The aim of the current trial is to evaluate the efficacy and safety of flat-dose nivolumab (40 mg) in combination with AVD in the management of patients with newly diagnosed advanced classic Hodgkin Lymphoma

开始日期2025-04-15

申办/合作机构

Russian Ministry of Health

NCT06655480

/ Not yet recruiting临床2期IIT

Effect on Clinical Status, Structural and Functional Cardiac Parameters and Myocardial Fibrosis of Triple Combination Therapy With a Sodium-glucose Cotransporter 2 Inhibitor, Angiotensin Receptor/Neprilysin Inhibitor and Mineralocorticoid Receptor Antagonist in Patients With Advanced HFpEF

Patients with advanced heart failure with preserved ejection fraction (HFpEF) will be randomly assigned in open-label multicenter study to receive triple combination therapy with [angiotensin receptor/neprilysin inhibitor [ARNI] + sodium-glucose cotransporter 2 inhibitor [SGLTi] + mineralocorticoid receptor antagonist [MRA]) or with individualized medical therapy [SGLTi + renin-angiotensin system inhibitor [RASi] [angiotensin receptor blocker [ARB] or angiotensin-converting enzyme inhibitor [ACE-I]), and will be treated for 52 weeks

开始日期2025-03-18

申办/合作机构

Russian Ministry of Health

[+1]

NCT06856603

/ Recruiting临床2期IIT

OLIGO-10: Stereotactic Ablative Radiation Therapy for Metastatic Patients (6-10 Metastases): A Prospective Phase II Single-Arm Trial

Currently, the standard of care for patients with diagnosed metastatic cancer is drug therapy (chemotherapy, targeted therapy, or immunotherapy). However, the approach to oligometastatic disease (1-5 metastases) is evolving. An increasing number of de novo, persistent, and progressive oligometastatic tumors are now being treated with curative intent, with radiation therapy among the most effective treatment options, applied to metastatic sites in ablative doses. Emerging results from the SABR-COMET 3 and 5 trials, which investigate stereotactic ablative radiotherapy for patients with 1-3 and 1-5 metastatic sites, demonstrate a clear improvement in overall survival. However, patients with more than five metastases remain in a gray area.
The aim of our study is to assess the safety and effectiveness of radiation treatment for patients with tumors of various localizations and 6 to 10 metastases in the bones and internal organs. Stereotactic radiation therapy will be applied to patients with persistent or progressive metastatic forms of tumors, without changing their ongoing drug therapy regimen.

开始日期2025-02-07

申办/合作机构

Russian Ministry of Health

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项与 Russian Ministry of Health 相关的文献（医药）

2025-11-01·BIOSENSORS & BIOELECTRONICS

Nanozymes: a dual approach to bacterial colorimetric and luminescent detection and to bacterial pathogen killing

Review

作者: Liu, Qingyun ; Chumakov, Daniil S ; Zavyalova, Elena G ; Evstigneeva, Stella S ; Guliy, Olga I

Rapid identification of bacteria is a critical analytical procedure vital for laboratory diagnostics of infections and for monitoring technological processes in pharmaceuticals, the food industry, and agricultural biotechnology. Biosensor systems based on artificial enzyme mimics, nanozymes, offer a promising alternative to conventional bacterial detection methods due to their high sensitivity, rapid response times, and potential for miniaturization. Nanozymes possess advantageous properties such as high stability, tunable catalytic activity, and surface functionalization capabilities, enabling the development of portable point-of-care (POC) platforms for real-time, on-site pathogen detection. This review systematically examines advances in optical (colorimetric and luminescent) nanozyme-based sensors for bacterial detection. A significant advantage of these sensors is that their output signals can be easily observed with naked eye, requiring no complex equipment. As antibiotic-resistant bacteria become more widespread, the review emphasizes nanozyme-based theranostic strategies that integrate optical pathogen diagnostics with diverse therapeutic modalities, including photothermal therapy, photodynamic therapy, chemodynamic therapy, and biofilm matrix degradation. Challenges impeding the commercialization of nanozyme-based theranostic agents are discussed, along with potential solutions to address these barriers. The review underscores the need to resolve challenging problems to facilitate the translation of nanozyme-based theranostic agents into practical clinical and industrial applications.

