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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...
Real-World Comparative Analysis of Trastuzumab Originator and Biosimilars: Safety, Efficacy, and Cost Effectiveness
Real-World Comparative Analysis of Trastuzumab Originator and Biosimilars: Safety, Efficacy, and Cost Effectiveness
Despite the global use of trastuzumab biosimilars, concerns remain regarding their efficacy and safety. In particular, whe...
Biochemical Amenability in Fabry Patients Under Chaperone Therapy—How and When to Test?
Biochemical Amenability in Fabry Patients Under Chaperone Therapy—How and When to Test?
Current recommendations for Fabry disease include α-galactosidase A (AGAL) activity measurements to assess the bioche...
Patient Satisfaction and Experience with CT-P17 Following Transition from Reference Adalimumab or Another Adalimumab Biosimilar: Results from the Real-World YU-MATTER Study
Patient Satisfaction and Experience with CT-P17 Following Transition from Reference Adalimumab or Another Adalimumab Biosimilar: Results from the Real-World YU-MATTER Study
Biosimilars are cost-effective alternatives to reference products for patients with inflammatory bowel diseases (IBD) and ...
Chikungunya Virus Vaccines: A Review of IXCHIQ and PXVX0317 from Pre-Clinical Evaluation to Licensure
Chikungunya Virus Vaccines: A Review of IXCHIQ and PXVX0317 from Pre-Clinical Evaluation to Licensure
Chikungunya virus is an emerging mosquito-borne alphavirus that causes febrile illness and arthritic disease. Chikungunya ...
Adverse Impacts of PEGylated Protein Therapeutics: A Targeted Literature Review
Adverse Impacts of PEGylated Protein Therapeutics: A Targeted Literature Review
The beneficial effects of polyethylene glycol (PEG)-conjugated therapeutics, such as increased half-life, solubility, stab...
Discovery of Therapeutic Antibodies Targeting Complex Multi-Spanning Membrane Proteins
Discovery of Therapeutic Antibodies Targeting Complex Multi-Spanning Membrane Proteins
Complex integral membrane proteins, which are embedded in the cell surface lipid bilayer by multiple transmembrane spannin...
Pulmonary Arterial Hypertension and TGF-β Superfamily Signaling: Focus on Sotatercept
Pulmonary Arterial Hypertension and TGF-β Superfamily Signaling: Focus on Sotatercept
Pulmonary arterial hypertension (PAH) is a rare and progressive disease that continues to remain highly morbid despite mul...
Eblasakimab, an Anti-IL‑13Rα1 Antibody, Reduces Atopy-Associated Serum Biomarkers in Moderate‑to‑Severe Atopic Dermatitis
Eblasakimab, an Anti-IL‑13Rα1 Antibody, Reduces Atopy-Associated Serum Biomarkers in Moderate‑to‑Severe Atopic Dermatitis
Eblasakimab, a first-in-class monoclonal antibody with a unique mechanism to target the interleukin (IL)-13 receptor alpha...
Advanced Therapy Medicinal Products: Availability, Access and Expenditure in Italy
Advanced Therapy Medicinal Products: Availability, Access and Expenditure in Italy
Advanced therapy medicinal products (ATMPs) are an innovative output of biomedical research, characterized by a high level...
Introducing the Biosimilar Paradigm to Neurology: The Totality of Evidence for the First Biosimilar Natalizumab
Introducing the Biosimilar Paradigm to Neurology: The Totality of Evidence for the First Biosimilar Natalizumab
A biosimilar medicine is a successor to a reference (‘originator’/’original-brand’) biologic medic...
Pharmacokinetics, Safety, and Immunogenicity of a Biosimilar of Nivolumab (LY01015): A Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Trial in Healthy Chinese Male Subjects
Pharmacokinetics, Safety, and Immunogenicity of a Biosimilar of Nivolumab (LY01015): A Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Trial in Healthy Chinese Male Subjects
Nivolumab (Opdivo®) is the first anti-PD-1 antibody approved in the world. LY01015 is a potential biosimilar of nivol...
Effect of Biological Therapy for Psoriasis on the Development of Psoriatic Arthritis: A Population-Based Cohort Study
Effect of Biological Therapy for Psoriasis on the Development of Psoriatic Arthritis: A Population-Based Cohort Study
Evidence comparing the impact of various biologics for psoriasis on the progression to psoriatic arthritis (PsA) is limite...
Accelerating CAR-T Cell Therapies with Small-Molecule Inhibitors
Accelerating CAR-T Cell Therapies with Small-Molecule Inhibitors
Chimeric antigen receptor T-cell therapies have markedly improved the survival rates of patients with B-cell malignancies....
