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https://www.readbyqxmd.com/read/28445670/challenges-for-small-biopharmaceutical-companies
#1
Richard A Moscicki, P K Tandon
No abstract text is available yet for this article.
April 27, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28445669/challenges-for-small-biopharmaceutical-companies
#2
(no author information available yet)
No abstract text is available yet for this article.
April 27, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28445611/equivalence-of-complex-drug-products-advances-in-and-challenges-for-current-regulatory-frameworks
#3
Leonie Hussaarts, Stefan Mühlebach, Vinod P Shah, Scott McNeil, Gerrit Borchard, Beat Flühmann, Vera Weinstein, Sesha Neervannan, Elwyn Griffiths, Wenlei Jiang, Elena Wolff-Holz, Daan J A Crommelin, Jon S B de Vlieger
Biotechnology and nanotechnology provide a growing number of innovator-driven complex drug products and their copy versions. Biologics exemplify one category of complex drugs, but there are also nonbiological complex drug products, including many nanomedicines, such as iron-carbohydrate complexes, drug-carrying liposomes or emulsions, and glatiramoids. In this white paper, which stems from a 1-day conference at the New York Academy of Sciences, we discuss regulatory frameworks in use worldwide (e.g., the U...
April 26, 2017: Annals of the New York Academy of Sciences
https://www.readbyqxmd.com/read/28445563/outbreak-of-occupational-dermatitis-associated-with-pyemotes-ventricosus
#4
Martyna Tomczyk-Socha, Katarzyna Jedrzejewska-Jurga, Joanna Limburska, Jaroslaw Tomczyk
Importance: Although Pyemotes spp have been known to cause dermatitis, recent reports are rare. During the past 30 years, only 3 outbreaks of dermatitis caused by Pyemotes ventricosus have been reported. Objective: To analyze the causative agent of skin changes in employees of a company that produced herbal medicines. Design, Setting, and Participants: This case series includes 18 patients (8 men, 10 women; mean age, 44 years) who contracted unusual dermatitis after an occupational exposure in July and August of 2012 while working for a company that produced herbal medicines...
April 26, 2017: JAMA Dermatology
https://www.readbyqxmd.com/read/28445356/what-is-the-standard-volume-to-increase-a-cup-size-for-breast-augmentation-surgery-a-novel-three-dimensional-computed-tomographic-approach
#5
Nina-Marie King, Vedran Lovric, William C H Parr, W R Walsh, Pouria Moradi
BACKGROUND: Breast augmentation surgery poses many challenges, and meeting the patient's expectations is one of the most important. Previous reports equate 100 cc to a one-cup-size increase; however, no studies have confirmed this between commercially available bras. The aim of this study was to identify the volume increase between cup sizes across different brands and the relationship with implant selection. METHODS: Five bra cup sizes from three different companies were analyzed for their volume capacity...
May 2017: Plastic and Reconstructive Surgery
https://www.readbyqxmd.com/read/28445216/opposition-to-obamacare-a-closer-look
#6
Paul R Gordon, Laurel Gray, Alex Hollingsworth, Eve C Shapiro, James E Dalen
Prior telephone surveys have reported two main reasons for opposition to the Affordable Care Act (ACA): distrust of government and opposition to the universal coverage mandate. The authors set out to elucidate the reasons for this opposition. This article describes how the authors used qualitative methods with semistructured interviewing as a principal investigative method to gather information from people they met while bicycling across the United States from April through July 2016. During this time, the authors conducted open-ended, semistructured conversations with people they met as they rode their bicycles from Washington, DC, to Seattle, Washington...
April 25, 2017: Academic Medicine: Journal of the Association of American Medical Colleges
https://www.readbyqxmd.com/read/28444492/optimal-radial-force-and-size-for-palliation-in-gastroesophageal-adenocarcinoma-a-comparative-analysis-of-current-stent-technology
#7
Nsehniitooh Mbah, Prejesh Philips, Michael J Voor, Robert C G Martin
BACKGROUND: The optimal use of esophageal stents for malignant and benign esophageal strictures continues to be plagued with variability in pain tolerance, migration rates, and reflux-related symptoms. The aim of this study was to evaluate the differences in radial force exhibited by a variety of esophageal stents with respect to the patient's esophageal stricture. METHODS: Radial force testing was performed on eight stents manufactured by four different companies using a hydraulic press and a 5000 N force gage...
April 25, 2017: Surgical Endoscopy
https://www.readbyqxmd.com/read/28443154/drug-induced-liver-injury-do-we-know-everything
#8
REVIEW
Tamara Alempijevic, Simon Zec, Tomica Milosavljevic
Interest in drug-induced liver injury (DILI) has dramatically increased over the past decade, and it has become a hot topic for clinicians, academics, pharmaceutical companies and regulatory bodies. By investigating the current state of the art, the latest scientific findings, controversies, and guidelines, this review will attempt to answer the question: Do we know everything? Since the first descriptions of hepatotoxicity over 70 years ago, more than 1000 drugs have been identified to date, however, much of our knowledge of diagnostic and pathophysiologic principles remains unchanged...
