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https://www.readbyqxmd.com/read/29679282/burosumab-first-global-approval
#1
Yvette N Lamb
Burosumab (Crysvita® ; Kyowa Hakko Kirin Co., Ltd. and Ultragenyx Pharmaceutical Inc.) is a fully human monoclonal antibody directed at fibroblast growth factor 23 (FGF23). Excessive FGF23 production has been implicated in various hypophosphataemic diseases. Inhibition of FGF23 by burosumab results in increased renal phosphate reabsorption and increased serum levels of phosphorus and active vitamin D. In February 2018, the EMA granted subcutaneous burosumab conditional marketing authorization for the treatment of X-linked hypophosphataemia (XLH) with radiographic evidence of bone disease in children one year of age and older and adolescents with growing skeletons...
April 20, 2018: Drugs
https://www.readbyqxmd.com/read/29677006/evidence-basis-for-integrated-management-of-mineral-metabolism-in-patients-with-end-stage-renal-disease
#2
Julia J Scialla
PURPOSE OF REVIEW: Treatment of mineral metabolism is a mainstay of dialysis care including some of its most widely used and costly pharmaceuticals. Although many mineral metabolites are associated with increased risk of mortality, cardiovascular disease, and other morbidities, few clinical trials are available to guide therapy and most focus on single drug approaches. In practice, providers manage many aspects of mineral metabolism simultaneously in integrated treatment approaches that incorporate multiple agents and changes in the dialysis prescription...
April 6, 2018: Current Opinion in Nephrology and Hypertension
https://www.readbyqxmd.com/read/29676523/characterization-of-low-abundance-species-in-the-active-pharmaceutical-ingredient-of-cigb-300-a-clinical-grade-anticancer-synthetic-peptide
#3
Hilda Garay, Luis Ariel Espinosa, Yasser Perera, Aniel Sánchez, David Diago, Silvio E Perea, Vladimir Besada, Osvaldo Reyes, Luis Javier González
CIGB-300 is a first-in-class synthetic peptide-based drug of 25 amino acids currently undergoing clinical trials in cancer patients. It contains an amidated disulfide cyclic undecapeptide fused to the TAT cell-penetrating peptide through a beta-alanine spacer. CIGB-300 inhibits the CK2-mediated phosphorylation leading to apoptosis of tumor cells in vitro, and in vivo in cancer patients. Despite the clinical development of CIGB-300, the characterization of peptide-related impurities present in the active pharmaceutical ingredient has not been reported earlier...
April 20, 2018: Journal of Peptide Science: An Official Publication of the European Peptide Society
https://www.readbyqxmd.com/read/29672720/how-views-of-the-organization-of-primary-care-among-patients-with-hypertension-vary-by-race-or-ethnicity
#4
George L Jackson, Karen M Stechuchak, Morris Weinberger, Hayden B Bosworth, Cynthia J Coffman, Miriam A Kirshner, David Edelman
INTRODUCTION: We assessed potential racial or ethnic differences in the degree to which veterans with pharmaceutically treated hypertension report experiences with their primary care system that are consistent with optimal chronic illness care as suggested by Wagner's Chronic Care Model (CCM). MATERIALS AND METHODS: A cross-sectional analysis of the results of the Patient Assessment of Chronic Illness Care (PACIC), which measured components of the care system suggested by the CCM and was completed at baseline by participants in a hypertension disease management clinical trial...
April 17, 2018: Military Medicine
https://www.readbyqxmd.com/read/29671615/patient-reported-outcomes-for-the-detection-quantification-and-evaluation-of-chronic-obstructive-pulmonary-disease-exacerbations
#5
Alex J Mackay, Konstantinos Kostikas, Lindsey Murray, Fernando J Martinez, Marc Miravitlles, Gavin Donaldson, Donald Banerji, Francesco Patalano, Jadwiga A Wedzicha
An exacerbation of Chronic Obstructive Pulmonary Disease (COPD) is an acute worsening of respiratory symptoms, accompanied by a variable degree of physiological deterioration. The traditional assessment of an exacerbation consists of the reporting of symptoms directly by the patient to a clinician and subsequent clinical assessment. It would be valuable to also gather symptom reports directly from patients and thus patient-reported outcome (PRO) tools should be ideally suited to the evaluation of COPD exacerbations...
