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https://www.readbyqxmd.com/read/28334772/transparency-policies-of-the-european-medicines-agency-has-the-paradigm-shifted
#1
Daria Kim
This article reflects on the state of play as regards access to non-summary clinical trial data in the European Union (EU). In particular, it examines the scope of access under the recent transparency policies of the European Medicines Agency (EMA) that attempt to break away from the presumptively confidential treatment of clinical trial data. In light of the emerging case law of the Court of Justice of the European Union on clinical trial data disclosure, it remains highly uncertain what data, and under what conditions, can be lawfully released by the EMA...
February 23, 2017: Medical Law Review
https://www.readbyqxmd.com/read/28316783/current-and-future-prospects-for-nanotechnology-in-animal-production
#2
REVIEW
Emily K Hill, Julang Li
Nanoparticles have been used as diagnostic and therapeutic agents in the human medical field for quite some time, though their application in veterinary medicine and animal production is still relatively new. Recently, production demands on the livestock industry have been centered around the use of antibiotics as growth promoters due to growing concern over microbial antibiotic resistance. With many countries reporting increased incidences of antibiotic-resistant bacteria, laws and regulations are being updated to end in-feed antibiotic use in the animal production industry...
2017: Journal of Animal Science and Biotechnology
https://www.readbyqxmd.com/read/28299610/pharmacovigilance-of-regenerative-medicine-under-the-amended-pharmaceutical-affairs-act-in-japan
#3
Yasuko Inokuma
Two Japanese regulatory agencies, the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency announced the implementation of a new review system called 'Conditional Approval,' specifically for the emerging field of regenerative medicine, in an amendment to the Pharmaceutical Affairs Act in 2014. Regenerative medicine was regulated in the category of 'Medical Devices' prior to the amendment and was not covered by the Relief Service, a system that provides financial aid to people who have experienced an adverse drug reaction and developed serious side effects as a result...
March 15, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28297571/prolongation-of-cardiac-allograft-survival-by-endometrial-regenerative-cells-focusing-on-b-cell-responses
#4
Xiaoxi Xu, Xiaochun Li, Xiangying Gu, Bai Zhang, Weijun Tian, Hongqiu Han, Peng Sun, Caigan Du, Hao Wang
Endometrial regenerative cells (ERCs) have been recently evaluated as an attractive candidate source for emerging stem cell therapies in immunosuppression, but their role in immunoregulation is not fully understood. The present study was designed to investigate their effects, especially on B-cell responses in heart transplantation. In this study, ERCs were noninvasively obtained from menstrual blood. Heart transplantation was performed between C57BL/6 (H-2(b) ) donor mice and BALB/c (H-2(d) ) recipients. B-cell activation and antibody levels were determined using fluorescence-activated cell sorting, enzyme-linked immunosorbent assay and ELISpot...
March 2017: Stem Cells Translational Medicine
https://www.readbyqxmd.com/read/28297565/rationale-for-determining-the-functional-potency-of-mesenchymal-stem-cells-in-preventing-regulated-cell-death-for-therapeutic-use
#5
Abderrahim Naji, Narufumi Suganuma, Nicolas Espagnolle, Ken-Ichi Yagyu, Nobuyasu Baba, Luc Sensebé, Frédéric Deschaseaux
Mesenchymal stem (stromal) cells (MSCs) are being investigated for treating degenerative and inflammatory disorders because of their reparative and immunomodulatory properties. Intricate mechanisms relate cell death processes with immune responses, which have implications for degenerative and inflammatory conditions. We review the therapeutic value of MSCs in terms of preventing regulated cell death (RCD). When cells identify an insult, specific intracellular pathways are elicited for execution of RCD processes, such as apoptosis, necroptosis, and pyroptosis...
