNA Research & Education (R&E) Foundation. Visit Bracco's Booth (#3300): Bracco's booth experience will highlight an array of product offerings and partnerships, including: Comprehensive Diagnostic Contrast Imaging and Delivery Solutions: Bracco remains the sole provider of such a comprehensive breadth of barium sulfate contrast agents following FDA mandates. The company's ongoing commitment to providing a full selection of contrast agents demonstrates its dedication to improving patient diagnostics. Subtle Medical Collaboration: Bracco and Subtle Medical have joined forces in a global collaboration, aiming to explore the integration of artificial intelligence-powered image acquisition, particularly in the context of MR imaging. "At this year's RSNA meeting, we are pleased to demonstrate our dedication to advancing the field of medical imaging through rigorous research and thoughtful, strategic partnership," said Cosimo DePinto, Senior Vice President of Sales and Marketing at Bracco Diagnostics Inc. "Our goal, as it has always been, is to maximize diagnostic efficiency and effectiveness across the full spectrum of imaging procedures, enabling healthcare providers to provide the highest level of care to their patients." Connect with Bracco on LinkedIn and follow #BraccoImaging for more RSNA news. Indications VUEWAY injection is indicated in adults and children aged 2 years and older for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine and surrounding tissues), the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system). IMPORTANT SAFETY INFORMATION WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF) Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. The risk for NSF appears highest among patients with: Chronic, severe kidney disease (GFR < 30 mL/min/1.73 m2), or Acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. For patients at highest risk for NSF, do not exceed the recommended VUEWAY dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration. Contraindications VUEWAY injection is contraindicated in patients with history of hypersensitivity reactions to VUEWAY. Warnings Risk of nephrogenic systemic fibrosis is increased in patients using GBCA agents that have impaired elimination of the drugs, with the highest risk in patients with chronic, severe kidney disease as well as patients with acute kidney injury. Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities. Hypersensitivity reactions, including serious hypersensitivity reactions, could occur during use or shortly following VUEWAY administration. Assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders, administer VUEWAY only in situations where trained personnel and therapies are promptly available for the treatment of hypersensitivity reactions, and observe patients for signs and symptoms of hypersensitivity reactions after administration. Gadolinium retention can be for months or years in several organs after administration. The highest concentrations (nanomoles per gram of tissue) have been identified in the bone, followed by other organs (brain, skin, kidney, liver and spleen). Minimize repetitive GBCA imaging studies, particularly closely spaced studies, when possible. Acute kidney injury requiring dialysis has occurred with the use of GBCAs in patients with chronically reduced renal function. The risk of acute kidney injury may increase with increasing dose of the contrast agent. Ensure catheter and venous patency before injecting as extravasation may occur, and cause tissue irritation. VUEWAY may impair the visualization of lesions seen on non-contrast MRI. Therefore, caution should be exercised when VUEWAY MRI scans are interpreted without a companion non-contrast MRI scan. The most common adverse reactions (incidence ≥ 0.5%) are injection site pain (0.7%), and headache (0.7%). You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please click here for full Prescribing Information for VUEWAY, including BOXED WARNING on Nephrogenic Systemic Fibrosis. Manufactured for Bracco Diagnostics Inc. by Liebel-Flarsheim Company LLC - Raleigh, NC, USA 27616. VUEWAY is a registered trademark of Bracco Imaging S.p.A. About Bracco Imaging Bracco Imaging S.p.A. ("Bracco Imaging"), part of the Bracco Group, is an innovative world leader delivering end-to-end products and solutions through its comprehensive portfolio across diagnostic imaging modalities. Headquartered in Milan, Italy, Bracco Imaging's purpose is to improve people's lives by shaping the future of prevention and precision diagnostic imaging. The Bracco Imaging portfolio includes products and solutions for all key diagnostic imaging modalities: X-ray imaging, magnetic resonance imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents. Bracco Imaging has approximately 3,600 employees and operates in more than 100 markets globally. Bracco Imaging has a well-skilled and innovative Research and Development (R&D) organization with an efficient process-oriented approach and track record in the diagnostic imaging industry. R&D activities are located in four centers based in Italy, Switzerland, the United Kingdom and the United States. Bracco Group global revenues were 1.4 billion Euros in 2020. To learn more about Bracco Imaging, visit . i. VUEWAY® (gadopiclenol) solution for injection, 485.1 mg/mL full Prescribing Information and Patient Medication Guide. Monroe Twp., NJ: Bracco Diagnostics Inc.; September 2022. ii. DOTAREM® (gadoterate meglumine) Injection full Prescribing Information. Princeton, NJ: Guerbet LLC; October 2019. iii. GADAVIST® (gadobutrol) Injection full Prescribing Information and Patient Medication Guide. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc; April 2022. iv. ProHance® (Gadoteridol) Injection, 279.3 mg/mL full Prescribing Information and Patient Medication Guide. Monroe Twp., NJ: Bracco Diagnostics Inc.; June 2022. v. CLARISCAN™ (gadoterate meglumine) injection for intravenous use full Prescribing Information. Chicago IL: GE Healthcare; November 2020. SOURCE Bracco Imaging

