Interleukin-1 Antagonists for the Treatment of Recurrent Pericarditis
AbstractAlthough most patients with acute pericarditis will recover, a minority will have recurrent, debilitating episodes. In these patients, refractory symptoms result in high morbidity, and typically require a prolonged duration of anti-inflammatory treatment. Initially, the efficacy of colchicine in both recurrent pericarditis and periodic fever syndromes suggested the central role of the inflammasome in pericarditis. Subsequently, the success of interleukin-1 antagonists in autoinflammatory diseases prompted further investigation in recurrent pericarditis. In current clinical practice, interleukin-1 antagonists includ...
Source: BioDrugs - May 31, 2022 Category: Drugs & Pharmacology Source Type: research
Dengue Vaccines: An Update
AbstractDengue is one of the most prevalent mosquito-borne diseases in the world, affecting an estimated 390 million people each year, according to models. For the last two decades, efforts to develop safe and effective vaccines to prevent dengue virus (DENV) infections have faced several challenges, mostly related to the complexity of conducting long-term studies to evaluate vaccine efficacy and safety to rule out the risk of vaccine-induced DHS/DSS, particularly in children. At least seven DENV vaccines have undergone different phases of clinical trials; however, only three of them (Dengvaxia®, TV003, and TAK-003) have ...
Source: BioDrugs - May 24, 2022 Category: Drugs & Pharmacology Source Type: research
Regulatory Evaluation of Biosimilars: Refinement of Principles Based on the Scientific Evidence and Clinical Experience
AbstractThe World Health Organization (WHO) guidelines on evaluation of similar biotherapeutic products (SBPs; also called biosimilars) were adopted by the WHO Expert Committee on Biological Standardization (ECBS) in 2009. In 2019, the ECBS considered that a more tailored and potentially reduced clinical data package may be acceptable in cases where this was clearly supported by the available scientific evidence. The goal of this publication is to review the current clinical experience and scientific evidence and to provide an expert perspective for updating the WHO guidelines to provide more flexibility and clarity. As ...
Source: BioDrugs - May 21, 2022 Category: Drugs & Pharmacology Source Type: research
HLX11, a Proposed Pertuzumab Biosimilar: Pharmacokinetics, Immunogenicity, and Safety Profiles Compared to Three Reference Biologic Products (US-, EU-, and CN-Approved Pertuzumab) Administered to Healthy Male Subjects
ConclusionThe PK, safety, and immunogenicity of HLX11 were highly similar to those of reference pertuzumab (US-, EU-, CN-approved products). The established bioequivalence supports further clinical trials of HLX11 in cancer treatment.Trial RegistrationThis study was registered with ClinicalTrials.gov (NCT04411550) and Chinadrugtrials.org.cn (CTR20200618). (Source: BioDrugs)
Source: BioDrugs - May 20, 2022 Category: Drugs & Pharmacology Source Type: research
Novel Migraine Therapies May Reduce Public and Personal Disadvantages for People with Migraine
AbstractThe introduction of new drug classes for migraine, such as monoclonal antibodies that target the calcitonin gene-related peptide (CGRP) or its receptor and small-molecule antagonists of CGRP, have opened a new scenario in a large population of individuals suffering from migraines. The provision of an effective and safe therapy can help overcome the high social and personal costs together with the burden of this disease by offering social, work and economic recovery to the people affected by migraine. Whether the satisfaction of personal and collective unmet needs will be achieved in the vast majority of migraine su...
Source: BioDrugs - May 16, 2022 Category: Drugs & Pharmacology Source Type: research
Passive Immunotherapy Against SARS-CoV-2: From Plasma-Based Therapy to Single Potent Antibodies in the Race to Stay Ahead of the Variants
AbstractThe COVID-19 pandemic is now approaching 2 years old, with more than 440 million people infected and nearly six million dead worldwide, making it the most significant pandemic since the 1918 influenza pandemic. The severity and significance of SARS-CoV-2 was recognized immediately upon discovery, leading to innumerable companies and institutes designing and generating vaccines and therapeutic antibodies literally as soon as recombinant SARS-CoV-2 spike protein sequence was available. Within months of the pandemic start, several antibodies had been generated, tested, and moved into clinical trials, including Eli Lil...
Source: BioDrugs - April 27, 2022 Category: Drugs & Pharmacology Source Type: research
Calcitonin Gene-Related Peptide (CGRP)-Targeted Monoclonal Antibodies and Antagonists in Migraine: Current Evidence and Rationale
AbstractCalcitonin gene-related peptide (CGRP), a 37 amino-acid neuropeptide found mostly in peptidergic sensory C-fibers, has been suggested to be implicated in the pathogenesis of migraine, which is one of the most common neurological disorders seen in medical practice, affecting almost 16% of the US population. While previously thought to be a vascular condition, migraine attacks are the result of neurogenic inflammation and peripheral/central sensitization through dysfunctional activation of the trigeminovascular system. To date, two classes of therapeutic agents have been developed to interrupt the function of CGRP: C...
Source: BioDrugs - April 27, 2022 Category: Drugs & Pharmacology Source Type: research
Passive Immunotherapy Against SARS-CoV-2: From Plasma-Based Therapy to Single Potent Antibodies in the Race to Stay Ahead of the Variants
AbstractThe COVID-19 pandemic is now approaching 2 years old, with more than 440 million people infected and nearly six million dead worldwide, making it the most significant pandemic since the 1918 influenza pandemic. The severity and significance of SARS-CoV-2 was recognized immediately upon discovery, leading to innumerable companies and institutes designing and generating vaccines and therapeutic antibodies literally as soon as recombinant SARS-CoV-2 spike protein sequence was available. Within months of the pandemic start, several antibodies had been generated, tested, and moved into clinical trials, including Eli Lil...
Source: BioDrugs - April 27, 2022 Category: Drugs & Pharmacology Source Type: research
Calcitonin Gene-Related Peptide (CGRP)-Targeted Monoclonal Antibodies and Antagonists in Migraine: Current Evidence and Rationale
AbstractCalcitonin gene-related peptide (CGRP), a 37 amino-acid neuropeptide found mostly in peptidergic sensory C-fibers, has been suggested to be implicated in the pathogenesis of migraine, which is one of the most common neurological disorders seen in medical practice, affecting almost 16% of the US population. While previously thought to be a vascular condition, migraine attacks are the result of neurogenic inflammation and peripheral/central sensitization through dysfunctional activation of the trigeminovascular system. To date, two classes of therapeutic agents have been developed to interrupt the function of CGRP: C...
Source: BioDrugs - April 27, 2022 Category: Drugs & Pharmacology Source Type: research
Correction to: Immunotherapy in Gastro-Oesophageal Cancer: Current Practice and the Future of Personalised Therapy
(Source: BioDrugs)
Source: BioDrugs - April 25, 2022 Category: Drugs & Pharmacology Source Type: research
