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https://www.readbyqxmd.com/read/28702973/clinical-and-histological-changes-in-hidradenitis-suppurativa-following-1064-nm-nd-yag-intralesional-laser-treatment
#1
N Zerbinati, E D'Este, L Ini, A Baruffato, V Premoli, A Calligaro, M Paulli
Hidradenitis Suppurativa (HS) is recently attracting much attention and awareness, often because it is misdiagnosed for years, restricting the therapeutic options. Moreover, this pathology arises in areas such as the inguinal region, that may cause embarrassment in young patients. Wrong diagnosis and delay in appropriate treatments lead to an exacerbation of the symptoms and a progression of the disease, which at the last stage can only be managed through extensive surgical excisions, ablation and vaporization of nodules with CO2 laser systems or aggressive chemotherapies such as anti-TNF-alpha like adalimumab (Humira®-AbbVie Inc...
July 13, 2017: Journal of Biological Regulators and Homeostatic Agents
https://www.readbyqxmd.com/read/28685239/a-biodesign-approach-to-obtain-high-yields-of-biosimilars-by-anti-apoptotic-cell-engineering-a-case-study-to-increase-the-production-yield-of-anti-tnf-alpha-producing-recombinant-cho-cells
#2
Sultan Gulce Iz, Muge Anil Inevi, Pelin Saglam Metiner, Duygu Ayyildiz Tamis, Nazli Kisbet
Recent developments in medical biotechnology have facilitated to enhance the production of monoclonal antibodies (mAbs) and recombinant proteins in mammalian cells. Human mAbs for clinical applications have focused on three areas, particularly cancer, immunological disorders, and infectious diseases. Tumor necrosis factor alpha (TNF-α), which has both proinflammatory and immunoregulatory functions, is an important target in biopharmaceutical industry. In this study, a humanized anti-TNF-α mAb producing stable CHO cell line which produces a biosimilar of Humira (adalimumab) was used...
July 6, 2017: Applied Biochemistry and Biotechnology
https://www.readbyqxmd.com/read/28584277/analysis-of-aquaporins-in-brassicaceae-species-reveals-high-level-of-conservation-and-dynamic-role-against-biotic-and-abiotic-stress-in-canola
#3
Humira Sonah, Rupesh K Deshmukh, Caroline Labbé, Richard R Bélanger
Aquaporins (AQPs) are of vital importance in the cellular transport system of all living organisms. In this study, genome-wide identification, distribution, and characterization of AQPs were determined in Arabidopsis lyrata, Capsella grandiflora, C. rubella, Eutrema salsugineum, Brassica rapa, B. oleracea, and B. napus (canola). Classification and phylogeny of AQPs revealed the loss of XIPs and NIP-IIIs in all species. Characterization of distinctive AQP features showed a high level of conservation in spacing between NPA-domains, and selectivity filters...
June 5, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28485681/humira-recent-developments
#4
Peter Norman
No abstract text is available yet for this article.
May 9, 2017: Pharmaceutical Patent Analyst
https://www.readbyqxmd.com/read/28474206/erratum-to-impact-of-participation-in-the-adalimumab-humira-patient-support-program-on-rheumatoid-arthritis-treatment-course-results-from-the-passion-study
#5
Filip Van den Bosch, Andrew J K Ostor, Siegfried Wassenberg, Naijun Chen, Chen Wang, Vishvas Garg, Jasmina Kalabic
No abstract text is available yet for this article.
June 2017: Rheumatology and Therapy
https://www.readbyqxmd.com/read/28361468/impact-of-participation-in-the-adalimumab-humira-patient-support-program-on-rheumatoid-arthritis-treatment-course-results-from-the-passion-study
#6
Filip Van den Bosch, Andrew J K Ostor, Siegfried Wassenberg, Naijun Chen, Chen Wang, Vishvas Garg, Jasmina Kalabic
INTRODUCTION: Patients with rheumatoid arthritis (RA) who are treated with adalimumab (ADA) are offered a proprietary patient support program (PSP, AbbVie Care(®)). The main objective of this study was to examine the effectiveness of ADA on RA treatment course over time in the context of PSP utilization. METHODS: PASSION was a 78-week post-marketing observational study of RA patients with an insufficient response to ≥1 DMARD newly initiating ADA in routine clinical care that was conducted in Europe, Israel, Mexico, Puerto Rico, and Australia...
