Surgical Prophylaxis: Assessing Decolonization Efficacy of Polyhexanide Versus Mupirocin and Chlorhexidine in Decolonizing Staphylococcus Aureus Preoperatively in Elective Spine Surgery (SPADE): A Pilot Randomized Controlled Trial

This pilot randomized controlled trial evaluates the feasibility, tolerability, and preliminary efficacy of a decolonization regimen using polyhexanide in reducing Staphylococcus aureus colonization in the preoperative phase of elective spine surgery, compared to the standard mupirocin and chlorhexidine regimen. The trial involves 24 participants randomized into two groups: one receiving polyhexanide and the other receiving mupirocin and chlorhexidine. The primary outcome is the randomization rate, with secondary outcomes including other feasibility outcomes, tolerability, and efficacy measures such as the reduction in S. aureus colony-forming units (CFUs) and changes in the nasal and skin microbiome composition.

开始日期2025-05-01

申办/合作机构-

NCT06338163

/ Not yet recruiting临床4期IIT

Polihexanide SSIs Measures Bundle (PSMB) During Enhanced Recovery After Major Digestive Surgery

This is a randomized controlled, prospective, multicenter superiority trial with two parallel treatment groups and single blinding (local investigators performing postoperative follow up will be blinded for group allocation), with prospective enrollment planned from July 2024 to June 2025 in 20 Italian surgical centers. All patients undergoing elective major gastro-intestinal (GI) tract surgery (upper GI, HPB, & lower GI) will be included in a prospective database after written informed consent. A total of 2,000 patients is expected based on a mean of 100 cases per center.

开始日期2024-07-01

申办/合作机构-

NCT06213649

/ Recruiting临床3期IIT

Parasitic Ulcer Treatment Trial

The Parasitic Ulcer Treatment Trial (PUTT) is a multi-center, parallel-group, randomized clinical trial. The purpose of this study is to determine whether including topical corticosteroids in a regimen for acanthamoeba keratitis (AK) will improve vision. Patients presenting to all enrollment centers with evidence of acanthamoeba keratitis will be eligible for the trial if there is evidence of ocular inflammation after 4 weeks of anti-amoebic therapy. Those who agree to participate will be randomized to one of two treatment groups:
* Group 1: Topical corticosteroid
* Group 2: Topical placebo

开始日期2024-07-01

申办/合作机构

The University of California, San Francisco

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100 项与聚己缩胍相关的临床结果

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100 项与聚己缩胍相关的转化医学

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100 项与聚己缩胍相关的专利（医药）

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项与聚己缩胍相关的文献（医药）

2025-10-01·Ocular Surface

Acanthamoeba keratitis treatment outcomes compared for drug delivery by protocol versus physician's individualised treatment

Article

作者: Mrukwa-Kominek, Ewa ; Rama, Paolo ; Jadczyk-Sorek, Katarzyna ; Minassian, Darwin C ; Papa, Vincenzo ; Sanchez, Sara ; Carley, Fiona ; Fasolo, Adriano ; Leon, Pia ; Dart, John K G ; Birattari, Federica ; Hau, Scott ; Parwez, Hossain ; Franch, Antonella ; Knutsson, Karl Anders ; Ahmad, Saj

PURPOSE:

To compare Acanthamoeba keratitis (AK) outcomes for treatment delivered using a detailed protocol versus physician's individualised treatment.

METHODS:

This double cohort study compared the outcomes of these different delivery methods for PHMB 0.02 % and diamidine 0.1 % dual therapy. The primary outcome was the medical cure rate without surgery within 12 months (MCR_12) and the secondary was visual acuity. Any change of treatment, any surgery, or treatment for >12 months was a failure. Outcomes were both unadjusted and adjusted, using multivariable analysis, for baseline differences affecting outcomes. Patients were from two centres in Milan and London treated at different times; the individualised cohort (1991-2012) and per-protocol cohort (2017-2021).

RESULTS:

The individualised cohort included 96 and the per-protocol 47 patients. Both unadjusted and adjusted results were similar. The unadjusted outcomes for both centres combined showed significantly improved outcomes for per-protocol treatment with a 1.59-fold improvement in MCR_12 (95 % CI 1.40-1.80, p < 0.001) and a 2.1-fold increase in visual acuity ≥20/25 (95 % CI 1.34-3.29, p < 0.001). Amongst potential confounding factors examined, neither baseline AK disease stage, treatment centre nor the type of diamidine significantly influenced outcomes.

