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Safety of Biological Therapies for Severe Asthma: An Analysis of Suspected Adverse Reactions Reported in the WHO Pharmacovigilance Database BioDrugs (IF 6.8) Pub Date : 2024-03-15 Paola Maria Cutroneo, Elena Arzenton, Fabiana Furci, Fabio Scapini, Maria Bulzomì, Nicoletta Luxi, Marco Caminati, Gianenrico Senna, Ugo Moretti, Gianluca Trifirò
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Targeted Gene Insertion: The Cutting Edge of CRISPR Drug Development with Hemophilia as a Highlight BioDrugs (IF 6.8) Pub Date : 2024-03-15 Zhenjie Zhang, Siqi Zhang, Hoi Ting Wong, Dali Li, Bo Feng
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Use of Biosimilars: A Systematic Review of Published Position Statements and Recommendations from Health Organisations and Societies BioDrugs (IF 6.8) Pub Date : 2024-03-12 Noraisyah Mohd Sani, Zoriah Aziz, Adeeba Kamarulzaman
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Can Endangered Biosimilar Markets be Rescued? The Need to Bridge Competing Interests for Long-Term Gain BioDrugs (IF 6.8) Pub Date : 2024-02-26 Teresa Barcina Lacosta, Arnold G. Vulto, Florian Turk, Isabelle Huys, Steven Simoens
Market signals such as: (1) the limited number of biosimilars in the development pipeline, (2) the focus of biosimilar development on high-profit therapeutic areas only, and (3) the increase in the number of biosimilar discontinuations and withdrawals, are indicative of sustainability threats facing biosimilar markets in Europe. Two prominent factors that undermine sustainability are: competing interests
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Cardiovascular Adverse Drug Reactions of Anti-Calcitonin Gene-Related Peptide Monoclonal Antibodies for Migraine Prevention: An Analysis from the European Spontaneous Adverse Event Reporting System BioDrugs (IF 6.8) Pub Date : 2024-02-25 Emanuela Elisa Sorbara, Maria Antonietta Barbieri, Giulia Russo, Giuseppe Cicala, Edoardo Spina
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Consensus-Based Overarching Principles and Recommendations on the Use of Biosimilars in the Treatment of Inflammatory Arthritis in the Gulf Region BioDrugs (IF 6.8) Pub Date : 2024-02-25 Khalid A. Alnaqbi, Nasra Al Adhoubi, Sara Aldallal, Samar Al Emadi, Adeeba Al-Herz, Amin M. El Shamy, Suad Hannawi, Mohammed A. Omair, Sahar A. Saad, Tore K. Kvien
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Nano–Bio Interactions: Exploring the Biological Behavior and the Fate of Lipid-Based Gene Delivery Systems BioDrugs (IF 6.8) Pub Date : 2024-02-12 Seigo Kimura, Hideyoshi Harashima
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Recombinant Antibody Fragments for Immunotherapy of Parkinson’s Disease BioDrugs (IF 6.8) Pub Date : 2024-01-27 Karen Manoutcharian, Goar Gevorkian
Parkinson’s disease (PD) is the second most common age-related neurodegenerative disorder. Multiple genetic and environmental factors leading to progressive loss of dopaminergic neurons in the substantia nigra pars compacta (SN) and consequent depletion of dopamine were described. Current clinical approaches, such as dopamine replacement or deep brain stimulation using surgically implanted probes,
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Reducing Immunogenicity by Design: Approaches to Minimize Immunogenicity of Monoclonal Antibodies BioDrugs (IF 6.8) Pub Date : 2024-01-23 Chantal T. Harris, Sivan Cohen
