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https://www.readbyqxmd.com/read/28424972/biosimilars-in-the-united-states-emerging-issues-in-litigation
#1
REVIEW
Alice Yuen-Ting Wong, Martha M Rumore, Albert Wai-Kit Chan
Many first-generation biologics will lose their patent protection by 2020. The biosimilars market is not only attractive but also competitive and tough. The United States (US) is the world's largest pharmaceutical market and is critical to the success of most drugs. However, unclear regulatory requirements and confusing patent resolution procedures create hurdles to market entry of biosimilars. Trade secret exposure and scant exclusivity and adoption also limit the market access of biosimilars. Both biologics and biosimilar developers should closely follow the regulatory and litigation landscape to successfully navigate through the challenges...
April 19, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28423884/integrating-market-chain-assessments-with-zoonoses-risk-analysis-in-two-cross-border-pig-value-chains-in-lao-pdr
#2
Anna Okello, Tassilo Tamino Tiemann, Phouth Inthavong, Boualam Khamlome, Ammaly Phengvilaysouk, Soukanh Keonouchanh, Chattouphone Keokhamphet, Virasack Somoulay, Kate Blaszak, Stuart Blacksell, Walter Okello, John Allen
Lao PDR's recent accession to the World Trade Organization necessitates a greater understanding of the patterns and risk of livestock production in order to better align national policy with the Agreement on the Application of Sanitary and Phytosanitary Measures. This eco-health study describes the integration of market chain and zoonoses risk analyses at two strategic cross border points between Lao PDR, Thailand and Viet Nam. Information gained from smallholder farmer/trader interviews was integrated with serological surveys for pig-associated zoonoses - including hepatitis E virus, Taenia solium and Trichinella - to identify potential linkages between disease risk and pig production and slaughter in low input systems common across the country...
March 25, 2017: Asian-Australasian Journal of Animal Sciences
https://www.readbyqxmd.com/read/28420990/managed-entry-agreements-for-oncology-drugs-lessons-from-the-european-experience-to-inform-the-future
#3
Kim Pauwels, Isabelle Huys, Sabine Vogler, Minne Casteels, Steven Simoens
Objectives: The aim of this study is to conduct an analysis on the regulation and application of managed entry agreements (MEA) for oncology drugs across different European countries. Methods: Literature search and document analysis were performed between September 2015 and June 2016 to collect information on the regulatory framework and practice of MEA in Belgium, The Netherlands, Scotland, England and Wales, Sweden, Italy, Czech Republic and France. An overview of the content and typology of MEA applied for oncology drugs between 2008 and 2015 was generated based on publically available sources and contributions by national health authorities...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28420189/demographic-and-environmental-factors-associated-with-mental-health-a-cross-sectional-study
#4
Jayeun Kim, Ho Kim
Relevant demographic and environmental conditions need to be understood before tailoring policies to improve mental health. Using community health survey data from 25 communities in Seoul, 2013, cross-sectional associations between mental health and community level environments were assessed. Mental health outcomes (self-rated stress levels (SRS) and depressive symptoms (DS)) were analyzed. Community environmental factors included green space, green facilities, and annual PM10 level (AnnPM10); socio-demographic factors included sex, age, education, labor market participation, comorbidity, sleep hours, physical activity, smoking, and drinking...
April 17, 2017: International Journal of Environmental Research and Public Health
https://www.readbyqxmd.com/read/28418681/mechanism-based-solution-to-the-protide-synthesis-problem-selective-access-to-sofosbuvir-acelarin-and-inx-08189
#5
Bryon Simmons, Zhuqing Liu, Artis Klapars, Ana Bellomo, Steven M Silverman
A general and efficient method for the synthesis of pronucleotide (ProTide) 5'-phosphoramidate monoesters is reported. This method consists of a highly stereoselective 5'-phosphorylation mediated by dimethylaluminum chloride to afford the desired target ProTides in excellent yields without employing 3'-protection strategies. The application of this methodology to the synthesis of a number of pharmaceutically relevant compounds currently marketed or under investigation in clinical research is demonstrated.