2025-09-01·JOURNAL OF NEURO-ONCOLOGY

Long-term neurocognitive sequelae in pediatric medulloblastoma survivors treated according to the HIT protocol

Article

作者: Karpova, Nadezhda M ; Aldeeva, Iuliia A ; Karelin, Alexander F ; Romanova, Elizaveta N ; Shapovalova, Valeriia G ; Glebova, Elena V ; Sarkisyan, Roza A

OBJECTIVE:

Medulloblastoma is the most prevalent malignant brain tumour in children. Although contemporary comprehensive anticancer therapy has been shown to result in favourable survival and relapse outcomes, the long-term toxic effects on cognitive and motor function remain a concern. This study aims to investigate the long-term neurotoxic effects on cognitive function in paediatric medulloblastoma survivors.

METHOD:

Data from 70 patients (M_age = 12.7 ± 2.94 years, 40% female) in remission treated according to the HIT protocol who underwent comprehensive neuropsychological assessment were analyzed. General linear models (GLMs) were constructed to assess the contribution of remission duration, chemotherapy type, and radiation dose to variability in cognitive performance on the CANTAB and DTKI tests.

RESULTS:

GLM revealed that remission > 4 years was associated with poorer processing speed, attention, and executive functions: cognitive flexibility, inhibitory control, planning, and working memory compared to participants with shorter remission. Induction therapy with methotrexate had more pronounced long-term negative effects on processing speed. However, no significant effects were observed across different radiation doses.

CONCLUSIONS:

Remission duration emerged as a more significant predictor of a poor neurocognitive outcome than chemotherapy type or radiation dose, that is, the longer the remission, the more pronounced the neurocognitive impairment becomes. This highlights the need for continued monitoring and the development of targeted rehabilitation interventions for paediatric medulloblastoma survivors.

2025-08-01·Urologia Journal

Erectile dysfunction in railway station workers: A randomized study of different treatment approaches

Article

作者: Andrey, Morozov ; Boris, Neymark ; Alexandr, Neymark ; Andrey, Momot ; Anzhelika, Arkhipova ; Leonid, Rapoport ; Leonid, Spivak ; Georgy, Tyshkevich ; Dmitry, Korolev

Introduction::

The profession of a locomotive engineer involves stress, lack of adequate sleep and rest, and a sedentary lifestyle, all of which can contribute to the development of erectile dysfunction (ErD) as well as arterial hypertension.

Materials and methods::

Consecutive patients of the railway hospital in Barnaul with arterial hypertension aged 30–60 who work as machinists or assistant locomotive drivers were enrolled. Those who have symptoms of ErD were randomized into three groups: group 1 received an endogenous nitric oxide-synthase (NOS) activator, group 2 received a combination of endogenous NOS activator and phosphodiesterase type 5 inhibitor (PDE-5i), and group 3 received no additional treatment for ErD. 20 individuals belonged to the control group without ErD. A follow-up was conducted after 2 and 4 months.

Results::

A total of 85 individuals were examined (65 with symptoms of ErD). After 2 months of treatment, no significant changes in biomarkers and LDF (laser Doppler flowmetry) values were observed in groups 1 and 3. In group 2, ET-1 (endothelin-1) and hs-CRP (high-sensitivity C-reactive protein) returned to reference levels, and ischemic manifestations decreased. After 4 months, group 1 had increased mean blood flow and hs-CRP returned to reference levels. Group 2 showed improved microhemodynamics and biomarkers values. Group 2 patients had a higher IIEF and ICF total scores.

Conclusion::

The combination of hypotensive drugs, PDE-5i, and NOS activator was the most effective method of treatment, improving hemodynamics and reparative properties of the endothelium by removing the substrate for thrombus formation. Treatment with an NO-synthase activator was shown to partially eliminate pathological processes in the endothelium.

