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https://www.readbyqxmd.com/read/28749100/medical-devices-cardiovascular-devices-classification-of-the-balloon-aortic-valvuloplasty-catheter-final-order
#1
(no author information available yet)
The Food and Drug Administration (FDA, Agency, or we) is classifying the balloon aortic valvuloplasty catheter into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the balloon aortic valvuloplasty catheter's classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.
July 27, 2017: Federal Register
https://www.readbyqxmd.com/read/28749099/medical-devices-immunology-and-microbiology-devices-classification-of-the-assayed-quality-control-material-for-clinical-microbiology-assays-final-order
#2
(no author information available yet)
The Food and Drug Administration (FDA, Agency, or we) is classifying the assayed quality control material for clinical microbiology assays into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the assayed quality control material for clinical microbiology assays' classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device...
July 27, 2017: Federal Register
https://www.readbyqxmd.com/read/28748401/system-biology-approach-to-identify-potential-receptor-for-targeting-cancer-and-biomolecular-interaction-studies-of-indole-2-1-a-isoquinoline-derivative-as-anticancerous-drug-candidate-against-it
#3
Devender Arora, Ritu Chaudhary, Ajeet Singh
Cancer is a public health concern which is spreading throughout the world. Different approaches have been employed to combat this disease. System biology approach has been used to understand the molecular mechanisms of drugs targeting cancer cell's receptor which have opened-up a window to develop effective drugs for it. We have demonstrated biomolecular interaction studies using the rational drug design of indole[2,1-a]isoquinoline derivative as a potent inhibitor against identified cancerous protein PIK3CA -a catalytic sub-unit of PI3K family protein-and compared its affinity with FDA approved drugs for receptors such as dactolisib, idelalisib, and several others such afatinib, avastin, ceritinib and crizotinib, etc...
July 26, 2017: Interdisciplinary Sciences, Computational Life Sciences
https://www.readbyqxmd.com/read/28747544/activation-of-cancerous-inhibitor-of-pp2a-cip2a-contributes-to-lapatinib-resistance-through-induction-of-cip2a-akt-feedback-loop-in-erbb2-positive-breast-cancer-cells
#4
Ming Zhao, Erin W Howard, Amanda B Parris, Zhiying Guo, Qingxia Zhao, Zhikun Ma, Ying Xing, Bolin Liu, Susan M Edgerton, Ann D Thor, Xiaohe Yang
Lapatinib, a small molecule ErbB2/EGFR inhibitor, is FDA-approved for the treatment of metastatic ErbB2-overexpressing breast cancer; however, lapatinib resistance is an emerging clinical challenge. Understanding the molecular mechanisms of lapatinib-mediated anti-cancer activities and identifying relevant resistance factors are of pivotal significance. Cancerous inhibitor of protein phosphatase 2A (CIP2A) is a recently identified oncoprotein that is overexpressed in breast cancer. Our study investigated the role of CIP2A in the anti-cancer efficacy of lapatinib in ErbB2-overexpressing breast cancer cells...
July 19, 2017: Oncotarget
https://www.readbyqxmd.com/read/28747053/eluxadoline-in-the-treatment-of-diarrhea-predominant-irritable-bowel-syndrome-the-sepd-perspective
#5
Isabel Vera, F Javier Júdez
Functional gut disorders, including diarrhea-predominant irritable bowel syndrome, are highly prevalent conditions worldwide that significantly impact health economy and patient quality of life, yet lacking fully satisfactory therapeutic options. These circumstances fostered research on various molecules with more specific therapeutic targets, including opioid receptors. Eluxadoline (Allergan's Vibercy® in the USA, Truberzi® in Europe) is a locally-acting mixed - and -opioid receptor agonist, and -opioid receptor antagonist, that was licensed in 2015 by the Food and Drug Administration (FDA) and in 2016 by the European Medicines Agency (EMA) for use in diarrhea-predominant irritable bowel syndrome...
