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https://www.readbyqxmd.com/read/28944741/the-application-of-nanoparticles-for-neuroprotection-in-acute-ischemic-stroke
#1
Lepei Chen, Xiaoling Gao
Stroke still represents one of the most common causes of death and disability worldwide. Acute ischemic stroke (AIS), caused by brain arterial occlusion resulting from a thrombus or embolus, is the most common form of stroke. However, current therapies in AIS are inadequate, and the only US FDA approved treatment is the thrombolytic drug Alteplase. Therefore, establishing effective therapeutic strategies for AIS is urgently needed. Using nanoparticle-based technologies to deliver neuroprotective agents to the ischemic area has attracted increasing attention of late...
October 2017: Therapeutic Delivery
https://www.readbyqxmd.com/read/28944733/performance-based-risk-sharing-arrangements-for-pharmaceutical-products-in-the-united-states-a-systematic-review
#2
Justin S Yu, Lauren Chin, Jennifer Oh, Jorge Farias
BACKGROUND: Value for money is a growing necessity in today's U.S. health care system in which drug spending is expected to increase by an average rate of 6.7% yearly through 2025. In response to uncertainty about real-world clinical and economic outcomes for many drugs, health insurers and pharmacy benefit managers (PBMs) have implemented various contracts and arrangements with drug manufacturers that can collectively be described as performance-based risk-sharing arrangements (PBRSAs)...
October 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28944732/patient-centered-drug-approval-the-role-of-patient-advocacy-in-the-drug-approval-process
#3
T Joseph Mattingly, Linda Simoni-Wastila
Recent approval of eteplirsen for Duchenne muscular dystrophy (DMD), a rare disease with few treatment alternatives, has reignited the debate over the U.S. drug approval process. The evolution of legal and regulatory restrictions to the marketing and sale of pharmaceuticals has spanned more than a century, and throughout this history, patient advocacy has played a significant role. Scientific evidence from clinical trials serves as the foundation for drug approval, but the patient voice has become increasingly influential...
October 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28944731/the-fda-unapproved-drugs-initiative-an-observational-study-of-the-consequences-for-drug-prices-and-shortages-in-the-united-states
#4
Ravi Gupta, Sanket S Dhruva, Erin R Fox, Joseph S Ross
BACKGROUND: Hundreds of drug products are currently marketed in the United States without approval from the FDA. The 2006 Unapproved Drugs Initiative (UDI) requires manufacturers to remove these drug products from the market or obtain FDA approval by demonstrating evidence of safety and efficacy. Once the FDA acts against an unapproved drug, fewer manufacturers remain in the market, potentially enabling drug price increases and greater susceptibility to drug shortages. There is a need for systematic study of the UDI's effect on prices and shortages of all targeted drugs...
October 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28943275/mifepristone-enhances-insulin-stimulated-akt-phosphorylation-and-glucose-uptake-in-skeletal-muscle-cells
#5
Izela Bernal-Sore, Mario Navarro-Marquez, César Osorio-Fuentealba, Francisco Díaz-Castro, Andrea Del Campo, Camila Donoso-Barraza, Omar Porras, Sergio Lavandero, Rodrigo Troncoso
Mifepristone is the only FDA-approved drug for glycaemia control in patients with Cushing's syndrome and type 2 diabetes. Mifepristone also has beneficial effects in animal models of diabetes and patients with antipsychotic treatment-induced obesity. However, the mechanisms through which Mifepristone produces its beneficial effects are not completely elucidated. PURPOSE: To determine the effects of mifepristone on insulin-stimulated glucose uptake on a model of L6 rat-derived skeletal muscle cells...
September 21, 2017: Molecular and Cellular Endocrinology
https://www.readbyqxmd.com/read/28942951/the-algorithmic-performance-of-j-tpeak-for-drug-safety-clinical-trial
#6
Simon C Chien, Richard E Gregg
INTRODUCTION: The interval from J-point to T-wave peak (JTp) in ECG is a new biomarker able to identify drugs that prolong the QT interval but have different ion channel effects. If JTp is not prolonged, the prolonged QT may be associated with multi ion channel block that may have low torsade de pointes risk. From the automatic ECG measurement perspective, accurate and repeatable measurement of JTp involves different challenges than QT. We evaluated algorithm performance and JTp challenges using the Philips DXL diagnostic 12/16/18-lead algorithm...
August 15, 2017: Journal of Electrocardiology
https://www.readbyqxmd.com/read/28942418/clinical-trial-transparency-a-reassessment-of-industry-compliance-with-clinical-trial-registration-and-reporting-requirements-in-the-united-states
#7
Scott M Lassman, Olivia M Shopshear, Ina Jazic, Jocelyn Ulrich, Jeffrey Francer
OBJECTIVE: To evaluate the accuracy of a 2015 cross-sectional analysis published in the BMJ Open which reported that pharmaceutical industry compliance with clinical trial registration and results reporting requirements under US law was suboptimal and varied widely among companies. DESIGN: We performed a reassessment of the data reported in Miller et al to evaluate whether statutory compliance analyses and conclusions were valid. DATA SOURCES: Information from the Dryad Digital Repository, ClinicalTrials...
