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BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy

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https://www.readbyqxmd.com/read/27848165/immune-related-adverse-events-associated-with-immune-checkpoint-inhibitors
#1
REVIEW
Daphne Day, Aaron R Hansen
Immune checkpoint inhibitors (ICIs), including antibodies targeting cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) and programmed cell death protein-1 (PD-1), have shown durable treatment responses in multiple tumor types by enhancing antitumor immunity. However, removal of self-tolerance can induce autoimmunity and produce a unique immune-driven toxicity profile, termed immune-related adverse events (irAEs). As ICIs gain approval for a growing number of indications, it is imperative clinicians increase their knowledge of and ability to manage irAEs...
November 15, 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27837414/acknowledgement-to-referees
#2
(no author information available yet)
No abstract text is available yet for this article.
November 11, 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27807766/monoclonal-antibody-and-fusion-protein-biosimilars-across-therapeutic-areas-a-systematic-review-of-published-evidence
#3
REVIEW
Ira Jacobs, Danielle Petersel, Lesley G Shane, Chee-Keng Ng, Carol Kirchhoff, Gregory Finch, Sadiq Lula
BACKGROUND: Despite regulatory efforts to formalize guidance policies on biosimilars, there remains a need to educate healthcare stakeholders on the acknowledged definition of biosimilarity and the data that underpin it. OBJECTIVES: The objectives of the study were to systematically collate published data for monoclonal antibodies and fusion protein biosimilars indicated for cancer, chronic inflammatory diseases, and other indications, and to explore differences in the type and weight (quantity and quality) of available evidence...
November 2, 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27761807/identification-of-potential-therapeutics-to-conquer-drug-resistance-in-salmonella-typhimurium-drug-repurposing-strategy
#4
Balasundaram Preethi, Veerappapillai Shanthi, Karuppasamy Ramanathan
BACKGROUND: Salmonella typhimurium is the main cause of gastrointestinal illness in humans, and treatment options are decreasing because drug-resistant strains have emerged. OBJECTIVE: The objective of this study was to use computational drug repurposing to identify a novel candidate with an effective mechanism of action to circumvent the drug resistance. METHODS: We used the Mantra 2.0 database to initially screen drug candidates that share similar gene expression profiles to those of quinolones...
October 19, 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27704400/certolizumab-pegol-a-review-in-inflammatory-autoimmune-diseases
#5
Emma D Deeks
Certolizumab pegol (Cimzia(®)) is a subcutaneously administered polyethylene glycolylated (PEGylated) antigen-binding fragment of a recombinant human monoclonal antibody that selectively neutralizes TNFα. The drug is indicated for a variety of inflammatory autoimmune diseases, including Crohn's disease (CD), rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA), based on its benefit in these settings in well-designed clinical trials. In these studies, certolizumab pegol (as first- or subsequent-line therapy) reduced the severity of CD when used as an induction or maintenance therapy, and improved the signs/symptoms and slowed the radiographic progression of RA (with or without concomitant methotrexate), PsA and axSpA...
October 4, 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27885553/biosimilars-for-the-treatment-of-chronic-inflammatory-diseases-a-systematic-review-of-published-evidence
#6
REVIEW
Ira Jacobs, Danielle Petersel, Leah Isakov, Sadiq Lula, K Lea Sewell
BACKGROUND: Clinicians are required to assimilate, critically evaluate, and extrapolate information to support appropriate use of biosimilars across indications. OBJECTIVES: The objective of this study was to systematically collate all published data in order to assess the weight (quantity and quality) of available evidence for each molecule and inform and support healthcare decision-making in chronic inflammatory diseases. METHODS: MEDLINE(®), EMBASE(®), and ISI Web of Science(®) were searched to September 2015...
December 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27848166/rheumatologists-perceptions-of-biosimilar-medicines-prescription-findings-from-a-french-web-based-survey
#7
Morgane Beck, Bruno Michel, Marie-Christine Rybarczyk-Vigouret, Dominique Levêque, Christelle Sordet, Jean Sibilia, Michel Velten
BACKGROUND: Healthcare cost savings are closely linked to prescribers' confidence in and acceptance of the prescription of biosimilar drugs. OBJECTIVES: The aim of this study was to assess the knowledge, experience and opinions of hospital-based and office-based French rheumatologists with regard to biosimilar medicines and to identify the barriers to and possible options to promote their prescription. METHODS: A web-based, self-administered survey was conducted among French rheumatologists from June 8 to August 2, 2015...