July 27, 2017: Revista Española de Enfermedades Digestivas
https://www.readbyqxmd.com/read/28744102/bioequivalence-of-generic-alendronate-sodium-tablets-70-mg-to-fosamax-%C3%A2-tablets-70-mg-in-fasting-healthy-volunteers-a-randomized-open-label-three-way-reference-replicated-crossover-study
#6
Yifan Zhang, Xiaoyan Chen, Yunbiao Tang, Youming Lu, Lixia Guo, Dafang Zhong
PURPOSE: The aim of this study was to evaluate the bioequivalence of a generic product 70 mg alendronate sodium tablets with the reference product Fosamax(®) 70 mg tablet. MATERIALS AND METHODS: A single-center, open-label, randomized, three-period, three-sequence, reference-replicated crossover study was performed in 36 healthy Chinese male volunteers under fasting conditions. In each study period, the volunteers received a single oral dose of the generic or reference product (70 mg)...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28743810/polymyxin-combinations-combat-escherichia-coli-harboring-mcr-1-and-blandm-5-preparation-for-a-postantibiotic-era
#7
Zackery P Bulman, Liang Chen, Thomas J Walsh, Michael J Satlin, Yuli Qian, Jürgen B Bulitta, Charles A Peloquin, Patricia N Holden, Roger L Nation, Jian Li, Barry N Kreiswirth, Brian T Tsuji
The rapid increase of carbapenem resistance in Gram-negative bacteria has resurrected the importance of the polymyxin antibiotics. The recent discovery of plasmid-mediated polymyxin resistance (mcr-1) in carbapenem-resistant Enterobacteriaceae serves as an important indicator that the golden era of antibiotics is under serious threat. We assessed the bacterial killing of 15 different FDA-approved antibiotics alone and in combination with polymyxin B in time-killing experiments against Escherichia coli MCR1_NJ, the first reported isolate in the United States to coharbor mcr-1 and a New Delhi metallo-β-lactamase gene (blaNDM-5)...
July 25, 2017: MBio
https://www.readbyqxmd.com/read/28742396/valbenazine-for-tardive-dyskinesia
#8
Oliver Freudenreich, Gary Remington
Tardive dyskinesia (TD) remains a clinical concern for any patient who receives an antipsychotic. While the overall risk of developing TD is lower with newer antipsychotics compared to older agents, a significant number of patients who require long-term treatment will develop TD. Recently, valbenazine (brand name Ingrezza) became the first drug to be approved by the FDA specifically for the treatment of TD. In this New Drug Review, we summarize the basic pharmacology and clinical trial results for valbenazine...
2017: Clinical Schizophrenia & related Psychoses
https://www.readbyqxmd.com/read/28742291/evaluating-the-effect-of-the-changes-in-fda-guidelines-for-clozapine-monitoring
#9
Ryan S Sultan, Mark Olfson, Christoph U Correll, Erica J Duncan
BACKGROUND: Concerns exist that clozapine is underutilized in the management of treatment-resistant schizophrenia. Although a 2015 change in the US Food and Drug Administration (FDA) monitoring recommendations lowered the threshold of the absolute neutrophil count for treatment interruption from 1,500/μL to 1,000/μL and removed white blood cell count thresholds from the monitoring algorithm, the implications of this policy change on clozapine interruptions remain unknown. METHODS: We analyzed outpatient prescribing records for antipsychotic medications in the Veterans Integrated Service Network 7 (VISN 7) database between 1999 and 2012 to assess the potential impact of the recent changes in FDA neutropenia monitoring recommendations on clozapine treatment discontinuation...
July 18, 2017: Journal of Clinical Psychiatry
https://www.readbyqxmd.com/read/28741800/eteplirsen-for-the-treatment-of-duchenne-muscular-dystrophy-quality-of-evidence-concerns-an-alternative-viewpoint
#10
Adriane N Irwin, Megan C Herink
We read the paper by Reinig AM and colleagues entitled "Advances in the Treatment of Duchenne Muscular Dystrophy: New and Emerging Pharmacotherapies" with great interest.(1) The authors discuss several novel therapies to increase production of dystrophin in myocytes, of which, eteplirsen (Exondys) is the only currently approved by the US Food & Drug Administration (FDA).(2) Pharmacologic management of Duchenne muscular dystrophy (DMD) centers on the use of glucocorticoids which works by decreasing inflammation and reducing immune system activity...