CONCLUSIONS:

This study shows significant advantages for the use of protocol delivered versus individualised treatment for AK. The use of evidence-based treatment delivery protocols, like the one used here for AK, might improve outcomes for all causes of microbial keratitis and could offer practitioners and patients the benefit of having an easy-to-follow drug delivery protocol, with known outcomes.

2025-09-01·EUROPEAN JOURNAL OF OPHTHALMOLOGY

Article

2025-09-01·IJID regions

Clinical presentation, genotypic diversity, and intracellular bacteria in Acanthamoeba keratitis patients treated at a referral eye hospital in Sydney, Australia

Article

作者: Chorny, Alexander ; Asrat, Yalewayker ; Hong, Sheng Chiong ; Carnt, Nicole ; Rayamajhee, Binod ; Henriquez, Fiona L ; Willcox, Mark ; Fazal, Amberin ; Yadav, Uday Narayan ; Petsoglou, Constantinos ; Shrestha, Gauri Sr

Objectives:

Acanthamoeba keratitis (AK) is an emerging corneal infection. This study evaluated the prevalence of AK, assessed circulating Acanthamoeba genotypes, and identified potential sources of infection.

Methods:

A prospective case series study was conducted at the Sydney Eye Hospital, Australia, from June 2021 and October 2022. Corneal swabs from AK patients were collected for culture, and their domestic water samples were also analyzed. Cyst morphology, polymerase chain reaction, and Sanger sequencing were performed to confirm the Acanthamoeba isolates.

Results:

A total of 21 AK patients were recruited in this study (41 ± 12.3 years). Six (28.6%) corneal and four (44.4%) water samples tested positive for Acanthamoeba genotype T4. One corneal and one water isolate harbored intracellular bacteria, with the water isolate containing Pseudomonas aeruginosa. Eight patients were contact lens wearers. Eye pain was the primary symptom (66.7%), followed by red eye. The median duration of symptoms was 24.5 days (interquartile range: 13-95 days). Polyhexamethylene biguanide was the main therapy, followed by chlorhexidine. The median treatment duration was 12 weeks (interquartile range: 8-26 weeks).

Conclusions:

In Sydney, the prevalent genotype of Acanthamoeba among AK patients and tap water was T4. This study suggests a higher annual incidence of AK than previously reported.

项与聚己缩胍相关的新闻（医药）

2025-06-11

·PipelineReview

SIFI merges into Faes Farma to become its ophthalmic franchise and expand international access to its portfolio and pipeline