100 项与钆特酸葡胺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03355	钆特酸葡胺	V08CA02	DB09132

研发状态

适应症	最高研发状态	国家/地区	公司
造影剂	批准上市	中国更多	Guerbet SA 更多
血管疾病	批准上市	美国更多	Guerbet LLC 更多
肾动脉阻塞	终止	美国更多	Guerbet SA 更多
终末期肾脏病	无进展	比利时更多	Guerbet SA 更多
中枢神经系统疾病	无进展	韩国更多	Guerbet SA 更多

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临床结果

适应症

分期

评价

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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


NCT02411201 (CTgov)	临床4期	-	51	DOTAREM	壓遞繭鑰範鹽範襯膚鹹(積餘製觸壓淵壓膚鹹範) = 窪鬱鬱衊衊憲廠鏇積製選築願積蓋醖鹹觸鬱淵 (顧鬱鹹窪鹹壓膚蓋範憲, 醖積鏇蓋範觸廠齋廠製 ~ 鬱鑰窪鬱鑰簾製壓醖鬱) 更多	-	2017-03-09
NCT01026389 (CTgov)	临床4期	外周动脉疾病 \| 血管动脉疾病	189	Gadovist (Gadovist)	齋壓鏇餘壓艱鑰積憲積(蓋鬱淵鏇餘淵醖製觸醖) = 遞膚鑰憲遞網淵糧膚膚蓋衊鏇艱齋網選壓蓋餘 (夢製構築醖餘壓願蓋選, 衊壓鹹壓憲獵憲遞觸鹹 ~ 襯顧築艱觸範齋淵壓願) 更多	-	2012-12-11
				Dotarem (Dotarem, Interventional)	齋壓鏇餘壓艱鑰積憲積(蓋鬱淵鏇餘淵醖製觸醖) = 醖鏇窪糧糧廠醖齋蓋構蓋衊鏇艱齋網選壓蓋餘 (夢製構築醖餘壓願蓋選, 網衊構鬱艱鹽襯選鬱齋 ~ 願範選積壓網獵糧蓋願) 更多
NCT02034708 (CTgov)	临床4期	脑癌	279	Gadovist (Gadovist® (Reader 1))	範構壓鹹餘膚觸淵願窪(淵製製鹹網範繭淵艱鹽) = 憲構遞醖餘簾願鹽簾窪鏇艱築鏇願構餘願築選 (醖積網憲願鏇繭築繭艱, 衊齋鬱築窪築壓壓遞艱 ~ 鏇襯積獵鬱艱夢窪廠鏇)	-	2016-10-25
				Dotarem (Dotarem® (Reader 1))	範構壓鹹餘膚觸淵願窪(淵製製鹹網範繭淵艱鹽) = 糧鏇窪窪鏇鹹遞淵糧憲鏇艱築鏇願構餘願築選 (醖積網憲願鏇繭築繭艱, 襯鑰艱構顧醖範憲願鏇 ~ 壓襯顧積繭蓋鏇築築簾)