April 18, 2017: Organic Letters
https://www.readbyqxmd.com/read/28418659/microbial-cell-factories-for-the-production-of-terpenoid-flavor-and-fragrance-compounds
#6
Florence M Schempp, Laura Drummond, Markus Buchhaupt, Jens Schrader
Terpenoid flavor and fragrance compounds are of high interest to the aroma industry. Microbial production offers an alternative sustainable access to the desired terpenoids independent of natural sources. Genetically engineered microorganisms can be used to synthesize terpenoids from cheap and renewable resources. Due to its modular architecture, terpenoid biosynthesis is especially well suited for the microbial cell factory concept: a platform host engineered for a high flux toward the central C5 prenyl diphosphate precursors enables the production of a broad range of target terpenoids just by varying the pathway modules converting the C5 intermediates to the product of interest...
April 18, 2017: Journal of Agricultural and Food Chemistry
https://www.readbyqxmd.com/read/28417941/mapping-patterns-and-trends-in-the-spatial-availability-of-alcohol-using-low-level-geographic-data-a-case-study-in-england-2003-2013
#7
Colin Angus, John Holmes, Ravi Maheswaran, Mark A Green, Petra Meier, Alan Brennan
Much literature examines the relationship between the spatial availability of alcohol and alcohol-related harm. This study aims to address an important gap in this evidence by using detailed outlet data to examine recent temporal trends in the sociodemographic distribution of spatial availability for different types of alcohol outlet in England. Descriptive analysis of measures of alcohol outlet density and proximity using extremely high resolution market research data stratified by outlet type and quintiles of area-level deprivation from 2003, 2007, 2010 and 2013 was undertaken and hierarchical linear growth models fitted to explore the significance of socioeconomic differences...
April 12, 2017: International Journal of Environmental Research and Public Health
https://www.readbyqxmd.com/read/28413842/-i-do-not-have-time-is-there-a-handout-i-can-use-combining-physicians-needs-and-behavior-change-theory-to-put-physical-activity-evidence-into-practice
#8
R E Clark, C McArthur, A Papaioannou, A M Cheung, J Laprade, L Lee, R Jain, L M Giangregorio
Guidelines for physical activity exist and following them would improve health. Physicians can advise patients on physical activity. We found barriers related to physicians' knowledge, a lack of tools and of physician incentives, and competing demands for limited time with a patient. We discuss interventions that could reduce these barriers. INTRODUCTION: Uptake of physical activity (PA) guidelines would improve health and reduce mortality in older adults. However, physicians face barriers in guideline implementation, particularly when faced with needing to tailor recommendations in the presence of chronic disease...
April 17, 2017: Osteoporosis International
https://www.readbyqxmd.com/read/28413248/smallholders-land-access-in-sub-saharan-africa-a-new-landscape
#9
Klaus Deininger, Sara Savastano, Fang Xia
While scholars long recognized the importance of land markets as a key driver of rural non-farm development and transformation in rural areas, evidence on the extent of their operation and the nature of participants remains limited. We use household data from 6 countries to show that there is great potential for such markets to increase productivity and equalize factor ratios. While rental markets transfer land to land-poor and labor-rich producers, their operation and thus impact may be constrained by policy restrictions...
February 2017: Food Policy
https://www.readbyqxmd.com/read/28413244/agricultural-intensification-the-status-in-six-african-countries
#10
Hans P Binswanger-Mkhize, Sara Savastano
Boserup and Ruthenberg (BR) provided the framework to analyze the impact of population growth and market access on the intensification of farming systems. Prior evidence in Africa is consistent with the framework. Over the past two decades, rapid population growth has put farming systems under stress, while rapid urbanization and economic growth have provided new market opportunities. New measures of agro-ecological potential and urban gravity are developed to analyze their impact on population density and market access...
