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https://www.readbyqxmd.com/read/29342367/cystic-fibrosis-pulmonary-guidelines-use-of-cftr-modulator-therapy-in-patients-with-cystic-fibrosis
#1
Clement L Ren, Rebecca L Morgan, Christopher Oermann, Helaine E Resnick, Cynthia Brady, Annette Campbell, Richard DeNagel, Margaret Guill, Jeffrey Hoag, Andrew Lipton, Thomas Newton, Stacy Peters, Donna Beth Willey-Courand, Edward T Naureckas
BACKGROUND: CFTR modulators are a new class of medications that target the underlying defect in in cystic fibrosis (CF). Ivacaftor (IVA) and IVA combined with lumacaftor (IVA/LUM) have been approved by the FDA for use in CF patients. However, the FDA label for these medications encompasses patient groups that were not studied as part of the drug approval process. CF clinicians, patients, and their families have recognized a need for recommendations to guide the use of these medications...
January 17, 2018: Annals of the American Thoracic Society
https://www.readbyqxmd.com/read/29341586/development-of-a-novel-cytopathic-effect-based-phenotypic-screening-assay-against-cryptosporidium
#2
Alexander T Chao, Boon Heng Lee, Kah Fei Wan, Jeremy Selva, Bin Zou, Peter Gedeck, David Beer, Thierry T Diagana, Ghislain Bonamy, Ujjini H Manjunatha
Cryptosporidiosis is a diarrheal disease predominantly caused by Cryptosporidium parvum (Cp) and Cryptosporidium hominis (Ch), apicomplexan parasites which infect the intestinal epithelial cells of their human hosts. The only approved drug for cryptosporidiosis is nitazoxanide, which shows limited efficacy in immunocompromised children, the most vulnerable patient population. Thus, new therapeutics and in vitro infection models are urgently needed to address the current unmet medical need. Toward this aim, we have developed novel cytopathic effect (CPE)-based Cp and Ch assays in human colonic tumor (HCT-8) cells and compared them to traditional imaging formats...
January 17, 2018: ACS Infectious Diseases
https://www.readbyqxmd.com/read/29341109/the-prescribable-drugs-with-efficacy-in-experimental-epilepsies-pde3-database-for-drug-repurposing-research-in-epilepsy
#3
Shayeeshan Sivapalarajah, Mathangi Krishnakumar, Harry Bickerstaffe, YikYing Chan, Joseph Clarkson, Alistair Hampden-Martin, Ahmad Mirza, Matthew Tanti, Anthony Marson, Munir Pirmohamed, Nasir Mirza
OBJECTIVE: Current antiepileptic drugs (AEDs) have several shortcomings. For example, they fail to control seizures in 30% of patients. Hence, there is a need to identify new AEDs. Drug repurposing is the discovery of new indications for approved drugs. This drug "recycling" offers the potential of significant savings in the time and cost of drug development. Many drugs licensed for other indications exhibit antiepileptic efficacy in animal models. Our aim was to create a database of "prescribable" drugs, approved for other conditions, with published evidence of efficacy in animal models of epilepsy, and to collate data that would assist in choosing the most promising candidates for drug repurposing...
January 17, 2018: Epilepsia
https://www.readbyqxmd.com/read/29340530/the-use-of-biosimilar-medicines-in-oncology-position-statement-of-the-brazilian-society-of-clinical-oncology-sboc
#4
G S Fernandes, C Sternberg, G Lopes, R Chammas, M A C Gifoni, R A Gil, D V Araujo
A biosimilar is a biologic product that is similar to a reference biopharmaceutical product, the manufacturing process of which hinders the ability to identically replicate the structure of the original product, and therefore, it cannot be described as an absolute equivalent of the original medication. The currently available technology does not allow for an accurate copy of complex molecules, but it does allow the replication of similar molecules with the same activity. As biosimilars are about to be introduced in oncology practice, these must be evaluated through evidence-based medicine...
January 11, 2018: Brazilian Journal of Medical and Biological Research, Revista Brasileira de Pesquisas Médicas e Biológicas
https://www.readbyqxmd.com/read/29339251/quinoxaline-derivatives-as-new-inhibitors-of-coxsackievirus-b5
#5
Antonio Carta, Giuseppina Sanna, Irene Briguglio, Silvia Madeddu, Gabriella Vitale, Sandra Piras, Paola Corona, Alessandra Tiziana Peana, Erik Laurini, Maurizio Fermeglia, Sabrina Pricl, Alessandra Serra, Elisa Carta, Roberta Loddo, Gabriele Giliberti
Enteroviruses are among the most common and important human pathogens for which there are no specific antiviral agents approved by the US Food and Drug Administration so far. Particularly, coxsackievirus infections have a worldwide distribution and can cause many important diseases. We here report the synthesis of new 14 quinoxaline derivatives and the evaluation of their cytotoxicity and antiviral activity against representatives of ssRNA, dsRNA and dsDNA viruses. Promisingly, three compounds showed a very potent and selective antiviral activity against coxsackievirus B5, with EC50 in the sub-micromolar range (0...
