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Expert Opinion on Biological Therapy

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https://www.readbyqxmd.com/read/28540760/biologicals-and-biosimilars-safety-issues-in-europe
#1
Maria da Conceição Constantino Portela, Carlos Sinogas, Fernando Albuquerque de Almeida, Ricardo Baptista-Leite, Alexandre Castro-Caldas
Medicinal products of a biological origin are approved by the EMA at a centralized level. However, there is no harmonization about their use in Europe. The current regulation referring to the safety of biological medicinal products and biosimilars in Europe has been identified. The safety associated with medicinal products of a biological origin is assured by the pharmacovigilance system, which has evolved, but doesn't yet incorporate all of the specific information from this market segment, namely that related to the identification of drugs, and its use - including the prescription and dispensing, given the possibility of interchangeability and substitution...
May 25, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28532226/novel-biological-therapies-for-the-treatment-of-diabetic-foot-ulcers
#2
Jennifer Adeghate, Syed Nurulain, Kornélia Tekes, Erzsébet Fehér, Huba Kalász, Ernest Adeghate
The number of people with diabetes mellitus (DM) is estimated to exceed 640 million by the year 2040. Diabetic foot ulcer (DFU) is a debilitating illness that affects more than 2% of DM patients. DFU is caused by DM-induced neural and vascular lesions leading to a reduced sensation and microcirculation. The increase in the prevalence of DFU has prompted researchers to find new therapies for the management of DFU. Areas covered: This review presents the current status of novel biological therapies used in the treatment of DFU...
May 22, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28532178/new-perspectives-on-biological-hdl-targeted-therapies
#3
Ilayaraja Muthuramu, Ruhul Amin, Bart De Geest
No abstract text is available yet for this article.
May 22, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28532177/targeting-non-hodgkin-lymphoma-with-blinatumomab
#4
Sheilagh Sanders, Douglas A Stewart
Management of patients with relapsed or refractory non-Hodgkin lymphoma (NHL) remains challenging, and novel effective agents are eagerly awaited. Blinatumomab is a bispecific T-cell engager, targeting CD19. While blinatumomab's primary clinical use has been in B-cell acute lymphoblastic leukemia (B-ALL), there are increasing data for its use in B-lineage lymphomas. Areas covered: The aim of this review is to highlight the clinical data for blinatumomab use in NHL. Herein, the authors provide an overview of blinatumomab, its mechanism of action, its proven efficacy against B-ALL, and its phase I-II data assessing its use in NHL Expert opinion: Blinatumomab has modest activity in phase I-II trials in NHL, and may represent a means of bridging patients with relapsed disease to hematopoietic stem cell transplant...
May 22, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28525959/challenges-and-opportunities-in-targeting-the-cd28-ctla-4-pathway-in-transplantation-and-autoimmunity
#5
Rebecca L Crepeau, Mandy L Ford
Introduction T cell activation is a complex process that requires multiple cell signaling pathways, including a primary recognition signal and additional costimulatory signals. One of the best-characterized costimulatory pathways includes the Ig superfamily members CD28 and CTLA-4 and their ligands CD80 and CD86. Areas Covered This review discusses past, current and future biological therapies that have been utilized to block the CD28/CTLA-4 cosignaling pathway in the settings of autoimmunity and transplantation, as well the challenges facing successful implementation of these therapies...
May 19, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28506131/new-drugs-and-allogeneic-hematopoietic-cell-transplantation-for-hematological-malignancies-do-they-have-a-role-in-bridging-consolidating-or-conditioning-transplantation-treatment
#6
Francesca Patriarca, Luisa Giaccone, Francesco Onida, Luca Castagna, Barbara Sarina, Vittorio Montefusco, Alberto Mussetti, Nicola Mordini, Elena Maino, Raffaella Greco, Jacopo Peccatori, Moreno Festuccia, Francesco Zaja, Stefano Volpetti, Antonio Risitano, Renato Bassan, Paolo Corradini, Fabio Ciceri, Renato Fanin, Michele Baccarani, Alessandro Rambaldi, Francesca Bonifazi, Benedetto Bruno
Novel targeted therapies and monoclonal antibodies can be combined with allogeneic stem cell transplantation (allo-SCT) at different time-points: 1) before the transplant to reduce tumour burden, 2) as part of the conditioning in place of or in addition to conventional agents 3) after the transplant to allow long-term disease control. Areas covered This review focuses on the current integration of new drugs with allo-SCT for the treatment of major hematological malignancies for which allo-SCT has been a widely-adopted therapy...
