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Over 40 years since the discovery of Ebola virus, the anti-Ebola virus vaccine efforts of the past 2 decades have culminated in over 12 different vaccine candidates that have been placed into a number of clinical trial phases, past and present. Of these 12 vaccines, four candidates are up to or in phase II clinical trials, and only one has completed the phase III clinical trial stage. While remarkable...
Objective The objective of this study was to compare the pharmacokinetics (PKs), safety, and immunogenicity of GB242 as a potential biosimilar infliximab with those of reference infliximab in healthy Chinese subjects. Methods We conducted a randomized, single-center, double-blind, parallel-controlled phase I study in which 48 healthy subjects were divided equally into a GB242 group and reference...
Objective The aim of this study was to investigate long-term clinical outcomes of extended treatment with CT-P10, a rituximab biosimilar, compared with rituximab reference products sourced from the USA and the EU (US-RTX and EU-RTX) in rheumatoid arthritis (RA) for up to 48 weeks. Methods In this multinational, randomized, double-blind trial, adults with active RA received up to two courses of CT-P10,...
Cytokines, many of which signal through the JAK–STAT (Janus kinase–Signal Transducers and Activators of Transcription) pathway, play a central role in the pathogenesis of inflammatory and autoimmune diseases. Currently three JAK inhibitors have been approved for clinical use in USA and/or Europe: tofacitinib for rheumatoid arthritis, psoriatic arthritis and ulcerative colitis, baricitinib for rheumatoid...
Hereditary angioedema (HAE) with C1 esterase inhibitor (C1-INH) deficiency (C1-INH-HAE) is a rare disease characterized by diminished levels or dysfunctional activity of C1-INH, leading to dysregulated plasma kallikrein activity within the kallikrein–kinin pathway. Symptoms manifest as painful, potentially life-threatening swelling of subcutaneous tissues throughout the body and/or submucosal edema...
Recent advances in culture-free methods of studying the human microbiome, coupled with strong bioinformatics tools, have provided new insights on the role of the human microbiome in health and disease. The human gut, in particular, houses a vast number and diverse variety of microbes. A plethora of evidence has demonstrated the significant effects of the gut microbiome on local and systemic immunity...
The use of monoclonal antibodies in multiple sclerosis (MS) patients is in a transitional period. Studies regarding well-established, effective antibodies such as natalizumab and alemtuzumab focus more and more on long-term efficacy and safety, risk management, and treating complications. Primary progressive MS, a disease that was long considered to be unmodifiable, is currently in focus following...
Chimeric antigen receptor T-cell (CAR-T) therapy has proven to be a very effective cancer immunotherapy. Axicabtagene ciloleucel and tisagenlecleucel are the first-in-class anti-CD19 CAR-T currently available for relapsed/refractory adult large B-cell lymphoma. Tisagenlecleucel is also available for pediatric and young adult (up to age 25 years) patients with relapsed/refractory B-acute lymphoblastic...
Objective This study compared the pharmacokinetic (PK), pharmacodynamic (PD), and safety properties of the test (CJ-40001) and reference (NESP®) versions of darbepoetin alfa following a single subcutaneous (SC) or intravenous (IV) administration in healthy male subjects. Methods A single-blind, randomized, single-dose, two-period, two-intervention crossover study was conducted, with two separate...
Pegfilgrastim-jmdb/MYL-1401H (FULPHILA™) [hereafter referred to as pegfilgrastim-jmdb] is a biosimilar of the reference pegylated recombinant granulocyte colony-stimulating factor pegfilgrastim. It is approved for use in patients receiving chemotherapy for malignancy to decrease the incidence of infection, as manifested by febrile neutropenia, in the USA and to reduce the duration of neutropenia and...
FKB327 (Hulio®) is a biosimilar of the reference monoclonal anti-TNFα antibody adalimumab, and is approved in the EU for use in the same indications as reference adalimumab. FKB327 has similar physicochemical and pharmacodynamic properties to those of reference adalimumab, and pharmacokinetic equivalence was shown in healthy volunteers and patients with moderate-to-severe rheumatoid arthritis (RA)...
Exosomes are very small extracellular vesicles secreted by cells to local and distant tissues. These mini signal transporters elicit acute and chronic effects on recipient cells. Studies regarding exosomes and their relationship to disease, as well as healthy functions, are eliciting extraordinary excitement as data pours in from groups around the world. Reporting of exosome biogenesis, selective...
The majority of patients with metastatic breast cancer (MBC) have hormone receptor-positive HER2-negative disease. For this subgroup, endocrine therapy is the key therapeutic option. Recently, therapeutic options have been expanded by introduction of the inhibitors of cyclin-dependent kinases 4/6 (CDK4/6i). Three compounds, palbociclib, ribociclib, and abemaciclib, have already been approved by the...
Background There are two products in which infliximab is the active pharmaceutical ingredient. These are Remicade® (INF; reference product) and Remsima™/Inflectra™ (CT-P13; infliximab biosimilar). Remsima™/Inflectra™ are bioidentical products. Different recommendations have been made for the clinical solutions of each brand (Remicade® or Remsima™/Inflectra™) despite the manufacturer of the biosimilar...
Introduction There has been a significant increase in the volume of biosimilar medicines recently due to the expiries of patent protections of biologic medicines. Biosimilars are considered new medicines, and their usage in therapy is often associated with uncertainty from the perspectives of physicians, pharmacists and patients. Objectives The purpose of this study was to identify hospital pharmacist...
Background CT-P10 is the first biosimilar of the anti-CD20 monoclonal antibody, rituximab. CT-P10 is currently available in over 51 countries worldwide, where it is approved in the same indications as its reference product rituximab. In-use stability studies are conducted for biologics to determine how conditions (e.g., temperature, light, humidity, length of time stored) affect drug quality following...
Treatment of advanced-stage or metastatic non-small-cell lung cancers (NSCLCs) without EGFR mutations or ALK rearrangements, which can now be treated with molecularly targeted therapies, had been based on cytotoxic chemotherapy for a long time. Immune checkpoint inhibitors (ICIs), notably antibodies directed against programmed cell-death protein-1 (PD-1) and its ligand (PD-L1) have transformed therapeutic...
Background CT-P16 is a candidate biosimilar of bevacizumab, a monoclonal antibody targeting vascular endothelial growth factor that is used in the treatment of a range of advanced solid cancers. Objective The objective of this study was to demonstrate the pharmacokinetic equivalence of CT-P16 and European Union (EU)-approved bevacizumab (EU-bevacizumab) and US-licensed bevacizumab (US-bevacizumab)...
LA-EP2006 (Ziextenzo®) is the fifth biosimilar of pegfilgrastim, a pegylated recombinant granulocyte colony-stimulating factor, to be approved in the EU. It is approved for use in adults treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) to reduce the duration of neutropenia and the incidence of febrile neutropenia. LA-EP2006...
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