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BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy

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https://www.readbyqxmd.com/read/30203252/risk-of-adverse-drug-events-observed-with-baricitinib-2-mg-versus-baricitinib-4-mg-once-daily-for-the-treatment-of-rheumatoid-arthritis-a-systematic-review-and-meta-analysis-of-randomized-controlled-trials
#1
REVIEW
Feng Huang, Zu-Chun Luo
BACKGROUND: On 23 April 2018, the Food and Drug Administration-based Advisory Committee approved the use of baricitinib 2 mg for the treatment of rheumatoid arthritis and suggested the possibility of serious adverse events associated with baricitinib 4 mg. Hence, we aimed to systematically compare the risk of adverse drug events observed with baricitinib 2 mg versus 4 mg for the treatment of patients with rheumatoid arthritis. METHODS: Electronic databases including the Cochrane library, MEDLINE, EMBASE and http://www...
September 10, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/30168070/small-molecule-immune-checkpoint-inhibitors-targeting-pd-1-pd-l1-and-other-emerging-checkpoint-pathways
#2
REVIEW
Pottayil G Sasikumar, Murali Ramachandra
Advances in harnessing the immune system for cancer treatment have been spectacular in recent years as witnessed by the approval of a number of antibodies targeting the PD-1/PD-L1 immune checkpoint pathway spanning an expanding list of indications. However, it is well recognized that while these antibodies show impressive clinical activity, they suffer from shortcomings including the failure to show response in a majority of patients, their need to be administered by intravenous injection, and immune-related adverse events due to the breaking of immune self-tolerance...
August 30, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/30143982/ensuring-product-quality-consistency-and-patient-supply-over-time-for-a-large-volume-biologic-experience-with-remicade-%C3%A2
#3
Richard Melsheimer, Melissa Calmann, Albert DeRitis, Vinod Philip, Frank Van Gog, Lawrence Doolittle, Kavitha Goyal, Donald Neblock
Biologics are produced from living organisms in complex, multi-stage manufacturing processes and contain inherent variability, which must be understood and controlled during manufacturing to avoid unexpected changes in key quality attributes that may contribute to clinically meaningful differences. The process must also meet large commercial demand, while simultaneously being able to accommodate change without sacrificing product consistency. The four key components of successful biologics manufacturing are (1) a stable, well-defined proprietary cell line; (2) a good manufacturing practice (GMP)-compliant supply chain with a process control strategy defining acceptable levels of variability for target product/process attributes and capable of managing complex material flows; (3) a tightly controlled procedure for implementation of proposed process changes that ensures product consistency; and (4) built-in redundancy and flexibility providing the ability to adapt rapidly to unexpected developments...
August 24, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/30132211/expanding-the-boundaries-of-biotherapeutics-with-bispecific-antibodies
#4
REVIEW
Bushra Husain, Diego Ellerman
Bispecific antibodies have moved from being an academic curiosity with therapeutic promise to reality, with two molecules being currently commercialized (Hemlibra® and Blincyto® ) and many more in clinical trials. The success of bispecific antibodies is mainly due to the continuously growing number of mechanisms of actions (MOA) they enable that are not accessible to monoclonal antibodies. One of the earliest MOA of bispecific antibodies and currently the one with the largest number of clinical trials is the redirecting of the cytotoxic activity of T-cells for oncology applications, now extending its use in infective diseases...
August 21, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/30132210/pharmacokinetic-and-immunological-considerations-for-expanding-the-therapeutic-window-of-next-generation-antibody-drug-conjugates
#5
REVIEW
Eshita Khera, Greg M Thurber
Antibody-drug conjugate (ADC) development has evolved greatly over the last 3 decades, including the Food and Drug Administration (FDA) approval of several new drugs. However, translating ADCs from the design stage and preclinical promise to clinical success has been a major hurdle for the field, particularly for solid tumors. The challenge in clinical development can be attributed to the difficulty in connecting the design of these multifaceted agents with the impact on clinical efficacy, especially with the accelerated development of 'next-generation' ADCs containing a variety of innovative biophysical developments...
August 21, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/30120705/biosimilar-knowledge-among-oncology-hematology-team-members-in-colorado-usa-an-educational-initiative-and-follow-up-survey
#6
Rovshan M Ismailov, Zaytuna D Khasanova
BACKGROUND: No data exist regarding oncology/hematology team members' knowledge of and views on biosimilars in Colorado, USA. Published research has suggested that health professionals may have a poor understanding of many issues related to biosimilars. OBJECTIVES: Our goal was to increase oncology/hematology team members' knowledge of biosimilars and then use an anonymous online survey to assess the knowledge gained. We also aimed to examine oncology/hematology team members' overall interest in the subject and their motivation to learn more about biosimilars in the future...