March 2017: Stem Cells Translational Medicine
https://www.readbyqxmd.com/read/28283046/recommendations-from-the-european-working-group-for-value-assessment-and-funding-processes-in-rare-diseases-orph-val
#6
Lieven Annemans, Ségolène Aymé, Yann Le Cam, Karen Facey, Penilla Gunther, Elena Nicod, Michele Reni, Jean-Louis Roux, Michael Schlander, David Taylor, Carlo Tomino, Josep Torrent-Farnell, Sheela Upadhyaya, Adam Hutchings, Lugdivine Le Dez
Rare diseases are an important public health issue with high unmet need. The introduction of the EU Regulation on orphan medicinal products (OMP) has been successful in stimulating investment in the research and development of OMPs. Despite this advancement, patients do not have universal access to these new medicines. There are many factors that affect OMP uptake, but one of the most important is the difficulty of making pricing and reimbursement (P&R) decisions in rare diseases. Until now, there has been little consensus on the most appropriate assessment criteria, perspective or appraisal process...
March 10, 2017: Orphanet Journal of Rare Diseases
https://www.readbyqxmd.com/read/28281696/plectin-is-a-novel-regulator-for-apical-extrusion-of-rasv12-transformed-cells
#7
Ailijiang Kadeer, Takeshi Maruyama, Mihoko Kajita, Tomoko Morita, Ayana Sasaki, Atsuko Ohoka, Susumu Ishikawa, Masaya Ikegawa, Takashi Shimada, Yasuyuki Fujita
Several lines of evidence have revealed that newly emerging transformed cells are often eliminated from the epithelium, though the underlying molecular mechanisms of this cancer preventive phenomenon still remain elusive. In this study, using mammalian cell culture systems we have identified plectin, a versatile cytoskeletal linker protein, as a novel regulator for apical extrusion of RasV12-transformed cells. Plectin is accumulated in RasV12 cells when they are surrounded by normal epithelial cells. Similarly, cytoskeletal proteins tubulin, keratin, and Epithelial Protein Lost In Neoplasm (EPLIN) are also accumulated in the transformed cells surrounded by normal cells...
March 10, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28275884/new-approaches-to-antibiotic-discovery
#8
REVIEW
C Kealey, C A Creaven, C D Murphy, C B Brady
New antibiotics are urgently required by human medicine as pathogens emerge with developed resistance to almost all antibiotic classes. Pioneering approaches, methodologies and technologies have facilitated a new era in antimicrobial discovery. Innovative culturing techniques such as iChip and co-culturing methods which use 'helper' strains to produce bioactive molecules have had notable success. Exploiting antibiotic resistance to identify antibacterial producers performed in tandem with diagnostic PCR based identification approaches has identified novel candidates...
March 8, 2017: Biotechnology Letters
https://www.readbyqxmd.com/read/28273097/characterization-of-the-human-aqueous-humour-proteome-a-comparison-of-the-genders
#9
Natarajan Perumal, Caroline Manicam, Matthias Steinicke, Sebastian Funke, Norbert Pfeiffer, Franz H Grus
Aqueous humour (AH) is an important biologic fluid that maintains normal intraocular pressure and contains proteins that regulate the homeostasis of ocular tissues. Any alterations in the protein compositions are correlated to the pathogenesis of various ocular disorders. In recent years, gender-based medicine has emerged as an important research focus considering the prevalence of certain diseases, which are higher in a particular sex. Nevertheless, the inter-gender variations in the AH proteome are unknown...
2017: PloS One
https://www.readbyqxmd.com/read/28271444/the-role-of-mitochondria-in-osteogenic-adipogenic-and-chondrogenic-differentiation-of-mesenchymal-stem-cells
#10
REVIEW
Qianqian Li, Zewen Gao, Ye Chen, Min-Xin Guan
Mesenchymal stem cells (MSCs) are progenitors of connective tissues, which have emerged as important tools for tissue engineering due to their differentiation potential along various cell types. In recent years, accumulating evidence has suggested that the regulation of mitochondria dynamics and function is essential for successful differentiation of MSCs. In this paper, we review and provide an integrated view on the role of mitochondria in MSC differentiation. The mitochondria are maintained at a relatively low activity level in MSCs, and upon induction, mtDNA copy number, protein levels of respiratory enzymes, the oxygen consumption rate, mRNA levels of mitochondrial biogenesis-associated genes, and intracellular ATP content are increased...