December 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27699710/erratum-to-recent-progress-in-jak-inhibitors-for-the-treatment-of-rheumatoid-arthritis
#8
Shingo Nakayamada, Satoshi Kubo, Shigeru Iwata, Yoshiya Tanaka
No abstract text is available yet for this article.
October 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27681238/erratum-to-etanercept-sb4-a-review-in-autoimmune-inflammatory-diseases
#9
Celeste B Burness, Sean T Duggan
No abstract text is available yet for this article.
October 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27670779/targeting-neovasculature-with-multitargeted-antiangiogenesis-tyrosine-kinase-inhibitors-in-non-small-cell-lung-cancer
#10
Vasileios S Skouras, Charis Maragkos, Dimitra Grapsa, Konstantinos N Syrigos
Chemotherapy has reached a plateau in the efforts for survival improvement in non-small cell lung cancer (NSCLC). The growing knowledge of NSCLC molecular pathobiology has led to the development of new treatments that target specific tumor functions. Angiogenesis is a tumor function leading to the formation of new tumor vessels that are crucial for its survival. Although vascular endothelial growth factor (VEGF) plays a primary role in angiogenesis, the inhibition of the VEGF pathway with VEGF-receptor (VEGFR) tyrosine kinase inhibitors (TKIs) is associated with a modest survival benefit due to the development of resistance by the tumor that has been mainly attributed to the up-regulation of other stimulators of angiogenesis...
October 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27650650/infliximab-biosimilar-ct-p13-infliximab-dyyb-a-review-in-autoimmune-inflammatory-diseases
#11
Hannah A Blair, Emma D Deeks
Infliximab biosimilar (CT-P13/infliximab-dyyb; Remsima(®), Inflectra(®)) is approved in several countries for use in all indications for which reference infliximab (Remicade(®)) is approved, including rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis, psoriasis, Crohn's disease, and ulcerative colitis. Clinical data contributing to the EU approval of infliximab biosimilar were obtained from two pivotal double-blind clinical trials in patients with AS (PLANETAS) or RA (PLANETRA)...
October 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27646589/reduction-of-isoagglutinin-in-intravenous-immunoglobulin-ivig-using-blood-group-a-and-b-specific-immunoaffinity-chromatography-industry-scale-assessment
#12
Simon Gerber, Annette Gaida, Nicole Spiegl, Sandra Wymann, Adriano Marques Antunes, Ibrahim El Menyawi, Brigitte Zurbriggen, Alphonse Hubsch, Martin Imboden
BACKGROUND: Hemolysis, a rare but potentially serious complication of intravenous immunoglobulin (IVIG) therapy, is associated with the presence of antibodies to blood groups A and B (isoagglutinins) in the IVIG product. An immunoaffinity chromatography (IAC) step in the production process could decrease isoagglutinin levels in IVIG. OBJECTIVES: Our objectives were to compare isoagglutinin levels in a large number of IVIG (Privigen(®)) batches produced with or without IAC and to assess the feasibility of the production process with an IAC step on an industrial scale...
October 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27577235/recent-progress-in-jak-inhibitors-for-the-treatment-of-rheumatoid-arthritis
#13
Shingo Nakayamada, Satoshi Kubo, Shigeru Iwata, Yoshiya Tanaka
Rheumatoid arthritis (RA) is a systemic autoimmune disease characterized by synovial inflammation and joint destruction. Considerable advance in the treatment of RA has been made following the advent of biological disease-modifying anti-rheumatic drugs (DMARDs). However, these biologics require intravenous or subcutaneous injection and some patients fail to respond to biological DMARDs or lose their primary response. Various cytokines and cell surface molecules bind to receptors on the cell surface, resulting in the activation of various cell signaling pathways, including phosphorylation of kinase proteins...
October 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27577234/bay-81-8973-octocog-alfa-kovaltry-%C3%A2-a-review-in-haemophilia-a
#14
Gillian M Keating
BAY 81-8973 (octocog alfa; Kovaltry(®)) is an unmodified, full-length, recombinant factor VIII (FVIII) concentrate with the same amino acid sequence as Kogenate(®) FS, but produced with innovative manufacturing technologies. This narrative review discusses the clinical efficacy and tolerability of BAY 81-8973 in haemophilia A, as well as summarizing its pharmacological properties. Results of the LEOPOLD I, LEOPOLD II and LEOPOLD Kids trials demonstrated that routine prophylaxis with intravenous BAY 81-8973 was associated with a low annualized bleeding rate (ABR) in previously treated adult and paediatric patients with severe haemophilia A...
