Pharmaceutical Medicine最新文献

{"title":"The Combat Against Antimicrobial Resistance: An Overview of EU Recent Health Policies and Drug Regulations Promoting the Development of New Antimicrobials.","authors":"Lena Daher, Ingrid Vilimelis-Piulats","doi":"10.1007/s40290-026-00601-5","DOIUrl":"10.1007/s40290-026-00601-5","url":null,"abstract":"<p><p>Antimicrobial resistance, including antibiotic resistance, constitutes a major global public health threat. In Europe, antimicrobial resistance is recognized among the top three health threats, in line with the World Health Organization's prioritization. This narrative review examines recent key health and pharmaceutical policies and drug regulations in the European Union, aimed at combating antimicrobial resistance and promoting the development of novel antibiotics and alternative therapeutic approaches. It also highlights potential limitations within these initiatives. Between 2015 and 2024, the authors have identified only 14 newly authorized antibiotics by the European Medicines Agency (excluding withdrawn applications, generics, and new formulations of existing medicines). This underscores the stagnation in the development of antibiotics, potentially attributable to limited investments because of fears of low profitability, and a loss of technical expertise within the pharmaceutical industry. At the European Union level, the One Health Action Plan (2017) established a strategic framework to implement anti-antimicrobial resistance measures and stimulate research on antimicrobials. Furthermore, the forthcoming reform of the European Union general pharmaceutical legislation introduces new incentives to support development of antimicrobials. In parallel, the European Medicines Agency has reinforced its efforts to support development of antimicrobials through updated, or planned updates, of its regulatory guidelines and through its innovation-support regulatory tools (e.g., \"Priority Medicine\" scheme). Concurrently, interest in bacteriophage-based therapies as antibiotic alternatives is increasing, as reflected in recent updates to the European Pharmacopoeia and the work initiated on the European Medicines Agency guidelines for bacteriophage therapy. While all these initiatives represent meaningful progress, significant challenges remain, necessitating sustained collaborative efforts across stakeholders.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"107-128"},"PeriodicalIF":4.7,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147290574","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"38th Congress of the European College of Neuropsychopharmacology (ECNP 2025).","authors":"Alma Orts-Sebastian","doi":"10.1007/s40290-026-00602-4","DOIUrl":"10.1007/s40290-026-00602-4","url":null,"abstract":"","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"163-166"},"PeriodicalIF":4.5,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146213769","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Beyond the Follicle: A Narrative Review on How Systemic Diseases and Drugs Affect Alopecia.","authors":"Debalina Bose, Depti Bellani, Raji Patil, Khusboo Jamasbi, Rinky Kapoor, Debraj Shome","doi":"10.1007/s40290-025-00600-y","DOIUrl":"10.1007/s40290-025-00600-y","url":null,"abstract":"<p><p>Alopecia is a multifactorial condition resulting from the convergence of systemic pathologies, pharmacologic exposures, genetic predispositions, and environmental factors. Among these, systemic diseases and medications play a prominent role by initiating biological cascades that disrupt follicular integrity. Systemic diseases and medications disrupt follicular homeostasis via mechanisms such as inflammation, oxidative stress, hormonal imbalance, and immune dysregulation. Endocrine disorders, metabolic syndromes, and nutritional deficiencies impair follicular function, while chemotherapeutics, antifungals, anticoagulants, and hormonal agents further compromise follicular cycling and stem cell viability. Understanding these mechanistic pathways is essential for predicting and mitigating drug-associated alopecia and informing targeted interventions. Precision medicine approaches that address systemic drivers while optimizing pharmacologic regimens are critical to preserving follicular integrity. Current treatments like minoxidil, platelet-rich plasma, and surgical restoration provide symptomatic relief but often fail to achieve lasting results. In contrast, emerging molecular therapies, including bioengineered exosomes, stem cell applications, and peptide-based formulations that target key signalling pathways and growth factors, hold promise for more regenerative and sustained hair restoration outcomes. Given the condition's complexity, a multidisciplinary framework integrating dermatology, endocrinology, immunology, and pharmacology is essential. Cross-specialty collaboration will be pivotal for advancing individualised, mechanism-driven care. Ultimately, accurate etiologic diagnosis remains the cornerstone of effective, tailored treatment strategies.