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Splice-Modulating Antisense Oligonucleotides as Therapeutics for Inherited Metabolic Diseases BioDrugs (IF 6.8) Pub Date : 2024-01-22 Suxiang Chen, Saumya Nishanga Heendeniya, Bao T. Le, Kamal Rahimizadeh, Navid Rabiee, Qurat ul ain Zahra, Rakesh N. Veedu
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Could a Long-Acting Prodrug of SN-38 be Efficacious in Sacituzumab Govitecan-Resistant Tumors? BioDrugs (IF 6.8) Pub Date : 2024-01-18
Abstract We previously proposed that sacituzumab govitecan (SG, Trodelvy®) likely acts as a simple prodrug of systemic SN-38 as well as an antibody drug conjugate (ADC). In the present commentary, we assess whether a long-acting SN-38 prodrug, such as PLX038, might be efficacious in SG-resistant patients. We first describe possible mechanisms of action of SG, with new insights on pharmacokinetics and
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Unveiling the Biosimilar Paradox of Oncologists’ Perceptions and Hesitations in South Korea: A Web-Based Survey Study BioDrugs (IF 6.8) Pub Date : 2024-01-12 Gyeongseon Shin, Byung Soo Kim, Do Yeun Kim, SeungJin Bae
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Safety, Tolerability, and Preliminary Efficacy of Serplulimab, a Novel Anti-PD-1 Antibody, in Patients with Metastatic or Recurrent Solid Tumors: A Phase I Study BioDrugs (IF 6.8) Pub Date : 2024-01-09 Ching-Liang Ho, Tsu-Yi Chao, Chia-Lun Chang, Hsuan-Yu Lin
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Safety, Tolerability, Pharmacokinetics, and Immunogenicity of the Anti-IFNAR1 Monoclonal Antibody QX006N: A First-in-Human Single Ascending Dose Study in Healthy Chinese Volunteers BioDrugs (IF 6.8) Pub Date : 2023-12-27
Abstract Background and Objective QX006N is a novel, humanized, IgG4κ monoclonal antibody targeting IFNAR1, developed for the treatment of systemic lupus erythematosus. This study aims to investigate the pharmacokinetics, safety, tolerability, and immunogenicity of QX006N when administered intravenously to healthy Chinese individuals. Methods A double-blind, randomized, placebo-controlled, single-ascending-dose
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Is the Availability of Biosimilar Adalimumab Associated with Budget Savings? A Difference-in-Difference Analysis of 14 Countries BioDrugs (IF 6.8) Pub Date : 2023-12-08 Hyunjung Woo, Gyeongseon Shin, Donghwan Lee, Hye-Young Kwon, SeungJin Bae
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Molecular Engineering of Interleukin-2 for Enhanced Therapeutic Activity in Autoimmune Diseases BioDrugs (IF 6.8) Pub Date : 2023-11-24 Luke M. Tomasovic, Kathy Liu, Derek VanDyke, Charina S. Fabilane, Jamie B. Spangler
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Targeting IL-6 or IL-6 Receptor in Rheumatoid Arthritis: What Have We Learned? BioDrugs (IF 6.8) Pub Date : 2023-11-21 Ali Berkant Avci, Eugen Feist, Gerd R. Burmester
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Efficacy and Safety of Candidate Biosimilar CT-P43 Versus Originator Ustekinumab in Moderate to Severe Plaque Psoriasis: 28-Week Results of a Randomised, Active-Controlled, Double-Blind, Phase III Study BioDrugs (IF 6.8) Pub Date : 2023-11-22 Kim A. Papp, Mark G. Lebwohl, Diamant Thaçi, Janusz Jaworski, Bartlomiej Kwiek, Jakub Trefler, Anna Dudek, Jacek C. Szepietowski, Nataliya Reznichenko, Joanna Narbutt, Wojciech Baran, Joanna Kolinek, Stefan Daniluk, Katarzyna Bartnicka-Maslowska, Adam Reich, Yuriy Andrashko, Sunghyun Kim, Yunju Bae, Dabee Jeon, Jinsun Jung, Hyunseung Lee, Tina Pyo, Woori Ko
