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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 ...
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...
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...
Characterization of Biosimilar Monoclonal Antibodies and Their Reference Products Approved in Japan to Reveal the Quality Characteristics in Post-approval Phase
Characterization of Biosimilar Monoclonal Antibodies and Their Reference Products Approved in Japan to Reveal the Quality Characteristics in Post-approval Phase
Promoting the use of biosimilars is a global issue from the perspective of reducing medical costs. In Japan, the replaceme...
Demand- Versus Supply-Side Policies in Market Penetration of Biosimilars: Which is More Effective?
Demand- Versus Supply-Side Policies in Market Penetration of Biosimilars: Which is More Effective?
To evaluate the impact of demand- and supply-side policies on the biosimilar market penetration and identify effective str...
Emerging Therapy in Osteoarthritis: Mesenchymal Stem Cells, Secretomes, and Using Hydrogels to Enhance Efficacy
Emerging Therapy in Osteoarthritis: Mesenchymal Stem Cells, Secretomes, and Using Hydrogels to Enhance Efficacy
Osteoarthritis is a prevalent condition among middle-aged and elderly populations characterized primarily by the progressi...
Beyond Cost: Observations on Clinical and Patient Benefits of Biosimilars in Real-World Settings
Beyond Cost: Observations on Clinical and Patient Benefits of Biosimilars in Real-World Settings
The introduction of biosimilars into healthcare systems globally is recognized by many as a healthcare success. Despite th...
The Use of Biologics for Thyroid Eye Disease
The Use of Biologics for Thyroid Eye Disease
Thyroid eye disease (TED) is the most common extrathyroidal manifestation of Graves’ disease. It is an autoimmune di...
Emerging Role of Targeted Monoclonal Antibodies in Neuromyelitis Optica Spectrum Disorders
Emerging Role of Targeted Monoclonal Antibodies in Neuromyelitis Optica Spectrum Disorders
Neuromyelitis optica spectrum disorder (NMOSD) is a rare, autoimmune disease that results in recurring, often severe attac...
Influence of Pharmacokinetic-Pharmacodynamic Failure Mechanisms on Outcomes in Biologic Therapy Sequencing in Inflammatory Bowel Disease: A Retrospective Cohort Study
Influence of Pharmacokinetic-Pharmacodynamic Failure Mechanisms on Outcomes in Biologic Therapy Sequencing in Inflammatory Bowel Disease: A Retrospective Cohort Study
Increasing therapeutic options for inflammatory bowel disease calls for tools to aid choice of sequencing. We investigated...
Lipid-Lowering RNA Therapeutics for Atherosclerotic Cardiovascular Disease Prevention: A State−of−the−Art Review
Lipid-Lowering RNA Therapeutics for Atherosclerotic Cardiovascular Disease Prevention: A State−of−the−Art Review
Despite the modern era of effective and safe high-intensity statins and non-statin agents, a significant portion of patien...
Analytical Data and Single-Dose PK are Sufficient to Conclude Comparable Immunogenicity for Biosimilars: An Ustekinumab Case Study
Analytical Data and Single-Dose PK are Sufficient to Conclude Comparable Immunogenicity for Biosimilars: An Ustekinumab Case Study
Comparative immunogenicity is a key regulatory requirement for biosimilars. In a streamlined biosimilar development proces...
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....
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