CATANIA, Italy I June 10, 2025 I SIFI, a leading international ophthalmic company, today announced that its shareholders have signed an agreement, subject to conditions precedent, to sell 100% of SIFI shares to Faes Farma, a leading European pharmaceutical company listed on the Spanish stock exchange. The transaction validates SIFI’s unique business model centred around the consolidated pharmaceutical and surgical units, combined with the fast-growing contract manufacturing and rare diseases units. SIFI will enable Faes Farma to offer one of the most comprehensive ophthalmology portfolios in the industry, with a complementary geographic presence. The integration of SIFI and Laboratorios Edol, a leading Portuguese pharmaceutical recently acquired by Faes Farma, positions ophthalmology as a pivotal area for the combined entity (the “Group”), representing approximately 20% of its pro-forma revenue, and allows for further portfolio synergies. SIFI facilitates the Group’s entry into new high-growth regions in Europe, such as Italy, France, Romania, and Turkey, while bolstering the Group’s presence in others, such as Iberia, Mexico and Latin America. Furthermore, product integration should unlock cross-selling opportunities, improving growth and margins through operational and cost efficiencies. The Group will invest into the further development of Akantior (polihexanide 0.08%) into existing and new geographies, most notably in the USA, as well as the development of polihexanide into additional orphan indications. Akantior is approved by the European Medicines Agency (EMA) and United Kingdom’s Medicines & Healthcare products Regulatory Agency (MHRA) for the treatment of Acanthamoeba Keratitis (AK) in adults and children aged 12 and older. Akantior is the first and only approved therapy for AK anywhere in the world, addressing an ultra-rare, severe, and progressive corneal infection affecting approximately 3,000 patients annually in Europe and the United States. Launched in Germany in October 2024, pricing and reimbursement procedures are underway in other European countries. It is also in the pre-registration phase with the FDA (U.S. Food and Drug Administration) with orphan drug designation. Polihexanide will soon begin clinical development for Fungal Keratitis, after promising preclinical data and the granting of orphan drug designation in Europe and US. SIFI will continue to operate its two state-of-the-art plants in Aci S. Antonio, focused on the production of ophthalmic medications and intraocular lenses, leveraging on recently secured long-term contract manufacturing agreements, with significant recurring revenue potential. Additionally, SIFI’s facilities will optimize the Group’s industrial capabilities, enhancing operational efficiency. “Faes Farma shares similar values, culture and is highly complementary to our organization, which is set to become the pillar of the enlarged group’s ambitious strategy in ophthalmology, a therapeutic area where the SIFI brand is synonymous with quality, innovation and long-term commitment. This transaction represents a key milestone for our company and will accelerate growth, unlock synergies, and enhance long-term value for all stakeholders, first and foremost by expanding global access to the medicines and devices we provide for ophthalmic patients.”, stated Fabrizio Chines , CEO of SIFI. “We are impressed with the strength of SIFI’s business model and the capabilities of its management team. This transaction strengthens our position in ophthalmology, a therapeutic area with significant growth potential, and accelerates our international expansion with direct access to new markets in Europe. We look forward to working with Fabrizio Chines and SIFI’s management team to fulfill our commitment to an innovative and more global ophthalmic franchise, offering a broader range of solutions aligned with the needs of professionals and patients and our common ambitions.”, stated Eduardo Recoder de la Cuadra , CEO of Faes Farma. The transaction values SIFI at an upfront Enterprise Value equal to a double-digit multiple of 2024 EBITDA, plus earn-outs linked to certain regulatory and commercial milestones related to Akantior. The transaction is expected to close in the third quarter of 2025, subject to customary approval by competition and foreign investment authorities and the extraordinary shareholders’ meeting of Faes Farma, which is expected during July 2025. Evercore Partners International LLP (“Evercore”) and Mediobanca – Banca di Credito Finanziario S.p.A. (“Mediobanca”) are acting as exclusive financial advisor to SIFI’s shareholders (founding families and 21 Invest SGR S.p.A. on behalf of managed fund 21 Investimenti III (“21 Invest”)). Hogan Lovells Studio Legale (“Hogan Lovells”) is acting as legal advisor. J.P. Morgan SE (“JPM”) is acting as Faes Farma’s exclusive financial advisor and debt financing provider in connection with the transaction. Cuatrecasas Legal SLP (“Cuatrecasas”) and Chiomenti Studio Legale (“Chiomenti”) serve as legal advisor and Ernst & Young Servicios Corporativos S.L. (“EY”), Gide Loyrette Nouel (“Gide”), Wolf Theiss Rechtsanwälte GmbH & Co KG (“Wolf Theiss”) and A.T. Kearney as due diligence providers for Faes Farma. About SIFI SIFI is a leading international ophthalmic company headquartered in Italy, featuring an integrated business model from research and development to manufacturing and commercialization in both pharmaceutical and biomedical sectors. Founded in 1935, SIFI’s mission is to improve people’s lives through meaningful innovation in eye care. The company exports to more than 60 countries worldwide with a direct presence in major European markets, Mexico, and through joint ventures in China and the United Arab Emirates. For more information, visit www.sifigroup.com About Faes Farma Faes Farma is a company with more than 90 years of experience and a presence in more than 130 countries through marketed or licensed products. Faes combine passion, science, and innovation to transform people’s health. Faes research, produce, and market prescription drugs, healthcare products, and animal nutrition products, and we aspire to become a leading pharmaceutical group in excellence and innovation. At Faes Farma, people are guided by our values: offering top-quality solutions for health and well-being, with the patient as our priority; developing innovative products that adapt to society’s needs; and ensuring integrity, transparency, and commitment through responsible management and excellence. For more information, visit www.faesfarma.com SOURCE: Faes Farma

孤儿药上市批准

2025-06-10

·PRNewswire

SIFI merges into Faes Farma to become its ophthalmic franchise and expand international access to its portfolio and pipeline

