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https://www.readbyqxmd.com/read/28636191/-fast-track-development-and-approval-process-for-heart-failure-therapeutics
#1
L Papadimitriou, J Butler
Heart failure (HF) is a global epidemic, with a high mortality and morbidity burden. In such diseases, earlier access to lifesaving therapeutic regimens is imperative, and could be accomplished by improving the drug development and approval process, without jeopardizing patient safety. The US Food and Drug Administration (FDA) has already established mechanisms facilitating the latter, but further guidance to enhance and expedite the process holds promise to further improve patient outcomes.
June 21, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28635354/the-effects-of-food-on-opioid-induced-nausea-and-vomiting-and-pharmacological-parameters-a-systematic-review
#2
Robert B Raffa, Robert Colucci, Joseph V Pergolizzi
Opioids remain the standard of care for treating moderate to severe pain resulting from surgery or injury in cases of acute pain, and are recommended for patients who have not responded to nonopioid analgesics. Effective management of pain has an impact on clinical course and often depends on achieving an acceptable balance between opioid efficacy, safety, and tolerability. Common opioid-related adverse events such as nausea and vomiting are associated with an overall lower achievement of effective pain management and patient satisfaction...
June 21, 2017: Postgraduate Medicine
https://www.readbyqxmd.com/read/28634592/euglycemic-diabetic-ketoacidosis-with-prolonged-glucosuria-associated-with-the-sodium-glucose-cotransporter-2-canagliflozin
#3
Daniel A Kelmenson, Kelsey Burr, Yusra Azhar, Paul Reynolds, Chelsea A Baker, Neda Rasouli
Sodium-glucose cotransporter-2 (SGLT2) inhibitors improve glycemic control by a reversible inhibition of the sodium-glucose cotransporters in the renal proximal tubules resulting in increased urinary glucose. This unique mechanism, independent of insulin secretion and beta cell function, has made this class of medication desirable in patients with type 2 diabetes. However in May 2015, the US Food and Drug Administration issued a safety warning pertaining to the development of diabetic ketoacidosis (DKA) with the use of SGLT2 inhibitors...
April 2017: Journal of Investigative Medicine High Impact Case Reports
https://www.readbyqxmd.com/read/28634536/telavancin-a-novel-semisynthetic-lipoglycopeptide-agent-to-counter-the-challenge-of-resistant-gram-positive-pathogens
#4
REVIEW
Biswadeep Das, Chayna Sarkar, Debasmita Das, Amit Gupta, Arnav Kalra, Shubham Sahni
Telavancin (TD-6424), a semisynthetic lipoglycopeptide vancomycin-derivative, is a novel antimicrobial agent developed by Theravance for overcoming resistant Gram-positive bacterial infections, specifically methicillin-resistant Staphylococcus aureus (MRSA). The US Food and Drug Administration (USFDA) had approved telavancin in 2009 for the treatment of complicated skin and skin structure infections (cSSSIs) caused by Gram-positive bacteria, including MRSA (S. aureus, Streptococcus agalactiae, Streptococcus pyogenes, Streptococcus anginosus group, or Enterococcus faecalis)...
March 2017: Therapeutic Advances in Infectious Disease
https://www.readbyqxmd.com/read/28633491/optimization-of-inactivated-h5n9-highly-pathogenic-avian-influenza-vaccine-and-inactivated-salmonella-enterica-serovar-typhimurium-vaccine-with-antigen-dose-and-prime-boost-regimen-in-domestic-ducks
#5
Seong-Su Yuk, Eredene-Ochir To, Jung-Hoon Kwon, Jin-Yong Noh, Woo-Tack Hong, Jei-Hyun Jeong, Gyeong-Bin Gwon, Chang-Seon Song
Owing to the increase in the number of diseases affecting ducks and the demand for food safety by consumers, vaccination has become one of the factors that influence duck meat productivity. The highly pathogenic avian influenza (HPAI) virus is one of the most prevalent and causes one of the most lethal diseases in domestic ducks, and Salmonella enterica serovar Typhimurium is a food-borne pathogen persistent in the domestic duck population. To better understand the optimal usage of HPAI and S. enterica serovar Typhimurium vaccines, we aimed to determine antigen dose, oil and gel adjuvant usage with prime-boost regimen, and vaccination age, inducing the best immune response in ducks, without an effect on body weight gain...
June 17, 2017: Poultry Science
https://www.readbyqxmd.com/read/28632997/epidemiology-of-obesity-and-pharmacologic-treatment-options
#6
Vignesh Shettar, Sarang Patel, Srividya Kidambi
Prevalence of obesity and its related morbidity have increased to alarming levels in adults and children in the United States and globally. Weight loss results in improvement of much of the obesity-related morbidity. Lifestyle changes such as dietary modifications, increased physical activity, and behavioral therapy form the crux of weight management. However, many individuals need additional assistance (pharmacologic or surgical) to initiate or sustain weight loss. Pharmacologic therapy consists of a number of agents that work by decreasing appetite, gastric emptying, or nutrient absorption or by increasing satiety...