项与 Russian Ministry of Health 相关的新闻（医药）

2025-06-10

·药时空

德国联邦联合委员会拟将呼吸道合胞病毒mRNA疫苗纳入国家接种指南

2025年6月5日，德国联邦联合委员会 ( G-BA ) 将德国疫苗接种常设委员会 ( STIKO ) 建议的呼吸道合胞病毒 (RSV) mRNA疫苗纳入其疫苗接种指南。STIKO在评估了mRNA疫苗mResvia®的数据后认为，这种疫苗总体上是安全、有效且与蛋白基RSV疫苗相当的。因此，STIKO在最新的疫苗接种建议中，建议mRNA疫苗mResvia®纳入针对RSV感染的疫苗接种选项中。据悉，该决定将提交联邦卫生部（BMG）进行法律审查，如未收到异议，预计将在7月底于联邦公报上公布后正式生效。STIKO建议哪些人接种 RSV 疫苗？自2024年8月起， STIKO 建议所有75岁及以上人士接种一次呼吸道合胞病毒疫苗。此外，还建议60岁及以上患有严重基础疾病或居住在疗养院的人士接种一次呼吸道合胞病毒疫苗。据 STIKO 介绍，一次性疫苗接种应在RSV季节前的秋季进行。针对老年人的RSV疫苗审查对于目前针对老年人的RSV疫苗接种建议， STIKO审查了现有的呼吸道合胞病毒疾病数据以及 2023 年批准的呼吸道合胞病毒疫苗（Abrysvo® 和 Arexvy®）。这两种疫苗都是蛋白质疫苗。它们均获准用于 60 岁及以上人群的呼吸道合胞病毒 (RSV) 疫苗接种。其中一种疫苗 Abrysvo® 也获准用于孕妇，以保护婴儿。一旦获得足够的证据表明接种疫苗对接种者以及整个人群的个体益处， STIKO将审查孕期接种呼吸道合胞病毒疫苗的可能建议。自STIKO发布老年人RSV疫苗接种建议以来，另一种RSV疫苗mResvia®已获批准，可供60岁以上人群接种。该疫苗于2024年8月底获批，是一种针对RSV的mRNA疫苗。STIKO将尽快审查该疫苗的相关数据。识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