June 2017: Rheumatology and Therapy
https://www.readbyqxmd.com/read/28290731/a-randomized-double-blind-single-dose-two-arm-parallel-study-comparing-pharmacokinetics-immunogenicity-and-tolerability-of-branded-adalimumab-and-its-biosimilar-lbal-in-healthy-male-volunteers
#7
RANDOMIZED CONTROLLED TRIAL
Kyoung Ryun Park, Hyewon Chung, Sung Mo Yang, SeungHwan Lee, Seo Hyun Yoon, Joo-Youn Cho, In-Jin Jang, Kyung-Sang Yu
OBJECTIVES: This study aimed to compare the pharmacokinetics (PK), immunogenicity, and tolerability of LBAL, a biosimilar of adalimumab, with the originator, Humira®, in healthy volunteers. METHODS: A randomized, double-blind, single-dose, two-arm, parallel-group study was conducted in 116 healthy subjects. They randomly received a single subcutaneous (SC) 40 mg injection of LBAL or Humira. Blood samples were collected for PK and immunogenicity assessment. PK parameters were determined using the noncompartmental method, and primary endpoint parameters were compared using the point estimates and 90% confidence intervals (CIs) of the geometric mean ratios (GMRs)...
May 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28229433/adalimumab-a-review-in-non-infectious-non-anterior-uveitis
#8
REVIEW
Sheridan M Hoy
Adalimumab (Humira(®)) is a tumour necrosis factor (TNF)-α inhibitor available in various countries worldwide, including the USA, Japan and those of the EU, for the treatment of non-infectious intermediate, posterior and panuveitis in adults. It is the first biological agent approved for this indication. In two multinational, phase III studies in adults with active and inactive disease, subcutaneous adalimumab significantly reduced the risk of treatment failure relative to placebo following the tapered withdrawal of corticosteroid therapy...
April 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28188167/hidradenitis-suppurativa-neutrophilic-dermatoses-and-diverticular-disease-in-a-young-african-american-patient
#9
Kavita Darji, Maulik M Dhandha, Mary Guo
Hidradenitis suppurativa (HS) is a chronic skin disorder of the terminal follicular epithelium of apocrine sweat glands, manifesting as painful and exudative papules, pustules, cysts or nodules. This inflammatory condition often presents with other systemic and cutaneous disorders. We present the case of an African-American man with HS who was also diagnosed with neutrophilic dermatoses and diverticular disease. Neutrophilic dermatosis was identified based on histopathology findings. Our patient underwent multiple surgeries for flaring of his skin condition...
February 10, 2017: BMJ Case Reports
https://www.readbyqxmd.com/read/28133772/pharmacokinetics-safety-tolerability-and-immunogenicity-of-fkb327-a-new-biosimilar-medicine-of-adalimumab-humira-in-healthy-subjects
#10
Adeep Puri, Andrew Niewiarowski, Yasumasa Arai, Hideaki Nomura, Mark Baird, Isobel Dalrymple, Steve Warrington, Malcolm Boyce
AIMS: To compare the pharmacokinetics, safety, tolerability and immunogenicity of FKB327, a biosimilar of adalimumab, with European Union (EU)-approved Humira and US-licensed Humira after single subcutaneous doses in healthy subjects. METHODS: In a randomized, double-blind, parallel-group study, 180 healthy subjects received by subcutaneous injection 40 mg of EU-Humira, or US-Humira, or FKB327, in a 1:1:1 ratio, stratified by bodyweight. Pharmacokinetics, local tolerability, immunogenicity, adverse events, vital signs, electrocardiography and laboratory safety tests were assessed prior to and up to 1536 h after treatment...