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Anti-Amyloid Monoclonal Antibodies for the Treatment of Alzheimer’s Disease BioDrugs (IF 6.8) Pub Date : 2023-11-13 Jeffrey Cummings, Amanda M. Leisgang Osse, Davis Cammann, Jayde Powell, Jingchun Chen
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Dystrophin- and Utrophin-Based Therapeutic Approaches for Treatment of Duchenne Muscular Dystrophy: A Comparative Review BioDrugs (IF 6.8) Pub Date : 2023-11-02 Sylwia Szwec, Zuzanna Kapłucha, Jeffrey S. Chamberlain, Patryk Konieczny
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AAV-Based Strategies for Treatment of Retinal and Choroidal Vascular Diseases: Advances in Age-Related Macular Degeneration and Diabetic Retinopathy Therapies BioDrugs (IF 6.8) Pub Date : 2023-10-25 Brenda F. M. Castro, Jason C. Steel, Christopher J. Layton
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Advancing Subcutaneous Dosing Regimens for Biotherapeutics: Clinical Strategies for Expedited Market Access BioDrugs (IF 6.8) Pub Date : 2023-10-13 Beate Bittner, Johannes Schmidt
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Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars? BioDrugs (IF 6.8) Pub Date : 2023-10-13 Nadine Kirsch-Stefan, Elena Guillen, Niklas Ekman, Sean Barry, Verena Knippel, Sheila Killalea, Martina Weise, Elena Wolff-Holz
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Outer Membrane Vesicle Vaccine Platforms BioDrugs (IF 6.8) Pub Date : 2023-10-05 Francesca Micoli, Roberto Adamo, Usman Nakakana
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Immunotherapy Guided by Immunohistochemistry PD-L1 Testing for Patients with NSCLC: A Microsimulation Model-Based Effectiveness and Cost-Effectiveness Analysis BioDrugs (IF 6.8) Pub Date : 2023-10-04 Mingjun Rui, Yingcheng Wang, Yunfei Li, Zhengyang Fei
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Real-World Clinical Outcomes of Bevacizumab-awwb Biosimilar versus Bevacizumab Reference Product in Patients with Metastatic Colorectal Cancer BioDrugs (IF 6.8) Pub Date : 2023-09-25 Catherine Pham, Fang Niu, Thomas Delate, Gary L. Buchschacher, Yan Li, Ekim Ekinci, Kim Le, Rita L. Hui
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Ixekizumab for Active Radiographic Axial Spondyloarthritis in Chinese Patients: 16- and 52-Week Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study BioDrugs (IF 6.8) Pub Date : 2023-09-22 Yu Xue, Jiankang Hu, Dongzhou Liu, Jingyang Li, Huaxiang Wu, Chunyu Tan, Lie Dai, Lingyun Sun, Zhijun Li, Zhengyu Xiao, Cibo Huang, Yan Yan, Fei Ji, Rong Chen, Hejian Zou
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Malaria Vaccines: Progress to Date BioDrugs (IF 6.8) Pub Date : 2023-09-20 Danielle I. Stanisic, Michael F. Good
Malaria is a mosquito-borne disease caused by protozoan parasites of the genus Plasmodium. Despite significant declines in malaria-attributable morbidity and mortality over the last two decades, it remains a major public health burden in many countries. This underscores the critical need for improved strategies to prevent, treat and control malaria if we are to ultimately progress towards the eradication
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Enzyme Engineering Strategies for the Bioenhancement of l-Asparaginase Used as a Biopharmaceutical BioDrugs (IF 6.8) Pub Date : 2023-09-12 Javiera Miranda, Nicolás Lefin, Jorge F. Beltran, Lisandra Herrera Belén, Argyro Tsipa, Jorge G. Farias, Mauricio Zamorano