May 16, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28503960/management-of-severe-complications-in-beh%C3%A3-et-s-disease-with-anti-tnf%C3%AE-inhibitors
#7
A C Desbois, H Vallet, F Domont, C Comarmond, P Cacoub, D Saadoun
The efficacy of anti-TNFα agents has been recently evaluated in many studies in Behçet's disease (BD), particularly in ocular and life-threatening manifestations such as neurological and vascular disease. Areas covered: The following article aims to summarize the currently available efficacy and safety data of anti-TNFα agents in BD. Expert opinion: Most studies have shown dramatic and rapid efficacy with anti-TNFα agents on the main BD-associated issues including posterior uveitis, gastro-intestinal and neurological complications as well as major vessel disease...
May 15, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28503956/sacituzumab-govitecan-an-antibody-drug-conjugate
#8
Sheena Sahota, Linda T Vahdat
Despite advances in the diagnosis and treatment of patients with cancer, patients with metastatic cancer have limited therapeutic options after initial lines of therapy. Understanding tumor biology has translated into the identification of actionable targets that resulted in therapeutics. Antibody-drug conjugates (ADC) are capitalizing on this explosion of scientific information. ADCs allow an antibody to a unique target to be conjugated via an innovative linker, to a highly toxic drug which is delivered to its target...
May 15, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28446053/immunotherapy-for-the-treatment-of-breast-cancer
#9
Mariela A Moreno Ayala, Maria Florencia Gottardo, Antonela S Asad, Camila Zuccato, Alejandro Nicola, Adriana Seilicovich, Marianela Candolfi
Breast cancer is the most common cancer as well as the first cause of death by cancer in women worldwide. Although routine treatment improves the outcome of early stage breast cancer patients, there is no effective therapy for the disseminated disease. Immunotherapy has emerged as a powerful therapeutic strategy for the treatment of many cancers. Although traditionally conceived as a non-immunogenic tumor, breast cancer is now considered a potential target for immunotherapy. Areas covered: In this review, the authors discuss different immunotherapeutic strategies that are currently being tested for the treatment of breast cancer: These strategies include: (i) blockade of immunological checkpoints, (ii) antitumor vaccines, (iii) regulatory T cell blockade, (iv) adoptive T cell transfer therapy, (iv) adoptive immunotherapy with monoclonal antibodies, and (v) combination of immunotherapy with chemotherapy...
May 8, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28443372/cord-blood-as-a-potential-therapeutic-for-amyotrophic-lateral-sclerosis
#10
Svitlana Garbuzova-Davis, Jared Ehrhart, Paul R Sanberg
Amyotrophic Lateral Sclerosis (ALS) is a fatal neurodegenerative disease characterized by progressive motor neuron degeneration in the brain and spinal cord. Treatment options are limited due to the complexity of underlying disease factors. Cell therapy, using human umbilical cord blood (hUCB) cells may be a promising new treatment for ALS, mainly by providing a protective microenvironment for motor neuron survival. Areas covered: Composition, in vitro and in vivo differentiation of hUCB cells, and the advantages of cord blood as a source of transplant cells are discussed...
May 8, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28480759/gad65-a-prospective-vaccine-for-treating-type-1-diabetes
#11
Johnny Ludvigsson
In spite of modern techniques, the burden for patients with type 1 diabetes (T1D) will not disappear and T1D remains a life-threatening disease causing severe complications and increased mortality. We have to learn how to preserve residual insulin secretion or even increase beta cell regeneration. This would give a milder disease, simpler treatment and perhaps even cure. Thus, there are good reasons to try therapies that may preserve beta cell function. Areas covered: In this review the author reviews the literature and registered ongoing trials using GAD-alum put in relation to the high number of published different immune interventions...
May 6, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28472597/golimumab-for-the-treatment-of-ulcerative-colitis
#12
Mathurin Flamant, Stephane Paul, Xavier Roblin
Tumor necrosis factor antagonists have revolutionized the therapeutic management of inflammatory bowel disease. Infliximab and adalimumab were the first biological agents used to induce and maintain remission in ulcerative colitis. More recently, a third tumor necrosis factor antagonist, golimumab, was approved, extending the therapeutic approach for moderate-to-severe ulcerative colitis. Areas covered: In this review, the authors review the literature on the efficacy and safety of golimumab in the context of other anti-TNF agents used in the treatment of this disease...
May 4, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28438082/radioimmunoconjugates-for-treating-cancer-recent-advances-and-current-opportunities
#13
Mickaël Bourgeois, Clément Bailly, Mathieu Frindel, François Guerard, Michel Chérel, Alain Faivre-Chauvet, Françoise Kraeber-Bodéré, Caroline Bodet-Milin
Radioimmunoconjugates have been used for 30 years to diagnose and treat cancer. For many years, the use of these therapeutic tools has been limited to haematological disorders, such as non-Hodgkin's lymphoma, given that they have only had a moderate effect on solid tumours. Areas covered: Recently, several strategies have revived the potential therapeutic application for radioimmunoconjugates. In this review, the authors review the advances in immunological engineering to develop new tools like monoclonal antibodies and their derivatives...
