SCI Abstract

search
+
Safety of Biological Therapies for Severe Asthma: An Analysis of Suspected Adverse Reactions Reported in the WHO Pharmacovigilance Database
Safety of Biological Therapies for Severe Asthma: An Analysis of Suspected Adverse Reactions Reported in the WHO Pharmacovigilance Database
The management of uncontrolled severe asthma has greatly improved since the advent of novel biologic therapies. Up to Augu...
Charting the Etanercept Journey: Tracing Cost Dynamics in Poland’s Off-Patent Market from Reference Drug Rivalry to Biosimilar Monopoly
Charting the Etanercept Journey: Tracing Cost Dynamics in Poland’s Off-Patent Market from Reference Drug Rivalry to Biosimilar Monopoly
To evaluate the pricing of etanercept (ETN) reference and biosimilar drugs in a changing competitive to monopolized market...
Demonstration of Physicochemical and Functional Similarity of the Biosimilar BAT1806/BIIB800 to Reference Tocilizumab
Demonstration of Physicochemical and Functional Similarity of the Biosimilar BAT1806/BIIB800 to Reference Tocilizumab
Tocilizumab is an immunoglobulin G1 monoclonal antibody targeting the interleukin-6 receptor (IL-6R). BAT1806/BIIB800 (toc...
Monoclonal Antibody Generation Using Single B Cell Screening for Treating Infectious Diseases
Monoclonal Antibody Generation Using Single B Cell Screening for Treating Infectious Diseases
The screening of antigen-specific B cells has been pivotal for biotherapeutic development for over four decades. Conventio...
Mechanisms of Action of the US Food and Drug Administration-Approved Antisense Oligonucleotide Drugs
Mechanisms of Action of the US Food and Drug Administration-Approved Antisense Oligonucleotide Drugs
Antisense oligonucleotides (ASOs) are single stranded nucleic acids that target RNA. The US Food and Drug Administration h...
Barriers and Enablers Affecting the Uptake of Biosimilar Medicines Viewed Through the Lens of Actor Network Theory: A Systematic Review
Barriers and Enablers Affecting the Uptake of Biosimilar Medicines Viewed Through the Lens of Actor Network Theory: A Systematic Review
Biosimilars represent an opportunity to realise savings against the costs of innovative medicines. Despite efforts made by...
Stem Cells and Stem Cell-Derived Factors for the Treatment of Inflammatory Bowel Disease with a Particular Focus on Perianal Fistulizing Disease: A Minireview on Future Perspectives
Stem Cells and Stem Cell-Derived Factors for the Treatment of Inflammatory Bowel Disease with a Particular Focus on Perianal Fistulizing Disease: A Minireview on Future Perspectives
Inflammatory bowel disease remains a difficult disease to effectively treat, especially fistulizing Crohn’s disease....
Targeting Neurological Aspects of Mucopolysaccharidosis Type II: Enzyme Replacement Therapy and Beyond
Targeting Neurological Aspects of Mucopolysaccharidosis Type II: Enzyme Replacement Therapy and Beyond
Mucopolysaccharidosis type II (MPS II) is a rare, pediatric, neurometabolic disorder due to the lack of activity of the ly...
Long-Term Efficacy and Safety of Stapokibart in Adults with Moderate-to-Severe Atopic Dermatitis: An Open-Label Extension, Nonrandomized Clinical Trial
Long-Term Efficacy and Safety of Stapokibart in Adults with Moderate-to-Severe Atopic Dermatitis: An Open-Label Extension, Nonrandomized Clinical Trial
Stapokibart/CM310, a humanized monoclonal antibody targeting the interleukin-4 receptor α chain, has shown promising ...
Insulin Icodec: First Approval
Insulin Icodec: First Approval
Insulin icodec (AWIQLI®) is an ultra-long-acting basal insulin analogue that is being developed by Novo Nordisk for t...
Systematic Review of Genetic Substrate Reduction Therapy in Lysosomal Storage Diseases: Opportunities, Challenges and Delivery Systems
Systematic Review of Genetic Substrate Reduction Therapy in Lysosomal Storage Diseases: Opportunities, Challenges and Delivery Systems
Genetic substrate reduction therapy (gSRT), which involves the use of nucleic acids to downregulate the genes involved in ...
A Population Pharmacokinetic Model of Tocilizumab in Kidney Transplant Patients Treated for Chronic Active Antibody-Mediated Rejection: Comparison of Plasma Exposure Between Intravenous and Subcutaneous Administration Schemes
A Population Pharmacokinetic Model of Tocilizumab in Kidney Transplant Patients Treated for Chronic Active Antibody-Mediated Rejection: Comparison of Plasma Exposure Between Intravenous and Subcutaneous Administration Schemes
Tocilizumab prevents the clinical worsening of chronic active antibody-mediated rejection (CAAMR) in kidney transplant rec...
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...
Malaria Vaccines: Progress to Date
Malaria Vaccines: Progress to Date
Malaria is a mosquito-borne disease caused by protozoan parasites of the genus Plasmodium. Despite significant declines in...
Enzyme Engineering Strategies for the Bioenhancement of l-Asparaginase Used as a Biopharmaceutical
Enzyme Engineering Strategies for the Bioenhancement of l-Asparaginase Used as a Biopharmaceutical
Over the past few years, there has been a surge in the industrial production of recombinant enzymes from microorganisms du...
Patients’ Perceptions of Biosimilars: A Systematic Review
Patients’ Perceptions of Biosimilars: A Systematic Review
To systematically summarize and evaluate the findings of existing studies about patients’ perceptions of biosimilars...
Acute Kidney Injury from Intravitreal Anti-vascular Endothelial Growth Factor Drugs: A Systematic Review and Meta-analysis of Randomized Controlled Trials
Acute Kidney Injury from Intravitreal Anti-vascular Endothelial Growth Factor Drugs: A Systematic Review and Meta-analysis of Randomized Controlled Trials
Several observational studies have reported acute kidney injury from intravitreal anti-vascular endothelial growth factor ...
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
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
The non-interventional PROPER study generated real-world evidence on clinical outcomes following transition in routine pra...
Load More
format_indent_increase