Biosimilars: A Critical Review of Development, Regulatory Landscape, and Clinical Implications.

The biopharmaceutical industry has witnessed significant growth in the development and approval of biosimilars. These biosimilars aim to provide cost-effective alternatives to expensive originator biosimilars, alleviating financial pressures within healthcare. The manufacturing of biosimilars is a highly complex process that involves several stages, each of which must meet strict regulatory standards to ensure that the final product is highly similar to the reference biologic.

Efficacy and safety of long-acting muscarinic antagonists in COPD: a meta-analysis and meta-regression with a focus on aging.

The increasing global elderly population, projected to reach 20% of individuals aged 65 and over by 2030, faces significant pulmonary challenges, including chronic obstructive pulmonary disease (COPD). Aging is associated with a natural decline in lung function and structural changes that exacerbate respiratory issues. COPD, characterized by chronic respiratory symptoms and airflow obstruction, presents a unique challenge in older patients due to the accelerated decline in lung function.

Lerodalcibep and evolocumab for the treatment of homozygous familial hypercholesterolaemia with PCSK9 inhibition (LIBerate-HoFH): a phase 3, randomised, open-label, crossover, non-inferiority trial.

Background: Lerodalcibep, a small binding anti-PCSK9 protein (adnectin), showed effective LDL cholesterol reduction in heterozygous familial hypercholesterolaemia. We aimed to assess the safety and efficacy of lerodalcibep and evolocumab in a globally diverse homozygous familial hypercholesterolaemia population.

Methods: This phase 3, randomised, open-label, crossover, non-inferiority study consisted of two 24-week treatment periods separated by an 8-week washout.

Effectiveness of Frequent Point-of-Care Molecular COVID-19 Surveillance in a Rural Workplace: Nonrandomized Controlled Clinical Trial Among Miners.

Background: Numerous studies have assessed the risk of SARS-CoV-2 exposure and infection among health care workers during the pandemic. However, far fewer studies have investigated the impact of SARS-CoV-2 on essential workers in other sectors. Moreover, guidance for maintaining a safely operating workplace in sectors outside of health care remains limited.

Clinical Outcomes and Safety Profiles of Generic Versus Brand-Name Clopidogrel in Patients Following Coronary Artery Stent Placement.

Coronary artery disease remains a significant global health issue and is a leading cause of mortality. Dual antiplatelet therapy, including clopidogrel, is essential for preventing stent thrombosis after coronary artery stenting. This study assessed the comparative efficacy and safety of generic versus brand-name clopidogrel in a large Taiwanese cohort.

Real-World Experience of Clascoterone Cream 1% in Acne Management: Case Series and Canadian Experience.

Acne vulgaris is a globally prevalent dermatological condition associated with substantial physical and psychological burden. Although acne typically presents during adolescence, it is a chronic condition that also affects many adults. Despite the spectrum of treatments available for acne, limitations in tolerability and safety concerns can present challenges for the use of conventional medications in clinical practice.

Comparative efficacy and safety of different recommended doses of telitacicept in patients with systemic lupus erythematosus in China: a systematic review and meta-analysis.

Background: Telitacicept, a new biological agent, was approved in China for treating systemic lupus erythematosus (SLE) in 2021. Its optimal dosing for treating SLE remains unclear. Therefore, the aim of this meta-analysis is to evaluate the efficacy and safety of various telitacicept doses in SLE treatment.

Phage therapy in the management of respiratory and pulmonary infections: a systematic review.

Background: Lower respiratory tract infections (LRTIs) pose a significant threat to global health, causing more than 2 million deaths worldwide. This menace is intensified by the alarming increase in drug resistance, which limits the availability of effective antibiotics for bacterial respiratory infections. Consequently, there is an urgent demand for alternative therapeutic options.

Improving clinical care of patients in Nipah outbreaks: moving beyond 'compassionate use'.

The 2024 Nipah outbreak in Kerala, India-its fifth in six years-and the recurring annual outbreaks in Bangladesh underscore the persistent threat posed by the Nipah virus (NiV) in the region. With a high mortality rate, human-to-human transmission potential, and the widespread presence of bats, the natural reservoir, NiV remains a significant epidemic threat. Despite being a WHO priority pathogen, there has been no systematic effort to improve patient care for NiVD, leading to consistently poor outcomes.

Immunotherapy in gastric cancer-A systematic review.

Background: Gastric Cancer (GC) is the 5th most prevalent and 4th most deadly neoplasm globally. Immunotherapy has emerged as a promising treatment approach in GC, potentially improving positive clinical outcomes while addressing the limitations of conventional therapies. GC immunotherapy modalities consist of adoptive cell therapy (ACT), cancer vaccines, and immune checkpoint inhibitors (ICI).

Umbilical cord-derived mesenchymal stromal cells: Promising therapy for heart failure.

Heart failure (HF) is a complex syndrome characterized by the reduced capacity of the heart to adequately fill or eject blood. Currently, HF remains a leading cause of morbidity and mortality worldwide, imposing a substantial burden on global healthcare systems. Recent advancements have highlighted the therapeutic potential of mesenchymal stromal cells (MSCs) in managing HF.

Afatinib and Necitumumab in -Mutant NSCLC with Acquired Resistance to Tyrosine Kinase Inhibitors.

