keyword
MENU ▼
Read by QxMD icon Read
search

Fda drug approval

keyword
https://www.readbyqxmd.com/read/29049113/the-us-opioid-crisis-current-federal-and-state-legal-issues
#1
Cobin D Soelberg, Raeford E Brown, Derick Du Vivier, John E Meyer, Banu K Ramachandran
The United States is in the midst of a devastating opioid misuse epidemic leading to over 33,000 deaths per year from both prescription and illegal opioids. Roughly half of these deaths are attributable to prescription opioids. Federal and state governments have only recently begun to grasp the magnitude of this public health crisis. In 2016, the Centers for Disease Control and Prevention released their Guidelines for Prescribing Opioids for Chronic Pain. While not comprehensive in scope, these guidelines attempt to control and regulate opioid prescribing...
November 2017: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/29048983/representation-of-women-and-minorities-in-clinical-trials-for-new-molecular-entities-and-original-therapeutic-biologics-approved-by-fda-cder-from-2013-to-2015
#2
Alice Chen, Hilary Wright, Hawi Itana, Merina Elahi, Ayomide Igun, Guoxing Soon, Anne R Pariser, Emmanuel O Fadiran
BACKGROUND: The U.S. Food and Drug Administration (FDA) has made efforts to encourage adequate assessment of women, racial/ethnic minorities, and geriatric participants in clinical trials through regulations and guidance documents. This study surveyed the demographics of clinical trial participants and the presence of efficacy and safety analyses by sex for new drugs approved between 2013 and 2015 by the FDA Center for Drug Evaluation and Research. METHODS: New drug marketing applications submitted to FDA were surveyed for demographic data (sex, race, ethnicity, and age) and the presence of sex-based analyses for efficacy and safety...
October 19, 2017: Journal of Women's Health
https://www.readbyqxmd.com/read/29048558/modeling-neuro-immune-interactions-during-zika-virus-infection
#3
Pinar Mesci, Angela Macia, Christopher N LaRock, Leon Tejwani, Isabella R Fernandes, Nicole A Suarez, Paolo M de A Zanotto, Patricia C B Beltrão-Braga, Victor Nizet, Alysson R Muotri
Although Zika virus (ZIKV) infection is often asymptomatic, in some cases it can lead to birth defects in newborns or serious neurologic complications in adults. However, little is known about the interplay between immune and neural cells that could contribute to the ZIKV pathology. To understand the mechanisms at play during infection and the antiviral immune response, we focused on neural precursor cells (NPC)-microglia interactions. Our data indicate that human microglia infected with the current circulating Brazilian ZIKV induces a similar pro-inflammatory response found in ZIKV-infected human tissues...
October 17, 2017: Human Molecular Genetics
https://www.readbyqxmd.com/read/29047301/pimavanserin-novel-pharmacotherapy-for-parkinson-s-disease-psychosis
#4
Zeyad T Sahli, Frank I Tarazi
Pimavanserin is the first FDA-approved atypical antipsychotic drug indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis (PDP). Areas covered: This review focuses on the preclinical discovery of pimavanserin. It analyzes the pharmacological, behavioral and molecular mechanisms of pimavanserin and their contribution to the therapeutic advantages of the drug as reported in published preclinical and clinical studies, and product labels. Expert opinion: Pimavanserin exhibits a unique pharmacological profile with nanomolar affinity at serotonin 5-HT2A and 5-HT2C receptors...
October 19, 2017: Expert Opinion on Drug Discovery
https://www.readbyqxmd.com/read/29047025/targeting-the-ubiquitin-proteasome-system-for-cancer-treatment-discovering-novel-inhibitors-from-nature-and-drug-repurposing
#5
Claire L Soave, Tracey Guerin, Jinbao Liu, Q Ping Dou
In the past 15 years, the proteasome has been validated as an anti-cancer drug target and 20S proteasome inhibitors (such as bortezomib and carfilzomib) have been approved by the FDA for the treatment of multiple myeloma and some other liquid tumors. However, there are shortcomings of clinical proteasome inhibitors, including severe toxicity, drug resistance, and no effect in solid tumors. At the same time, extensive research has been conducted in the areas of natural compounds and old drug repositioning towards the goal of discovering effective, economical, low toxicity proteasome-inhibitory anti-cancer drugs...
