Expert Opinion on Biological Therapy
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#1Carlo Alberto Maronese (Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico)H-Index: 1
#1Carlo A Maronese (Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico)
Last. Angelo V. Marzano (Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico)H-Index: 44
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#2Mohammad Farmahini Farahani (Tehran University of Medical Sciences)
Last. Morteza Azhdarzadeh (Tehran University of Medical Sciences)H-Index: 12
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BACKGROUND P044 is a proposed biosimilar candidate of Teriparatide for reference medicine, Forsteo®. This study was designed to evaluate the Pharmacokinetic/Pharmacodynamic (PK/PD) bioequivalence between P044 and Forsteo®. METHODS In this randomized, open-label, single-dose, crossover study, 66 healthy female subjects were randomized to receive P044 and Forsteo®. The primary PK endpoints of the study were the area under the concentration versus time from zero to infinity (AUC0-inf) and maximum p...
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#1Anurag S. Rathore (IITD: Indian Institute of Technology Delhi)H-Index: 33
#2Himanshu Malani (IITD: Indian Institute of Technology Delhi)H-Index: 1
INTRODUCTION Monoclonal antibodies, though a popular class of therapeutics, are complex molecules that are manufactured using complex processes, making it non-trivial to maintain high level of batch-to-batch consistency in product quality. Glycosylation is a post translation modification that is widely considered a critical quality attribute (CQA) as its variations are known to impact the Fc effector functions of mAbs. With continuing rise of biosimilars, comparability of these products to the r...
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#1Ryuma Iwaki (Nationwide Children's Hospital)H-Index: 1
#2Toshihiro Shoji (Nationwide Children's Hospital)H-Index: 7
Last. Toshiharu Shinoka (Nationwide Children's Hospital)H-Index: 52
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INTRODUCTION Cardiovascular disease (CVD) is the leading cause of death in western countries. Although surgical outcomes for CVD are dramatically improving with the development of surgical techniques, medications, and perioperative management strategies, adverse postoperative events related to the use of artificial prosthetic materials are still problematic. Moreover, in pediatric patients, using these artificial materials make future re-intervention inevitable due to their lack of growth potent...
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#1Ali T. Taher (AUB: American University of Beirut)H-Index: 66
#2Maria Domenica Cappellini (University of Milan)H-Index: 79
Introduction null Red blood cell transfusions and iron chelation therapy are the cornerstone of treatment for β-thalassemia, with allogeneic hematopoietic stem cell transplantation and gene therapy offering further disease-management options for eligible patients. With up to 90% of severe cases of β-thalassemia occurring in resource-constrained countries, and estimates indicating that 22,500 deaths occur annually as a direct consequence of undertransfusion, provision of adequate treatment remain...
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#1Dahna CoupezH-Index: 2
#2Pauline HuloH-Index: 2
Last. Jaafar BennounaH-Index: 58
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Introduction null : The high frequency of RAS mutations, particularly KRAS mutations, in colorectal cancer (CRC) and the ineffectiveness of anti-EGFR antibodies in treating this disease has created a significant unmet medical need, especially for treating patients in the metastatic phase of this disease. There are many different types of RAS mutations, the most frequent being G12V (c.35G>T (p.G12V)), G12D (c.35G>A (p.G12D)), and G13D (c.38G>A (p.G13D)). Here, we provide an overview of RAS mutati...
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#1Marina Talamonti (University of Rome Tor Vergata)H-Index: 15
#2Marco Galluzzo (University of Rome Tor Vergata)H-Index: 14
Introduction null : There is very limited knowledge about the safety of COVID-19 vaccines in patients with psoriasis who are being treated with biological agents. We present our experience in 369 patients with moderate-to-severe psoriasis undergoing therapy with anti-IL agents who were vaccinated against SARS-CoV-2. null Areas covered null : None of the 369 patients referred any serious adverse event related to vaccination against COVID-19, while about one-third reported mild adverse events simi...
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#1Caiguang Liu (SYSU: Sun Yat-sen University)H-Index: 2
#2Na Li (SYSU: Sun Yat-sen University)H-Index: 2
Last. Xiaojun Zhuang (SYSU: Sun Yat-sen University)H-Index: 5
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BACKGROUND Approximately half of patients with Crohn's disease (CD) may inevitably receive surgical intervention in the course of the disease. However, about 75% of CD patients will experience postoperative recurrence (POR). Biologics are appealing alternatives for the prevention of POR; however, it is still unclear which biological agents are more efficient. This meta-analysis aimed to investigate the efficacy of biologics for POR prevention and to compare the superiority of different biologics...
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#1FE Chen (Barts Health NHS Trust)H-Index: 10
#1Frederick Chen (Barts Health NHS Trust)H-Index: 10
Last. Adrian Newland (Barts Health NHS Trust)
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INTRODUCTION The management of ITP has in recent years been transformed from reliance on immunosuppressants and splenectomy to targeted therapy with thrombopoietin receptor agonists (TPO-RA) that directly stimulate platelet production in the bone marrow. This has reduced the long-term infective complications and toxicities associated with the use of potent immunosuppressants and splenectomy. The welltolerated romiplostim, itself a novel drug construct called peptibody, has established itself, al...
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#1Jeffrey P Aldinger (EVMS: Eastern Virginia Medical School)
#2Taylor Dobyns (EVMS: Eastern Virginia Medical School)
Last. Joseph K. Han (EVMS: Eastern Virginia Medical School)H-Index: 29
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Introduction: Chronic rhinosinusitis with nasal polyposis (CRSwNP) poses a significant healthcare challenge, with diminished quality of life for patients and high costs and resource utilization for disease management. The understanding of CRSwNP pathophysiology has progressed with identification of various inflammatory biomarkers and subsequent development of monoclonal antibodies that target the underlying mechanisms of inflammation.Areas covered: Omalizumab is a biologic agent for CRSwNP treat...
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