Consensus-Based Overarching Principles and Recommendations on the Use of Biosimilars in the Treatment of Inflammatory Arthritis in the Gulf Region
ConclusionsThese are the first consensus recommendations for the Gulf region based on a systematic literature review and Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guidelines, integrating clinical evidence with clinical expertise to optimize decision making for the use of biosimilars in patients with inflammatory arthritis. They were formulated based on predominantly international data because of the limited regional data and therefore can be generalized to serve as recommendations for healthcare professionals in other parts of the world. (Source: BioDrugs)
Source: BioDrugs - February 25, 2024 Category: Drugs & Pharmacology Source Type: research
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
ConclusionThe analysis of anti-CGRP-related CV ADRs was consistent with the information reported in the literature. However, hypertension with ERE, atrial fibrillation and myocardial infarction with GMB, as well as pallor, deep vein thrombosis, hot flush, and palpitations with FMB were not reported in the Summary of Product Characteristics (SmPCs). Considering this, more post-marketing analyses are needed to improve knowledge on the CV safety profiles of anti-CGRP-mAbs, especially for the last approved medication, EPT. (Source: BioDrugs)
Source: BioDrugs - February 25, 2024 Category: Drugs & Pharmacology Source Type: research
Consensus-Based Overarching Principles and Recommendations on the Use of Biosimilars in the Treatment of Inflammatory Arthritis in the Gulf Region
ConclusionsThese are the first consensus recommendations for the Gulf region based on a systematic literature review and Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guidelines, integrating clinical evidence with clinical expertise to optimize decision making for the use of biosimilars in patients with inflammatory arthritis. They were formulated based on predominantly international data because of the limited regional data and therefore can be generalized to serve as recommendations for healthcare professionals in other parts of the world. (Source: BioDrugs)
Source: BioDrugs - February 25, 2024 Category: Drugs & Pharmacology Source Type: research
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
ConclusionThe analysis of anti-CGRP-related CV ADRs was consistent with the information reported in the literature. However, hypertension with ERE, atrial fibrillation and myocardial infarction with GMB, as well as pallor, deep vein thrombosis, hot flush, and palpitations with FMB were not reported in the Summary of Product Characteristics (SmPCs). Considering this, more post-marketing analyses are needed to improve knowledge on the CV safety profiles of anti-CGRP-mAbs, especially for the last approved medication, EPT. (Source: BioDrugs)
Source: BioDrugs - February 25, 2024 Category: Drugs & Pharmacology Source Type: research
Nano –Bio Interactions: Exploring the Biological Behavior and the Fate of Lipid-Based Gene Delivery Systems
AbstractGene therapy for many diseases is rapidly becoming a reality, as demonstrated by the recent approval of various nucleic acid-based therapeutics. Non-viral systems such as lipid-based carriers, lipid nanoparticles (LNPs), for delivering different payloads including small interfering RNA, plasmid DNA, and messenger RNA have been particularly extensively explored and developed for clinical uses. One of the most important issues in LNP development is delivery to extrahepatic tissues. To achieve this, various lipids and lipid-like materials are being examined and screened. Several LNP formulations that target extrahepat...
Source: BioDrugs - February 12, 2024 Category: Drugs & Pharmacology Source Type: research
Recombinant Antibody Fragments for Immunotherapy of Parkinson ’s Disease
AbstractParkinson ’s disease (PD) is the second most common age-related neurodegenerative disorder. Multiple genetic and environmental factors leading to progressive loss of dopaminergic neurons in the substantia nigra pars compacta (SN) and consequent depletion of dopamine were described. Current clinical approach es, such as dopamine replacement or deep brain stimulation using surgically implanted probes, provide symptomatic relief but cannot modify disease progression. Therefore, disease-modifying therapeutic tools are urgently needed. Immunotherapy approaches, including passive transfer of protective antib odies and ...
Source: BioDrugs - January 27, 2024 Category: Drugs & Pharmacology Source Type: research
Reducing Immunogenicity by Design: Approaches to Minimize Immunogenicity of Monoclonal Antibodies
AbstractMonoclonal antibodies (mAbs) have transformed therapeutic strategies for various diseases. Their high specificity to target antigens makes them ideal therapeutic agents for certain diseases. However, a challenge to their application in clinical practice is their potential risk to induce unwanted immune response, termed immunogenicity. This challenge drives the continued efforts to deimmunize these protein therapeutics while maintaining their pharmacokinetic properties and therapeutic efficacy. Because mAbs hold a central position in therapeutic strategies against an array of diseases, the importance of conducting c...
Source: BioDrugs - January 23, 2024 Category: Drugs & Pharmacology Source Type: research
Splice-Modulating Antisense Oligonucleotides as Therapeutics for Inherited Metabolic Diseases
AbstractThe last decade (2013 –2023) has seen unprecedented successes in the clinical translation of therapeutic antisense oligonucleotides (ASOs). Eight such molecules have been granted marketing approval by the United States Food and Drug Administration (US FDA) during the decade, after the first ASO drug, fomivirsen, was ap proved much earlier, in 1998. Splice-modulating ASOs have also been developed for the therapy of inborn errors of metabolism (IEMs), due to their ability to redirect aberrant splicing caused by mutations, thus recovering the expression of normal transcripts, and correcting the deficiency of functio...
Source: BioDrugs - January 22, 2024 Category: Drugs & Pharmacology Source Type: research
Correction to: Is the Availability of Biosimilar Adalimumab Associated with Budget Saving? A Difference-in-Difference Analysis of 14 Countries
(Source: BioDrugs)
Source: BioDrugs - January 22, 2024 Category: Drugs & Pharmacology Source Type: research
Splice-Modulating Antisense Oligonucleotides as Therapeutics for Inherited Metabolic Diseases
AbstractThe last decade (2013 –2023) has seen unprecedented successes in the clinical translation of therapeutic antisense oligonucleotides (ASOs). Eight such molecules have been granted marketing approval by the United States Food and Drug Administration (US FDA) during the decade, after the first ASO drug, fomivirsen, was ap proved much earlier, in 1998. Splice-modulating ASOs have also been developed for the therapy of inborn errors of metabolism (IEMs), due to their ability to redirect aberrant splicing caused by mutations, thus recovering the expression of normal transcripts, and correcting the deficiency of functio...
Source: BioDrugs - January 22, 2024 Category: Drugs & Pharmacology Source Type: research
Correction to: Is the Availability of Biosimilar Adalimumab Associated with Budget Saving? A Difference-in-Difference Analysis of 14 Countries
(Source: BioDrugs)
Source: BioDrugs - January 22, 2024 Category: Drugs & Pharmacology Source Type: research