October 18, 2017: Cancer Metastasis Reviews
https://www.readbyqxmd.com/read/29045731/the-chimpanzee-model-of-viral-hepatitis-advances-in-understanding-the-immune-response-and-treatment-of-viral-hepatitis
#6
Robert E Lanford, Christopher M Walker, Stanley M Lemon
Chimpanzees (Pan troglodytes) have contributed to diverse fields of biomedical research due to their close genetic relationship to humans and in many instances due to the lack of any other animal model. This review focuses on the contributions of the chimpanzee model to research on hepatitis viruses where chimpanzees represented the only animal model (hepatitis B and C) or the most appropriate animal model (hepatitis A). Research with chimpanzees led to the development of vaccines for HAV and HBV that are used worldwide to protect hundreds of millions from these diseases and, where fully implemented, have provided immunity for entire generations...
October 17, 2017: ILAR Journal
https://www.readbyqxmd.com/read/29045001/anti-inflammaging-effects-of-human-alpha-1-antitrypsin
#7
Ye Yuan, Benedetto DiCiaccio, Ying Li, Ahmed S Elshikha, Denis Titov, Brian Brenner, Lee Seifer, Hope Pan, Nurdina Karic, Mohammad A Akbar, Yuanqing Lu, Sihong Song, Lei Zhou
Inflammaging plays an important role in most age-related diseases. However, the mechanism of inflammaging is largely unknown, and therapeutic control of inflammaging is challenging. Human alpha-1 antitrypsin (hAAT) has immune-regulatory, anti-inflammatory, and cytoprotective properties as demonstrated in several disease models including type 1 diabetes, arthritis, lupus, osteoporosis, and stroke. To test the potential anti-inflammaging effect of hAAT, we generated transgenic Drosophila lines expressing hAAT...
October 17, 2017: Aging Cell
https://www.readbyqxmd.com/read/29042487/differential-response-of-glioma-stem-cells-to-arsenic-trioxide-therapy-is-regulated-by-mnk1-and-mrna-translation
#8
Jonathan B Bell, Frank Eckerdt, Harshil Dhruv, Darren Finlay, Sen Peng, Seungchan Kim, Barbara Kroczynska, Elspeth Beauchamp, Kristen Alley, Jessica Clymer, Stewart Goldman, Shi-Yuan Cheng, C David James, Ichiro Nakano, Craig Horbinski, Andrew P Mazar, Kristiina Vuori, Priya Kumthekar, Jeffery Raizer, Michael E Berens, Leonidas C Platanias
Mesenchymal (MES) and proneural (PN) are two distinct glioma stem cells (GSCs) populations that drive therapeutic resistance in glioblastoma (GBM). We screened a panel of 650 small molecules against patient-derived GBM cells to discover compounds targeting specific GBM subtypes. Arsenic trioxide (ATO), a FDA-approved drug that crosses the blood-brain barrier, was identified as a potent PN-specific compound in the initial screen and follow-up validation studies. Furthermore, MES and PN GSCs exhibited differential sensitivity to ATO...
October 17, 2017: Molecular Cancer Research: MCR
https://www.readbyqxmd.com/read/29042256/antiseptic-effects-of-dabrafenib-on-tgfbip-induced-septic-responses
#9
In-Chul Lee, Jong-Sup Bae
Transforming growth factor-β-induced protein (TGFBIp), an extracellular protein, is expressed on several cell types in response to TGF-β stimulation. Human umbilical vein endothelial cell (HUVEC)-derived TGFBIp functions as a mediator of sepsis. Screening of bioactive compound libraries is an effective approach for repositioning FDA-approved drugs or discovering new treatments for human diseases (drug repositioning). Dabrafenib (DAB), a B-Raf inhibitor, was initially used for treating metastatic melanoma...
October 14, 2017: Chemico-biological Interactions
https://www.readbyqxmd.com/read/29042210/the-physicochemical-basis-of-clofazimine-induced-skin-pigmentation
#10
Mikhail D Murashov, Vernon LaLone, Phillip M Rzeczycki, Rahul K Keswani, Gi S Yoon, Sudha Sud, Walajapet Rajeswaran, Scott Larsen, Kathleen A Stringer, Gus R Rosania
Clofazimine is a weakly basic, FDA-approved antibiotic recommended by the World Health Organization to treat leprosy and multi-drug-resistant tuberculosis. Upon prolonged treatment, clofazimine extensively bioaccumulates and precipitates throughout the organism, forming crystal-like drug inclusions (CLDIs). Because of the drug's red color, it is widely believed that clofazimine bioaccumulation results in skin pigmentation, its most common side effect. To test whether clofazimine-induced skin pigmentation is due to CLDI formation, we synthesized a closely related clofazimine analog that does not precipitate under physiological pH and chloride conditions that are required for CLDI formation...