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"129-144"},"PeriodicalIF":4.7,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146011478","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Evolution of Medical Affairs Central Teams: Shaping Strategic Action and Driving Healthcare Transformation Through Scientific Interaction.","authors":"Manuel Leal Beckouche, Gustavo Resler Plat, Jorge A Marinich, Carmen Moreno, Marta Moreno, Joana Gostkorzewicz, Inmaculada Iglesias, Ana Pérez Domínguez","doi":"10.1007/s40290-025-00592-9","DOIUrl":"10.1007/s40290-025-00592-9","url":null,"abstract":"<p><p>The evolving role of Medical Affairs (MA) has positioned this department as a key element in the development and lifecycle management of pharmaceutical products. In response to internal and external assessments, AstraZeneca (AZ) Spain implemented a transformation of its MA central teams through a newly designed Working Model. This model ensures full engagement across the product lifecycle, spanning early access, pre-launch, launch, and post-launch, balancing global strategy with local execution, enhancing cross-functional collaboration, and timely evidence generation. Central to this transformation is the deployment of four coordinated teams: the Early Asset Strategy Team, the Launch Readiness Team, the Core Value Team, and the Brand Team. These teams follow a structured work methodology and coordination model underpinned by dedicated information management processes that streamline communication and knowledge transfer. Training and capability-building programmes were also introduced to strengthen critical functional and leadership competencies. These changes aim to improve product positioning, accelerate market access, and drive value-based healthcare outcomes. The initiative aligns with broader industry trends emphasising early stakeholder engagement, data integration, and patient-centric strategies. By fostering agility, strategic foresight, and internal consistency, the transformation of MA central teams at AZ Spain provides a replicable model for enhancing MA's contribution to product development and healthcare ecosystem innovation. This article builds on our previous publications about the national ecosystem assessment of stakeholder needs, the definition of our MA transformation framework (articulating the strategic roadmap), and the description of the evolution of in-field MA teams in AZ Spain. Here we detail the transformation of the MA central teams and their working model. Future MA evolution will integrate emerging technologies like artificial intelligence (AI) and digital tools, improving stakeholder engagement, evidence generation, and decision making. The transformative potential of AI in anticipating trends and optimising trials will enhance the role of MA in driving innovation and improving patient outcomes.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"9-18"},"PeriodicalIF":4.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12783193/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145452667","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating the Readability of Clinical Trial Content for Patients on Pharmaceutical Company Websites.","authors":"Christopher Felix Brewer","doi":"10.1007/s40290-025-00595-6","DOIUrl":"10.1007/s40290-025-00595-6","url":null,"abstract":"<p><strong>Background and objectives: </strong>Efficient and informed patient recruitment, followed by successful enrolment, is essential for the conduct of clinical trials. As major stakeholders in the research process, pharmaceutical companies have an important role in ensuring that information for patients is available and readable. Several global institutions recommend that patient-facing material be written at a literacy level suitable for 11-12-year-olds. This study assessed the availability and readability of clinical trial sections on UK, Canadian, Australian, and global pharmaceutical company websites.</p><p><strong>Methods: </strong>The 30 largest global pharmaceutical companies (assessed by market capitalisation in April 2025) were selected. Clinical trial content was reviewed for availability and analysed using three validated readability metrics: the Flesch-Kincaid Grade (FKG), Flesch Reading Ease Score (FRES) and Simple Measure of Gobbledygook (SMOG) Index.</p><p><strong>Results: </strong>Of 115 websites assessed, 54 were eligible for readability analysis. While 96% of global websites included clinical trial information, 55% of non-global websites lacked such content or contained only external links. FKG scores, which estimate the US school grade level needed for comprehension, averaged 10.9 (± 3.5) for global, 14.2 (± 2.0) for UK, 12.1 (± 2.7) for Canadian and 12.8 (± 1.9) for Australian websites-suggesting readability at high school to college level. FRES scores showed similar trends: 42.2 (± 8.0) global, 31.2 (± 9.4) UK, 38.8 (± 12.3) Canadian and 35.7 (± 12.3) Australian, indicating college-level complexity. SMOG scores suggested that 13-15 years of education were needed to understand the material.</p><p><strong>Conclusions: </strong>These results indicate that clinical trial information on pharmaceutical company websites is often missing or difficult to read and exceeds recommended literacy levels, which may limit comprehension and engagement. Poor readability disproportionately affects individuals with lower literacy, limited English proficiency or disabilities, creating inequities in trial participation. Applying health literacy and plain-language principles-such as simplifying terminology, shortening sentences and using clear formatting-could improve accessibility and support informed decision-making.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"79-86"},"PeriodicalIF":4.