December 27, 2017: European Journal of Medicinal Chemistry
https://www.readbyqxmd.com/read/29338042/a-pharmacological-screen-for-compounds-that-rescue-the-developmental-lethality-of-a-drosophila-atm-mutant
#6
Stacey A Rimkus, David A Wassarman
Ataxia-telangiectasia (A-T) is a neurodegenerative disease caused by mutation of the A-T mutated (ATM) gene. ATM encodes a protein kinase that is activated by DNA damage and phosphorylates many proteins, including those involved in DNA repair, cell cycle control, and apoptosis. Characteristic biological and molecular functions of ATM observed in mammals are conserved in Drosophila melanogaster. As an example, conditional loss-of-function ATM alleles in flies cause progressive neurodegeneration through activation of the innate immune response...
2018: PloS One
https://www.readbyqxmd.com/read/29337703/new-antibiotics-for-ventilator-associated-pneumonia
#7
Matteo Bassetti, Antionio Vena, Nadia Castaldo, Elda Righi, Maddalena Peghin
PURPOSE OF REVIEW: Ventilator-associated pneumonia (VAP) caused by multidrug-resistant (MDR) bacteria represents a global emerging problem. Delayed prescription of an adequate treatment for VAP has been associated with higher morbidity and mortality. New molecules have been developed to face the need of compounds that are active against resistant Gram-positive and Gram-negative pathogens. The aim of this review is to summarize the current scenario of new therapeutic options for the treatment of VAP...
January 13, 2018: Current Opinion in Infectious Diseases
https://www.readbyqxmd.com/read/29336981/challenges-and-opportunities-for-the-subcutaneous-delivery-of-therapeutic-proteins
#8
REVIEW
Michael R Turner, Sathy V Balu-Iyer
Biotherapeutics are a rapidly growing drug class and well over 200 biotherapeutics have already obtained approval, with about fifty of these being approved in 2015 and 2016 alone 1. Several hundred protein therapeutic products are still in the pipeline, including interesting new approaches to treatment. Due to patients' convenience of at home administration and reduced number of hospital visits as well as the reduction in treatment costs, subcutaneous (SC) administration of biologics is of increasing interest...
January 11, 2018: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29335817/repurposing-existing-drugs-for-new-ampk-activators-as-a-strategy-to-extend-lifespan-a-computer-aided-drug-discovery-study
#9
Sepideh Mofidifar, Farzin Sohraby, Milad Bagheri, Hassan Aryapour
Dietary restriction is one of the several ways which could putatively extend organisms' lifespan, ranging from Saccharomyces cerevisiae to rodents, by activating the AMP-activated protein kinase (AMPK), an ATP/AMP sensor. Extensive researches have shown that aging reduces sensibility of AMPK and eventually causes energy imbalance in cells. Research in mammals' AMPK depicts that this signaling molecule could control autophagy, improve cellular stress resistance and suppress inflammatory responses. Hence, in this study we performed a drug repurposing of 1908 FDA-approved drugs in order to discover putative safe activators of AMPK and to find new applications for existing drugs...
January 15, 2018: Biogerontology
https://www.readbyqxmd.com/read/29334251/discussing-edaravone-with-the-als-patient-an-ethical-framework-from-a-u-s-perspective
#10
Crystal Jing Jing Yeo, Zachary Simmons
The recent approval of edaravone by the United States Food and Drug Administration has generated a mix of hope tempered by reality. The costs of the drug, both monetarily and with regard to intensity of treatment, are high. The benefits, while modest, will be viewed through a very different lens by individuals depending on their goals of care. By virtue of our training and experience, physicians are ideally suited to understand and explain new treatments to our patients. As healthcare providers with a fiduciary responsibility to our patients, we must make sure they are fully informed about both the costs and benefits of non-curative therapies such as edaravone, and be prepared to discuss these in the context of their goals of care and potential impact on quality of life...
