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TL1A Inhibition in Inflammatory Bowel Disease: A Pipeline Review
TL1A Inhibition in Inflammatory Bowel Disease: A Pipeline Review
Inflammatory bowel disease (IBD), encompassing Crohn’s disease (CD) and ulcerative colitis (UC), remains challenging...
Islet Cell Replacement and Regeneration for Type 1 Diabetes: Current Developments and Future Prospects
Islet Cell Replacement and Regeneration for Type 1 Diabetes: Current Developments and Future Prospects
Type 1 diabetes (T1D) is a chronic autoimmune disorder characterized by the destruction of insulin-producing beta cells in...
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...
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...
Interrogation of Structure–Activity Relationships in Charge Variants of Therapeutic IgG2s Enabled by Free-Flow Isoelectric Focusing Fractionation
Interrogation of Structure–Activity Relationships in Charge Variants of Therapeutic IgG2s Enabled by Free-Flow Isoelectric Focusing Fractionation
Recombinant immunoglobulin G2 (IgG2) antibodies are effective neutralization agents or antagonists with high medical value...
Progress and Challenges in the Treatment of Fabry Disease
Progress and Challenges in the Treatment of Fabry Disease
Fabry disease is a rare but life-threatening, X-linked, inherited lysosomal storage disorder in which globotriaosylceramid...
Is the Availability of Biosimilar Adalimumab Associated with Budget Savings? A Difference-in-Difference Analysis of 14 Countries
Is the Availability of Biosimilar Adalimumab Associated with Budget Savings? A Difference-in-Difference Analysis of 14 Countries
The aim was to assess the influence of the presence of biosimilar adalimumab on adalimumab budget savings in 14 high- and ...
Targeting IL-6 or IL-6 Receptor in Rheumatoid Arthritis: What Have We Learned?
Targeting IL-6 or IL-6 Receptor in Rheumatoid Arthritis: What Have We Learned?
The use of different pathways in the treatment of rheumatoid arthritis has led to a significant decrease in the number of ...
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
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
CT-P43 is a candidate ustekinumab biosimilar in clinical development. This paper aims to demonstrate equivalent efficacy o...
Molecular Engineering of Interleukin-2 for Enhanced Therapeutic Activity in Autoimmune Diseases
Molecular Engineering of Interleukin-2 for Enhanced Therapeutic Activity in Autoimmune Diseases
The interleukin-2 (IL-2) cytokine plays a crucial role in regulating immune responses and maintaining immune homeostasis. ...
Dystrophin- and Utrophin-Based Therapeutic Approaches for Treatment of Duchenne Muscular Dystrophy: A Comparative Review
Dystrophin- and Utrophin-Based Therapeutic Approaches for Treatment of Duchenne Muscular Dystrophy: A Comparative Review
Duchenne muscular dystrophy is a devastating disease that leads to progressive muscle loss and premature death. While medi...
Anti-Amyloid Monoclonal Antibodies for the Treatment of Alzheimer’s Disease
Anti-Amyloid Monoclonal Antibodies for the Treatment of Alzheimer’s Disease
Two monoclonal antibodies (mAbs), aducanumab and lecanemab, have received accelerated approval from the US FDA for initiat...
AAV-Based Strategies for Treatment of Retinal and Choroidal Vascular Diseases: Advances in Age-Related Macular Degeneration and Diabetic Retinopathy Therapies
AAV-Based Strategies for Treatment of Retinal and Choroidal Vascular Diseases: Advances in Age-Related Macular Degeneration and Diabetic Retinopathy Therapies
Age-related macular degeneration (AMD) and diabetic retinopathy (DR) are vascular diseases with high prevalence, ranking a...
Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?
Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?
There is an increasing body of evidence supporting a more flexible approach in clinical data requirements for the approval...
Advancing Subcutaneous Dosing Regimens for Biotherapeutics: Clinical Strategies for Expedited Market Access
Advancing Subcutaneous Dosing Regimens for Biotherapeutics: Clinical Strategies for Expedited Market Access
In recent years, subcutaneous administration of biotherapeutics has made significant progress. The self-administration mar...
Outer Membrane Vesicle Vaccine Platforms
Outer Membrane Vesicle Vaccine Platforms
Outer membrane vesicles (OMVs) are spontaneously released by many gram-negative bacteria during their growth and constitut...
Immunotherapy Guided by Immunohistochemistry PD-L1 Testing for Patients with NSCLC: A Microsimulation Model-Based Effectiveness and Cost-Effectiveness Analysis
Immunotherapy Guided by Immunohistochemistry PD-L1 Testing for Patients with NSCLC: A Microsimulation Model-Based Effectiveness and Cost-Effectiveness Analysis
On the basis of immunohistochemistry PD-L1 testing results, patients with advanced non-small cell lung cancer (NSCLC) are ...
Ixekizumab for Active Radiographic Axial Spondyloarthritis in Chinese Patients: 16- and 52-Week Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study
Ixekizumab for Active Radiographic Axial Spondyloarthritis in Chinese Patients: 16- and 52-Week Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study
Ixekizumab, an interleukin-17A inhibitor, was efficacious and well tolerated for the treatment of active radiographic axia...
Real-World Clinical Outcomes of Bevacizumab-awwb Biosimilar versus Bevacizumab Reference Product in Patients with Metastatic Colorectal Cancer
Real-World Clinical Outcomes of Bevacizumab-awwb Biosimilar versus Bevacizumab Reference Product in Patients with Metastatic Colorectal Cancer
Bevacizumab-awwb was the first biosimilar approved for cancer treatment in the USA. Limited information is available on th...
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