June 1, 2017: Nutrition in Clinical Practice
https://www.readbyqxmd.com/read/28632953/updates-to-the-us-food-and-drug-administration-regulations-for-mifepristone-implications-for-clinical-practice-and-access-to-abortion
#7
Katherine E Simmonds, Margaret W Beal, Meghan K Eagen-Torkko
This article provides information on recent changes in the US Food and Drug Administration (FDA) labeling and safety regulations for mifepristone (Mifeprex). The revised label now permits midwives, advanced practice nurses, and physician assistants to order and prescribe mifepristone, eliminating the requirement for physician supervision. The updated label also extends eligibility for use from 49 to 70 days' gestation and decreases the number of required visits from 3 to 2. The recommended dose of mifepristone has been reduced, and the dosage, timing, and route of administration for misoprostol have also been changed to reflect current research...
May 2017: Journal of Midwifery & Women's Health
https://www.readbyqxmd.com/read/28632188/smartphone-based-food-diagnostic-technologies-a-review
#8
REVIEW
Giovanni Rateni, Paolo Dario, Filippo Cavallo
A new generation of mobile sensing approaches offers significant advantages over traditional platforms in terms of test speed, control, low cost, ease-of-operation, and data management, and requires minimal equipment and user involvement. The marriage of novel sensing technologies with cellphones enables the development of powerful lab-on-smartphone platforms for many important applications including medical diagnosis, environmental monitoring, and food safety analysis. This paper reviews the recent advancements and developments in the field of smartphone-based food diagnostic technologies, with an emphasis on custom modules to enhance smartphone sensing capabilities...
June 20, 2017: Sensors
https://www.readbyqxmd.com/read/28631817/application-of-high-resolution-melting-analysis-for-authenticity-testing-of-valuable-dendrobium-commercial-products
#9
Xiaoman Dong, Chao Jiang, Yuan Yuan, Daiyin Peng, Yuqin Luo, Yuyang Zhao, Luqi Huang
BACKGROUND: The accurate identification of botanical origin in commercial products is important to ensure food authenticity and safety for consumers. The Dendrobium species have long been commercialized as functional food supplements and herbal medicines in Asia. Three valuable Dendrobium species, namely Dendrobium officinale, D. huoshanense and D. moniliforme, are often mutually adulterated in trade products in pursuit of higher profit. RESULTS: In this paper, a rapid and reliable semi-quantitative method for identifying the botanical origin of Dendrobium products in terminal markets was developed using HRM (High-Resolution Melting) analysis with specific primer pairs to target the trnL-F region...
June 20, 2017: Journal of the Science of Food and Agriculture
https://www.readbyqxmd.com/read/28631599/efficacy-and-safety-of-omalizumab-in-children-and-adolescents-with-moderate-to-severe-asthma-a-systematic-literature-review
#10
J Corren, A Kavati, B Ortiz, J A Colby, K Ruiz, B A Maiese, S M Cadarette, R A Panettieri
BACKGROUND: There are limited pediatric data about the use of omalizumab, especially the effectiveness and safety ofomalizumab in the real-world management of allergic asthma. OBJECTIVE: The objective of this study was to summarize the safety and efficacy of omalizumab in both randomized clinicaltrials (RCT) used for U.S. Food and Drug Administration registration and real-world studies (RWS) based on clinical care of children with moderate-to-severe asthma. METHODS: Studies that evaluated omalizumab use in patients < 18 years old and with asthma, published between January2003 and October 2016, were retrieved from medical literature data bases...
June 19, 2017: Allergy and Asthma Proceedings:
https://www.readbyqxmd.com/read/28631591/comparative-evaluation-of-veriflow-%C3%A2-listeria-species-to-usda-culture-based-method-for-the-detection-of-listeria-spp-in-food-and-environmental-samples
#11
Adam C Joelsson, Shawn P Terkhorn, Ashley S Brown, Amrita Puri, Benjamin J Pascal, Zara E Gaudioso, Nicholas A Siciliano
Veriflow(®)Listeria species (Veriflow LS) isa molecular-based assay for the presumptive detection of Listeria spp. from environmental surfaces (stainless steel, sealed concrete, plastic, and ceramic tile) and ready-to-eat (RTE) food matrixes (hot dogs and deli meat). The assay utilizes a PCR detection method coupled with a rapid, visual, flow-based assay that develops in 3 min post-PCR amplification and requires only a 24 h enrichment for maximum sensitivity. The Veriflow LS system eliminates the need for sample purification, gel electrophoresis, or fluorophore-based detection of target amplification and does not require complex data analysis...