The transaction will enable strong commercial synergies, thanks to Faes Farma's presence in complementary markets and recent acquisition of Laboratorios Edol It enables funding further development of SIFI's portfolio, most notably Akantior in the USA SIFI's existing infrastructure, including its Aci S. Antonio facilities, will further expand under the combined entity CATANIA, Italy, June 10, 2025 /PRNewswire/ -- SIFI, a leading international ophthalmic company, today announced that its shareholders have signed an agreement, subject to conditions precedent, to sell 100% of SIFI shares to Faes Farma, a leading European pharmaceutical company listed on the Spanish stock exchange. The transaction validates SIFI's unique business model centred around the consolidated pharmaceutical and surgical units, combined with the fast-growing contract manufacturing and rare diseases units. SIFI will enable Faes Farma to offer one of the most comprehensive ophthalmology portfolios in the industry, with a complementary geographic presence. The integration of SIFI and Laboratorios Edol, a leading Portuguese pharmaceutical recently acquired by Faes Farma, positions ophthalmology as a pivotal area for the combined entity (the "Group"), representing approximately 20% of its pro-forma revenue, and allows for further portfolio synergies. SIFI facilitates the Group's entry into new high-growth regions in Europe, such as Italy, France, Romania, and Turkey, while bolstering the Group's presence in others, such as Iberia, Mexico and Latin America. Furthermore, product integration should unlock cross-selling opportunities, improving growth and margins through operational and cost efficiencies. The Group will invest into the further development of Akantior (polihexanide 0.08%) into existing and new geographies, most notably in the USA, as well as the development of polihexanide into additional orphan indications. Akantior is approved by the European Medicines Agency (EMA) and United Kingdom's Medicines & Healthcare products Regulatory Agency (MHRA) for the treatment of Acanthamoeba Keratitis (AK) in adults and children aged 12 and older. Akantior is the first and only approved therapy for AK anywhere in the world, addressing an ultra-rare, severe, and progressive corneal infection affecting approximately 3,000 patients annually in Europe and the United States. Launched in Germany in October 2024, pricing and reimbursement procedures are underway in other European countries. It is also in the pre-registration phase with the FDA (U.S. Food and Drug Administration) with orphan drug designation. Polihexanide will soon begin clinical development for Fungal Keratitis, after promising preclinical data and the granting of orphan drug designation in Europe and US. SIFI will continue to operate its two state-of-the-art plants in Aci S. Antonio, focused on the production of ophthalmic medications and intraocular lenses, leveraging on recently secured long-term contract manufacturing agreements, with significant recurring revenue potential. Additionally, SIFI's facilities will optimize the Group's industrial capabilities, enhancing operational efficiency. "Faes Farma shares similar values, culture and is highly complementary to our organization, which is set to become the pillar of the enlarged group's ambitious strategy in ophthalmology, a therapeutic area where the SIFI brand is synonymous with quality, innovation and long-term commitment. This transaction represents a key milestone for our company and will accelerate growth, unlock synergies, and enhance long-term value for all stakeholders, first and foremost by expanding global access to the medicines and devices we provide for ophthalmic patients.", stated Fabrizio Chines, CEO of SIFI. "We are impressed with the strength of SIFI's business model and the capabilities of its management team. This transaction strengthens our position in ophthalmology, a therapeutic area with significant growth potential, and accelerates our international expansion with direct access to new markets in Europe. We look forward to working with Fabrizio Chines and SIFI's management team to fulfill our commitment to an innovative and more global ophthalmic franchise, offering a broader range of solutions aligned with the needs of professionals and patients and our common ambitions.", stated Eduardo Recoder de la Cuadra, CEO of Faes Farma. The transaction values SIFI at an upfront Enterprise Value equal to a double-digit multiple of 2024 EBITDA, plus earn-outs linked to certain regulatory and commercial milestones related to Akantior. The transaction is expected to close in the third quarter of 2025, subject to customary approval by competition and foreign investment authorities and the extraordinary shareholders' meeting of Faes Farma, which is expected during July 2025. Evercore Partners International LLP ("Evercore") and Mediobanca - Banca di Credito Finanziario S.p.A. ("Mediobanca") are acting as exclusive financial advisor to SIFI's shareholders (founding families and 21 Invest SGR S.p.A. on behalf of managed fund 21 Investimenti III ("21 Invest")). Hogan Lovells Studio Legale ("Hogan Lovells") is acting as legal advisor. J.P. Morgan SE ("JPM") is acting as Faes Farma's exclusive financial advisor and debt financing provider in connection with the transaction. Cuatrecasas Legal SLP ("Cuatrecasas") and Chiomenti Studio Legale ("Chiomenti") serve as legal advisor and Ernst & Young Servicios Corporativos S.L. ("EY"), Gide Loyrette Nouel ("Gide"), Wolf Theiss Rechtsanwälte GmbH & Co KG ("Wolf Theiss") and A.T. Kearney as due diligence providers for Faes Farma. About SIFI SIFI is a leading international ophthalmic company headquartered in Italy, featuring an integrated business model from research and development to manufacturing and commercialization in both pharmaceutical and biomedical sectors. Founded in 1935, SIFI's mission is to improve people's lives through meaningful innovation in eye care. The company exports to more than 60 countries worldwide with a direct presence in major European markets, Mexico, and through joint ventures in China and the United Arab Emirates. For more information, visit About Faes Farma Faes Farma is a company with more than 90 years of experience and a presence in more than 130 countries through marketed or licensed products. Faes combine passion, science, and innovation to transform people's health. Faes research, produce, and market prescription drugs, healthcare products, and animal nutrition products, and we aspire to become a leading pharmaceutical group in excellence and innovation. At Faes Farma, people are guided by our values: offering top-quality solutions for health and well-being, with the patient as our priority; developing innovative products that adapt to society's needs; and ensuring integrity, transparency, and commitment through responsible management and excellence. For more information, visit WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

