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https://www.readbyqxmd.com/read/28103214/association-between-the-real-cost-media-campaign-and-smoking-initiation-among-youths-united-states-2014-2016
#1
Matthew C Farrelly, Jennifer C Duke, James Nonnemaker, Anna J MacMonegle, Tesfa N Alexander, Xiaoquan Zhao, Janine C Delahanty, Pamela Rao, Jane A Allen
In the United States, approximately 900,000 youths smoke their first cigarette each year (1). Health communication interventions are evidence-based strategies for preventing the initiation of tobacco use, promoting and facilitating cessation, and changing beliefs and attitudes about tobacco use (2,3). This report describes the association between the Food and Drug Administration's (FDA's) first national tobacco public education campaign, The Real Cost, and rates of smoking initiation among youths in the United States from 2014 to 2016...
January 20, 2017: MMWR. Morbidity and Mortality Weekly Report
https://www.readbyqxmd.com/read/28102980/microbiology-devices-reclassification-of-influenza-virus-antigen-detection-test-systems-intended-for-use-directly-with-clinical-specimens-final-order
#2
(no author information available yet)
The Food and Drug Administration (FDA) is reclassifying antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents from class I into class II with special controls and into a new device classification regulation.
12, 2017: Federal Register
https://www.readbyqxmd.com/read/28102848/statins-in-anthracycline-induced-cardiotoxicity-rac-and-rho-and-the-heartbreakers
#3
REVIEW
Christian Henninger, Gerhard Fritz
Cancer patients receiving anthracycline-based chemotherapy are at risk to develop life-threatening chronic cardiotoxicity with the pathophysiological mechanism of action not fully understood. Besides the most common hypothesis that anthracycline-induced congestive heart failure (CHF) is mainly caused by generation of reactive oxygen species, recent data point to a critical role of topoisomerase II beta (TOP2B), which is a primary target of anthracycline poisoning, in the pathophysiology of CHF. As the use of the only clinically approved cardioprotectant dexrazoxane has been limited by the FDA in 2011, there is an urgent need for alternative cardioprotective measures...
January 19, 2017: Cell Death & Disease
https://www.readbyqxmd.com/read/28102520/us-fda-perspective-on-elbasvir-grazoprevir-treatment-for-patients-with-chronic-hepatitis-c-virus-genotype-1-or-4-infection
#4
Sarita D Boyd, LaRee Tracy, Takashi E Komatsu, Patrick R Harrington, Prabha Viswanathan, Jeff Murray, Adam Sherwat
Elbasvir/grazoprevir demonstrated high sustained virologic response rates 12 weeks after the end of treatment (SVR12) across five clinical trials in subjects infected with chronic hepatitis C virus (HCV) genotype 1, including those with advanced chronic kidney disease (CKD), and GT4. Despite favorable results overall, the US Food and Drug Administration (FDA) encountered challenging regulatory issues due to the limitations of clinical trial data in certain subpopulations. In GT1a-infected subjects, baseline NS5A resistance-associated polymorphisms emerged as the strongest baseline characteristic associated with diminished SVR12 rates following 12 weeks of elbasvir/grazoprevir treatment...
January 19, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28101492/trends-and-predictors-of-chemotherapy-use-among-thyroid-cancer-patients-in-the-national-cancer-database-2004-2013
#5
Stacey A Fedewa, Ahmedin Jemal, Amy Y Chen
BACKGROUND/AIM: Beginning in 2011, the Food and Drug Administration (FDA) approved the use of multikinase inhibitors (MKIs) for medullary thyroid cancers (MTCs), and in 2013 MKIs were approved for metastatic differentiated thyroid cancers (DTCs). However, little is known about the use of chemotherapy in thyroid cancer patients. Thus, the goal of our study was to describe patterns of chemotherapy use, including MKIs, among DTC and MTC patients in the National Cancer Database (NCDB). METHODS: Chemotherapy use, along with other treatment types (surgery and radiation), was assessed between 2004 and 2013...