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Acute Kidney Injury from Intravitreal Anti-vascular Endothelial Growth Factor Drugs: A Systematic Review and Meta-analysis of Randomized Controlled Trials BioDrugs (IF 6.8) Pub Date : 2023-09-07 Yu-Chien Tsao, Ting-Ying Chen, Li-An Wang, Chia-Chun Lee, Wan-Ju Annabelle Lee, Sheng-Min Hsu, Chi-Chun Lai, Shih-Chieh Shao, Jia-Horung Hung, Edward Chia-Cheng Lai
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Patients’ Perceptions of Biosimilars: A Systematic Review BioDrugs (IF 6.8) Pub Date : 2023-09-07 Qiyou Wu, Zhitao Wang, Xin Wang, Hui Yu, Jing Sun
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The PROPER Study: A 48-Week, Pan-European, Real-World Study of Biosimilar SB5 Following Transition from Reference Adalimumab in Patients with Immune‐Mediated Inflammatory Disease BioDrugs (IF 6.8) Pub Date : 2023-08-26 Ulf Müller-Ladner, Axel Dignass, Karl Gaffney, Deepak Jadon, Marco Matucci-Cerinic, Triana Lobaton, Philippe Carron, Javier P. Gisbert, Ira Pande, Maximilian Utzinger, Janet Addison
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Neoadjuvant Immunotherapy for Non-Small Cell Lung Cancer BioDrugs (IF 6.8) Pub Date : 2023-08-21 Khaled Sanber, Samuel Rosner, Patrick M. Forde, Kristen A. Marrone
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Future Evolution of Biosimilar Development by Application of Current Science and Available Evidence: The Developer’s Perspective BioDrugs (IF 6.8) Pub Date : 2023-08-05 Hillel P. Cohen, Matthew Turner, Dorothy McCabe, Gillian R. Woollett
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Evaluating Gene Therapy as a Potential Paradigm Shift in Treating Severe Hemophilia BioDrugs (IF 6.8) Pub Date : 2023-07-25 Courtney D. Thornburg, Dana H. Simmons, Annette von Drygalski
Hemophilia is characterized by a deficiency in coagulation factors VIII or IX. The general standard of care for severe hemophilia is frequent intravenous recombinant or plasma-derived factor replacement to prevent bleeding. While this treatment is effective in preventing bleeding, frequent infusions are burdensome for patients. Nonadherence to the therapeutic regimen leaves people with hemophilia at
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Recurrent Clostridioides difficile Infection: Current Clinical Management and Microbiome-Based Therapies BioDrugs (IF 6.8) Pub Date : 2023-07-26 Parul Berry, Sahil Khanna
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Unlocking the Power of Complement-Dependent Cytotoxicity: Engineering Strategies for the Development of Potent Therapeutic Antibodies for Cancer Treatments BioDrugs (IF 6.8) Pub Date : 2023-07-24 Wonju Lee, Sang Min Lee, Sang Taek Jung
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Staying Ahead of the Game: How SARS-CoV-2 has Accelerated the Application of Machine Learning in Pandemic Management BioDrugs (IF 6.8) Pub Date : 2023-07-18 Alexander H. Williams, Chang-Guo Zhan
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Treatment with Biologic Drugs in Pediatric Behçet’s Disease: A Comprehensive Analysis of the Published Data BioDrugs (IF 6.8) Pub Date : 2023-06-29 Ezgi Deniz Batu, Seher Sener, Veysel Cam, Nuray Aktay Ayaz, Seza Ozen
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The Emerging Safety Profile of JAK Inhibitors in Rheumatic Diseases BioDrugs (IF 6.8) Pub Date : 2023-06-23 Jasvinder A. Singh
Janus kinase inhibitor (JAKi) medications are small-molecule drugs that affect intracellular signal transduction. They are highly effective oral medications that have been approved for the treatment of various rheumatic diseases, with rheumatoid arthritis being a key example of an autoimmune rheumatic disease. JAKi are oral-route medications that are alternatives to injectable biologic therapies, launched