October 14, 2017: Journal of Investigative Dermatology
https://www.readbyqxmd.com/read/29040826/maintenance-on-naltrexone-amphetamine-decreases-cocaine-vs-food-choice-in-male-rhesus-monkeys
#11
Megan J Moerke, Matthew L Banks, Kejun Cheng, Kenner C Rice, S Stevens Negus
BACKGROUND: Cocaine use disorder remains a significant public health issue for which there are no FDA-approved pharmacotherapies. Amphetamine maintenance reduces cocaine use in preclinical and clinical studies, but the mechanism of this effect is unknown. Previous studies indicate a role for endogenous opioid release and subsequent opioid receptor activation in some amphetamine effects; therefore, the current study examined the role of mu-opioid receptor activation in d-amphetamine treatment effects in an assay of cocaine-vs-food choice...
October 13, 2017: Drug and Alcohol Dependence
https://www.readbyqxmd.com/read/29040128/single-dose-preoperative-vitamin-d-supplementation-decreases-infection-in-a-mouse-model-of-periprosthetic-joint-infection
#12
Vishal Hegde, Erik M Dworsky, Alexandra I Stavrakis, Amanda H Loftin, Stephen D Zoller, Howard Y Park, Sherif Richman, Daniel Johansen, Yan Hu, Julie A Taylor, Christopher D Hamad, Rene F Chun, Weixian Xi, John S Adams, Nicholas M Bernthal
BACKGROUND: Despite recent advances, infection remains the most common etiology of arthroplasty failure. Recent work suggests that 25-hydroxyvitamin D (25D) deficiency correlates with the frequency of periprosthetic joint infection (PJI). We endeavored to examine whether 25D3 deficiency leads to increased bacterial burden in vivo in an established mouse model of PJI and, if so, whether this effect can be reversed by preoperative 25D3 supplementation. METHODS: Mice (lys-EGFP) possessing fluorescent neutrophils were fed a vitamin D3-sufficient (n = 20) or deficient (n = 40) diet for 6 weeks...
October 18, 2017: Journal of Bone and Joint Surgery. American Volume
https://www.readbyqxmd.com/read/29038906/pcsk9-mutations-in-familial-hypercholesterolemia-from-a-groundbreaking-discovery-to-anti-pcsk9-therapies
#13
REVIEW
Petra El Khoury, Sandy Elbitar, Youmna Ghaleb, Yara Abou Khalil, Mathilde Varret, Catherine Boileau, Marianne Abifadel
PURPOSE OF REVIEW: In 2003, Abifadel et al. (Nat. Genet. 34:154-156, 2003) identified PCSK9, encoding proprotein convertase subtilisin/kexin type 9, as the third causal gene for autosomal dominant hypercholesterolemia. This review focuses on the main steps from this major breakthrough in familial hypercholesterolemia (FH) to the latest clinical trials with the anti-PCSK9 antibodies. RECENT FINDINGS: The year 2015 was remarkable in cardiovascular disease through the field of cholesterol...
October 17, 2017: Current Atherosclerosis Reports
https://www.readbyqxmd.com/read/29038584/dual-drug-containing-core-shell-nanoparticles-for-lung-cancer-therapy
#14
Jyothi U Menon, Aneetta Kuriakose, Roshni Iyer, Elizabeth Hernandez, Leah Gandee, Shanrong Zhang, Masaya Takahashi, Zhang Zhang, Debabrata Saha, Kytai T Nguyen
Late-stage diagnosis of lung cancer occurs ~95% of the time due to late manifestation of its symptoms, necessitating rigorous treatment following diagnosis. Existing treatment methods are limited by lack of specificity, systemic toxicity, temporary remission, and radio-resistance in lung cancer cells. In this research, we have developed a folate receptor-targeting multifunctional dual drug-loaded nanoparticle (MDNP) containing a poly(N-isopropylacrylamide)-carboxymethyl chitosan shell and poly lactic-co-glycolic acid (PLGA) core for enhancing localized chemo-radiotherapy to effectively treat lung cancers...
October 16, 2017: Scientific Reports
https://www.readbyqxmd.com/read/29038464/unveiling-some-fda-approved-drugs-as-inhibitors-of-the-store-operated-ca-2-entry-pathway
#15
Saifur Rahman, Taufiq Rahman
The store-operated calcium entry (SOCE) pathway is an important route for generating cytosolic Ca(2+) signals that regulate a diverse array of biological processes. Abnormal SOCE seem to underlie several diseases that notably include allergy, inflammation and cancer. Therefore, any modulator of this pathway is likely to have significant impact in cell biology under both normal and abnormal conditions. In this study, we screened the FDA-approved drug library for agents that share significant similarity in 3D shape and surface electrostatics with few, hitherto best known inhibitors of SOCE...