并购上市批准孤儿药

2025-05-27

·蒲公英Ouryao

一周｜国际法规药事(05.19-05.25)

◆ ◆ ◆ ◆Paul's Insight2025年5月19日-5月25日◆ ◆ ◆ ◆在全球药品监管加速趋同的背景下，过去一周，各大监管机构与行业组织密集发布政策与警示，勾勒出当前制药行业在合规与创新之间所面临的双重挑战。从FDA对中国企业的高压执法，到ICH新指南推动的全球协调，再到ISPE倡导的智能制造转型，这一系列动态不仅彰显监管标准的不断提高，也指明了产业技术革新的关键路径。美国FDA跨境监管执法强化质量底线1. 无菌生产体系危机警示5月20日，FDA向中国无锡某医疗器械公司发出的警告信成为本周全球药政焦点。该信揭露企业无菌生产体系存在"系统性崩溃"，包括环境控制失效（虫害污染、设备老化）、灭菌工艺验证缺失等严重缺陷。值得注意的是，企业回复483表格时承认"无力通过FDA检查"却继续分销产品的行为，凸显跨境监管中企业在国际法规合规意识上的薄弱环节。图：FDA重磅警告：无锡某企业无菌生产体系“全线崩溃”https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wuxi-medical-instrument-factory-co-ltd-701044-040420252. 检测数据诚信风暴5月22日，FDA器械与放射健康中心（CDRH）针对天津海河标测和苏州苏大检测两家中国机构发布声明，认定其提交的测试数据存在"伪造或其他无效"问题。FDA局长Marty Makary强调此举旨在维护全球医疗器械供应链的数据可靠性，所有引用问题数据的上市申请将面临系统性驳回。这一行动与FDA近年推行的"数据可靠性全球追溯"政策形成呼应。图：FDA重拳出击：天津、苏州检测机构数据造假被通报https://www.fda.gov/news-events/press-announcements/fda-takes-action-address-data-integrity-concerns-two-chinese-third-party-testing-firms美国PDAmRNA技术产业化5月21日，美国注射剂协会PDA 于一篇文章指出，mRNA疫苗因其快速、可定制的特性，正在重塑全球疫苗研发格局。该技术在新冠疫情中表现出高效和安全性，代表疫苗开发的重要突破。与传统疫苗相比，mRNA疫苗生产更快捷，能迅速应对病毒变异。但其不稳定性、高冷链要求及递送系统效率低等问题仍待解决。当前研究正聚焦于改进脂质纳米颗粒等载体，提升疫苗稳定性与免疫效果。mRNA疫苗的应用正从传染病扩展至癌症等领域，随着监管体系的适应和技术进步，其全球影响力有望持续扩大。图：PDA就mRNA技术产业化撰文https://www.pda.org/pda-letter-portal/home/full-article/the-mrna-revolution欧盟EMA药品生命周期下的审评1. 5月19日至22日CHMP会议摘要5月24日，EMA发布了人用药品委员会（CHMP）2025年5月19日至22日会议的要点摘要，介绍了多项上市许可相关决策。本次会议推荐批准10款新药，包括用于治疗急性淋巴细胞白血病（ALL）的UCART22，这是一款靶向CD22的嵌合抗原受体T细胞（CAR-T）疗法；此外还包括用于多发性骨髓瘤的elpamotide、治疗哮喘的reslizumab（新剂型）、以及数款仿制药和生物类似药。会议期间，CHMP还启动了对多款含伊匹达克林（ipidacrine）药品的审查，以评估其效益风险平衡，并更新了有关多药监管程序启动情况的文件。图：人用药品委员会会议摘要https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-19-22-may-20252. 启动药品安全审查程序5月23日，EMA公告表示其启动了对伊匹达克林（ipidacrine）类药物的药品安全审查程序，源于某些成员国提出的安全性疑虑。该药主要用于神经系统疾病，如阿尔茨海默病和多发性神经病，其在一些国家作为处方药长期使用。此次审查旨在重新评估其在整个欧盟的益处与风险。图：EMA启动药品安全审查程序https://www.ema.europa.eu/en/news/ema-starts-review-ipidacrine-containing-medicines3. 植物药监管EMA植物药委员会（HMPC）公布了其在5月5日至7日会议上的总结报告。报告内容涵盖对欧洲药典植物药专论、单方草药制剂评估、以及传统植物药产品的更新审批情况。该次会议还讨论了与国际草药标准协调的事项。图：EMA公布植物药监管报告https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-other-activities-05-07-may-2025_en.pdf欧洲EDQM质量标准的技术协调1. 血液制品标准迭代EDQM发布了第22版《血液成分制备、使用和质量保证指南》。这本内容全面的指南将继续作为医疗专业人员、监管者、政策制定者以及所有参与献血和输血相关人员的重要技术参考。新版本历经两年更新，全面回顾了所有章节，深入修订了“血液警戒”章节，并新增了两个章节：局部用或注射用血液成分和“血液供应应急和应急计划”。其他重大变化涉及捐献者选择标准（克雅氏病、疟疾、血压和脉搏、血浆置换、铁储备、捐献者年龄和胰岛素），以及术语的标准化。