January 15, 2018: Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration
https://www.readbyqxmd.com/read/29332597/synthesis-of-a-novel-class-of-1-3-oxathiolane-nucleoside-derivatives-of-t-705-and-evaluation-of-their-anti-influenza-a-virus-and-anti-hiv-activity
#11
Mingming Han, Xu Zhao, Xuedong Wu, Wei Huang, Xingzhou Li, Fang Yu
Backgroud: T-705 (Favipiravir) is a broad spectrum antiviral agent approved for stockpiling in Japan and currently in Phase 3 testing in the United States. Against influenza acts as a prodrug, converted intracellularly to selectively inhibit viral RNA-dependent RNA polymerase or similar enzymes. This is regarded as a novel antiviral mechanism of action, reducing cross-resistance to other existing anti-influenza drugs. OBJECTIVE: To develop new analogs, a class of 1,3-oxathiolane nucleoside derivatives of T-705 were designed and synthesized in this work...
January 11, 2018: Medicinal Chemistry
https://www.readbyqxmd.com/read/29332585/new-tacrines-as-anti-alzheimer-s-disease-agents-ii-the-benzo-chromenopyranotacrines
#12
Maria J Oset-Gasque, Jose Marco-Contelles
Tacrine was the first drug approved by FDA (US) for the treatment of Alzheimer's disease suffering patients. Nowadays, this agent has been withdrawn from the clinics due to secondary effects, among them, and the most important, its hepatotoxicity. However, the research on new tacrine analogues devoid of these therapeutically undesirable effects, but benefiting of their high and well known positive cholinergic power, has produced a number of new non-hepatotoxic tacrines. In this context, in our laboratory, in the last years we have prepared a new heterocyclic tacrines by changing the benzene ring present in tacrine by appropriate heterocyclic motifs...
January 12, 2018: Current Topics in Medicinal Chemistry
https://www.readbyqxmd.com/read/29329784/regulatory-science-an-underappreciated-component-of-translational-research
#13
Rodney Rouse, Issam Zineh, David G Strauss
Translational science refers to translating basic scientific findings to practical application (i.e., 'bench-to-bedside'). An underappreciated aspect of translational science is regulatory science. Herein, we focus on the importance of regulatory science to facilitate development of innovative new drugs and optimize use of approved drugs, with a call for community participation.
January 9, 2018: Trends in Pharmacological Sciences
https://www.readbyqxmd.com/read/29329002/integration-of-multi-scale-molecular-modeling-approaches-with-experiments-for-the-in-silico-guided-design-and-discovery-of-novel-herg-neutral-antihypertensive-oxazalone-and-imidazolone-derivatives-and-analysis-of-their-potential-restrictive-effects-on-cell
#14
Serdar Durdagi, Busecan Aksoydan, Ismail Erol, Isik Kantarcioglu, Yavuz Ergun, Gulay Bulut, Melih Acar, Timucin Avsar, George Liapakis, Vlasios Karageorgos, Ramin E Salmas, Barış Sergi, Sara Alkhatib, Gizem Turan, Berfu Nur Yigit, Kutay Cantasir, Bahar Kurt, Turker Kilic
AT1 antagonists is the most recent drug class of molecules against hypertension and they mediate their actions through blocking detrimental effects of angiotensin II (A-II) when acts on type I (AT1) A-II receptor. The effects of AT1 antagonists are not limited to cardiovascular diseases. AT1 receptor blockers may be used as potential anti-cancer agents - due to the inhibition of cell proliferation stimulated by A-II. Therefore, AT1 receptors and the A-II biosynthesis mechanisms are targets for the development of new synthetic drugs and therapeutic treatment of various cardiovascular and other diseases...
December 11, 2017: European Journal of Medicinal Chemistry
https://www.readbyqxmd.com/read/29327295/common-deficiencies-of-in-vitro-binding-bioequivalence-be-studies-submitted-in-abbreviated-new-drug-applications-andas
#15
Dongmei Lu, Diana Vivian, Ping Ren, Yongsheng Yang, Hongling Zhang, Xiaojian Jiang, Ethan Stier
There are several drug products that bind phosphate or bile acid in the gastrointestinal (GI) tract to exert their therapeutic efficacy. In vitro binding studies are used to assess bioequivalence (BE) of these products. The objective of this study is to identify the common deficiencies in Abbreviated New Drug Applications (ANDAs) for these products. Deficiencies were compiled from ANDAs containing in vitro binding BE studies. The deficiencies were classified into eight categories: Pre-Study Method Validation, During-Study Sample Analysis, Study Design, Study Procedure, Dissolution/Disintegration, Analytical Site Inspection, Data Submission, and Formulations...