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The Role of Biologics in the Treatment of Chronic Rhinosinusitis BioDrugs (IF 6.8) Pub Date : 2023-06-15 Nora Haloob, Katerina Karamali, Claire Hopkins
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Home-Based Infusion of Alglucosidase Alfa Can Safely be Implemented in Adults with Late-Onset Pompe Disease: Lessons Learned from 18,380 Infusions BioDrugs (IF 6.8) Pub Date : 2023-06-16 Imke A. M. Ditters, Harmke A. van Kooten, Nadine A. M. E. van der Beek, Jacqueline F. Hardon, Gamida Ismailova, Esther Brusse, Michelle E. Kruijshaar, Ans T. van der Ploeg, Johanna M. P. van den Hout, Hidde H. Huidekoper
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Base Editing and Prime Editing: Potential Therapeutic Options for Rare and Common Diseases BioDrugs (IF 6.8) Pub Date : 2023-06-14 Lauren C. Testa, Kiran Musunuru
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Going Beyond Host Defence Peptides: Horizons of Chemically Engineered Peptides for Multidrug-Resistant Bacteria BioDrugs (IF 6.8) Pub Date : 2023-06-10 Bernardo Cavallazzi Sebold, Junjie Li, Guoying Ni, Quanlan Fu, Hejie Li, Xiaosong Liu, Tianfang Wang
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In Vitro Biological Characterization of Recombinant Insulin Aspart from Biogenomics and Originator Insulin Aspart BioDrugs (IF 6.8) Pub Date : 2023-06-07 Akshay G. Mishra, Rutuja B. Deshmane, Damodar K. Thappa, Jeseena Lona, Nikhil S. Ghade, Sanjay M. Sonar, Archana R. Krishnan
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Phase I, Randomized, Placebo-Controlled, Dose-Escalation Study of GB223, a Fully-Humanized Monoclonal Antibody to RANKL, in Healthy Chinese Adults BioDrugs (IF 6.8) Pub Date : 2023-06-06 Chen Li, Haiyan Liu, Yixiang Liao, Yu Zhu, Jingyuan Tian, Xuan Wang, Zhiqin Hu, Yaoxuan Zhan, Xianbo Li, Xintong Liang, Jin He, Yongmei Li, Dewei Shang, Qingshan Zheng, Tenghua Wang, Haifeng Song, Yi Fang
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Assessment of Reported Adverse Events After Interchanging Between TNF-α Inhibitor Biosimilars in the WHO Pharmacovigilance Database BioDrugs (IF 6.8) Pub Date : 2023-06-06 Orhon Pauline, Marion Robert, Claire Bernardeau, Alex Hlavaty, Michele Fusaroli, Matthieu Roustit, Jean-Luc Cracowski, Charles Khouri
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Novel Immunotherapeutic Approaches for the Treatment of Glioblastoma BioDrugs (IF 6.8) Pub Date : 2023-05-31 Saïf Eddine Zaidi, Eliese Moelker, Kirit Singh, Aditya Mohan, Miguel A. Salgado, Muhammed Amir Essibayi, Kelly Hotchkiss, Steven Shen, William Lee, John Sampson, Mustafa Khasraw
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Antibody–Drug Conjugates in the Treatment of Urothelial Cancer BioDrugs (IF 6.8) Pub Date : 2023-05-31 Avani M. Singh, Jose A. Guevara-Patino, Xuefeng Wang, Roger Li, Guru Sonpavde, Rohit K. Jain
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Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009–2022 BioDrugs (IF 6.8) Pub Date : 2023-05-25 Ryosuke Kuribayashi, Ayuki Nakano, Aya Hariu, Yasuhiro Kishioka, Futaba Honda