September 23, 2017: BMJ Open
https://www.readbyqxmd.com/read/28942107/the-market-of-chiral-drugs-chiral-switches-versus-de-novo-enantiomerically-pure-compounds
#8
REVIEW
Andrea Calcaterra, Ilaria D'Acquarica
This review article is aimed at providing an overview of the current market of chiral drugs by exploring which is the nowadays tendency, for the pharmaceutical industry, either to exploit the chiral switching practice from already marketed racemates or to develop de novo enantiomerically pure compounds. A concise illustration of the main techniques developed to assess the absolute configuration (AC) and enantiomeric purity of chiral drugs has been given, where greater emphasis was placed on the contribution of enantioselective chromatography (HPLC, SFC and UHPC)...
July 10, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28940894/the-antiretroviral-nelfinavir-mesylate-a-potential-therapy-for-systemic-scleroderma
#9
Cecilia G Sanchez, Steven V Molinski, Rafael Gongora, Meredith Sosulski, Taylor Fuselier, Stephen S MacKinnon, Debasis Mondal, Joseph A Lasky
Transforming growth factor (TGF)-β1 is considered a key factor in fibrogenesis, and blocking TGF-β1 signaling pathways diminishes fibrogenesis in animal models. The objective of this study was to determine whether nelfinavir mesylate (NFV), a drug approved by the Food and Drug Administration (FDA) for treating HIV infection can be repurposed to treat pulmonary fibrosis in systemic scleroderma (SSc) METHODS: Normal human lung, ventricular, and skin fibroblasts, as well as lung fibroblasts from SSc patients, were used to determine the effects of NFV on fibroblast to myofibroblast differentiation (FMD) mediated by TGF-β1...
September 21, 2017: Arthritis & Rheumatology
https://www.readbyqxmd.com/read/28940400/reply-to-risk-of-malignancies-associated-with-ustekinumab
#10
B Nardone, D P West
For, "Malignancies and ustekinumab: an analysis of the FDA Adverse Event Reporting System and the European Union Drug Regulating Authorities Pharmacovigilance database" [1], Greenspan et al. [2] raise the issue about adding to the understanding of the drug safety profile, underscoring the need for robust evidence in determination of incidence rate and true risk. In response to this important issue, it must be emphasized to the reader that the approach to pharmacovigilance that we have utilized in this instance is not designed to address causality and/or risk quantification, but rather this widely accepted approach focuses on detection of safety signal...
September 22, 2017: British Journal of Dermatology
https://www.readbyqxmd.com/read/28939018/a-comprehensive-review-of-the-fda-approved-labels-of-diabetes-drugs-indications-safety-and-emerging-cardiovascular-safety-data
#11
Evgenia Gourgari, Vanita R Aroda, Erin E Wilhelm, Hamid Hassanzadeh, Ira Shoulson
AIMS: FDA-approved drug labels are an important source of information for clinicians who prescribe medications for treatment of diabetes. We reviewed drug labels to (1) understand the landscape of classes of medications approved for type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM), (2) explore the indications and safety information and (3) examine their cardiovascular safety. METHODS: We searched four public references and reviewed all FDA-approved labels for "indication and usage," "adverse effects," "warnings and precautions," and "cardiovascular outcomes" from October 1982 to July 2016...
August 12, 2017: Journal of Diabetes and its Complications
https://www.readbyqxmd.com/read/28938602/activation-of-cancerous-inhibitor-of-pp2a-cip2a-contributes-to-lapatinib-resistance-through-induction-of-cip2a-akt-feedback-loop-in-erbb2-positive-breast-cancer-cells
#12
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...
August 29, 2017: Oncotarget
https://www.readbyqxmd.com/read/28938590/ocular-toxicities-associated-with-targeted-anticancer-agents-an-analysis-of-clinical-data-with-management-suggestions
#13
Chen Fu, Dan S Gombos, Jared Lee, Goldy C George, Kenneth Hess, Andrew Whyte, David S Hong
Ocular toxicities are among the most common adverse events resulting from targeted anticancer agents and are becoming increasingly relevant in the management of patients on these agents. The purpose of this study is to provide a framework for management of these challenging toxicities based on objective data from FDA labels and from analysis of the literature. All oncologic drugs approved by the FDA up to March 14, 2015, were screened for inclusion. A total of 16 drugs (12 small-molecule drugs and 4 monoclonal antibodies) were analyzed for ocular toxicity profiles based on evidence of ocular toxicity...