图：EDQM发布了第22版《血液成分制备、使用和质量保证指南》https://www.edqm.eu/en/-/edqm-publishes-22nd-edition-of-the-blood-guide2. 药典讨论组（PDG）召开临时会议，推进全球会员扩展与协调工作药典讨论组（PDG）通过视频召开了临时会议，重点讨论全球会员扩展计划的下一阶段。会议还就细菌内毒素检测中使用重组试剂的协调方法进行了深入讨论。PDG同时审议了与ICH Q4B附件相关的维护工作，包括剂量均匀性、溶出度和无菌性等章节的修订进展和挑战。未来将逐步扩大纳入更多药典和监管机构，以推进协调标准的广泛认可。此外，会议批准了修订后的PDG工作程序，并签署了包含“氨基酸测定”通则更正的工作计划。药典讨论组（PDG）是由美国、欧洲、日本和印度药典机构组成的国际协调组织，致力于统一药典标准，特别是通用章节和辅料规范，以促进全球药品质量一致性与监管协调。图：药典讨论组(PDG)讨论内容公布https://www.edqm.eu/en/-/pharmacopoeial-discussion-group-achievements-14英国MHRA真实世界证据的监管实践1. RWD应用框架指南更新英国药监部门MHRA近日更新了其关于在临床研究中使用真实世界数据（RWD）以支持监管决策的相关指南：《MHRA 关于在临床研究中使用真实世界数据支持监管决策的指导》：作为MHRA RWD 指南系列的一部分，该指南概述了评估 RWD 来源质量时应考虑的关键要素，以判断其是否适用于预期监管用途。《MHRA 关于使用真实世界数据支持监管决策的随机对照试验指南》：该指南聚焦于在设计前瞻性随机对照试验时，如何科学合理地利用 RWD 来源，旨在为监管决策提供有力支持。图：MHRA更新其在临床研究中使用真实世界数据支持监管决策的指南https://www.gov.uk/government/publications/mhra-guidance-on-the-use-of-real-world-data-in-clinical-studies-to-support-regulatory-decisions2. 创新眼科疗法获批准上市5月23日，MHRA表示，Polihexanide 正式获批用于治疗棘阿米巴性角膜炎，这是一种严重且剧烈疼痛的角膜感染，影响眼睛前部的透明结构——角膜。新药 Akantior（Polihexanide）是一种抗阿米巴聚合物，可有效作用于原生动物棘阿米巴的滋养体和囊体。该药物以单药治疗形式作为滴眼液使用，并采用单剂量容器包装。Akantior 已获得欧盟委员会和美国 FDA 授予的孤儿药资格。此次在英国的批准是通过国际认可程序（IRP）完成的，该程序允许英国药品和医疗产品监管局（MHRA）参考其信赖的国际监管伙伴的专业评估和决定，以加快英国患者的用药可及性。图：创新眼科疗法获批准在英国上市https://www.gov.uk/government/news/mhra-approves-polihexanide-to-treat-acanthamoeba-keratitisICH全球技术标准的战略扩容5月21日，国际人用药品注册技术协调会（ICH）发表公告，其在西班牙马德里召开年会，会议上通过了四个新指南的启动计划，具体启动时间将后续中确定。这些新指南涵盖真实世界证据（RWE）支持监管决策、比较疗效研究（CER）、罕见病药物研发以及先进疗法产品（如基因疗法、细胞疗法等）生产工艺变更等领域。ICH自成立以来一直致力于全球监管协调。其质量（Q）、安全性（S）、有效性（E）及综合类（M）等系列指南为全球大部分区域所遵循。此次，ICH选择在核心议题上持续扩容指南体系，可视为对全球制药业和监管界共同呼声的回应。图：ICH官网新闻稿https://ich.org/pressrelease/press-release-ich-assembly-meeting-madrid-spain-may-2025ISPE建模技术预测多模态工厂瓶颈5月23日，ISPE撰文报道武田多模态工厂案例。武田制药在马萨诸塞生物生产基地利用定制化模型预测资源冲突和产能瓶颈。该模型基于确定性模拟，设定85%关键设备利用率作为缓冲，用于长期产能规划和调整新产品引入节奏。尽管尚未实现实时联动，模型已可用于快速评估生产调整方案。未来，武田计划将其纳入实时调度系统，实现更高效应对生产变动。图：ISPE撰文报道武田多模态工厂案例https://ispe.org/news/how-modeling-predicts-bottlenecks-takedas-multimodal-facilities结语本周全球药政动态呈现出“监管强化”与“技术革新”双轨并进的鲜明格局：一方面，FDA、EMA 与 MHRA 通过跨境执法及技术标准升级，不断提升合规门槛；另一方面，ICH、PDA 与 ISPE 推出的新指南与前瞻性思路，则为医药产业打开了新的成长空间与转型契机。END声明：本文仅代表作者个人观点，不代表任何组织及本公众号立场，如有不当之处，敬请指正。如需转载，请注明作者及来源：蒲公英Biopharma。活动推荐5月28日 | 线上 | 计算机化系统合规高效管理分享5月29日 | 线上 | 2025新药典升级：制药质控实验室技术及管理应对策略6月12日 | 线下 | 生物药物的“颜”究新时代—生物技术在医美中的应用6月19日 | 线下 | 中国先进治疗药物先锋论坛6月25日 | 线下 | 2025 CPHI 生物药商业化生产与创新论坛——分论坛：抗体药物生产能力建设研讨会6月25日 | 线下 | 2025 CPHI 生命科学与技术创新发展论坛——论坛二：细胞药物质量控制法规与技术论坛