July 25, 2017: Pharmacotherapy
https://www.readbyqxmd.com/read/28741518/companion-and-complementary-diagnostics-clinical-and-regulatory-perspectives
#11
REVIEW
Jan Trøst Jørgensen
Nearly 20 years ago, the US Food and Drug Administration (FDA) approved the first companion diagnostic assay and, today, this type of test governs the use of 18 different drugs. With the appearance of PD-L1 immunohistochemistry (IHC) assays linked to the use of different PD-1/PD-L1 immune checkpoint inhibitors, a new class of predictive biomarker assays has emerged; the complementary diagnostics. These are predictive biomarker assays that aid the therapeutic decision process but are not a prerequisite for receiving a specific drug, as is the case with companion diagnostics...
December 2016: Trends in Cancer
https://www.readbyqxmd.com/read/28740397/eligibility-for-alirocumab-or-evolocumab-treatment-in-1090-hypercholesterolemic-patients-referred-to-a-regional-cholesterol-treatment-center-with-ldl-cholesterol-%C3%A2-70-mg-dl-despite-maximal-tolerated-ldl-cholesterol-lowering-therapy
#12
Vybhav Jetty, Charles J Glueck, Kevin Lee, Naila Goldenberg, Marloe Prince, Ashwin Kumar, Michael Goldenberg, Ishan Anand, Ping Wang
BACKGROUND: Proprotein convertase subtilisin/kexin type 9 inhibitors, Praluent (alirocumab [ALI]) and Repatha (evolocumab [EVO]) have been approved as adjuncts to the standard-of-care maximal-tolerated dose (MTD) of low-density lipoprotein cholesterol (LDLC)-lowering therapy (LLT), statin therapy, in heterozygous (HeFH) (ALI or EVO) or homozygous (EVO) familial hypercholesterolemia, or clinical atherosclerotic cardiovascular disease (CVD) where LDLC lowering is insufficient (both). Since LDLC lowering has been revolutionized by ALI and EVO, specialty pharmaceutical pricing models will be applied to a mass market...
2017: Vascular Health and Risk Management
https://www.readbyqxmd.com/read/28739585/the-burdens-and-uncertainties-of-doing-what-one-should-do
#13
EDITORIAL
Victor G Vogel
Despite FDA approval of drugs to reduce the risk of breast cancer in women at increased risk, uptake of these drugs has been poor despite the publication of numerous studies that demonstrate both their effectives and safety. National organizations have made recommendations for their use, but both physicians and their patients do not fully understand either breast cancer risk factors or risk assessment or the indications for using risk-reducing agents. Histologically predisposing conditions, such as ductal or lobular atypia and lobular carcinoma in situ, impart particularly high risks of developing subsequent invasive breast cancer...
July 24, 2017: Cancer Prevention Research
https://www.readbyqxmd.com/read/28739575/fda-regulatory-perspectives-for-studies-on-hemodialysis-vascular-access
#14
Frank P Hurst, Robert E Lee, Aliza M Thompson, Brian D Pullin, Douglas M Silverstein
In an effort to foster innovation and new product development, the American Society of Nephrology and the US Food and Drug Administration partnered to form the Kidney Health Initiative in 2012. Part of the Kidney Health Initiative's mission is to foster development of therapies by creating a collaborative environment where the US Food and Drug Administration and the greater nephrology community can interact to optimize product evaluation. This particular Kidney Health Initiative project focused on products related to hemodialysis vascular access, with the goal of clarifying appropriate trial end points that could subsequently inform clinical, regulatory, and coverage decisions...
July 24, 2017: Clinical Journal of the American Society of Nephrology: CJASN
https://www.readbyqxmd.com/read/28738891/pivotal-trials-of-orthopedic-surgical-devices-in-the-united-states-predominance-of-two-arm-non-inferiority-designs
#15
S Raymond Golish
BACKGROUND: The United States Food and Drug Administration (FDA) reviews class III orthopedic devices submitted for premarket approval with pivotal clinical trials. The purpose of this study was to determine the types of orthopedic devices reviewed, the design of their pivotal clinical trials, and the subjective factors affecting the interpretation of clinical trial data. METHODS: Meetings of the FDA Orthopaedic and Rehabilitation Devices Panel were identified from 2000-2016...