疫苗信使RNA临床研究

2025-05-21

·医药健闻

GE医疗天津基地获批全球保税维修业务；驯鹿生物上海外高桥全球研发中心启用；全国首家三级标准外商独资心血管专科医院揭牌 | 日报

全球医疗行业每日重点资讯文 | 苏丁企业动态GE医疗天津基地近日正式获批成为京津冀首批医疗器械保税维修试点企业，可面向全球承接高端医疗设备及备件的检测与维修服务。依托获批的保税维修资质，GE医疗天津基地可在综合保税区外直接承接全球高端医械备品、备件的检测、维修服务。与传统模式相比，这项新业务可将设备的备品、备件维修周期缩短约30%。驯鹿生物上海外高桥保税区的全球研发中心正式启用。驯鹿生物全球研发中心，建筑面积约30,000平方米，将依托外高桥保税区独特的政策优势，布局最前沿的细胞与基因治疗技术。驯鹿生物与来自日本、墨西哥、俄罗斯、印尼等国家的合作伙伴以及深圳残友集团达成重要战略合作：一方面加速CAR-T产品在海外市场的注册申报与商业化布局，另一方面引进国际先进的干细胞治疗技术和产品，拓展治疗领域。位于上海大虹桥核心区域的威高云行智创园举行开园庆典。威高集团拥有医疗器械和药品1000多种、20多万个规格。威高云行智创园占地面积约61亩，总建筑面积约18万平方米。园区以先进医疗器械及大健康产业为核心定位，规划建设集研发、办公、商业及生活配套等多功能于一体的医械垂直型产业社区。全国首家三级标准的外商独资心血管专科医院上海德达心血管医院5月17日正式揭牌，标志着我国心血管专科医疗领域迈入国际化、专业化发展新阶段。作为上海医疗卫生对外开放的标志性成果，上海德达心血管医院以“以患者为中心”为核心理念，融合国际前沿技术与人文关怀，致力于打造心血管诊疗新高地。复星医药公告，近日公司董事会收到Rong Yang的书面辞职函，因个人原因申请辞去高级副总裁职务。Rong Yang自2025年5月16日起不再担任公司高级副总裁职务。君合盟生物制药（杭州）有限公司完成数千万元战略融资，由石药国方基金独家投资。本轮融资将用于推进公司在研产品管线开发，深化在严肃医疗及消费医疗领域的技术布局，加快公司产品管线临床进展、申报进程及市场推广。帕母医疗宣布完成新一轮数千万美元加轮融资，由欧洲千亿级私募股权投资机构EQT领投，上轮新晋投资方启明创投继续支持。本轮募集资金将主要用于帕母医疗在海外市场的布局与推进，包括全球临床注册、产品适应证拓展及产业化体系深化等重点方向。产业动态强生尼卡利单抗注射液跨境分段生产试点获国家药监局批复同意，这是全球同步上市的创新产品，也是全国首个治疗12岁及以上青少年和成人患者罕见病“全身型重症肌无力”的生物制品。该品种原液在国内生产，制剂和包装在境外生产。美谷分子仪器新品“QPix FLEX微生物克隆筛选系统”全球发布。这是美谷分子首台由中国团队主导研发、上海制造、面向全球市场的产品。此次新品的推出，是丹纳赫生命科学平台成员在中国的又一本土化新进展。靖因药业与CRISPR Therapeutics宣布达成战略合作伙伴关系，将携手推进siRNA疗法的联合开发与商业化进程。根据协议条款，靖因药业将获得CRISPR Therapeutics支付的9500万美元现金及现金等价物作为首付款，并有资格获得超8亿美元的预付款和里程碑付款。双方将以50-50的成本和利润分摊机制共同开发SRSD107。此外，协议还授予CRISPR Therapeutics在未来独家引进最多两个额外siRNA项目的优先授权权利。锐正基因自主研发用于治疗转甲状腺素蛋白相关淀粉样变性（ATTR）的以LNP为载体的体内基因编辑创新药ART001已获得美国食品药品监督管理局（FDA）授予的再生医学先进疗法（RegeneRMAT）认定。这是中国第一个获美国FDA RMAT认定的基因编辑产品。亿帆医药控股子公司EVIVE BIOTECHNOLOGY IRELAND LTD与LENIS farmacevtika d.o.o.签订合作协议，协议约定亿一将新型生物药Ryzneuta（艾贝格司亭α注射液，中国商品名“亿立舒”）在东欧8国的独家经销权许可给LENIS公司，LENIS公司负责Ryzneuta在东欧8国的市场规划及销售。绿谷医药科技宣布，基于多维度的证据体系评价与分级，其调节脑肠轴的创新药物甘露特钠（商品名：九期一）获《阿尔茨海默病多元康复干预中国专家共识（2025）》强推荐，并被评定为高证据质量级别。本次甘露特钠作为西药治疗方面调节脑肠轴的药物，在该《共识》中获得高证据质量级别、强推荐，并被推荐描述为“可改善轻至中度阿尔茨海默病患者的认知功能、日常生活能力，长期使用可延缓疾病进展”。华润双鹤公告，全资子公司华润紫竹药业有限公司的地诺孕素片获得俄罗斯联邦卫生部颁发的《药品注册证书》。该药品用于治疗子宫内膜异位症。上海医药下属常州制药厂有限公司收到美国食品药品监督管理局通知，其利伐沙班片简略新药申请已获得批准。该药品主要用于降低非瓣膜性房颤患者卒中和全身性栓塞的风险等，常州制药厂于2021年12月提出ANDA申请，近日获得批准文号。爱博合创连续第四年亮相世界神经介入治疗大会（WLNC）暨东方脑血管病大会（OCIN），展示旗下自主研发的产品——PANVIS-A脑血管介入手术辅助操作系统。PANVIS-A系统搭载两项全球原创技术：VIS COF（Catheter-On-Finger ）指尖导管直观操作系统和多器械协同驱动系统。实现类手感控制，显著缩短学习曲线；支持多个手术器械的精确控制，实现亚毫米级的操作精度。人工智能（AI）在医疗领域持续取得重大进展，中国最近公布一项突破性进展：成立全球首家由42名人工智能医生组成的人工智能医院。这个由清华大学智能产业研究院（AIR）开发的创新型医疗机构，整合了21项医疗科室的尖端技术。这标志着中国向AI驱动医疗护理迈出的重要一步。联系美通社+86-10-5953 9500info@prnasia.com