疫苗信使RNA加速审批紧急使用授权核酸药物

100 项与聚己缩胍相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D08399	聚己缩胍	D08AC05	DB12277

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
棘阿米巴角膜炎	欧盟	SIFI SpA	2024-08-22
棘阿米巴角膜炎	冰岛	SIFI SpA	2024-08-22
棘阿米巴角膜炎	列支敦士登	SIFI SpA	2024-08-22
棘阿米巴角膜炎	挪威	SIFI SpA	2024-08-22
消毒剂	-	B. Braun Medical, Inc.	-
创伤和损伤	-	B. Braun Medical, Inc.	-

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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


NCT03274895 (Pubmed) 人工标引	临床3期	棘阿米巴角膜炎	127	PHMB 0.02%+ propamidine 0.1%	構網廠繭夢願壓築襯選(獵壓範餘淵築壓夢壓鬱) = 範壓範積製淵顧艱鑰鹹淵願壓築夢製製選夢顧 (築積鬱願構鹽鬱憲淵繭 ) 更多	积极	2024-03-01
				PHMB 0.08%+ placebo	構網廠繭夢願壓築襯選(獵壓範餘淵築壓夢壓鬱) = 淵糧廠範窪鹽淵範簾範淵願壓築夢製製選夢顧 (築積鬱願構鹽鬱憲淵繭 ) 更多
NCT03274895 (The Orphan Drug for Acanthamoeba Keratitis (ODAK) Trial, CTgov)	临床3期	棘阿米巴角膜炎	135	placebo+PHMB 0.08% (PHMB 0.08% Plus Placebo)	構網繭鹽願獵憲顧壓餘 = 蓋繭製鹹憲範憲觸築觸鬱獵獵選壓鬱選獵餘鏇 (衊鹹壓衊鬱艱夢膚遞鑰, 鹹齋積憲鹽醖蓋齋糧艱 ~ 艱鬱鬱遞淵積鏇鬱憲艱) 更多	-	2023-08-02
				Propamidine 0.1%+PHMB 0.02% (PHMB 0.02% Plus Propamidine 0.1%)	構網繭鹽願獵憲顧壓餘 = 醖衊築衊齋憲顧膚膚糧鬱獵獵選壓鬱選獵餘鏇 (衊鹹壓衊鬱艱夢膚遞鑰, 廠獵遞壓築艱鹽齋繭觸 ~ 遞積積衊窪獵鬱餘鏇廠) 更多
NCT03274895 (PRNewswire) 人工标引	临床3期	棘阿米巴角膜炎	135	Placebo+Polihexanide	積憲艱積獵築糧蓋齋構(鏇遞鹽鹽衊製簾簾淵顧) = 蓋獵觸築糧積餘鬱選蓋築簾製餘餘積醖繭範遞 (鏇製構襯築觸鹹鏇襯鑰 ) 更多	非劣	2022-10-13