January 11, 2018: AAPS Journal
https://www.readbyqxmd.com/read/29325272/-advances-in-the-treatment-of-primary-biliary-cholangitis
#16
Y M Li, Q X Wang, X Ma
Primary biliary cholangitis (PBC) is an autoimmune liver disease mainly involving intrahepatic interlobular bile ducts and can progress to liver fibrosis, liver cirrhosis, and even liver failure. Ursodeoxycholic acid (UDCA) is the first-line therapeutic drug for PBC and can delay disease progression, but as high as 40% of patients have suboptimal response to UDCA. Obeticholic acid, a farnesoid X receptor agonist, has been approved by FDA in May 2016 for patients who have no response to UDCA treatment or cannot tolerate such treatment...
November 20, 2017: Zhonghua Gan Zang Bing za Zhi, Zhonghua Ganzangbing Zazhi, Chinese Journal of Hepatology
https://www.readbyqxmd.com/read/29325271/-research-advances-in-primary-biliary-cholangitis
#17
W J Duan, J D Jia
Primary biliary cholangitis (PBC) is a chronic cholestatic disease with unknown pathogenesis. Positive anti-mitochondrial antibody has high sensitivity and specificity in the diagnosis of this disease. Ursodeoxycholic acid is mainly used for the treatment of PBC, but 40% of patients have an unsatisfactory biochemical response to this drug. 6-Ethylchenodeoxycholic acid is a new drug approved for the treatment of PBC, and liver transplantation remains the only effective method for the treatment of patients with end-stage PBC...
November 20, 2017: Zhonghua Gan Zang Bing za Zhi, Zhonghua Ganzangbing Zazhi, Chinese Journal of Hepatology
https://www.readbyqxmd.com/read/29321022/serum-metabolic-profiling-identified-a-distinct-metabolic-signature-in-patients-with-idiopathic-pulmonary-fibrosis-a-potential-biomarker-role-for-lysopc
#18
Barbara Rindlisbacher, Cornelia Schmid, Thomas Geiser, Cédric Bovet, Manuela Funke-Chambour
BACKGROUND: Idiopathic pulmonary fibrosis (IPF) is a lethal lung disease of unknown etiology. Patients present loss of lung function, dyspnea and dry cough. Diagnosis requires compatible radiologic imaging and, in undetermined cases, invasive procedures such as bronchoscopy and surgical lung biopsy. The pathophysiological mechanisms of IPF are not completely understood. Lung injury with abnormal alveolar epithelial repair is thought to be a major cause for activation of profibrotic pathways in IPF...
January 10, 2018: Respiratory Research
https://www.readbyqxmd.com/read/29320954/the-value-of-fixed-rasburicase-dosing-versus-weight-based-dosing-in-the-treatment-and-prevention-of-tumor-lysis-syndrome
#19
Alyssa Boutin, Alison Blackman, David M O'Sullivan, Nicholas Forcello
Background Rasburicase is a recombinant urate oxidase enzyme used for the treatment and prevention of tumor lysis syndrome. Our objective was to assess the efficacy of indication-based, low-dose rasburicase administration compared to the Food and Drug Administration-approved weight-based dosing. Methods This was a retrospective cohort study utilizing data from a tertiary medical center including patients admitted from 2012 to 2016, who received at least one dose of rasburicase. The primary outcome was achieving a uric acid level less than 7...
January 1, 2018: Journal of Oncology Pharmacy Practice
https://www.readbyqxmd.com/read/29318649/treatment-related-changes-in-bone-turnover-and-fracture-risk-reduction-in-clinical-trials-of-anti-resorptive-drugs-a-meta-regression
#20
Douglas C Bauer, Dennis M Black, Mary L Bouxsein, Li-Yung Lui, Jane A Cauley, Anne E de Papp, Andreas Grauer, Sundeep Khosla, Charles E McCulloch, Richard Eastell
Few pooled analyses of antiresorptive (AR) treatment trials relate short-term changes in bone turnover markers (BTMs) to subsequent fracture reduction. Such information would be useful to assess new ARs or novel dosing regimens. In the Foundation for the National Institutes of Health (FNIH) Bone Quality project, we analyzed individual-level data from 28,000 participants enrolled in 11 bisphosphonate (BP) and three selective estrogen receptor modulator (SERM) placebo-controlled fracture endpoint trials. Using BTM results for two bone formation markers (bone-specific alkaline phosphatase [bone ALP] and pro-collagen I N-propeptide [PINP]) and two bone resorption markers (N-terminal and C-terminal telopeptide of type I collagen) and incident fracture outcome data, we performed a meta-regression relating the mean net effect of treatment on change in bone turnover (active minus placebo % difference after 3 to 12 months) to the log of study-wide fracture risk reduction, and used linear regression to plot the best fitting line...
January 10, 2018: Journal of Bone and Mineral Research: the Official Journal of the American Society for Bone and Mineral Research
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