July 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27990146/comparative-transcriptomic-analysis-of-virulence-factors-in-leptosphaeria-maculans-during-compatible-and-incompatible-interactions-with-canola
#11
Humira Sonah, Xuehua Zhang, Rupesh K Deshmukh, M Hossein Borhan, W G Dilantha Fernando, Richard R Bélanger
Leptosphaeria maculans is a hemibiotrophic fungus that causes blackleg of canola (Brassica napus), one of the most devastating diseases of this crop. In the present study, transcriptome profiling of L. maculans was performed in an effort to understand and define the pathogenicity genes that govern both the biotrophic and the necrotrophic phase of the fungus, as well as those that separate a compatible from an incompatible interaction. For this purpose, comparative RNA-seq analyses were performed on L. maculans isolate D5 at four different time points following inoculation on susceptible cultivar Topas-DH16516 or resistant introgression line Topas-Rlm2...
2016: Frontiers in Plant Science
https://www.readbyqxmd.com/read/27965661/clinical-evaluation-of-humira-%C3%A2-biosimilar-ons-3010-in-healthy-volunteers-focus-on-pharmacokinetics-and-pharmacodynamics
#12
Marlous R Dillingh, Joannes A A Reijers, Karen E Malone, Jacobus Burggraaf, Kenneth Bahrt, Liz Yamashita, Claudia Rehrig, Matthijs Moerland
ONS-3010 is being developed by Oncobiologics Inc. (Cranbury, NJ, USA) as a biosimilar of Humira(®). This randomized, double blind, single-center phase I study (EudraCT registration # 2013-003551-38) was performed to demonstrate pharmacokinetic (PK) biosimilarity between two reference products (Humira(®) EU and US) and ONS-3010 in healthy volunteers, and to compare the safety and immunogenicity profiles. In addition, the intended pharmacological activity was assessed and compared by application of a whole blood challenge...
2016: Frontiers in Immunology
https://www.readbyqxmd.com/read/27900937/post-authorization-changes-in-the-safety-and-efficacy-assessment-recommended-indications-and-drug-quality-profile-of-adalimumab-a-chronological-overview
#13
REVIEW
Gergely Iványi, Romána Zelkó
OBJECTIVE: The intention of the present study was to demonstrate the postauthorization changes of adalimumab (European trade name: Humira), evaluating the variations in its safety, efficacy, and quality profile. METHODS: Type-II, major variations of the Summary of Product Characteristics (SmPC) from September 8, 2003 to November 19, 2015, were analyzed, which, according to Commission Regulation (EC) No. 1234/2008, have to reflect changes that may have a significant impact on the safety, efficacy, or quality profile of a medicinal product...
February 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27883347/-adalimumab-as-induction-therapy-for-crohn-s-disease-one-center-study
#14
Maciej Gonciarz, Aldona Mularczyk, Dawid Szkudłapski, Iwona Piątek, Marek Kopała
Adalimumab is a subcutaneously administered recombinant fully human monoclonal antibody targeting tumor necrosis factor alpha. It has been approved for use in Poland to treat patients with Crohn's disease under the program of Polish National Health Found since 2010. AIM: The aim of this study was to evaluate the efficacy of adalimumab monotherapy for inducing clinical remission in patients with active Crohn's disease . The primary outcome assessment was the reduction in score to 150 or below on the Crohn's Disease Activity Index (CDAI) at 12 weeks and the secondary one was the reduction in ΔCDAI of at least 100 points...
November 25, 2016: Polski Merkuriusz Lekarski: Organ Polskiego Towarzystwa Lekarskiego
https://www.readbyqxmd.com/read/27876365/midyear-commentary-on-trends-in-drug-delivery-and-clinical-translational-medicine-growth-in-biosimilar-complex-injectable-drug-formulation-products-within-evolving-collaborative-regulatory-interagency-fda-ftc-and-doj-practices-and-enforcement
#15
Rodney J Y Ho
Before the 2009 Biologics Price Competition and Innovation Act that enabled the U.S. Federal Drug Administration (FDA) to create the 351(k) Biologic License Application-an abbreviated biosimilar approval process, FDA approved follow-on biomolecule products such as beta-interferon, glucagon, hyaluronidase, and somatropin (human growth hormone) under varying and evolving rules. With the 351(k) Biologic License Application biosimilar approval process in place, currently, there are 4 (licensed in 2015-2016) biosimilars available, namely Neupogen (filgrastim; $1 B/y), Humira (adalumumab; $14...