Introduction: Although tyrosine kinase inhibitors (TKIs) are effective against NSCLC harboring sensitizing gene mutations, acquired resistance is inevitable. Preclinical studies suggest that combining EGFR TKI and monoclonal antibody therapies may have activity in mutated NSCLC that has progressed on TKI therapy alone. Therefore, we prospectively evaluated afatinib plus necitumumab in patients with mutated NSCLC.

Mechanistic Insight of Pharmacological Aspects of Violacein: Recent Trends and Advancements.

Since its discovery in the bacterium Chromobacterium violaceum, violacein-a striking purple pigment-has garnered significant interest due to its promising applications in the food and pharmaceutical industries. Violacein exhibits a range of pharmacological properties, including anti-inflammatory, anticancer, antibacterial, and antiparasitic effects, yet its complete molecular mechanisms are still being elucidated. Its mechanisms of action likely involve complex interactions with cellular receptors, signaling pathways, and specific molecular targets.

Research Progress of Microneedles in Vaccine Delivery.

Large-scale infectious diseases have become a significant threat to human health and safety. The successful invention of vaccines is the most powerful means for preventing infectious diseases and has greatly improved global human health. Even during the pandemic of COVID-19, which has affected the world, vaccines have played an irreplaceable role.

Mercury levels in freshwater aquatic products across China: Spatial distribution, species differences, and health risk assessment.

Freshwater product consumption is a major source of mercury (Hg) exposure in China. This study analyzed Hg concentrations in 12,560 samples from 29 provinces across China (2010-2021) and conducted probabilistic health risk assessments across various life stages. The average Hg concentration in China's freshwater products was 40.

Real World Evidence From 2 Decades of First-Line TKI Therapy in Chronic Myeloid Leukemia (CML): Insights From ACHO's RENEHOC Registry.

Background: Chronic myeloid leukemia (CML) treatment has significantly evolved with the introduction of tyrosine kinase inhibitors. However, access to these treatments and outcomes vary globally. This study examines 2 decades of CML management in Colombia using the RENEHOC registry, focusing on TKI efficacy, safety, and healthcare system challenges.

Stopping of adalimumab in juvenile idiopathic arthritis-associated uveitis (ADJUST): a multicentre, double-masked, randomised controlled trial.

Background: Adalimumab is an effective treatment for juvenile idiopathic arthritis-associated uveitis. Data are scarce on the effects of discontinuing adalimumab after control of the disease had been reached. We aimed to assess efficacy and safety of discontinuing treatment in patients with juvenile idiopathic arthritis-associated uveitis.

Rationale and Design of the Prevail Global Trial Program Evaluating the Prevail Drug-Coated Balloon in Patients with In-stent Restenosis and De Novo Small Vessel Disease.

Background And Rationale: In-stent restenosis (ISR) remains the leading cause of treatment failure following percutaneous coronary intervention (PCI) with contemporary drug-eluting stents. Especially in small caliber coronary arteries, restenosis is common following PCI and represents a treatment challenge. Drug-coated balloons (DCB) are an attractive alternative to stents for treatment of both ISR and small vessel disease.

Safety and efficacy of satralizumab in patients with generalised myasthenia gravis (LUMINESCE): a randomised, double-blind, multicentre, placebo-controlled phase 3 trial.

Background: Evidence from preclinical studies suggests that IL-6 signalling has the potential to modulate immunopathogenic mechanisms upstream of autoantibody effector mechanisms in patients with generalised myasthenia gravis. We aimed to assess the safety and efficacy of satralizumab, a humanised monoclonal antibody targeting the IL-6 receptor, in patients with generalised myasthenia gravis.

Methods: LUMINESCE was a randomised, double-blind, placebo-controlled, multicentre, phase 3 study at 105 sites, including hospitals and clinics, globally.

Safety and efficacy of nipocalimab in adults with generalised myasthenia gravis (Vivacity-MG3): a phase 3, randomised, double-blind, placebo-controlled study.

Background: Given burdensome side-effects and long latency for efficacy with conventional agents, there is a continued need for generalised myasthenia gravis treatments that are safe and provide consistently sustained, long-term disease control. Nipocalimab, a neonatal Fc receptor blocker, was associated with dose-dependent reductions in total IgG and anti-acetylcholine receptor (AChR) antibodies and clinically meaningful improvements in the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale in patients with generalised myasthenia gravis in a phase 2 study. We aimed to assess the safety and efficacy of nipocalimab in a phase 3 study.

Safety and Efficacy of Fecal Microbiota, Live-jslm (REBYOTA®), for the Prevention of Recurrent Clostridioides difficile Infection in Participants With Inflammatory Bowel Disease in PUNCH CD3-OLS.

Background: Fecal microbiota, live-jslm (RBL; REBYOTA®), is the first single-dose, broad consortia, microbiota-based live biotherapeutic approved by the US Food and Drug Administration to prevent recurrent Clostridioides difficile infection (rCDI) in adults following standard-of-care antimicrobials. Inflammatory bowel disease (IBD) is a common risk factor for rCDI, yet patients with IBD are often excluded from prospective trials. This subgroup analysis of PUNCH CD3-OLS (NCT03931941) evaluated the safety and efficacy of RBL in participants with rCDI and IBD.