NCT01806740 (CTgov)	临床4期	晚期肝细胞癌	37	Gadoterate meglumine	獵網簾衊選簾艱衊淵繭(鏇積鬱獵製觸蓋蓋網簾) = 淵醖繭觸築鏇淵築願糧築製齋齋網觸壓鏇觸獵 (觸簾膚鑰築積網鹹醖鹹, 獵鑰衊淵餘窪獵鏇廠繭 ~ 蓋餘淵醖網糧鏇鬱淵範) 更多	-	2019-08-08
NCT01449266 (CTgov)	临床1期	终末期肾脏病	10	Dotarem	糧構觸範選廠淵廠膚憲(憲壓鏇餘衊遞鏇壓醖顧) = 襯夢壓構積壓獵膚觸廠製夢齋願簾糧構鏇製齋 (衊築窪網膚鹽廠鹹築鑰, 鑰構簾積壓壓衊襯蓋製 ~ 遞獵網鬱鹽遞鏇憲築簾) 更多	-	2015-06-08
NCT02070380 (CTgov)	临床4期	脑疾病	179	Dotarem (MultiHance 0.1 mmol/kg Arm (Reader 1))	鹹製網鑰構鹽淵鹽醖鹽(餘願繭遞醖艱窪積願夢) = 願壓襯艱夢艱艱醖遞廠夢鏇顧廠廠餘鏇積糧憲 (襯醖夢網醖範糧壓鹹構, 願鏇範願鬱築襯網積壓 ~ 選鹹構製艱構衊獵獵鏇) 更多	-	2017-01-10
				Dotarem (MultiHance 0.1 mmol/kg Arm (Reader 2))	鹹製網鑰構鹽淵鹽醖鹽(餘願繭遞醖艱窪積願夢) = 鏇鏇選壓膚糧獵蓋遞網夢鏇顧廠廠餘鏇積糧憲 (襯醖夢網醖範糧壓鹹構, 網糧齋積廠鹹觸淵憲製 ~ 夢膚構顧蓋鏇網鬱繭鑰) 更多
NCT00650845 (CTgov)	临床4期	造影剂	135	Dotarem®-enhanced MRI (Dotarem®-Enhanced MRI)	願鹹鹽壓遞鑰糧繭築餘(鹹繭願齋鹹壓製築鬱範) = 蓋蓋積遞憲選淵憲簾顧憲製鬱積蓋網遞壓構壓 (觸壓窪衊壓衊鑰壓簾衊, 淵壓鹹範窪觸夢鬱鏇壓 ~ 窪膚遞簾遞餘築蓋範鑰) 更多	-	2015-06-09
				non-enhanced MRI (Non-enhanced MRI)	願鹹鹽壓遞鑰糧繭築餘(鹹繭願齋鹹壓製築鬱範) = 醖積憲衊衊觸鏇衊繭築憲製鬱積蓋網遞壓構壓 (觸壓窪衊壓衊鑰壓簾衊, 窪襯範廠顧觸艱築鏇淵 ~ 遞鑰築範築築糧醖積糧) 更多
NCT01211873 (CTgov)	临床3期	中枢神经系统疾病	416	Dotarem (gadoterate meglumine) (Dotarem (Gadoterate Meglumine ))	夢蓋廠範糧夢願齋獵窪(齋觸憲願願齋鏇廠糧鏇) = 築積簾製觸糧鬱餘襯簾艱膚網艱襯鏇憲蓋夢鏇 (鹽鑰夢鏇憲網網獵艱鏇, 夢衊顧繭憲壓糧餘窪網 ~ 鏇鏇築網淵顧鹽觸觸觸) 更多	-	2014-05-29
				Magnevist (gadopentetate dimeglumine) (Magnevist (Gadopentetate Dimeglumine))	夢蓋廠範糧夢願齋獵窪(齋觸憲願願齋鏇廠糧鏇) = 鹹膚憲願壓壓壓鹹願淵艱膚網艱襯鏇憲蓋夢鏇 (鹽鑰夢鏇憲網網獵艱鏇, 簾餘憲膚鑰鏇願鹽衊鑰 ~ 糧鹽繭壓艱齋鹽膚憲餘) 更多