Relevance of Neutralizing Antibodies for the Pharmacokinetics of Pegunigalsidase Alfa in Patients with Fabry Disease
Relevance of Neutralizing Antibodies for the Pharmacokinetics of Pegunigalsidase Alfa in Patients with Fabry Disease
Pegunigalsidase alfa is a newly approved drug for the treatment of Fabry disease, designed to increase the plasma half-lif...
Investigational RNA Interference Agents for Hepatitis B
Investigational RNA Interference Agents for Hepatitis B
Functional cure of chronic hepatitis B (CHB)—defined as sustained seroclearance of hepatitis B surface antigen (HBsA...
The Evolving Applications of Bispecific Antibodies: Reaping the Harvest of Early Sowing and Planting New Seeds
The Evolving Applications of Bispecific Antibodies: Reaping the Harvest of Early Sowing and Planting New Seeds
After decades of gradual progress from conceptualization to early clinical trials (1960–2000), the therapeutic poten...
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
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
Serplulimab is a novel, recombinant, humanized, monoclonal, anti-programmed death 1 antibody with a similar or better affi...
Reducing Immunogenicity by Design: Approaches to Minimize Immunogenicity of Monoclonal Antibodies
Reducing Immunogenicity by Design: Approaches to Minimize Immunogenicity of Monoclonal Antibodies
Monoclonal antibodies (mAbs) have transformed therapeutic strategies for various diseases. Their high specificity to targe...
Splice-Modulating Antisense Oligonucleotides as Therapeutics for Inherited Metabolic Diseases
Splice-Modulating Antisense Oligonucleotides as Therapeutics for Inherited Metabolic Diseases
The last decade (2013–2023) has seen unprecedented successes in the clinical translation of therapeutic antisense ol...
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
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
Anti-calcitonin gene-related peptide monoclonal antibodies (anti-CGRP-mAbs) have recently been approved for the prevention...
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of the Anti-IFNAR1 Monoclonal Antibody QX006N: A First-in-Human Single Ascending Dose Study in Healthy Chinese Volunteers
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of the Anti-IFNAR1 Monoclonal Antibody QX006N: A First-in-Human Single Ascending Dose Study in Healthy Chinese Volunteers
QX006N is a novel, humanized, IgG4κ monoclonal antibody targeting IFNAR1, developed for the treatment of systemic lup...
Nano–Bio Interactions: Exploring the Biological Behavior and the Fate of Lipid-Based Gene Delivery Systems
Nano–Bio Interactions: Exploring the Biological Behavior and the Fate of Lipid-Based Gene Delivery Systems
Gene therapy for many diseases is rapidly becoming a reality, as demonstrated by the recent approval of various nucleic ac...
Impact of Early Access Reform on Oncology Innovation in France: Approvals, Patients, and Costs
Impact of Early Access Reform on Oncology Innovation in France: Approvals, Patients, and Costs
An ambitious reform of the early access (EA) process was set up in July 2021 in France, aiming to simplify procedures and ...
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...
Use of Biosimilars: A Systematic Review of Published Position Statements and Recommendations from Health Organisations and Societies
Use of Biosimilars: A Systematic Review of Published Position Statements and Recommendations from Health Organisations and Societies
Hesitation about using biosimilars still exists among healthcare professionals (HCPs), despite extensive experience with t...
CRISPR-Cas System: A New Dawn to Combat Antibiotic Resistance
CRISPR-Cas System: A New Dawn to Combat Antibiotic Resistance
Antimicrobial resistance (AMR) can potentially harm global public health. Horizontal gene transfer (HGT), which speeds up ...
Targeted Gene Insertion: The Cutting Edge of CRISPR Drug Development with Hemophilia as a Highlight
Targeted Gene Insertion: The Cutting Edge of CRISPR Drug Development with Hemophilia as a Highlight
The remarkable advance in gene editing technology presents unparalleled opportunities for transforming medicine and findin...
Next-Generation Anti-TNFα Agents: The Example of Ozoralizumab
Next-Generation Anti-TNFα Agents: The Example of Ozoralizumab
Biologic therapy involving anti-tumor necrosis factor-α (anti-TNFα) agents has fundamentally changed the managem...
Research Advances in Stem Cell Therapy for Erectile Dysfunction
Research Advances in Stem Cell Therapy for Erectile Dysfunction
Erectile dysfunction (ED) is a common clinical condition that mainly affects men aged over 40 years. Various causes contri...
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