April 19, 2018: American Journal of Respiratory and Critical Care Medicine
https://www.readbyqxmd.com/read/29670611/advances-in-biomarker-guided-therapy-for-pediatric-and-adult-onset-neuroinflammatory-disorders-targeting-chemokines-cytokines
#6
REVIEW
Michael R Pranzatelli
The concept and recognized components of "neuroinflammation" are expanding at the intersection of neurobiology and immunobiology. Chemokines (CKs), no longer merely necessary for immune cell trafficking and positioning, have multiple physiologic, developmental, and modulatory functionalities in the central nervous system (CNS) through neuron-glia interactions and other mechanisms affecting neurotransmission. They issue the "help me" cry of neurons and astrocytes in response to CNS injury, engaging invading lymphoid cells (T cells and B cells) and myeloid cells (dendritic cells, monocytes, and neutrophils) (adaptive immunity), as well as microglia and macrophages (innate immunity), in a cascade of events, some beneficial (reparative), others destructive (excitotoxic)...
2018: Frontiers in Immunology
https://www.readbyqxmd.com/read/29662024/pkidb-a-curated-annotated-and-updated-database-of-protein-kinase-inhibitors-in-clinical-trials
#7
Fabrice Carles, Stéphane Bourg, Christophe Meyer, Pascal Bonnet
The number of protein kinase inhibitors (PKIs) approved worldwide continues to grow steadily, with 39 drugs approved in the period between 2001 and January 2018. PKIs on the market have been the subject of many reviews, and structure-property relationships specific to this class of drugs have been inferred. However, the large number of PKIs under development is often overlooked. In this paper, we present PKIDB (Protein Kinase Inhibitor Database), a monthly-updated database gathering approved PKIs as well as PKIs currently in clinical trials...
April 15, 2018: Molecules: a Journal of Synthetic Chemistry and Natural Product Chemistry
https://www.readbyqxmd.com/read/29660367/natural-killer-cells-and-their-therapeutic-role-in-pancreatic-cancer-a-systematic-review
#8
REVIEW
Jonas R M Van Audenaerde, Geert Roeyen, Phillip K Darcy, Michael H Kershaw, M Peeters, Evelien L J Smits
Pancreatic cancer is among the three deadliest cancers worldwide with the lowest 5-year survival of all cancers. Despite all efforts, therapeutic improvements have barely been made over the last decade. Even recent highly promising targeted and immunotherapeutic approaches did not live up to their expectations. Therefore, other horizons have to be explored. Natural Killer (NK) cells are gaining more and more interest as a highly attractive target for cancer immunotherapies, both as pharmaceutical target and for cell therapies...
April 13, 2018: Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29658845/nivolumab-plus-ipilimumab-in-lung-cancer-with-a-high-tumor-mutational-burden
#9
Matthew D Hellmann, Tudor-Eliade Ciuleanu, Adam Pluzanski, Jong Seok Lee, Gregory A Otterson, Clarisse Audigier-Valette, Elisa Minenza, Helena Linardou, Sjaak Burgers, Pamela Salman, Hossein Borghaei, Suresh S Ramalingam, Julie Brahmer, Martin Reck, Kenneth J O'Byrne, William J Geese, George Green, Han Chang, Joseph Szustakowski, Prabhu Bhagavatheeswaran, Diane Healey, Yali Fu, Faith Nathan, Luis Paz-Ares
Background Nivolumab plus ipilimumab showed promising efficacy for the treatment of non-small-cell lung cancer (NSCLC) in a phase 1 trial, and tumor mutational burden has emerged as a potential biomarker of benefit. In this part of an open-label, multipart, phase 3 trial, we examined progression-free survival with nivolumab plus ipilimumab versus chemotherapy among patients with a high tumor mutational burden (≥10 mutations per megabase). Methods We enrolled patients with stage IV or recurrent NSCLC that was not previously treated with chemotherapy...