August 17, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/30117118/comment-on-the-end-of-phase-3-clinical-trials-in-biosimilars-development
#7
LETTER
Christopher J Webster, Gillian R Woollett
No abstract text is available yet for this article.
August 16, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/30117117/author-s-reply-to-webster-and-woollett-the-end-of-phase-3-clinical-trials-in-biosimilars-development
#8
LETTER
Francois-Xavier Frapaise
No abstract text is available yet for this article.
August 16, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/30069733/correction-to-gp2015-an-etanercept-biosimilar
#9
Emma D Deeks
The article GP2015: An Etanercept Biosimilar, written by Emma D. Deeks, was originally published Online First without open access. After publication in volume 31, issue 6, pages 555-558 HEXAL AG requested that the article be Open Choice to make the article an open access publication. Post-publication open access was funded by HEXAL AG. The article is forthwith distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4...
August 1, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/30043229/subcutaneous-administration-of-biotherapeutics-an-overview-of-current-challenges-and-opportunities
#10
REVIEW
Beate Bittner, Wolfgang Richter, Johannes Schmidt
Subcutaneous delivery of biotherapeutics has become a valuable alternative to intravenous administration across many disease areas. Although the pharmacokinetic profiles of subcutaneous and intravenous formulations differ, subcutaneous administration has proven effective, safe, well-tolerated, generally preferred by patients and healthcare providers and to result in reduced drug delivery-related healthcare costs and resource use. The aim of this article is to discuss the differences between subcutaneous and intravenous dosing from both health-economic and scientific perspectives...
July 24, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/30006915/determination-of-similarity-margin-in-comparative-clinical-studies-to-support-the-development-of-biosimilar-products-of-neupogen-%C3%A2-filgrastim-granulocyte-colony-stimulating-factor-g-csf
#11
Lei Nie, Donna Przepiorka, Albert Deisseroth, Rajeshwari Sridhara, Thomas E Gwise
To demonstrate a biological product is biosimilar to a reference product, the applicant needs to show that the product is highly similar and has no clinically meaningful differences. Comparative clinical studies are often conducted to support the conclusion of no clinically meaningful differences, as a part of totality of evidence. The FDA has published several guidance documents to facilitate the development of biosimilar products. While the guidance documents define the role and objective of comparative clinical studies, they do not provide details about the determination of the similarity margin...
July 13, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/30030767/comparative-safety-of-originator-and-biosimilar-epoetin-alfa-drugs-an-observational-prospective-multicenter-study
#12
Giovanna Stoppa, Carmen D'Amore, Anita Conforti, Giuseppe Traversa, Mauro Venegoni, Maurizio Taglialatela, Roberto Leone
BACKGROUND: Erythropoiesis-stimulating agents (ESAs) are biological molecules approved for the treatment of anemia associated with chronic renal failure. Biosimilars were licensed for use in Europe in 2007. AIM: This study aimed to compare the safety profile of biosimilars with respect to the reference product in a nephrology setting. METHODS: A prospective study was conducted in four Italian regions between 1 October 2013 and 30 June 2015...
August 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/30027398/regenerative-therapies-for-parkinson-s-disease-an-update
#13
REVIEW
Thomas B Stoker, Roger A Barker
Parkinson's disease is the second most common neurodegenerative disorder. It is characterised by a typical movement disorder that occurs in part because of the selective degeneration of the dopaminergic neurons of the substantia nigra pars compacta. Current treatment for the motor disorder of Parkinson's disease consists of dopaminergic medications, but these come with significant adverse effects, themselves an important part of the clinical course of Parkinson's disease, particularly in advanced stages. Therefore, treatment is needed that can restore dopaminergic tone in the striatum in a physiological and targeted manner to avert these side effects...
August 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/30022433/pegvaliase-first-global-approval
#14
Anthony Markham
BioMarin Pharmaceutical is developing pegvaliase (PALYNZIQ™) as a treatment for phenylketonuria, a genetic disorder caused by deficiency of phenylalanine hydroxylase which leads to neurotoxic accumulation of phenylalanine. Data from the phase III PRISM clinical trial program indicate treatment with pegvaliase is associated with sustained reductions in blood phenylalanine levels and sustained improvements in neurological sequelae in patients with phenylketonuria. Based on these positive results pegvaliase was recently approved in the US for adults with phenylketonuria who have uncontrolled blood phenylalanine concentrations on current treatment...