August 29, 2017: Oncotarget
https://www.readbyqxmd.com/read/28938421/bortezomib-alone-and-in-combination-with-salinosporamid-a-induces-apoptosis-and-promotes-pheochromocytoma-cell-death-in-vitro-and-in-female-nude-mice
#14
Petra Bullova, Antony Cougnoux, Geena Marzouca, Juraj Kopacek, Karel Pacak
Proteasome inhibitors have been frequently used in treating hematologic and solid tumors. They are administered individually or in combination with other regimens, to prevent severe side effects and resistance development. Since they have been shown to be efficient and are pharmaceutically available, we tested the first FDA-approved proteasome inhibitor bortezomib alone and in combination with another proteasome inhibitor, salinosporamid A, in pheochromocytoma cells. Pheochromocytomas/paragangliomas (PHEOs/PGLs) are neuroendocrine tumors for which no definite cure is yet available...
August 15, 2017: Endocrinology
https://www.readbyqxmd.com/read/28935287/past-present-and-future-of-pharmacotherapy-for-obesity
#15
David Benaiges, Juan Pedro-Botet, Juana A Flores-Le Roux, Elisenda Climent, Albert Goday
Conventional treatment for obesity with diet, exercise and bariatric surgery has limitations; thus, it is necessary to have pharmacological tools. In the past, different drugs were marketed that were withdrawn due to safety problems. There are currently 3 drugs approved by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) for obesity therapy (orlistat, combination of bupropion and delayed-release naltrexone and liraglutide) and two more only authorized by FDA (lorcaserin and the combination of phentermine and extended release topiramate)...
September 18, 2017: Clínica e Investigación en Arteriosclerosis
https://www.readbyqxmd.com/read/28935255/a-comprehensive-approach-to-qualify-and-validate-the-essential-parameters-of-an-in-vitro-release-test-ivrt-method-for-acyclovir-cream-5
#16
Katrin I Tiffner, Isadore Kanfer, Thomas Augustin, Reingard Raml, Sam G Raney, Frank Sinner
The rate of release of an active pharmaceutical ingredient (API) from a topical semisolid dosage form can be influenced by its physical and structural properties. An In Vitro Release Test (IVRT) is an established method to characterize this rate of API release and compare the underlying sameness in product quality characteristics. The purpose of this work was to validate an IVRT method to compare acyclovir cream, 5% products. However, despite widespread use of the IVRT since 1997, there was no established approach to validate an IVRT method...
September 18, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28932272/the-place-of-eluxadoline-in-the-management-of-irritable-bowel-syndrome-with-diarrhea
#17
REVIEW
Sherry Levio, Brooks D Cash
Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder characterized by abdominal pain associated with defecation with altered stool frequency or stool form. The global prevalence of IBS ranges from 10% to 15% and total healthcare cost attributable to IBS is significant. Among individuals with IBS, the condition has dramatic effects on health-related quality of life, work and school productivity, and activities of daily living. It may be diagnosed with confidence, based on symptom-based diagnostic criteria, exclusion of alarm features and directed diagnostic testing...
September 2017: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/28931908/drug-release-from-core-shell-pva-silk-fibroin-nanoparticles-fabricated-by-one-step-electrospraying
#18
Yang Cao, Fengqiu Liu, Yuli Chen, Tao Yu, Deshuai Lou, Yuan Guo, Pan Li, Zhigang Wang, Haitao Ran
Silk fibroin (SF), a FDA-approved natural protein, is renowned for its great biocompatibility, biodegradability, and mechanical properties. SF-based nanoparticles provide new options for drug delivery with their tunable drug loading and release properties. To take advantage of the features of carrier polymers, we present a one-step electrospraying method that combines SF, polyvinyl alcohol (PVA) and therapeutic drugs without an emulsion process. A distinct core-shell structure was obtained with the PVA core and silk shell after the system was properly set up...
September 20, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28931515/gemtuzumab-ozogamicin-makes-a-comeback
#19
(no author information available yet)
After being pulled from the market 7 years ago, gemtuzumab ozogamicin has been reapproved by the FDA, this time for adults newly diagnosed with acute myeloid leukemia, as well as patients 2 years of age and older with relapsed/refractory disease. The CD33-targeting antibody-drug conjugate can be given as a single agent or in combination with chemotherapy.
September 20, 2017: Cancer Discovery
https://www.readbyqxmd.com/read/28931315/the-liver-toxicity-knowledge-base-lktb-and-drug-induced-liver-injury-dili-classification-for-assessment-of-human-liver-injury
#20
Shraddha Thakkar, Weida Tong, Minjun Chen, Hong Fang, Zhichao Liu, Ruth Roberts
Drug-induced liver injury (DILI) is challenging drug development, clinical practice and regulation. The Liver Toxicity Knowledge Base (LTKB) provides essential data for DILI study. Areas Covered: The LTKB provided various types of data that can be used to assess and predict DILI. Among much information available, several reference drug lists with annotated human DILI risk are of important. The LTKB DILI classification data include DILI severity concern determined by the FDA drug labeling, DILI severity score from the NIH LiverTox database, and other DILI classification schemes from the literature...
September 21, 2017: Expert Review of Gastroenterology & Hepatology
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