June 20, 2017: Journal of AOAC International
https://www.readbyqxmd.com/read/28631590/comparative-evaluation-of-veriflow-%C3%A2-salmonella-species-to-usda-and-fda-culture-based-methods-for-the-detection-of-salmonella-spp-in-food-and-environmental-samples
#12
Amrita Puri, Adam C Joelsson, Shawn P Terkhorn, Ashley S Brown, Zara E Gaudioso, Nicholas A Siciliano
Veriflow(®)Salmonella species (Veriflow SS)is a molecular-based assay for the presumptive detection of Salmonella spp. from environmental surfaces (stainless steel, sealed concrete, plastic, and ceramic tile), dairy (2% milk), raw meat (20% fat ground beef), chicken carcasses, and ready-to-eat (RTE) food (hot dogs). The assay utilizes a PCR detection method coupled with a rapid, visual, flow-based assay that develops in 3 min post-PCR amplification and requires only an 18 h enrichment for maximum sensitivity...
June 20, 2017: Journal of AOAC International
https://www.readbyqxmd.com/read/28630857/effectiveness-of-a-commercial-lactic-acid-bacteria-intervention-applied-to-inhibit-shiga-toxin-producing-escherichia-coli-on-refrigerated-vacuum-aged-beef
#13
Katie R Kirsch, Tamra N Tolen, Jessica C Hudson, Alejandro Castillo, Davey Griffin, T Matthew Taylor
Because of their antagonistic activity towards pathogenic and spoilage bacteria, some members of the lactic acid bacteria (LAB) have been evaluated for use as food biopreservatives. The objectives of this study were to assess the antimicrobial utility of a commercial LAB intervention against O157 and non-O157 Shiga-toxigenic E. coli (STEC) on intact beef strip loins during refrigerated vacuum aging and determine intervention efficacy as a function of mode of intervention application. Prerigor strip loins were inoculated with a cocktail (8...
2017: International journal of food science
https://www.readbyqxmd.com/read/28628689/aggressive-skin-cancers-occurring-in-patients-treated-with-the-janus-kinase-inhibitor-ruxolitinib
#14
Adam B Blechman, Christine E Cabell, Christine H Weinberger, Anna Duckworth, Justin J Leitenberger, Fiona O Zwald, Mark A Russell
<p>The Food and Drug Administration approved Ruxolitinib in 2011 for the treatment of primary myelofibrosis. Five-year safety data showed a higher incidence of skin cancer in patients treated with Ruxolitinib compared to best available therapy for myelofibrosis. This report presents a series of five patients with history of myelofibrosis treated with Ruxolitinib who subsequently developed numerous skin cancers with aggressive biological behavior. Each patient in this report was treated by a Mohs surgeon affiliated with an academic institution...
May 1, 2017: Journal of Drugs in Dermatology: JDD
https://www.readbyqxmd.com/read/28627937/the-safety-of-intra-articular-injections-for-the-treatment-of-knee-osteoarthritis-a-critical-narrative-review
#15
Christelle Nguyen, François Rannou
International guidelines recommend that the management of knee osteoarthritis (OA) combine both nonpharmacological and pharmacological interventions. Intra-articular (IA) therapies are considered part of this multimodal approach and are well-established Food and Drug Administration (FDA) and European Medicines Agency (EMA)-approved treatments. Areas covered. Safety data for knee OA, including IA corticosteroids, hyaluronic acid, platelet-rich plasma and botulinum toxin are critically reviewed, and evidence- and pratice-based measures to improve safety of IA therapies are discussed...
June 19, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28627385/advances-in-antibody-drug-conjugates-a-new-era-of-targeted-cancer-therapy
#16
REVIEW
Samaresh Sau, Hashem O Alsaab, Sushil Kumar Kashaw, Katyayani Tatiparti, Arun K Iyer
Antibody-drug conjugates (ADCs), a potent class of anticancer therapeutics, comprise a high-affinity antibody (Ab) and cytotoxic payload coupled via a suitable linker for selective tumor cell killing. In the initial phase of their development, two ADCs, Mylotarg(®), and Adcetris(®) were approved by the US Food and Drug Administration (FDA) for treating hematological cancer, but the real breakthrough came with the discovery of the breast cancer-targeting ADC, Kadcyla(®). With advances in bioengineering, linker chemistry, and potent cytotoxic payload, ADC technology has become a more powerful tool for targeted cancer therapy...
