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BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy

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https://www.readbyqxmd.com/read/30430367/bispecific-antibody-emicizumab-for-haemophilia-a-a-breakthrough-for-patients-with-inhibitors
#1
Johnny N Mahlangu
Current unmet needs in haemophilia A patients with inhibitors include the need for intravenous infusion of replacement therapy and the high burden of treatment associated with prophylaxis. Emicizumab is a humanised bispecific monoclonal antibody designed to address these unmet needs and has completed phase III clinical trials in adolescents/adults (HAVEN 1) and paediatric (HAVEN 2) inhibitor populations. In HAVEN 1, there was an 80% bleed reduction across all bleeds, 89% reduction in treated joint bleeds, 92% reduction in treated spontaneous bleeds, and 95% reduction in treated target joint bleeds on emicizumab compared with no prophylaxis...
November 14, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/30386977/in-use-physicochemical-and-biological-stability-of-the-trastuzumab-biosimilar-ct-p6-upon-preparation-for-intravenous-infusion
#2
Su Jung Kim, Joon Won Lee, Hye Young Kang, So Young Kim, Yeon Kyeong Shin, Kwang Woo Kim, Jun Seok Oh, Ki Jung Lim, Ji Young Kim
BACKGROUND: CT-P6 is a biosimilar of trastuzumab, a monoclonal antibody targeting human epidermal growth factor 2 (HER2), that is used in the treatment of breast and gastric cancers. OBJECTIVE: The aim of this study was to evaluate the in-use physicochemical and biological stability of CT-P6 following preparation for intravenous (IV) infusion. METHODS: One batch of CT-P6 within the final month of its 48-month shelf life was used to simulate sub-optimal administration conditions...
November 2, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/30341487/real-world-data-on-the-utilization-pattern-and-safety-profile-of-infliximab-originator-versus-biosimilars-in-italy-a-multiregional-study
#3
Cristina Scavone, Maurizio Sessa, Emilio Clementi, Giovanni Corrao, Roberto Leone, Alessandro Mugelli, Francesco Rossi, Edoardo Spina, Annalisa Capuano
BACKGROUND: In recent years, several biosimilar drugs, including those of infliximab, have obtained marketing authorization from the European Medicines Agency (EMA). Given the peculiarity of the safety profile of biological medical products (originator and biosimilars), the evaluation of their tolerability represents an important component of pre-marketing and post-marketing clinical development. For example, infliximab products may cause adverse drug reactions (ADRs) including acute infusion reactions, delayed hypersensitivity reactions, and loss of efficacy, as a direct consequence of immunogenicity...
October 20, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/30306341/emerging-technologies-for-delivery-of-biotherapeutics-and-gene-therapy-across-the-blood-brain-barrier
#4
Danica B Stanimirovic, Jagdeep K Sandhu, Will J Costain
Antibody, immuno- and gene therapies developed for neurological indications face a delivery challenge posed by various anatomical and physiological barriers within the central nervous system (CNS); most notably, the blood-brain barrier (BBB). Emerging delivery technologies for biotherapeutics have focused on trans-cellular pathways across the BBB utilizing receptor-mediated transcytosis (RMT). 'Traditionally' targeted RMT receptors, transferrin receptor (TfR) and insulin receptor (IR), are ubiquitously expressed and pose numerous translational challenges during development, including species differences and safety risks...
October 10, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/30298387/darvadstrocel-a-review-in-treatment-refractory-complex-perianal-fistulas-in-crohn-s-disease
#5
Lesley J Scott
Darvadstrocel (Alofisel® ) consists of a suspension of expanded human allogeneic adipose-derived mesenchymal stem cells (eASCs). It is the first mesenchymal stem cell (MSC) advanced therapy approved in the EU for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn's disease, when fistulas have shown an inadequate response to ≥ 1 conventional or biologic therapy. In the pivotal phase 3 ADMIRE-CD trial in this difficult-to-treat patient population, after standard-of-care fistula conditioning, add-on therapy with a single dose of darvadstrocel (120 million eASC) administered into the tissue surrounding complex perianal fistulas was significantly more effective than placebo (saline), with the darvadstrocel group having a higher combined remission rate (i...