December 2016: European Thyroid Journal
https://www.readbyqxmd.com/read/28100580/venetoclax-in-patients-with-previously-treated-chronic-lymphocytic-leukemia
#6
Andrew W Roberts, Stephan Stilgenbauer, John F Seymour, David C S Huang
Venetoclax is the first BCL2 inhibitor to enter routine clinical practice. It is an orally bioavailable small molecule that binds BCL2 very specifically. Acting as a pharmacological mimic of the proteins that initiate apoptosis (a so-called BH3-mimetic), venetoclax rapidly induces apoptosis in chronic lymphocytic leukemia (CLL) cells which express high levels of BCL2 and rely on it to maintain their survival. As a single agent, daily venetoclax treatment induced durable responses in 79% of patients with relapsed or refractory CLL or small lymphocytic lymphoma in a Phase 1 study, including complete remissions in 20% of patients...
January 18, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28100464/six-month-market-exclusivity-extensions-to-promote-research-offer-substantial-returns-for-many-drug-makers
#7
Aaron S Kesselheim, Benjamin N Rome, Ameet Sarpatwari, Jerry Avorn
To incentivize pharmaceutical manufacturers to invest in areas of unmet medical need, policy makers frequently propose extending the market exclusivity period of desired drugs. Some such proposals are modeled after the pediatric exclusivity patent extension program, which since 1997 has provided six additional months of market exclusivity for drugs studied in children. The most recent proposal would encourage rare disease research by providing six months of extended exclusivity for any existing drug that is granted subsequent FDA approval for a new rare disease indication...
January 18, 2017: Health Affairs
https://www.readbyqxmd.com/read/28100254/challenges-in-orphan-drug-development-and-regulatory-policy-in-china
#8
REVIEW
Alice Cheng, Zhi Xie
While regulatory policy is well defined for orphan drug development in the United States and Europe, rare disease policy in China is still evolving. Many Chinese patients currently pay out of pocket for international treatments that are not yet approved in China. The lack of a clear definition and therefore regulatory approval process for rare diseases has, until now, de-incentivized pharmaceutical companies to pursue rare disease drug development in China. In turn, many grassroots movements have begun to support rare disease patients and facilitate drug discovery through research...
January 18, 2017: Orphanet Journal of Rare Diseases
https://www.readbyqxmd.com/read/28099856/screening-bioactives-reveals-nanchangmycin-as-a-broad-spectrum-antiviral-active-against-zika-virus
#9
Keiko Rausch, Brent A Hackett, Nathan L Weinbren, Sophia M Reeder, Yoel Sadovsky, Christopher A Hunter, David C Schultz, Carolyn B Coyne, Sara Cherry
Zika virus is an emerging arthropod-borne flavivirus for which there are no vaccines or specific therapeutics. We screened a library of 2,000 bioactive compounds for their ability to block Zika virus infection in three distinct cell types with two different strains of Zika virus. Using a microscopy-based assay, we validated 38 drugs that inhibited Zika virus infection, including FDA-approved nucleoside analogs. Cells expressing high levels of the attachment factor AXL can be protected from infection with receptor tyrosine kinase inhibitors, while placental-derived cells that lack AXL expression are insensitive to this inhibition...
January 17, 2017: Cell Reports
https://www.readbyqxmd.com/read/28099783/ketosis-and-diabetic-ketoacidosis-in-response-to-sglt2-inhibitors-basic-mechanisms-and-therapeutic-perspectives
#10
REVIEW
Hongyu Qiu, Aleksandra Novikov, Volker Vallon
Inhibitors of the sodium-glucose cotransporter SGLT2 are a new class of anti-hyperglycemic drugs that have been approved for the treatment of type 2 diabetes mellitus (T2DM). These drugs inhibit glucose reabsorption in the proximal tubules of the kidney thereby enhancing glucosuria and lowering blood glucose levels. Additional consequences and benefits include a reduction in body weight, uric acid levels, and blood pressure. Moreover, SGLT2 inhibition can have protective effects on the kidney and cardiovascular system in patients with T2DM and high cardiovascular risk...
