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Real-World Data Included in Post-authorisation Measures: A Case Study of Approved Advanced Therapy Medicinal Products in the European Union between 2013 and 2024
Real-World Data Included in Post-authorisation Measures: A Case Study of Approved Advanced Therapy Medicinal Products in the European Union between 2013 and 2024
Advanced therapy medicinal products (ATMPs) often require long-term monitoring to assess both safety and efficacy post-aut...
Targeting CD20 for B-cell Depletion in Autoimmune Kidney Disease: Next Generation
Targeting CD20 for B-cell Depletion in Autoimmune Kidney Disease: Next Generation
Anti-CD20 monoclonal antibodies are gaining clinical relevance in the nephrology community due to their demonstrated effic...
The Present and Future of Monoclonal Antibody Therapies for Multiple Sclerosis
The Present and Future of Monoclonal Antibody Therapies for Multiple Sclerosis
Multiple sclerosis (MS) is a chronic autoimmune disease of the central nervous system characterized by inflammation, demye...
Oncolytic Virotherapy in Solid Tumors: A Current Review
Oncolytic Virotherapy in Solid Tumors: A Current Review
Oncolytic viruses (OVs) are naturally occurring or genetically modified viruses that selectively target cancer cells for i...
Advances of Antimicrobial Peptides in the Treatment of Multidrug-Resistant Bacteria
Advances of Antimicrobial Peptides in the Treatment of Multidrug-Resistant Bacteria
Drug-resistant bacteria have become one of the greatest threats to human health in recent decades. With the large-scale ab...
Bidirectional Interplay Between IBD Therapies and the Gut Microbiota: A Pharmacomicrobiomic Approach to Personalized Treatment
Bidirectional Interplay Between IBD Therapies and the Gut Microbiota: A Pharmacomicrobiomic Approach to Personalized Treatment
The interplay between inflammatory bowel disease pharmacotherapies and the gut microbiota is increasingly recognized as a ...
Biological Therapies in Chronic Obstructive Pulmonary Disease: New Directions in Personalised Respiratory Medicine
Biological Therapies in Chronic Obstructive Pulmonary Disease: New Directions in Personalised Respiratory Medicine
Chronic obstructive pulmonary disease (COPD), a leading cause of global morbidity and mortality, is a complex and heteroge...
Toward Regulatory Convergence and Streamlined Biosimilar Development: Recommendations from an International Qualitative Study
Toward Regulatory Convergence and Streamlined Biosimilar Development: Recommendations from an International Qualitative Study
This study aims to assess perspectives of stakeholders on scientific and regulatory challenges associated with biosimilari...
Efficacy and Safety of Biosimilar AVT05 Versus Reference Product Golimumab in Combination with Methotrexate in Moderate-to-Severe Rheumatoid Arthritis: 52-Week Results of a Randomized, Parallel-Group, Double-Blind Study
Efficacy and Safety of Biosimilar AVT05 Versus Reference Product Golimumab in Combination with Methotrexate in Moderate-to-Severe Rheumatoid Arthritis: 52-Week Results of a Randomized, Parallel-Group, Double-Blind Study
Golimumab is a safe and effective treatment for patients with rheumatoid arthritis. Biosimilars to the reference product (...
Pharmacokinetic Similarity of Biosimiliar AVT05 Versus Reference Product Golimumab in Healthy Adults: A Double-Blind, Three-Arm, Parallel-Group Study
Pharmacokinetic Similarity of Biosimiliar AVT05 Versus Reference Product Golimumab in Healthy Adults: A Double-Blind, Three-Arm, Parallel-Group Study
AVT05, a recombinant, human, immunoglobulin G1қ monoclonal antibody, is a biosimilar to Simponi®. The purpose o...
Xeligekimab, an Interleukin-17A Antagonist for Active Radiographic Axial Spondyloarthritis in Chinese Patients: 16- and 48-Week Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study
Xeligekimab, an Interleukin-17A Antagonist for Active Radiographic Axial Spondyloarthritis in Chinese Patients: 16- and 48-Week Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study
Xeligekimab is a novel immunoglobulin G4 (IgG4) monoclonal antibody targeting interleukin-17A (IL-17A). In a phase III tri...
Clinical Qualification of Subcutaneous Injection Devices for Monoclonal Antibodies
Clinical Qualification of Subcutaneous Injection Devices for Monoclonal Antibodies
Subcutaneous autoinjectors serve as a convenient and user-friendly alternative to manual injection using prefilled syringe...
Cell Engineering for Increasing Production of Recombinant Proteins in Mammalian Cells
Cell Engineering for Increasing Production of Recombinant Proteins in Mammalian Cells
Mammalian cell lines are the preferred host cells for the biopharmaceutical industry. Chinese hamster ovary (CHO) and huma...
Biosimilar Uptake in Spain from 2016 to 2023: Analysis Based on Official Data Collection
Biosimilar Uptake in Spain from 2016 to 2023: Analysis Based on Official Data Collection
Even though the use of biosimilar medicines is increasing across European countries, detailed and regularly published offi...
Can Alpha-Glucosidase Activity in Plasma or Leukocytes Serve as a Biomarker for Future Gene Therapy in Classic Infantile Pompe Disease?
Can Alpha-Glucosidase Activity in Plasma or Leukocytes Serve as a Biomarker for Future Gene Therapy in Classic Infantile Pompe Disease?
We studied alpha-glucosidase activity in plasma and leukocytes after an infusion of 40 mg/kg of recombinant alglucosidase ...