May 4, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28460578/belimumab-in-the-management-of-systemic-lupus-erythematosus-an-update
#14
Vladimir Tesar, Zdenka Hruskova
Belimumab is a fully humanised mAb against B lymphocyte stimulator (B-LyS). It is the first biological drug licensed and approved by the US FDA and the European Medicines Agency (EMA) for use in combination with standard immunosuppressants in autoantibody-positive systemic lupus erythematosus (SLE). Areas covered: This manuscript evalues the recent data concerning belimumab's safety and clinical effectiveness and its current place in the treatment of SLE. This includes an overview of the recent data coming from the post-hoc analyses of the BLISS trials, real-life experience with belimumab and the accumulating data on its safety...
May 2, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28434255/daratumumab-for-the-treatment-of-multiple-myeloma
#15
Cyrille Touzeau, Philippe Moreau
Proteasome inhibitors and immunomodulatory drugs have contributed to the dramatic improvement in survival for patients with myeloma over the past decades. However, the disease typically relapses and new classes of drugs are needed. In 2015, two monoclonal antibodies were approved for the treatment of patients with relapsed multiple myeloma, and immunotherapy has rapidly become indispensable in the management of myeloma patients. Areas covered: Here, the authors discuss the published data regarding the mechanism of action, safety and clinical efficacy of the CD38-targeted monoclonal antibody daratumumab for the treatment of patients with multiple myeloma...
April 24, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28429626/promising-immunotherapy-against-fungal-diseases
#16
Wilfried Posch, Marion Steger, Doris Wilflingseder, Cornelia Lass-Flörl
Despite the relatively high efficacy of antifungal drugs, invasive fungal infections (IFIs) are still associated with tremendous morbidity and mortality, since late diagnosis makes an antifungal drug therapy inefficient. Therefore, antifungal immunotherapies to specifically strengthen the host´s own immune mechanisms constitute an additional promising strategy in taking action against fungal pathogens. Areas covered: The authors summarize efforts in research and clinical trials to provide safe and efficient immunotherapeutic options against invasive fungal diseases...
April 21, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28406319/benralizumab-as-a-potential-treatment-of-asthma
#17
Sabina Antonela Antoniu
Current anti-inflammatory asthma therapies including inhaled corticosteroids and leukotriene modifiers, are not always able to appropriately control the disease and other approaches are needed. These therapies specific target IgE (omalizumab) or IL-5 (mepolizumab). However, there is research underway investigating interleukin-based monoclonal antibodies such as benralizumab, an anti-IL-5R monoclonal antibody which is currently in phase III clinical development. Areas covered: This review summarizes the existing preclinical and clinical data of benralizumab...
April 19, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28316250/adalimumab-in-ulcerative-colitis-efficacy-safety-and-optimization-in-the-era-of-treat-to-target
#18
Miles P Sparrow
Active ulcerative colitis is associated with significant morbidity and impairment to quality of life. Adalimumab is a welcome addition to the therapeutic armamentarium for clinicians treating patients with moderate-severe ulcerative colitis refractory to conventional therapies, an indication with few prior treatment options. It offers the convenience of self-injection and is most appropriate for outpatients with moderate disease activity. Areas covered: This review briefly summarizes data from well-designed clinical trials and observational real-life studies that demonstrate the safety and efficacy of adalimumab in UC...
March 28, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28303723/decellularized-material-as-scaffolds-for-tissue-engineering-studies-in-long-gap-esophageal-atresia
#19
Esmond Lee, Anna Milan, Luca Urbani, Paolo De Coppi, Mark W Lowdell
Esophageal atresia refers to an anomaly in foetal development in which the esophagus terminates in a blind end. Whilst surgical correction is achievable in most patients, when a long gap is present it still represents a major challenge associated with higher morbidity and mortality. In this context, tissue engineering could represent a successful alternative to restore oesophageal function and structure. Naturally derived biomaterials made of decellularized tissues retain native extracellular matrix architecture and composition, providing a suitable bed for the anchorage and growth of relevant cell types...
March 27, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28286975/single-vs-combination-immunotherapeutic-strategies-for-glioma
#20
Mayuri Chandran, Marianela Candolfi, Diana Shah, Yohei Mineharu, Viveka Nand Yadav, Carl Koschmann, Antonela S Asad, Pedro R Lowenstein, Maria G Castro
Malignant gliomas are highly invasive tumors, associated with a dismal survival rate despite standard of care, which includes surgical resection, radiotherapy and chemotherapy with temozolomide (TMZ). Precision immunotherapies or combinations of immunotherapies that target unique tumor-specific features may substantially improve upon existing treatments. Areas covered: Clinical trials of single immunotherapies have shown therapeutic potential in high-grade glioma patients, and emerging preclinical studies indicate that combinations of immunotherapies may be more effective than monotherapies...
March 20, 2017: Expert Opinion on Biological Therapy
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