April 8, 2017: World Journal of Hepatology
https://www.readbyqxmd.com/read/28443022/evaluating-quality-of-decision-making-processes-in-medicines-development-regulatory-review-and-health-technology-assessment-a-systematic-review-of-the-literature
#9
REVIEW
Magdalena Bujar, Neil McAuslane, Stuart R Walker, Sam Salek
Introduction: Although pharmaceutical companies, regulatory authorities, and health technology assessment (HTA) agencies have been increasingly using decision-making frameworks, it is not certain whether these enable better quality decision making. This could be addressed by formally evaluating the quality of decision-making process within those organizations. The aim of this literature review was to identify current techniques (tools, questionnaires, surveys, and studies) for measuring the quality of the decision-making process across the three stakeholders...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28441917/identification-of-il-17a-derived-neural-cell-type-and-dynamic-changes-of-il-17a-in-serum-csf-of-mice-with-ischemic-stroke
#10
Shujuan Li, Qingqing Dai, Jinling Yu, Ting Liu, Shuiqiao Liu, Longhui Ma, Ying Zhang, Song Han, Junfa Li
BACKGROUND: Interleukin (IL)-17A was reported to be involved in the development of post-ischemic stroke inflammatory response and functional recovery. However, the IL-17A dynamic changes in serum/cerebrospinal fluid (CSF) and its role in neuronal injury following ischemic stroke are unclear. METHODS: In vivo ischemic stroke was induced by 1 h of middle cerebral artery occlusion (MCAO) and 6 h-7 d reperfusion (R) in mice, while in vitro stroke was induced by 1 h oxygen-glucose deprivation (OGD)/24 h reoxygenation (R) in cultured cortical neurons...
April 25, 2017: Neurological Research
https://www.readbyqxmd.com/read/28441789/comparing-apoptosis-and-necrosis-effects-of-arctium-lappa-root-extract-and-doxorubicin-on-mcf7-and-mda-mb-231-cell-lines
#11
Fereshteh Ghafari, Mohammad Reza Rajabi, Tahereh Mazoochi, Mohsen Taghizadeh, Hossein Nikzad, Mohammad Ali Atlasi, Aliakbar Taherian
Objective: Breast cancer is a heterogeneous disease and very common malignancy in women worldwide. The efficacy of chemotherapy as an important part of breast cancer treatment is limited due to its side effects. While pharmaceutical companies are looking for better chemicals, research on traditional medicines that generally have fewer side effects is quite interesting. In this study, apoptosis and necrosis effect of Arctium lappa and doxorubicin was compared in MCF7, and MDA-MB-231 cell lines. Materials and Methods: MCF7 and MDA-MB-231 cells were cultured in RPMI 1640 containing 10% FBS and 100 U/ml penicillin/streptomycin...
March 1, 2017: Asian Pacific Journal of Cancer Prevention: APJCP
https://www.readbyqxmd.com/read/28441283/early-intake-of-radiocesium-by-residents-living-near-the-tepco-fukushima-dai-ichi-nuclear-power-plant-after-the-accident-part-2-relationship-between-internal-dose-and-evacuation-behavior-in-individuals
#12
Naoaki Kunishima, Osamu Kurihara, Eunjoo Kim, Tetsuo Ishikawa, Takashi Nakano, Kumiko Fukutsu, Kotaro Tani, Kazuo Furuyama, Shozo Hashimoto, Misao Hachiya, Yutaka Naoi, Makoto Akashi
The Tokyo Electric Power Company's Fukushima Dai-ichi Nuclear Power Plant (FDNPP) accident exposed members of the public to radiation. This study analyses the relation between personal behavior data obtained from 112 out of 174 subjects who underwent whole-body measurements by the National Institute of Radiological Sciences (NIRS) during the period from 27 June to 28 July 2011 and their committed effective doses (CEDs) from Cs and Cs. The whereabouts of the 112 persons living in municipalities near the FDNPP (mainly, Namie town) on several days in March 2011 are graphed on maps...
June 2017: Health Physics
https://www.readbyqxmd.com/read/28441147/can-the-generic-antiretroviral-industry-support-access-to-a-universal-antiretroviral-regimen
#13
Carolyn D Amole, Caroline Middlecote, Vineet R Prabhu, N Kumarasamy
PURPOSE OF REVIEW: The generic antiretroviral (ARV) industry played a critical role in the massive scale-up of HIV treatment in low-income and middle-income countries since 2000. As the global community looks ahead to a universal antiretroviral regimen, this article considers the industry's role in supporting universal access to affordable, simpler, more durable, and tolerable HIV treatment regimens. RECENT FINDINGS: Generic manufacturers made treatment scale-up in low-income and middle-income countries possible through reducing prices, combining molecules from different originator companies to develop optimal fixed-dose combinations, and investing in production capacity to meet escalating demand...