August 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29980987/indoleamine-2-3-dioxygenase-ido-inhibition-as-a-strategy-to-augment-cancer-immunotherapy
#15
Sarah Yentz, David Smith
Indoleamine 2,3-dioxygenase (IDO) is an enzyme of interest in immuno-oncology because of the immunosuppressive effects that result from its role in tryptophan catabolism. IDO is upregulated in malignancy and is associated with poor prognosis in multiple cancer types. IDO inhibitors have been developed to target IDO, both directly and indirectly. Pre-clinical data have shown combined IDO and checkpoint inhibition to be an efficacious strategy for tumor control. Clinical trials of IDO inhibitors with chemotherapy or immunotherapy are currently underway...
August 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29959665/spherical-nucleic-acid-nanoparticles-therapeutic-potential
#16
Chintan H Kapadia, Jilian R Melamed, Emily S Day
Spherical nucleic acids (SNAs) are highly oriented, well organized, polyvalent structures of nucleic acids conjugated to hollow or solid core nanoparticles. Because they can transfect many tissue and cell types without toxicity, induce minimum immune response, and penetrate various biological barriers (such as the skin, blood-brain barrier, and blood-tumor barrier), they have become versatile tools for the delivery of nucleic acids, drugs, and proteins for various therapeutic purposes. This article describes the unique structures and properties of SNAs and discusses how these properties enable their application in gene regulation, immunomodulation, and drug and protein delivery...
August 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29948918/oligonucleotide-based-therapies-for-inflammatory-bowel-disease
#17
REVIEW
Gerolamo Bevivino, Silvia Sedda, Irene Marafini, Giovanni Monteleone
The growing understanding of the immunopathogenesis of inflammatory bowel diseases (IBDs) has contributed to the identification of new targets whose expression/activity can be modulated for therapeutic purposes. Several approaches have been employed to develop selective pharmaceutical compounds; among these, antisense oligonucleotides (ASOs) or synthetic oligonucleotides represent a valid option for inhibiting or enhancing, respectively, the expression/function of molecules that have been implicated in the control of IBD-related inflammation...
August 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29943088/the-end-of-phase-3-clinical-trials-in-biosimilars-development
#18
Francois-Xavier Frapaise
Most patients still have limited or no access to life-changing therapeutic proteins in the treatment of their cancer or autoimmune disorders. The current clinical development model of biosimilars is expensive, and in most cases, large, phase 3 trials do not provide meaningful information on the clinical equivalence of biosimilars and reference compounds. At the same time, the development of state-of-the-art orthogonal analytical methods has enabled a better understanding of the structure and structure-function relationship of biotherapeutics...
August 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29934752/therapeutic-monoclonal-antibodies-to-complex-membrane-protein-targets-antigen-generation-and-antibody-discovery-strategies
#19
REVIEW
Roger B Dodd, Trevor Wilkinson, Darren J Schofield
Cell surface membrane proteins comprise a wide array of structurally and functionally diverse proteins involved in a variety of important physiological and homeostatic processes. Complex integral membrane proteins, which are embedded in the lipid bilayer by multiple transmembrane-spanning helices, are represented by families of proteins that are important target classes for drug discovery. Such protein families include G-protein-coupled receptors, ion channels and transporters. Although these targets have typically been the domain of small-molecule drugs, the exquisite specificity of monoclonal antibodies offers a significant opportunity to selectively modulate these target proteins...
June 23, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29873000/safety-of-biologics-approved-for-the-treatment-of-rheumatoid-arthritis-and-other-autoimmune-diseases-a-disproportionality-analysis-from-the-fda-adverse-event-reporting-system-faers
#20
Ariane G S Araujo, Helena H L Borba, Fernanda S Tonin, Luana Lenzi, Rafael Venson, Roberto Pontarolo, Astrid Wiens
INTRODUCTION: The molecular and pharmacological complexity of biologic disease-modifying antirheumatic drugs used for the management of rheumatoid arthritis (RA) favors the occurrence of adverse drug reactions (ADRs), which should be constantly monitored in post-marketing safety studies. OBJECTIVE: The aim of this study was to identify signals of disproportionate reporting (SDR) of clinical relevance related to the use of biologic drugs approved for RA and other autoimmune diseases...
June 5, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
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