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145757176","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of a Competency Framework for Medical Affairs Professionals in Australasia.","authors":"Andrew Weekes, Matthew Britland, Cathey Saha, Simon McErlane, Niloufar Ansari, Daniel Thurley, Victoria Elegant, Orin Chisholm","doi":"10.1007/s40290-025-00585-8","DOIUrl":"10.1007/s40290-025-00585-8","url":null,"abstract":"<p><strong>Background and objectives: </strong>Medical Affairs (MA) plays a critical role in bridging the gap between research, clinical practice and business strategy. With the rapid growth in this field, it is essential to have a competency framework to support individuals' professional development. A well-defined competency framework will not only empower MA professionals to excel and develop in their roles but also contribute to better patient outcomes and improved stakeholder engagement. This paper discusses the development of a competency framework for Medical Affairs professionals in Australasia.</p><p><strong>Methods: </strong>The MA competency framework was developed using an iterative method by a team of MA professionals across Australia through a series of workshops and surveys over 2 years with the cooperation of the local MA community. The core development team debated and finessed the final framework over this time via meetings and discussions to arrive at the draft framework. This was pilot tested by a local pharmaceutical organisation and feedback informed some minor changes to the final framework. This was then endorsed by the Medical Affairs of Australasia (MAPA) Executive Committee.</p><p><strong>Results: </strong>The framework consists of six domains: Scientific/Technical Knowledge, Evidence Generation, Compliance, Governance and Ethics, Leadership/Professionalism, Communication and Collaboration and Business Acumen, each with specific competencies and across four clearly defined levels from novice to expert.</p><p><strong>Conclusion: </strong>This framework has been endorsed by the Medical Affairs Professionals of Australasia Executive Committee and provides a clear framework for the professional development of medical affairs professionals across our region. It is also applicable to MA professionals more broadly.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"61-68"},"PeriodicalIF":4.5,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12783252/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145177434","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Joint Clinical Assessments in Europe: Implications for Market Access, Reimbursement, and National HTA Alignment.","authors":"Amit Dang, Sameera Tak","doi":"10.1007/s40290-025-00594-7","DOIUrl":"10.1007/s40290-025-00594-7","url":null,"abstract":"<p><p>The Joint Clinical Assessment is a crucial development under the European Union Health Technology Assessment Regulation (EU HTAR, 2021/2282), aimed at standardizing clinical assessments across the Member States. This review explores the opportunities, challenges, and future actions for Joint Clinical Assessment implementation, particularly emphasizing methodological, regulatory, and stakeholder considerations. With the evolution of the European healthcare landscape from decentralized health technology assessment processes to a more streamlined framework, the Joint Clinical Assessment aims to enhance efficiency, reduce duplication, and expedite patient access to novel therapies while maintaining national reimbursement autonomy. Central to the Joint Clinical Assessment is the Patients, Interventions, Comparator, Outcomes (PICO) framework, which guides evidence generation but varies across countries, creating uncertainty and requiring early transparent agreement. Challenges to Joint Clinical Assessment implementation include tight timelines, misalignment with national processes, autonomy of national health technology assessment agencies over reimbursement, and the uncertainty about real-world evidence, specifically for oncology and rare diseases. Orphan drugs, gene therapies, and vaccines present unique concerns owing to smaller patient populations, limited data from clinical trials, or ethical restrictions in conducting randomized controlled trials. These concerns can be overcome with scientifically robust alternatives, such as adaptive assessment approaches enabling staged assessments and updates with evolving data. Early patient involvement through advisory panels, surveys, and feedback loops in processes, such as scoping, assessment, and evidence-generation phases can improve transparency and integration of patient preferences while reflecting real-world treatment needs in clinical evaluations. The long-term success of the Joint Clinical Assessment will depend on both standardisation and flexibility, supported by stakeholder collaboration and robust methodological guidance.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"19-31"},"PeriodicalIF":4.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145605370","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clearing the Mist: The Distinct Roles of Transparency and Explainability for Using AI in Drug and Device Development.","authors":"Timothé Ménard, Katrina A Bramstedt","doi":"10.1007/s40290-025-00589-4","DOIUrl":"10.1007/s40290-025-00589-4","url":null,"abstract":"","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"5-7"},"PeriodicalIF":4.5,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145452740","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating the MAPA Medical Affairs Competency Framework: Insights from Amgen-Led Pilot Study in Australia, Japan and China.","authors":"Riaz Abbas, Orin Chisholm, Victoria Elegant, Seigo Susa, Samantha Richards, Cae Tolman","doi":"10.1007/s40290-025-00590-x","DOIUrl":"10.1007/s40290-025-00590-x","url":null,"abstract":"<p><strong>Background and objectives: </strong>The biopharmaceutical industry requires fast role adaptation and comprehensive competency development to thrive in a rapidly evolving and challenging environment. Whilst competency frameworks exist for some roles, lack of a function-wide framework remains a challenge. The objective of this pilot study was to evaluate the applicability and potential utility of the Medical Affairs Professionals of Australasia (MAPA) competency framework within Amgen's Medical Affairs to support role-specific competency development.