October 8, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/30284704/pf-06438179-gp1111-an-infliximab-biosimilar
#6
Zaina T Al-Salama
PF-06438179/GP1111 (Zessly® ; Ixifi® ) [hereafter referred to as GP1111] is a biosimilar of the reference monoclonal anti-TNF-α antibody infliximab, and is approved in the EU and USA for the same indications as the reference drug, including rheumatoid arthritis (RA), Crohn's disease, ulcerative colitis (including paediatric ulcerative colitis in the EU), ankylosing spondylitis, psoriatic arthritis and plaque psoriasis; GP1111 is also approved in Japan. GP1111 has similar physicochemical characteristics and pharmacodynamic properties to those of reference infliximab, and the pharmacokinetic similarity of the agents has been shown in healthy volunteers and patients with moderate-to-severe RA despite methotrexate therapy...
October 4, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/30264234/abp-980-a-trastuzumab-biosimilar
#7
Sohita Dhillon
ABP 980 (KANJINTI™) is a biosimilar of the reference anti-HER2 antibody trastuzumab. In the EU, ABP 980 is approved for use in all indications for which reference trastuzumab is approved, including HER2-positive early breast cancer, metastatic breast cancer and metastatic gastric cancer. ABP 980 has similar physicochemical and functional properties to those of reference trastuzumab, and the pharmacokinetic biosimilarity of the agents has been shown in healthy subjects. In the phase 3 LILAC study, ABP 980 demonstrated similar clinical efficacy (based on central laboratory review sensitivity analysis) and tolerability to that of reference trastuzumab in patients with HER2-positive early breast cancer...
September 27, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/30251234/sb5-an-adalimumab-biosimilar
#8
James E Frampton
SB5 (Imraldi® ) is a biosimilar of the reference anti-TNF monoclonal antibody adalimumab. It is approved for use in the following indications for which reference adalimumab is approved: rheumatoid arthritis (RA), juvenile idiopathic arthritis [polyarticular juvenile idiopathic arthritis (pJIA) and enthesitis-related arthritis (ERA)], axial spondyloarthritis [ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)], psoriatic arthritis (PsA), psoriasis, pediatric plaque psoriasis, hidradenitis suppurativa (HS), Crohn's disease, pediatric Crohn's disease, ulcerative colitis (UC), and non-infectious uveitis...
September 24, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
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
#9
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
#10
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/30132210/pharmacokinetic-and-immunological-considerations-for-expanding-the-therapeutic-window-of-next-generation-antibody-drug-conjugates
#11
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/30280367/pf-05280014-a-trastuzumab-biosimilar
#12
Julia Paik
PF-05280014 (Trazimera™) is the fourth biosimilar of the reference anti-HER2 antibody trastuzumab to be approved in the EU. It is approved for use in all indications for which reference trastuzumab is approved, including HER2-positive metastatic or early breast cancer and metastatic gastric cancer. PF-05280014 has similar physicochemical and pharmacodynamic properties to those of reference trastuzumab, and the pharmacokinetic similarity of the agents has been shown in women with metastatic or early HER2-positive breast cancer and healthy male volunteers...
October 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/30269270/non-pharmacological-effects-in-switching-medication-the-nocebo-effect-in-switching-from-originator-to-biosimilar-agent
#13
Lars Erik Kristensen, Rieke Alten, Luis Puig, Sandra Philipp, Tore K Kvien, Maria Antonia Mangues, Frank van den Hoogen, Karel Pavelka, Arnold G Vulto
The nocebo effect is defined as the incitement or the worsening of symptoms induced by any negative attitude from non-pharmacological therapeutic intervention, sham, or active therapies. When a patient anticipates a negative effect associated with an intervention, medication or change in medication, they may then experience either an increase in this effect or experience it de novo. Although less is known about the nocebo effect compared with the placebo effect, widespread interest in the nocebo effect observed with statin therapy and a literature review highlighting the nocebo effect across at least ten different disease areas strongly suggests this is a common phenomenon...
October 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
#14
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...
October 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/30132211/expanding-the-boundaries-of-biotherapeutics-with-bispecific-antibodies
#15
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...
October 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
#16
LETTER
Christopher J Webster, Gillian R Woollett
No abstract text is available yet for this article.
October 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
#17
LETTER
Francois-Xavier Frapaise
No abstract text is available yet for this article.
October 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/30069733/correction-to-gp2015-an-etanercept-biosimilar
#18
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...
October 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
#19
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...
October 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
#20
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
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