January 18, 2017: Diabetes/metabolism Research and Reviews
https://www.readbyqxmd.com/read/28099079/lymphangioleiomyomatosis-a-monogenic-model-of-malignancy
#11
Vera P Krymskaya, Francis X McCormack
Lymphangioleiomyomatosis (LAM) is a rare, low-grade, metastasizing neoplasm that arises from an unknown source, spreads via the lymphatics, and targets the lungs. All pulmonary structures become infiltrated with benign-appearing spindle and epithelioid cells (LAM cells) that express smooth-muscle and melanocyte-lineage markers, harbor mTOR-activating mutations in tuberous sclerosis complex (TSC) genes, and recruit abundant stromal cells. Elaboration of lymphangiogenic growth factors and matrix remodeling enzymes by LAM cells enables their access to lymphatic channels and likely drives the cystic lung remodeling that often culminates in respiratory failure...
January 14, 2017: Annual Review of Medicine
https://www.readbyqxmd.com/read/28098491/particle-sizing-methods-for-the-detection-of-protein-aggregates-in-biopharmaceuticals
#12
Akram Khodabandehloo, David Da Yong Chen
Protein aggregation is a common biological phenomenon which is responsible for degenerative diseases and is problematic in the pharmaceutical industry. According to the rules provided by regulatory agencies, industry is supposed to assess the product quality regarding the presence of subvisible particles. Also, they should evaluate the technologies that are used to measure these particles. Therefore, US FDA and industry have been looking for methods capable of accurately characterizing the protein products...
January 18, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28098395/first-uhplc-ms-ms-method-coupled-with-automated-on-line-spe-for-quantification-both-of-tacrolimus-and-everolimus-in-peripheral-blood-mononuclear-cells-and-its-application-on-samples-from-co-treated-pediatric-patients
#13
Debora Pensi, Amedeo De Nicolò, Michele Pinon, Clarissa Pisciotta, Pier Luigi Calvo, Antonello Nonnato, Renato Romagnoli, Francesco Tandoi, Giovanni Di Perri, Antonio D'Avolio
Tacrolimus (TAC, FK-506) and everolimus (EVE, RAD001) are immunosuppressors used to treat pediatric patients undergoing liver transplantation. Their hematic TDM by liquid chromatography became standard practice. However, it does not always reflect concentrations at their active site. Our aim was to develop and validate a new method for the simultaneous TAC and EVE quantification into target cells: Peripheral-Blood-Mononuclear-Cells (PBMCs). PBMCs were collected using Cell-Preparation-Tubes; cells number and MCV were evaluated by an automatic cell counter...
January 18, 2017: Journal of Mass Spectrometry: JMS
https://www.readbyqxmd.com/read/28097882/antidiabetic-agents-and-cardiovascular-outcomes-in-patients-with-heart-diseases
#14
Judy W M Cheng, Hisham A Badreldin, Dhiren K Patel, Snehal H Bhatt
This article reviews evidence of benefits and risk of antidiabetic agents in cardiovascular (CV) outcomes, with a focus on medications approved by the FDA since 2008. Peer-reviewed articles were identified from MEDLINE and Current Content database (both 1966 to October 1, 2016) using the search terms insulin, metformin, rosiglitazone, pioglitazone, glyburide, glipizide, glimepiride, acarbose, miglitol, albiglutide, exenatide, liraglutide, lixisenatide, dulaglutide, pramlintide, meglitinide, alogliptin, linagliptin, saxagliptin, sitagliptin, canagliflozin, dapagliflozin, empagliflozin, colesevalam, bromocriptine, mortality, myocardial infarction (MI), heart failure, (HF) and stroke...
January 18, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28097641/natural-products-diversity-of-marine-ascidians-tunicates-ascidiacea-and-successful-drugs-in-clinical-development
#15
REVIEW
Satheesh Kumar Palanisamy, N M Rajendran, Angela Marino
This present study reviewed the chemical diversity of marine ascidians and their pharmacological applications, challenges and recent developments in marine drug discovery reported during 1994-2014, highlighting the structural activity of compounds produced by these specimens. Till date only 5% of living ascidian species were studied from <3000 species, this study represented from family didemnidae (32%), polyclinidae (22%), styelidae and polycitoridae (11-12%) exhibiting the highest number of promising MNPs...