July 24, 2017: Trials
https://www.readbyqxmd.com/read/28737885/classics-in-chemical-neuroscience-memantine
#16
Shahrina Alam, Kaelyn Skye Lingenfelter, Aaron M Bender, Craig W Lindsley
Memantine was the first breakthrough medication for the treatment of moderate to severe Alzheimer's disease (AD) patients, and represents a fundamentally new mechanism of action (moderate-affinity, uncompetitive, voltage-dependent, N-methyl-D-aspartate (NMDA) receptor antagonist that exhibits fast on/off kinetics) to modulate glutamatergic dysfunction. Since its approval by the FDA in 2003, memantine, alone, and in combination with donepezil, has improved patient outcomes in terms of cognition, behavioral disturbances, daily functioning and delaying time to institutionalization...
July 24, 2017: ACS Chemical Neuroscience
https://www.readbyqxmd.com/read/28737743/development-of-gene-therapies-lessons-from-nusinersen
#17
REVIEW
L Xu, I Irony, W W Bryan, B Dunn
The nusinersen development and approval process provide important lessons regarding the pathway to marketing approval for gene therapies. These lessons emphasize rigorous clinical trial design, flexibility in trial design and analysis, a collaborative effort with regular communications between the drug developer and the FDA, and use of FDA's expedited programs. These lessons are critical to the development of gene therapies for the treatment of serious or life-threatening rare diseases.Gene Therapy accepted article preview online, 24 July 2017...
July 24, 2017: Gene Therapy
https://www.readbyqxmd.com/read/28737730/sildenafil-in-infants-and-children
#18
REVIEW
Larisa Simonca, Robert Tulloh
Pulmonary arterial hypertension (PAH) management has been transformed in recent times with the advent of cheap and effective diagnostic tools and therapy. Sildenafil, a phosphodiesterase-V inhibitor, has been at the centre of this treatment, and its success in treating PAH has led to its widespread uptake in adult and paediatric pulmonary hypertension (PH), as a first line treatment choice. This might apply to persistent pulmonary hypertension of the newborn (PPHN) or bronchopulmonary dysplasia, as well as to more complex diseases, such as idiopathic pulmonary hypertension...
July 24, 2017: Children
https://www.readbyqxmd.com/read/28737679/modernization-of-enoxaparin-molecular-weight-determination-using-homogeneous-standards
#19
Katelyn M Arnold, Stephen J Capuzzi, Yongmei Xu, Eugene N Muratov, Kevin Carrick, Anita Y Szajek, Alexander Tropsha, Jian Liu
Enoxaparin is a low-molecular weight heparin used to treat thrombotic disorders. Following the fatal contamination of the heparin supply chain in 2007-2008, the U.S. Pharmacopeia (USP) and U.S. Food and Drug Administration (FDA) have worked extensively to modernize the unfractionated heparin and enoxaparin monographs. As a result, the determination of molecular weight (MW) has been added to the monograph as a measure to strengthen the quality testing and to increase the protection of the global supply of this life-saving drug...
July 22, 2017: Pharmaceuticals
https://www.readbyqxmd.com/read/28737432/integrin-targeted-nano-sized-polymeric-systems-for-paclitaxel-conjugation-a-comparative-study
#20
Anat Eldar-Boock, Rachel Blau, Claudia Ryppa, Hemda Baabur-Cohen, Ariel Many, María J Vicent, Felix Kratz, Joaquin Sanchis, Ronit Satchi-Fainaro
The generation of rationally-designed polymer therapeutics via the conjugation of low molecular weight anti-cancer drugs to water-soluble polymeric nanocarriers aims to improve the therapeutic index. Here, we focus on applying polymer therapeutics to target two cell compartments simultaneously - tumor cells and angiogenic endothelial cells. Comparing different polymeric backbones carrying the same therapeutic agent and targeting moiety may shed light on any correlation between the choice of polymer and the anti-cancer activity of the conjugate...
July 24, 2017: Journal of Drug Targeting
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