June 13, 2017: Drug Discovery Today
https://www.readbyqxmd.com/read/28627373/development-and-application-of-a-population-physiologically-based-pharmacokinetic-model-for-penicillin-g-in-swine-and-cattle-for-food-safety-assessment
#17
Miao Li, Ronette Gehring, Jim E Riviere, Zhoumeng Lin
Penicillin G is a widely used antimicrobial in food-producing animals, and one of the most predominant drug residues in animal-derived food products. Due to reduced sensitivity of bacteria to penicillin, extralabel use of penicillin G is common, which may lead to violative residues in edible tissues and cause adverse reactions in consumers. This study aimed to develop a physiologically based pharmacokinetic (PBPK) model to predict drug residues in edible tissues and estimate extended withdrawal intervals for penicillin G in swine and cattle...
June 13, 2017: Food and Chemical Toxicology
https://www.readbyqxmd.com/read/28627317/the-european-system-for-the-control-of-the-safety-of-food-contact-materials-needs-restructuring-a-review-and-outlook-for-discussion
#18
Koni Grob
The present European system to assure the safety of migrates from food-contact materials (FCMs) needs improvement. It is proposed to implement better the self-control by the producers through improved official control and more attractive listing of approved substances and materials (the latter being subject of another discussion paper). The initial concept of a positive list for the substances used, a limit for the overall migration and regulation of compliance testing was recognised as insufficient long ago, as it does not properly cover reaction products (including oligomers) and impurities...
June 19, 2017: Food Additives & Contaminants. Part A, Chemistry, Analysis, Control, Exposure & Risk Assessment
https://www.readbyqxmd.com/read/28627166/self-assembled-conjugated-polymer-chitosan-graft-oleic-acid-micelles-for-fast-visible-detection-of-aliphatic-biogenic-amines-by-a-turn-on-fret
#19
Haoquan Zhong, Chunchen Liu, Wenjiao Ge, Run-Cang Sun, Fei Huang, Xiaohui Wang
A fluorescent "turn-on" sensor for fast measuring aliphatic biogenic amines (BAs) was developed based on fluorescent carboxylated polyfluorene (PFTBTCOOH)/ chitosan-graft-oleic acid (CS-graft-OA) micelles. In this system, biobased CS-graft-OA micelles prepared by graft modification of chitosan with oleic acid serve as the vector of hydrophobic fluorescent probe. Bright "turn-on" fluorescence was achieved by the intermolecular fluorescence resonance energy transfer (FRET) of the encapsulated PFTBTCOOH driven by the formation of electrostatic complex with aliphatic BAs, which facilitate a visual identification...
June 19, 2017: ACS Applied Materials & Interfaces
https://www.readbyqxmd.com/read/28626454/a-syst-omics-approach-to-ensuring-food-safety-and-reducing-the-economic-burden-of-salmonellosis
#20
Jean-Guillaume Emond-Rheault, Julie Jeukens, Luca Freschi, Irena Kukavica-Ibrulj, Brian Boyle, Marie-Josée Dupont, Anna Colavecchio, Virginie Barrere, Brigitte Cadieux, Gitanjali Arya, Sadjia Bekal, Chrystal Berry, Elton Burnett, Camille Cavestri, Travis K Chapin, Alanna Crouse, France Daigle, Michelle D Danyluk, Pascal Delaquis, Ken Dewar, Florence Doualla-Bell, Ismail Fliss, Karen Fong, Eric Fournier, Eelco Franz, Rafael Garduno, Alexander Gill, Samantha Gruenheid, Linda Harris, Carol B Huang, Hongsheng Huang, Roger Johnson, Yann Joly, Maud Kerhoas, Nguyet Kong, Gisèle Lapointe, Line Larivière, Stéphanie Loignon, Danielle Malo, Sylvain Moineau, Walid Mottawea, Kakali Mukhopadhyay, Céline Nadon, John Nash, Ida Ngueng Feze, Dele Ogunremi, Ann Perets, Ana V Pilar, Aleisha R Reimer, James Robertson, John Rohde, Kenneth E Sanderson, Lingqiao Song, Roger Stephan, Sandeep Tamber, Paul Thomassin, Denise Tremblay, Valentine Usongo, Caroline Vincent, Siyun Wang, Joel T Weadge, Martin Wiedmann, Lucas Wijnands, Emily D Wilson, Thomas Wittum, Catherine Yoshida, Khadija Youfsi, Lei Zhu, Bart C Weimer, Lawrence Goodridge, Roger C Levesque
The Salmonella Syst-OMICS consortium is sequencing 4,500 Salmonella genomes and building an analysis pipeline for the study of Salmonella genome evolution, antibiotic resistance and virulence genes. Metadata, including phenotypic as well as genomic data, for isolates of the collection are provided through the Salmonella Foodborne Syst-OMICS database (SalFoS), at https://salfos.ibis.ulaval.ca/. Here, we present our strategy and the analysis of the first 3,377 genomes. Our data will be used to draw potential links between strains found in fresh produce, humans, animals and the environment...
2017: Frontiers in Microbiology
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