October 16, 2017: Scientific Reports
https://www.readbyqxmd.com/read/29036253/understanding-state-regulation-of-biosimilars-and-effect-on-prescribers
#16
Katerina Yale, Olabola Awosika, Monica Rengifo-Pardo, Alison Ehrlich
Biologics are a mainstay of treatment for many dermatologic conditions, however the high costs can be prohibitive for many patients. A growing market of biosimilar drugs is emerging with the hope of providing patients access to more affordable medications. While the FDA has created an abbreviated licensure pathway for these drugs, states are still in the process of creating regulations regarding their substitution for reference biologics. This article looks to raise awareness of the current federal regulations and the differences among state regulations regarding the use of biosimilars...
October 1, 2017: Journal of Drugs in Dermatology: JDD
https://www.readbyqxmd.com/read/29036249/cost-effectiveness-analysis-of-ixekizumab-vs-etanercept-and-their-manufacturer-recommended-dosing-regimens-in-moderate-to-severe-plaque-psoriasis
#17
Jeremy Udkoff, Lawrence F Eichenfield
INTRODUCTION: Biologic therapies have revolutionized the treatment of psoriasis; however, their use is limited by costs. Ixekizumab was more effective than etanercept in the UNCOVER trials, and the Food and Drug Administration (FDA) approved ixekizumab for treating psoriasis. Evaluating the cost-effectiveness of these therapies is crucial for medical decision making and our objective was to determine the cost-effectiveness of various ixekizumab dosing frequencies compared with etanercept...
October 1, 2017: Journal of Drugs in Dermatology: JDD
https://www.readbyqxmd.com/read/29035761/lab-on-a-chip-systems-for-photodynamic-therapy-investigations
#18
REVIEW
Michał Chudy, Katarzyna Tokarska, Elżbieta Jastrzębska, Magdalena Bułka, Sławomir Drozdek, Łukasz Lamch, Kazimiera A Wilk, Zbigniew Brzózka
In recent years photodynamic therapy (PDT) has received widespread attention in cancer treatment due to its smaller surgical trauma, better selectivity towards tumor cells, reduced side effects and possibility of repeatable treatment. Since cancer is the second cause of death worldwide, scientists constantly seek for new potential therapeutic agents including nanotechnology-based photosensitizers used in PDT. The new-designed nanostructures must be carefully studied and well characterized what require analytically useful and powerful tools that enable real progress in nanoscience development...
October 7, 2017: Biosensors & Bioelectronics
https://www.readbyqxmd.com/read/29035327/immortalized-muscle-cell-model-to-test-the-exon-skipping-efficacy-for-duchenne-muscular-dystrophy
#19
REVIEW
Quynh Nguyen, Toshifumi Yokota
Duchenne muscular dystrophy (DMD) is a lethal genetic disorder that most commonly results from mutations disrupting the reading frame of the dystrophin (DMD) gene. Among the therapeutic approaches employed, exon skipping using antisense oligonucleotides (AOs) is one of the most promising strategies. This strategy aims to restore the reading frame, thus producing a truncated, yet functioning dystrophin protein. In 2016, the Food and Drug Administration (FDA) conditionally approved the first AO-based drug, eteplirsen (Exondys 51), developed for DMD exon 51 skipping...
October 16, 2017: Journal of Personalized Medicine
https://www.readbyqxmd.com/read/29034293/comprehensive-data-on-a-2d-qsar-model-for-heme-oxygenase-isoform-1-inhibitors
#20
Emanuele Amata, Agostino Marrazzo, Maria Dichiara, Maria N Modica, Loredana Salerno, Orazio Prezzavento, Giovanni Nastasi, Antonio Rescifina, Giuseppe Romeo, Valeria Pittalà
The data have been obtained from the Heme Oxygenase Database (HemeOxDB) and refined according to the 2D-QSAR requirements. These data provide information about a set of more than 380 Heme Oxygenase-1 (HO-1) inhibitors. The development of the 2D-QSAR model has been undertaken with the use of CORAL software using SMILES, molecular graphs and hybrid descriptors (SMILES and graph together). The 2D-QSAR model regressions for HO-1 half maximal inhibitory concentration (IC50) expressed as pIC50 (pIC50=-LogIC50) are here included...
December 2017: Data in Brief
keyword
keyword
73790
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"