February 2017: Food Policy
https://www.readbyqxmd.com/read/28412577/describing-heterogeneity-of-unmet-needs-among-adults-with-a-developmental-disability-an-examination-of-the-2012-canadian-survey-on-disability
#11
Jennifer Zwicker, Arezou Zaresani, J C Herb Emery
BACKGROUND: As a signatory to the UN Convention on the Rights of Persons with Disabilities, Canada has committed to protect the rights and dignity of persons with developmental disabilities (DD), which means that labour markets, education, and training opportunities should be inclusive and accessible. PURPOSE: Describe the unmet employment, education and daily needs of adults with DD, with a sub analysis of persons with autism spectrum disorder (ASD) and cerebral palsy (CP) in Canada, to inform efficient and equitable policy development...
April 13, 2017: Research in Developmental Disabilities
https://www.readbyqxmd.com/read/28412327/place-over-traits-purchasing-edibles-from-medical-marijuana-dispensaries-in-los-angeles-ca
#12
Nancy Jo Kepple, Bridget Freisthler
OBJECTIVES: To examine discrete purchasing behaviors of marijuana-infused edibles from medical marijuana dispensaries with the aim to identify potential venue- and individual-level targets for prevention. METHODS: Two-stage, venue-based sampling approach was used to randomly select patrons exiting 16 medical marijuana dispensaries in Los Angeles, California during Spring 2013. Hierarchical generalized linear modeling was used to examine the likelihood of purchasing edibles among 524 patrons reporting a discrete purchase regressed on characteristics of the sampled dispensaries and their patrons...
April 7, 2017: Addictive Behaviors
https://www.readbyqxmd.com/read/28411403/ni-ir-catalyzed-photoredox-decarboxylative-coupling-of-s-substituted-thiolactic-acids-with-hetero-aryl-bromides-short-synthesis-of-sulfoxaflor-and-its-sf5-analog
#13
William Dolbier, Oleksandr Kanishchev
Metallaphotoredox cross-coupling reactions have recently emerged as a powerful tool for the construction of C(sp2)-C(sp3) bonds between alkyl chains and aromatic systems, including electron-deficient hetero(aryls) which are known to be the most challenging coupling partners. In this article we disclose Ni/Ir-catalyzed photoredox decarboxylative coupling of readily available S-substituted thiolactic acids with electron-deficient (hetero)aryl bromides, which resulted in the formation of simple but otherwise not easily accessible hetero(arenes) with alkylsulfide side chain...
April 15, 2017: Chemistry: a European Journal
https://www.readbyqxmd.com/read/28408362/ehealth-search-patterns-a-comparison-of-private-and-public-health-care-markets-using-online-panel-data
#14
Janina Anne Schneider, Christopher Patrick Holland
BACKGROUND: Patient and consumer access to eHealth information is of crucial importance because of its role in patient-centered medicine and to improve knowledge about general aspects of health and medical topics. OBJECTIVES: The objectives were to analyze and compare eHealth search patterns in a private (United States) and a public (United Kingdom) health care market. METHODS: A new taxonomy of eHealth websites is proposed to organize the largest eHealth websites...
April 13, 2017: Journal of Medical Internet Research
https://www.readbyqxmd.com/read/28406472/lunch-salad-bars-in-new-orleans-middle-and-high-schools-student-intake-of-fruit-and-vegetables
#15
Carolyn C Johnson, Leann Myers, Adrienne R Mundorf, Keelia O'Malley, Lori Andersen Spruance, Diane M Harris
The school lunch salad bar (SB) is a recommended food environmental strategy to increase access to, and consumption of fruit and vegetables (F/V). In a study to examine use of school lunch SBs, middle and high school students provided data via the Automated Self-Administered 24-h dietary recall (24HDR) tool for kids (ASA24-Kids-2012), a web-based data collection platform. Kilocalories were computed, food groups were assigned and F/V sources were obtained. Students (n = 718) from 12 schools with SBs and nine schools without SBs were approximately 87% African American, over 64% female and most were 7th and 8th graders...