January 17, 2017: Natural Products and Bioprospecting
https://www.readbyqxmd.com/read/28097005/the-cardioprotective-efficacy-of-tvp1022-against-ischemia-reperfusion-injury-and-cardiac-remodeling-in-rats
#16
Assaf Malka, Offir Ertracht, Noa Bachner-Hinenzon, Irina Reiter, Ofer Binah
Following acute myocardial infarction (MI), early and successful reperfusion is the most effective strategy for reducing infarct size and improving the clinical outcome. However, immediate restoration of blood flow to the ischemic zone results in myocardial damage, defined as "reperfusion-injury". Whereas we previously reported that TVP1022 (the S-isomer of rasagiline, FDA-approved anti-Parkinson drug) decreased infarct size 24 h post ischemia reperfusion (I/R) in rats, in this study we investigated the chronic cardioprotective efficacy of TVP1022 14 days post-I/R...
December 2016: Pharmacology Research & Perspectives
https://www.readbyqxmd.com/read/28096973/a-fission-yeast-cell-based-system-for-multidrug-resistant-hiv-1-proteases
#17
Zsigmond Benko, Dong Liang, Ge Li, Robert T Elder, Anindya Sarkar, Jun Takayama, Arun K Ghosh, Richard Y Zhao
BACKGROUND: HIV-1 protease (PR) is an essential enzyme for viral production. Thus, PR inhibitors (PIs) are the most effective class of anti-HIV drugs. However, the main challenge to the successful use of PI drugs in patient treatment is the emergence of multidrug resistant PRs (mdrPRs). This study aimed to develop a fission yeast cell-based system for rapid testing of new PIs that combat mdrPRs. RESULTS: Three mdrPRs were isolated from HIV-infected patients that carried seven (M7PR), ten (M10PR) and eleven (M11PR) PR gene mutations, respectively...
2017: Cell & Bioscience
https://www.readbyqxmd.com/read/28096476/accuracy-of-oxygen-consumption-and-carbon-dioxide-elimination-measurements-in-2-breath-by-breath-devices
#18
Craig D Smallwood, John N Kheir, Brian K Walsh, Nilesh M Mehta
BACKGROUND: Although accurate quantification of oxygen consumption (V̇O2 ) and carbon dioxide elimination (V̇CO2 ) provides important insights into a patient's nutritional and hemodynamic status, few devices exist to accurately measure these parameters in children. Therefore, we assessed the accuracy and agreement of 2 devices currently on the market using a pediatric in vitro model of gas exchange. METHODS: We utilized a Huszczuk simulation model, which simulates oxygen consumption and carbon dioxide production using gas dilution, to examine the accuracy of two FDA-cleared respiratory modules (E-COVX and E-sCAiOVX-00)...
January 17, 2017: Respiratory Care
https://www.readbyqxmd.com/read/28095946/electroconvulsive-therapy-ect-for-treating-agitation-in-dementia-major-neurocognitive-disorder-a-promising-option
#19
Oliver M Glass, Brent P Forester, Adriana P Hermida
BACKGROUND: Agitation in patients with dementia increases caretaker burden, increases healthcare costs, and worsens the patient's quality of life. Antipsychotic medications, commonly used for the treatment of agitation in patients with dementia have a box warning from the FDA for elevated mortality risk. Electroconvulsive therapy (ECT) has made significant advances over the past several years, and is efficacious in treating a wide range of psychiatric conditions. We provide a systematic review of published literature regarding the efficacy of ECT for the treatment of agitation in patients with dementia (major neurocognitive disorder)...
January 18, 2017: International Psychogeriatrics
https://www.readbyqxmd.com/read/28095674/the-century-of-biology-and-the-evolving-role-of-medicinal-chemists-in-neuroscience
#20
Dario Doller
Society expects that the wave of contemporary new discoveries in biological sciences will soon lead to novel treatments for human diseases, including many devastating brain disorders. Historically, medicinal chemists have contributed to drug discovery teams in ways that synergize with those from their partner sciences, and help transform new knowledge into the ultimate tangible asset: a new drug. The optimal balance of resources and the right strategy to minimize the risk of late clinical failure may differ for different therapeutic indications...
January 18, 2017: ACS Chemical Neuroscience
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