April 24, 2017: Current Opinion in HIV and AIDS
https://www.readbyqxmd.com/read/28440796/the-importance-of-international-collaboration-for-rare-diseases-research-a-european-perspective
#14
REVIEW
D Julkowska, C P Austin, C M Cutillo, D Gancberg, C Hager, J Halftermeyer, A H Jonker, L P L Lau, I Norstedt, A Rath, R Schuster, E Simelyte, S van Weely
Over the last two decades, important contributions were made at national, European and international levels to foster collaboration into rare diseases research. The European Union (EU) has put much effort into funding rare diseases research, encouraging national funding organizations to collaborate together in the E-Rare programme, setting up European Reference Networks for rare diseases and complex conditions, and initiating the International Rare Diseases Research Consortium (IRDiRC) together with the National Institutes of Health in the USA...
April 25, 2017: Gene Therapy
https://www.readbyqxmd.com/read/28440027/the-crispr-cas9-system-their-delivery-in-vivo-and-ex-vivo-applications-and-clinical-development-by-startups
#15
REVIEW
Minjung Song
The CRISPR/Cas9 gene editing system was originally derived from the prokaryotic adaptive immune system mediated by Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) and CRISPR-associated proteins (Cas). The system has been successfully applied to genome editing in eukaryotes and has contributed to remarkable advances in the life sciences, in areas ranging from agriculture to genetic disease therapies. For efficient editing and extending the influence of this system, proper delivery of its components is crucial...
April 25, 2017: Biotechnology Progress
https://www.readbyqxmd.com/read/28439247/when-corporate-social-responsibility-csr-meets-organizational-psychology-new-frontiers-in-micro-csr-research-and-fulfilling-a-quid-pro-quo-through-multilevel-insights
#16
David A Jones, Chelsea R Willness, Ante Glavas
Researchers, corporate leaders, and other stakeholders have shown increasing interest in Corporate Social Responsibility (CSR)-a company's discretionary actions and policies that appear to advance societal well-being beyond its immediate financial interests and legal requirements. Spanning decades of research activity, the scholarly literature on CSR has been dominated by meso- and macro-level perspectives, such as studies within corporate strategy that examine relationships between firm-level indicators of social/environmental performance and corporate financial performance...
2017: Frontiers in Psychology
https://www.readbyqxmd.com/read/28438271/how-does-an-inventor-find-an-investor-or-partner-raising-funds-to-start-a-company
#17
Rudy A Mazzocchi
Rudy Mazzocchi has over 25 years of senior executive management, technology and intellectual property development, and financing experience in the medical-technology/biotechnology industries. He serves currently as cofounder/chief executive officer of ELENZA, Inc, an ophthalmology company that has developed an electro-active, autofocusing, implantable lens; executive chairman of Establishment Labs; executive chairman of LAFORGE Optical; and executive chairman of OptiSTENT, Inc. He served previously as managing director of Accuitive Medical Ventures and The Innovation Factory; cofounder/chief executive officer of Image-Guided NEUROLOGICS, acquired by Medtronic in 2005; and founding chief executive officer of MICROVENA Corporation, which became "eV3," acquired by Covidien...
May 2017: Surgery
https://www.readbyqxmd.com/read/28437821/-rapid-cycling-in-bipolar-disorders-symptoms-%C3%A2-background%C3%A2-and-treatment-recommendations
#18
Stephan Köhler, Eva Friedel, Thomas Stamm
Rapid cycling bipolar disorder is encountered frequently in clinical practice with a lifetime prevalence of up to 31 %. Besides its association with greater illness severity, increased suicide and comorbidity rates, rapid cycling bipolar disorder has been closely associated with a longer and more complicated course of disease and inadequate treatment response compared to non-rapid cycling bipolar disorder. However rapid cycling does not serve as a stable characteristic of bipolar disorder, though its prevalence increases with illness duration...
April 2017: Fortschritte der Neurologie-Psychiatrie
https://www.readbyqxmd.com/read/28436455/the-impact-of-gold-mining-and-agricultural-concessions-on-the-tree-cover-and-local-communities-in-northern-myanmar
#19
Sarah Papworth, Madhu Rao, Myint Myint Oo, Kyaw Thinn Latt, Robert Tizard, Thomas Pienkowski, L Roman Carrasco
Myanmar offers unique opportunities for both biodiversity conservation and foreign direct investment due to projected economic growth linked to natural resource exploitation. Industrial-scale development introduces new land uses into the landscape, with unknown repercussions for local communities and biodiversity conservation. We use participatory mapping of 31 communities, focus groups in 28 communities, and analyses of forest cover change during 2000-2010 using MODIS vegetation continuous fields images, to understand the social and environmental impacts of gold mining and agricultural concessions in Myanmar's Hukaung Valley (~21,800 km(2))...
April 24, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28435812/scientometrics-on-public-health-research-in-iran-increase-of-area-studies-despite-embargoes-a-review-article
#20
REVIEW
Brice Poreau
BACKGROUND: Due to embargoes and sanctions from 1979 until 2015, impact on scientific research in Iran may be critical. Public health is the main example of this burning point. In this paper, the aim was to map the scientific research in public health in Iran until 2014 with area studies as well as networks of countries involved. METHODS: We used bibliographic analyses using VOS viewer software for network analysis during the period 1975-2014. Two databases were used: Web of Science and PubMed...
March 2017: Iranian Journal of Public Health
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