October 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27516203/talimogene-laherparepvec-a-review-in-unresectable-metastatic-melanoma
#15
Karly P Garnock-Jones
Talimogene laherparepvec (Imlygic™) is a first-in-class oncolytic viral immunotherapy derived from herpes simplex virus type 1, which has been genetically modified to increase tumour selectivity and stimulate antitumour immune response. This article reviews the pharmacological properties of intralesional talimogene laherparepvec and its clinical efficacy and tolerability in patients with unresectable metastatic melanoma. In the phase III OPTiM trial, talimogene laherparepvec was more effective than subcutaneous human granulocyte-macrophage colony-stimulating factor (GM-CSF), both in patients with stage IIIB-IV melanoma [intention-to-treat (ITT) population] and in those with stage IIIB-IVM1a disease (in an exploratory subgroup analysis)...
October 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27435213/hylan-g-f-20-versus-low-molecular-weight-hyaluronic-acids-for-knee-osteoarthritis-a-meta-analysis
#16
Hongmou Zhao, Hongliang Liu, Xiaojun Liang, Yi Li, Junhu Wang, Cheng Liu
BACKGROUND: Hyaluronic acid injection has been reported to decrease pain compared with baseline levels in knee joint osteoarthritis. Hylan G-F 20 is distinguished from the other products by its chemical structure and relatively higher molecular weight. Many trials have compared hylan G-F 20 and low molecular weight hyaluronic acids (LMWHAs); however, their relative efficacy and safety are still debated. OBJECTIVE: The aim was to compare the effectiveness and safety of intra-articular injection of hylan G-F 20 and LMWHA in the treatment of knee joint osteoarthritis...
October 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27411930/advances-in-the-treatment-of-non-small-cell-lung-cancer-focus-on-nivolumab-pembrolizumab-and-atezolizumab
#17
Konstantinos Leventakos, Aaron S Mansfield
Immunotherapy is revolutionizing the treatment of non-small cell lung cancer (NSCLC). Immune checkpoint inhibitors, including programmed cell death protein 1 (PD-1) and programmed cell death ligand 1 (PD-L1) monoclonal antibodies, are being introduced to routine clinical practice. This review summarizes clinical trials of nivolumab, pembrolizumab, and atezolizumab in patients with NSCLC. These agents have efficacy against NSCLC and a unique toxicity profile. The role of PD-L1 as a predictive biomarker is still unclear, partially because of the nuances of PD-L1 testing...
October 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27461107/assessing-analytical-similarity-of-proposed-amgen-biosimilar-abp-501-to-adalimumab
#18
Jennifer Liu, Tamer Eris, Cynthia Li, Shawn Cao, Scott Kuhns
BACKGROUND: ABP 501 is being developed as a biosimilar to adalimumab. Comprehensive comparative analytical characterization studies have been conducted and completed. OBJECTIVE: The objective of this study was to assess analytical similarity between ABP 501 and two adalimumab reference products (RPs), licensed by the United States Food and Drug Administration (adalimumab [US]) and authorized by the European Union (adalimumab [EU]), using state-of-the-art analytical methods...
August 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27455991/etanercept-sb4-a-review-in-autoimmune-inflammatory-diseases
#19
Celeste B Burness, Sean T Duggan
Etanercept (SB4) [Benepali(®)], a tumour necrosis factor inhibitor that is a biosimilar of reference etanercept (Enbrel(®)), is approved in the EU for use in all adult indications for which reference etanercept is approved, namely rheumatoid arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis), psoriatic arthritis, and plaque psoriasis. The approval of etanercept (SB4) was based on the results of stringent comparability exercises designed to demonstrate similarity to reference etanercept in terms of quality, biological activity, efficacy, safety, and immunogenicity...
August 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27422671/demonstration-of-functional-similarity-of-proposed-biosimilar-abp%C3%A2-501-to-adalimumab
#20
Jyoti Velayudhan, Yuh-Feng Chen, Amanda Rohrbach, Christina Pastula, Gwen Maher, Heather Thomas, Ryan Brown, Teresa L Born
BACKGROUND: Due to the complex molecular structure and proprietary manufacturing processes of monoclonal antibodies (mAbs), differences in structure and function may be expected during development of biosimilar mAbs. Important regulatory requirements for approval of biosimilar products involve comprehensive assessments of any potential differences between proposed biosimilars and reference mAbs, including differences in all known mechanisms of action, using sensitive and relevant methods...
August 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
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