April 13, 2017: International Journal of Environmental Research and Public Health
https://www.readbyqxmd.com/read/28402826/the-affordable-care-act-implications-for-health-care-equity
#16
REVIEW
Adam Gaffney, Danny McCormick
Inequalities in medical care are endemic in the USA. The Affordable Care Act (ACA), passed in 2010 and fully implemented in 2014, was intended to expand coverage and bring about a new era of health-care access. In this review, we evaluate the legislation's impact on health-care equity. We consider the law's coverage expansion, insurance market reforms, cost and affordability provisions, and delivery-system reforms. Although the ACA improved coverage and access-particularly for poorer Americans, women, and minorities-its overall impact was modest in comparison with the gaps present before the law's implementation...
April 8, 2017: Lancet
https://www.readbyqxmd.com/read/28402231/a-comparison-of-interventional-approaches-for-increasing-power-take-off-shielding-on-ny-farms
#17
Julie A Sorensen, Pamela J Tinc, Deb Dalton, Erika E Scott, Paul L Jenkins
OBJECTIVE: Power take-off (PTO) driveline entanglements are a primary source of injury on US farms. As with many farm injury concerns, hazard control technology is widely available for mitigating the risk of these entanglements. Despite the availability of hazard control technology, PTO shields are damaged or missing on approximately 57% of PTO driveline implements in New York. Given the catastrophic nature of entanglements and the ready access to safety technology, a better understanding of what motivates farmers to install or replace PTO shields is warranted...
April 12, 2017: Journal of Agromedicine
https://www.readbyqxmd.com/read/28397080/the-rituximab-biosimilar-ct-p10-in-rheumatology-and-cancer-a-budget-impact-analysis-in-28-european-countries
#18
László Gulácsi, Valentin Brodszky, Petra Baji, Fanni Rencz, Márta Péntek
INTRODUCTION: New biosimilars of monoclonal antibodies are anticipated to bring significant cost savings and increase access to treatment. The rituximab biosimilar CT-P10 has recently been approved in Europe in all indications held by reference rituximab (RTX), including rheumatoid arthritis, non-Hodgkin's lymphoma, and chronic lymphocytic leukemia. We analyzed the budgetary impact of the introduction of CT-P10 into the European Union (EU) for use in patients with rheumatoid arthritis and cancer diagnoses, using a budget impact analysis model...
April 10, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28396587/social-media-reveal-that-charismatic-species-are-not-the-main-attractor-of-ecotourists-to-sub-saharan-protected-areas
#19
Anna Hausmann, Tuuli Toivonen, Vuokko Heikinheimo, Henrikki Tenkanen, Rob Slotow, Enrico Di Minin
Charismatic megafauna are arguably considered the primary attractor of ecotourists to sub-Saharan African protected areas. However, the lack of visitation data across the whole continent has thus far prevented the investigation of whether charismatic species are indeed a key attractor of ecotourists to protected areas. Social media data can now be used for this purpose. We mined data from Instagram, and used generalized linear models with site- and country-level deviations to explore which socio-economic, geographical and biological factors explain social media use in sub-Saharan African protected areas...
April 10, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28395239/eco-innovations-in-the-functioning-of-companies
#20
A Ociepa-Kubicka, P Pachura
The development of entrepreneurships in the 21st century cannot occur without taking care of the natural environment. The article presents issues related to eco-innovation. Despite the opportunities offered by eco-innovations, implementation of such initiatives remains to lead to various difficulties. They vary across countries and sectors. The insufficient number of enterprises in Poland and other European countries implement adequate level of eco-innovations. The main aim of this paper is to indicate the causes of this status and activities aimed to develop eco-innovativeness...
April 7, 2017: Environmental Research
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