细胞疗法高管变更上市批准

2025-05-06

·FiercePharma

Vertex, with new launches gaining steam, boosts revenue forecast despite Trikafta dilemma in Russia

Vertex's momentum for its two new launches were partly overshadowed by a loss of Trikafta sales in Russia. For Vertex Pharmaceuticals, the first quarter of 2025 brought good news and bad news. On the bright side, early momentum for newly launched cystic fibrosis (CF) med Alyftrek and pain treatment Journavx contributed to a U.S. revenue boost and the company's increased 2025 outlook. But, on the other hand, a unique generics situation in Russia weighed on the biopharma's international sales. The mixed bag evened out to a 3% year-over-year revenue gain to $2.77 billion, with $1.66 billion coming from the U.S., where Vertex grew sales by 9%.Outside of the U.S., the company's $1.11 billion in first-quarter sales represented a 5% slide from the same period last year.Despite “strong patient demand” in markets outside of the U.S., Vertex's international revenue was impacted by an “expected” decline in Russia, where the company is “experiencing violation of its intellectual property rights,” Vertex explained in its earnings release.“Vertex has strong intellectual property protection for its medicines around the world and believes this violation in Russia is a limited and isolated matter,” the company said.The situation boils down to an unauthorized generic of Vertex’s top-selling CF med Trikafta marketed in Russia. Since January, the Russian Ministry of Health has been switching children who take Trikafta to an Argentina-made generic called Trilexa, independent Russian news publication Okho reported in March, citing stories from parents of patients. The drug has not been tested in clinical studies, and the move has prompted protests within the CF community, according to Okho. As that situation plays out, Vertex’s quarterly revenues came in below consensus expectations of of $2.83 billion, Evercore ISI analysts wrote in a note to clients. BMO analyst Evan Seigerman also cited the “onetime headwinds” from Russia, plus “new product launch noise,” as reasons for the revenue miss.Still, given the trajectory of its two new launches—plus “contributed uptake” of CRISPR Therapeutics-partnered sickle cell and beta thalassemia gene therapy Casgevy—Vertex opted to slightly boost its full-year revenue guidance. Now, the company is eyeing 2025 revenues of $11.85 billion to $12 billion, up from prior guidance of $11.75 billion to $12 billion. Journavx's journey Vertex’s non-opioid Journavx was approved in January to much fanfare considering its unique position as a nonaddictive pain management treatment. The company quickly set out to begin shipments and has since racked up more than 20,000 prescriptions, Vertex reported, although revenue from the drug was “insignificant” during the first quarter because it's still so early in the launch. In his note to clients, Seigerman praised the company's access efforts and said he expects more revenue contributions from the med in the second half of the year.Ensuring patients have access to Journavx is especially key given the cheap generic opioids that currently dominate the pain market. Alyftrek, meanwhile, won a December FDA approval as a once-daily triple combination for CF patients that have certain mutations. The drug has “potential to set a new standard of CF care,” according to Vertex, which looks to transition patients currently taking established Trikafta over to Alyftrek. So far, the company is seeing “enthusiastic feedback” from physicians and patients, it said in its earnings presentation. The company racked up $53.9 million in Alyftrek revenues in the first quarter.