April 16, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29656311/consensus-paper-neurophysiological-assessments-of-ataxias-in-daily-practice
#10
REVIEW
W Ilg, M Branscheidt, A Butala, P Celnik, L de Paola, F B Horak, L Schöls, H A G Teive, A P Vogel, D S Zee, D Timmann
The purpose of this consensus paper is to review electrophysiological abnormalities and to provide a guideline of neurophysiological assessments in cerebellar ataxias. All authors agree that standard electrophysiological methods should be systematically applied in all cases of ataxia to reveal accompanying peripheral neuropathy, the involvement of the dorsal columns, pyramidal tracts and the brainstem. Electroencephalography should also be considered, although findings are frequently non-specific. Electrophysiology helps define the neuronal systems affected by the disease in an individual patient and to understand the phenotypes of the different types of ataxia on a more general level...
April 14, 2018: Cerebellum
https://www.readbyqxmd.com/read/29653414/new-insights-on-the-modulatory-roles-of-metformin-or-alpha-lipoic-acid-versus-their-combination-in-dextran-sulfate-sodium-induced-chronic-colitis-in-rats
#11
Fatma S Samman, Samah M Elaidy, Soha S Essawy, Mohammad S Hassan
BACKGROUND: Dextran sulfate sodium (DSS)-induced colitis is the most widely used model that resembles ulcerative colitis (UC) in human with challenging chronic mechanistic oxidative stress-inflammatory/immunological cascades. In models of acute colitis, reduction of oxidative stress and inflammatory burdens beside manipulation of many transcriptional factors were achieved by metformin or alpha-lipoic acid (α-LA). Currently, in vivo DSS-induced chronic colitis was conducted and the possible therapeutic roles of metformin and/or α-LA were explored...
November 24, 2017: Pharmacological Reports: PR
https://www.readbyqxmd.com/read/29651962/phase-iv-studies-some-insights-clarifications-and-issues
#12
Elia Mario Biganzoli, Bruno Mario Cesana
BACKGROUND: There is an increasing need to face regulatory aspects as well as ethics and scientific ones in the pharmaceutical research phase after the authorization of a drug. Traditionally, the Phase IV studies, after the authorization for a drug to be marketed by the Competent Authority like the Food and Drug Administration (FDA) (in Europe, European Medicine Agency -EMA- through National Procedures or Community Procedures) have been considered mainly aimed to the assessment of the new drug safety profile...
April 12, 2018: Current Clinical Pharmacology
https://www.readbyqxmd.com/read/29649849/-copd-importance-of-lung-function-testing-for-diagnosis-and-treatment
#13
Wolfram Windisch, Carl Peter Criée
Pulmonary function testing is essential for diagnosis and treatment-guidance of chronic obstructive pulmonary disease (COPD). Airway obstruction as assessed by spirometry should follow the reference-values provided by the Global Lung Initiative (GLI) of the European Respiratory Society (ERS). In addition, lung function testing should also include the assessment of lung hyperinflation and pulmonary emphysema by full-body plethysmography and determination of diffusion capacity. This is important since both, lung hyperinflation and pulmonary emphysema, can present without existing airway obstruction...
April 2018: Deutsche Medizinische Wochenschrift
https://www.readbyqxmd.com/read/29628727/inositols-in-midlife
#14
Sanjay Kalra, Bharti Kalra
This review describes the mechanistic, animal, and clinical data related to the use of inositols in midlife. It covers studies related to the mechanism of action of myo-inositol and D-chiro-inositol and randomized controlled trials conducted in postmenopausal women with metabolic syndrome and supports these data with the results of in vitro and animal studies on inositol in nephropathy and other related conditions. Recent advances related to biochemistry, pharmaceutical science, and genetics are discussed. It concludes that inositols have a potential role to play in maintaining metabolic health in postmenopausal women...
January 2018: Journal of Mid-life Health
https://www.readbyqxmd.com/read/29627231/status-of-vaccine-research-and-development-for-helicobacter-pylori
#15
Philip Sutton, Joanne M Boag
Gastric adenocarcinoma is globally the third leading cause of death due to malignancy, with the bulk of this disease burden being suffered by low and middle income countries (LMIC), especially in Asia. The majority of these cancers develop as a result of a chronic gastritis that arises in response to infection with the stomach-dwelling bacterium, Helicobacter pylori. A vaccine against this pathogen would therefore be a powerful tool for preventing gastric adenocarcinoma. However, notwithstanding a proof-of-concept that vaccination can protect children from acquisition of H...