</p><p><strong>Methods: </strong>This competency framework encompasses six domains: scientific and technical knowledge; evidence generation; compliance, governance and ethics; leadership, strategic vision and professionalism; communication and collaboration; and business knowledge/acumen; each with specific sub-domains with four clearly defined levels from novice to expert. Implementation involved self-assessment followed by managerial ratification for competency level. Overall team and affiliate results were made available on a PowerBI dashboard. The pilot included a diverse range of roles from Amgen Medical Affairs, such as Medical Science Liaisons (MSLs), MSL Managers, Medical Advisors, Medical Capability & Operations, Medical Communications, and Therapy Area Leads.</p><p><strong>Results: </strong>Our pilot consisted of 42 staff and revealed relatively general levels of consistency for benchmarks across our three affiliates. Most participants met or exceeded the benchmark set for their roles. We observed some variance between self and manager competency level assessment and relevance/applicability of all capabilities for all roles but this was addressed by self and manager discussions to agree on a consensus value.</p><p><strong>Conclusion: </strong>This pilot confirmed the MAPA competency framework's feasibility and relevance across diverse Medical Affairs roles and affiliates. While benchmarks were generally consistent, minor differences were observed across Australia, China, and Japan. The successful pilot outcomes highlight the potential for this framework's adoption across the biopharmaceutical industry's medical affairs for developmental discussions and planning.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"69-77"},"PeriodicalIF":4.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145445255","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Considerations for Biosimilar Adoption in Pediatrics: A Scoping Review.","authors":"Elaine Lau, Alicia Koo, Han Byul Kang, Meredith Ames, Cheyenne Matinnia, Avram Denburg","doi":"10.1007/s40290-025-00593-8","DOIUrl":"10.1007/s40290-025-00593-8","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The growing number of indications and patent expirations for biologic drugs has created opportunities for market expansion of biosimilars; however, biosimilar uptake in children has lagged behind adults. There is limited clinical evidence for the use of biosimilars in pediatrics, thereby creating uncertainty surrounding safety and efficacy in children. This scoping review sought to identify themes related to biosimilar adoption in pediatrics to inform decision-making at pediatric healthcare institutions in Canada and internationally.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A review of the academic and grey literature relevant to pediatrics was conducted. The OVID Medline, Embase and International Pharmaceutical Abstracts databases were searched from inception to September 20, 2024. This was complemented by a search of the websites of major regulatory and health technology assessment (HTA) agencies internationally and select professional organizations impacted by biosimilars. Studies relevant to pediatrics that discussed considerations for institutional decision-making about biosimilar use were included. Studies written from the regulatory, payor or industry perspective about market entry, those not written in English or those focused solely on biosimilar use for non-pediatric indications were excluded. Study and patient characteristics and the type of biosimilar drug were extracted from the included studies. The aims, key findings and recommendations from these studies were summarized to determine preliminary themes, which were refined in consultation with institutional stakeholders.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 35 articles were included, of which 26 were pediatric specific or referred to pediatrics in the article. The other nine articles did not refer specifically to pediatrics but included general themes that were applicable to both adults and pediatrics. Results were categorized into 14 themes under two overarching categories. Substantive principles consisted of clinical trial evidence, real-world experience, regulatory approval, cost and affordability, availability of supply, suitability of dosage forms for pediatrics, societal values and health risks. Procedural principles consisted of approval body and stakeholder representation, interchangeability, inventory management, computerized physician order entry (CPOE) builds and maintenance, education, and follow-up and monitoring. The implications of the themes on pediatric institutional decision-making informed the development of a policy framework for biosimilar adoption in pediatrics.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;A key health-system gap in pediatric biosimilar adoption was identified. There is a need for robust pediatric efficacy and safety studies by industry during the product development stage prior to market approval. Sustained development of pharmacovigilance systems and patient registries will be important to generate more real-world evidence","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"45-60"},"PeriodicalIF":4.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145649118","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}