February 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27854156/demonstration-of-physicochemical-and-functional-similarity-between-the-proposed-biosimilar-adalimumab-msb11022-and-humira%C3%A2
#16
Laurent Magnenat, Angelo Palmese, Christèle Fremaux, Fabio D'Amici, Mariagrazia Terlizzese, Mara Rossi, Laurent Chevalet
Biosimilars are biological products that are highly similar to existing products approved by health authorities. Demonstration of similarity starts with the comprehensive analysis of the reference product and its proposed biosimilar at the physicochemical and functional levels. Here, we report the results of a comparative analysis of a proposed biosimilar adalimumab MSB11022 and its reference product, Humira®. Three batches of MSB11022 and up to 23 batches of Humira® were analyzed by a set of state-of-the-art orthogonal methods...
January 2017: MAbs
https://www.readbyqxmd.com/read/27845027/clinical-effectiveness-and-cost-effectiveness-of-use-of-therapeutic-monitoring-of-tumour-necrosis-factor-alpha-tnf-%C3%AE-inhibitors-lisa-tracker%C3%A2-enzyme-linked-immunosorbent-assay-elisa-kits-tnf-%C3%AE-blocker-elisa-kits-and-promonitor%C3%A2-elisa-kits-versus-standard-care
#17
Karoline Freeman, Martin Connock, Peter Auguste, Sian Taylor-Phillips, Hema Mistry, Deepson Shyangdan, Rachel Court, Ramesh Arasaradnam, Paul Sutcliffe, Aileen Clarke
BACKGROUND AND OBJECTIVES: Systematic reviews and economic modelling of clinical effectiveness and cost-effectiveness of therapeutic monitoring of tumour necrosis factor alpha (TNF-α) inhibitors [using LISA-TRACKER(®) enzyme-linked immunosorbent assay (ELISA) kits (Theradiag, Marne La Vallee, France, or Alpha Laboratories, Heriot, UK), TNF-α-Blocker ELISA kits (Immundiagnostik AG, Bensheim, Germany) and Promonitor(®) ELISA kits (Proteomika, Progenika Biopharma, Bizkaia, Spain)] versus standard care for Crohn's disease (CD)...
November 2016: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/27813422/bioequivalence-safety-and-immunogenicity-of-bi-695501-an-adalimumab-biosimilar-candidate-compared-with-the-reference-biologic-in-a-randomized-double-blind-active-comparator-phase-i-clinical-study-voltaire%C3%A2-pk-in-healthy-subjects
#18
RANDOMIZED CONTROLLED TRIAL
Christopher Wynne, Mario Altendorfer, Ivo Sonderegger, Lien Gheyle, Rod Ellis-Pegler, Susanne Buschke, Benjamin Lang, Deepak Assudani, Sandeep Athalye, Niklas Czeloth
BACKGROUND: This Phase I study (VOLTAIRE®-PK) aimed to evaluate three-way pharmacokinetic similarity (bioequivalence), safety, and immunogenicity of BI 695501 (a Humira® [adalimumab] biosimilar candidate) compared with US- and EU-approved Humira in healthy male subjects. METHODS: Subjects (N = 327) were randomized 1:1:1 to receive one 40-mg subcutaneous dose of BI 695501, US- or EU-approved Humira; safety was assessed for 70 days. Bioequivalence was evaluated using the average bioequivalence method to test if the 90% confidence intervals (CIs) of the geometric means (BI 695501 vs US- and EU-approved Humira) for the primary end points were within prespecified acceptance ranges (80-125%)...
December 2016: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/27792008/of-patents-and-patent-disputes-the-tnf%C3%AE-patent-files-part-1-humira
#19
Ulrich Storz
This article discusses the patent strategy underlying the world's best selling drug, AbbVie's Humira®. Despite a non-optimal starting position, AbbVie has established an extensive portfolio to fend off biosimilar competition. This article is the first part of a trilogy that discusses IP issues related to anti-Tumor Necrosis factor α (TNFα) biologics.
2017: Human Antibodies
https://www.readbyqxmd.com/read/27784520/adalimumab-humira-%C3%A2-for-hidradenitis-suppurativa
#20
Aditya K Gupta, Maria Cernea, William Abramovits, Kimberly Dawn Vincent
No abstract text is available yet for this article.
2016: Skinmed
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