April 4, 2018: Vaccine
https://www.readbyqxmd.com/read/29626048/dabigatran-persistence-and-adherence-in-new-zealand-a-nationwide-retrospective-observational-study
#16
Paul Harper, Daryl Pollock, Matt Stephens
OBJECTIVE: To determine the effect of age and gender on persistence and adherence in patients taking dabigatran for atrial fibrillation. DESIGN: A retrospective observational study over 4 years using refill prescription data from the National Pharmaceutical Database. SETTING: All patients in New Zealand who received dabigatran from July 2011 to September 2015. POPULATION: 43 339 people filled at least one prescription of dabigatran...
April 5, 2018: BMJ Open
https://www.readbyqxmd.com/read/29620999/dose-dependent-lowering-of-mutant-huntingtin-using-antisense-oligonucleotides-in-huntington-disease-patients
#17
Willeke M C van Roon-Mom, Raymund A C Roos, Susanne T de Bot
On December 11 of 2017, Ionis Pharmaceuticals published a press release announcing dose-dependent reductions of mutant huntingtin protein in their HTTRx Phase 1/2a study in Huntington disease (HD) patients. The results from this Ionis trial have gained much attention from the patient community and the oligonucleotide therapeutics field, since it is the first trial targeting the cause of HD, namely the mutant huntingtin protein, using antisense oligonucleotides (ASOs). The press release also states that the primary endpoints of the study (safety and tolerability) were met, but does not contain data...
April 2018: Nucleic Acid Therapeutics
https://www.readbyqxmd.com/read/29620793/antidepressants-versus-placebo-for-panic-disorder-in-adults
#18
REVIEW
Irene Bighelli, Mariasole Castellazzi, Andrea Cipriani, Francesca Girlanda, Giuseppe Guaiana, Markus Koesters, Giulia Turrini, Toshi A Furukawa, Corrado Barbui
BACKGROUND: Panic disorder is characterised by repeated, unexpected panic attacks, which represent a discrete period of fear or anxiety that has a rapid onset, reaches a peak within 10 minutes, and in which at least four of 13 characteristic symptoms are experienced, including racing heart, chest pain, sweating, shaking, dizziness, flushing, stomach churning, faintness and breathlessness. It is common in the general population with a lifetime prevalence of 1% to 4%. The treatment of panic disorder includes psychological and pharmacological interventions...
April 5, 2018: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29618488/steroid-sulfatase-inhibition-by-aryl-sulfamates-clinical-progress-mechanism-and-future-prospects
#19
Barry V L Potter
Steroid sulfatase is an emerging drug target for the endocrine therapy of hormone-dependent diseases, catalyzing estrogen sulfate hydrolysis to estrogen. Drug discovery, developing the core aryl O-sulfamate pharmacophore, has led to steroidal and non-steroidal drugs entering numerous clinical trials, with promising results in oncology and women's health. Steroidal estrogen sulfamate derivatives were the first irreversible active-site-directed inhibitors and one was developed clinically as an oral estradiol pro-drug and for endometriosis applications...
April 4, 2018: Journal of Molecular Endocrinology
https://www.readbyqxmd.com/read/29611870/initial-severity-of-major-depression-and-efficacy-of-new-generation-antidepressants-individual-participant-data-meta-analysis
#20
T A Furukawa, K Maruo, H Noma, S Tanaka, H Imai, K Shinohara, K Ikeda, S Yamawaki, S Z Levine, Y Goldberg, S Leucht, A Cipriani
OBJECTIVE: The role of baseline severity as effect modifier in various psychiatric disorders is a topic of controversy and of clinical import. This study aims to examine whether baseline severity modifies the efficacy of various antidepressants for major depression through individual participant data (IPD) meta-analysis. METHOD: We identified all placebo-controlled, double-blind randomised trials of new generation antidepressants in the acute phase treatment of major depression conducted in Japan and requested their IPD through the public-private partnerships (PPPs) between the relevant academic societies and the pharmaceutical companies...
April 3, 2018: Acta Psychiatrica Scandinavica
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