Conditionally Activatable Antibody Platforms: Mechanisms, Modalities, and Clinical Translation Potential
Conditionally Activatable Antibody Platforms: Mechanisms, Modalities, and Clinical Translation Potential
Conditionally activatable antibodies represent a promising strategy to improve the therapeutic index of antibody-based dru...
Use of Semaglutide (Wegovy) in Adults in France: A Nationwide Drug Utilization Study
Use of Semaglutide (Wegovy) in Adults in France: A Nationwide Drug Utilization Study
Glucagon-like peptide 1 receptor agonists have shown promising results in obesity treatment. In France, semaglutide 2.4-mg...
Primary and Acquired Resistance to Immunotherapy with Checkpoint Inhibitors in NSCLC: From Bedside to Bench and Back
Primary and Acquired Resistance to Immunotherapy with Checkpoint Inhibitors in NSCLC: From Bedside to Bench and Back
Immunotherapy with checkpoint inhibitors has become the cornerstone of systemic treatment for non-oncogene addicted non-sm...
The Path to Accessible Care: Development and Impact of Eculizumab Biosimilars for Paroxysmal Nocturnal Hemoglobinuria and Atypical Hemolytic Uremic Syndrome
The Path to Accessible Care: Development and Impact of Eculizumab Biosimilars for Paroxysmal Nocturnal Hemoglobinuria and Atypical Hemolytic Uremic Syndrome
Eculizumab, a humanized monoclonal antibody targeting complement C5, is the first approved drug for complement-mediated di...
Biosimilar Policies and Their Impact on Market Penetration of Adalimumab, Etanercept and Infliximab: A Policy Synthesis and Descriptive Analysis in 13 OECD Countries
Biosimilar Policies and Their Impact on Market Penetration of Adalimumab, Etanercept and Infliximab: A Policy Synthesis and Descriptive Analysis in 13 OECD Countries
Different biosimilar-promoting policies have been implemented worldwide to improve biosimilar uptake and reduce expenditur...
Defining a Framework for Sustainable Global Biosimilars Markets Using Findings from a Targeted Literature Review
Defining a Framework for Sustainable Global Biosimilars Markets Using Findings from a Targeted Literature Review
A biosimilar is a biologic medication that is highly similar to and has no clinically meaningful differences from an exist...
Comparative Structure Activity Relationship Characterization of the Biosimilar BAT1806/BIIB800 to Reference Tocilizumab
Comparative Structure Activity Relationship Characterization of the Biosimilar BAT1806/BIIB800 to Reference Tocilizumab
BAT1806/BIIB800 (Tofidence™/tocilizumab-bavi), a biosimilar of tocilizumab, demonstrated a high degree of analytical...
Multispecific Antibodies Targeting PD-1/PD-L1 in Cancer
Multispecific Antibodies Targeting PD-1/PD-L1 in Cancer
The development of immune checkpoint inhibitors has revolutionized the treatment of patients with cancer. Targeting the pr...
Extracellular Vesicles and Immune Activation in Solid Organ Transplantation: The Impact of Immunosuppression
Extracellular Vesicles and Immune Activation in Solid Organ Transplantation: The Impact of Immunosuppression
Recent advances in extracellular vesicle (EV) research in organ transplantation have highlighted the crucial role of donor...
Targeting the Neonatal Fc Receptor in Autoimmune Diseases: Pipeline and Progress
Targeting the Neonatal Fc Receptor in Autoimmune Diseases: Pipeline and Progress
Autoimmune diseases are highly prevalent and affect people at all ages, women more often than men. The most prominent immu...
First-in-Human Study on Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Escalating Doses of HEC88473, a Novel Dual GLP-1 and FGF21 Receptor Agonist in Healthy and Obese Chinese Subjects
First-in-Human Study on Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Escalating Doses of HEC88473, a Novel Dual GLP-1 and FGF21 Receptor Agonist in Healthy and Obese Chinese Subjects
HEC88473 is a novel long-acting dual agonist of glucagon-like peptide 1 (GLP-1) and fibroblast growth factor 21 (FGF21) re...
Frequency of Biological Drug Use in Older Patients with Immune-Mediated Inflammatory Diseases: Results from the Large-Scale Italian VALORE Distributed Database Network
Frequency of Biological Drug Use in Older Patients with Immune-Mediated Inflammatory Diseases: Results from the Large-Scale Italian VALORE Distributed Database Network
Limited real-world data on biological drug use in older patients with immune-mediated inflammatory diseases (IMIDs) exist ...
Translational Investigation of CM326 from Preclinical Studies to Randomized Phase I Clinical Trials in Healthy Adults
Translational Investigation of CM326 from Preclinical Studies to Randomized Phase I Clinical Trials in Healthy Adults
Thymic stromal lymphopoietin (TSLP) plays a pivotal role in immune responses. CM326 is a humanized monoclonal antibody tar...
The Fomivirsen, Patisiran, and Givosiran Odyssey: How the Success Stories May Pave the Way for Future Clinical Translation of Nucleic Acid Drugs
The Fomivirsen, Patisiran, and Givosiran Odyssey: How the Success Stories May Pave the Way for Future Clinical Translation of Nucleic Acid Drugs
Over the past 25 years, the approval of several nucleic acid-based drugs by the US Food and Drug Administration (FDA) has ...
Understanding IgM Structure and Biology to Engineer New Antibody Therapeutics
Understanding IgM Structure and Biology to Engineer New Antibody Therapeutics
Immunoglobulin M (IgM) antibodies are an essential and conserved part of adaptive immunity. IgMs assemble into pentamers a...
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