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Assessing the Interchangeability of AVT02 and Humira® in Participants with Moderate‑to‑Severe Chronic Plaque Psoriasis: Pharmacokinetics, Efficacy, Safety, and Immunogenicity Results from a Multicenter, Double-Blind, Randomized, Parallel-Group Study BioDrugs (IF 6.8) Pub Date : 2023-05-19 Steven R. Feldman, Richard Kay, Nataliya Reznichenko, Joanna Sobierska, Roshan Dias, Hendrik Otto, Halimu N. Haliduola, Abid Sattar, Ruth Ruffieux, Heimo Stroissnig, Fausto Berti
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Advanced Delivery Strategies for Immunotherapy in Type I Diabetes Mellitus BioDrugs (IF 6.8) Pub Date : 2023-05-13 Mingshu Huang, Weixing Chen, Min Wang, Yisheng Huang, Hongyu Liu, Yue Ming, Yuanxin Chen, Zhengming Tang, Bo Jia
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CAR-T Cells and the Kidney: Insights from the WHO Safety Database BioDrugs (IF 6.8) Pub Date : 2023-05-11 Alexandre O. Gérard, Diane Merino, Alexis Charbinat, Joseph Fournier, Alexandre Destere, Michael Loschi, Thomas Cluzeau, Antoine Sicard, Milou-Daniel Drici
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Exploring the Use of Monoclonal Antibodies and Antiviral Therapies for Early Treatment of COVID-19 Outpatients in a Real-World Setting: A Nationwide Study from England and Italy BioDrugs (IF 6.8) Pub Date : 2023-05-06 Francesco Ciccimarra, Nicoletta Luxi, Chiara Bellitto, Luca L’ Abbate, Pasquale De Nardo, Alessia Savoldi, Alison Yeomans, Mariam Molokhia, Evelina Tacconelli, Gianluca Trifirò
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Review and Update of Active and Passive Immunization Against Respiratory Syncytial Virus BioDrugs (IF 6.8) Pub Date : 2023-04-25 Charl Verwey, Shabir A. Madhi
Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infection (LRTI) in children, causing approximately 3.6 million hospitalizations per year, and has been associated with long-term pulmonary sequelae for up to 30 years after infection, yet preventative strategies and active treatment options remain elusive. The associated morbidity and healthcare related costs could
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Modification of Extracellular Vesicle Surfaces: An Approach for Targeted Drug Delivery BioDrugs (IF 6.8) Pub Date : 2023-04-24 Amir Hossein Mohammadi, Zeinab Ghazvinian, Fatemeh Bagheri, Masako Harada, Kaveh Baghaei
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Lupus Nephritis: New and Emerging Biologic and Targeted Therapies BioDrugs (IF 6.8) Pub Date : 2023-04-24 Ajinath Kale, Maciej Lech, Hans-Joachim Anders, Anil Bhanudas Gaikwad
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Characterization for the Similarity Assessment between Proposed Biosimilar SB12 and Eculizumab Reference Product Using a State-of-the-Art Analytical Method BioDrugs (IF 6.8) Pub Date : 2023-04-15 Hyunsoo Kim, Eunkyoung Hong, Jungmin Lee, Seokku Hong, Jihye Kim, Miju Cho, Yikwon Kim, Taekyung Yoo
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Characterization of a HIR-Fab-IDS, Novel Iduronate 2-Sulfatase Fusion Protein for the Treatment of Neuropathic Mucopolysaccharidosis Type II (Hunter Syndrome) BioDrugs (IF 6.8) Pub Date : 2023-04-04 Valentina D. Gusarova, Maxim A. Smolov, Ivan V. Lyagoskin, Maksim B. Degterev, Elizaveta V. Rechetnik, Alexander V. Rodionov, Marina S. Pantyushenko, Rahim R. Shukurov
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Recurring Fatigue After Biologic Administration: Patient-Reported Data from the Dutch Biologic Monitor BioDrugs (IF 6.8) Pub Date : 2023-04-03 Jette A. van Lint, Naomi T. Jessurun, Sander W. Tas, Harald E. Vonkeman, Martijn B. A. van Doorn, Frank Hoentjen, Michael T. Nurmohamed, Eugene P. van Puijenbroek, Bart J. F. van den Bemt