				polihexanide+Polihexanide	積憲艱積獵築糧蓋齋構(鏇遞鹽鹽衊製簾簾淵顧) = 鬱窪窪簾範顧鬱鑰蓋繭築簾製餘餘積醖繭範遞 (鏇製構襯築觸鹹鏇襯鑰 ) 更多
NCT04055233 (RECIPE, Pubmed \| Ann Surg)	临床3期	手术伤口感染	456	Antiseptica (0.9% saline)	膚衊艱糧醖簾鹽簾淵醖(獵範壓夢夢鬱淵蓋觸簾) = 遞網鹹構齋鹹糧簾襯艱簾顧膚窪顧壓餘選網襯 (夢廠願網獵鏇夢選餘醖 )	积极	2020-07-01
NCT02506257 (CTgov)	临床1期	棘阿米巴角膜炎	90	0.04% PHMB (0.04% PHMB)	淵遞夢網顧醖製獵襯膚 = 鏇繭範窪餘製遞選鏇製願鑰鹹選窪衊範艱繭窪 (夢構廠選獵廠構構膚鹹, 網獵範艱積淵顧築膚積 ~ 網窪艱築鏇觸糧積願鑰) 更多	-	2016-11-23
				0.06% PHMB (0.06% PHMB)	淵遞夢網顧醖製獵襯膚 = 願餘襯築醖糧鏇夢壓鏇願鑰鹹選窪衊範艱繭窪 (夢構廠選獵廠構構膚鹹, 遞艱願夢範簾構壓衊願 ~ 壓鏇膚簾襯齋襯製膚顧) 更多
ODAK (ARVO2014)	N/A	棘阿米巴角膜炎	100	Polyhexamethylene biguanide (PHMB)	製淵窪淵廠廠繭獵網鏇(夢襯鹽憲鬱膚齋夢遞鬱) = 選鑰簾淵簾鏇構願鹹鑰壓襯繭製壓範獵鬱鹽簾 (鹹繭願築廠艱積膚壓醖 )	-	2014-04-01
				Combination therapy (PHMB and propamidine)	製淵窪淵廠廠繭獵網鏇(夢襯鹽憲鬱膚齋夢遞鬱) = 範構鑰獵積憲顧願衊鏇壓襯繭製壓範獵鬱鹽簾 (鹹繭願築廠艱積膚壓醖 )
NCT01153620 (Lavasept 2, CTgov)	临床4期	创伤和损伤	61	Lavasept 0.04% (Lavasept 0.04%)	鹽築廠廠憲選顧願糧構(獵範獵蓋觸鑰遞願淵構) = 遞鹹鏇構醖衊醖構鹹壓壓窪獵壓鏇蓋築顧觸範 (窪網構鹹糧築構夢鹹齋, 1.00) 更多	-	2011-11-29
				Ringer's Solution (Ringer's Solution)	鹽築廠廠憲選顧願糧構(獵範獵蓋觸鑰遞願淵構) = 鏇窪壓繭鏇顧廠夢觸遞壓窪獵壓鏇蓋築顧觸範 (窪網構鹹糧築構夢鹹齋, 0.85) 更多
AAO2004	N/A	-	43	Polyhexamethylene Biguanide (PHMB)	顧醖壓積鏇壓餘齋獵壓(繭淵築壓醖醖選鹽憲餘) = 獵壓齋艱蓋艱觸鹽鏇壓艱網齋獵鑰築餘製窪艱 (膚範製衊窪齋簾齋衊壓 ) 更多	不佳	2004-10-25
				Chlorhexidine (CH)	顧醖壓積鏇壓餘齋獵壓(繭淵築壓醖醖選鹽憲餘) = 鹽壓衊築積繭壓積餘選艱網齋獵鑰築餘製窪艱 (膚範製衊窪齋簾齋衊壓 ) 更多