March 7, 2017: Protein & Cell
https://www.readbyqxmd.com/read/28238004/effects-of-therapeutic-hypothermia-for-neuroprotection-from-the-viewpoint-of-redox-regulation
#11
REVIEW
Nobuyuki Nosaka, Ayumi Okada, Hirokazu Tsukahara
Redox regulation has recently been recognized as an important factor in acute illnesses as well as in chronic diseases. It has also become a target for neuroprotection in acute intensive care. Despite its well-known therapeutic effects, therapeutic hypothermia has recently been re-evaluated for its potential use in emergency and critical care medicine. Hypothermia is an undesirable physiological condition that can increase oxidative stress and decrease anti-oxidative potency. However, many studies have shown that under ischemia/reperfusion conditions, therapeutic hypothermia actually suppresses enhanced oxidative stress and maintains or increases anti-oxidative potency...
February 2017: Acta Medica Okayama
https://www.readbyqxmd.com/read/28235408/the-chinese-prescription-lianhuaqingwen-capsule-exerts-anti-influenza-activity-through-the-inhibition-of-viral-propagation-and-impacts-immune-function
#12
Yuewen Ding, Lijuan Zeng, Runfeng Li, Qiaoyan Chen, Beixian Zhou, Qiaolian Chen, Pui Leng Cheng, Wang Yutao, Jingping Zheng, Zifeng Yang, Fengxue Zhang
BACKGROUND: Lianhuaqingwen Capsule (LH-C) is a traditional Chinese medicine (TCM) formula used to treat respiratory tract infectious diseases in Chinese. The aim of this study was to determine the antiviral activity of LH-C and its immunomodulatory effects on viral infection. METHOD: The in vitro cytotoxicity and antiviral activity of LH-C was determined by MTT and Plaque reduction assays. Time course study under single-cycle virus growth conditions were used to determine which stage of viral replication was blocked...
February 24, 2017: BMC Complementary and Alternative Medicine
https://www.readbyqxmd.com/read/28220611/non-coding-rnas-emerging-regulatory-factors-in-the-derivation-and-differentiation-of-mammalian-parthenogenetic-embryonic-stem-cells
#13
REVIEW
Jihong Cui, Xin Xie
Parthenogenetic embryonic stem cells (PESCs) are ESCs derived from early parthenogenetic embryos. Haploid PESCs, containing haploid DNA, originate from a single sperm or occyte, while, diploid PESCs originate from two fused occytes. Most PESC lines used so far are diploid. PESCs exhibit representative pluripotent stem cell features, such as the capacity for self-renewal and the pariticular molecular signatures. Whereas, PESCs display distinctive properties, such as differential regulation of X-chromosome inactivation (XCI) and divergent monitor of genes involved in multiple biological processes...
February 21, 2017: Cell Biology International
https://www.readbyqxmd.com/read/28212647/an-interpretive-review-of-consensus-statements-on-clinical-guideline-development-and-their-application-in-the-field-of-traditional-and-complementary-medicine
#14
REVIEW
Jennifer Hunter, Matthew Leach, Lesley Braun, Alan Bensoussan
BACKGROUND: Despite ongoing consumer demand and an emerging scientific evidence-base for traditional and complementary medicine (T&CM), there remains a paucity of reliable information in standard clinical guidelines about their use. Often T&CM interventions are not mentioned, or the recommendations arising from these guidelines are unhelpful to end-users (i.e. patients, practitioners and policy makers). Insufficient evidence of efficacy may be a contributing factor; however, often informative recommendations could still be made by drawing on relevant information from other avenues...
February 17, 2017: BMC Complementary and Alternative Medicine
https://www.readbyqxmd.com/read/28206829/validity-of-low-contrast-letter-acuity-as-a-visual-performance-outcome-measure-for-multiple-sclerosis
#15
Laura J Balcer, Jenelle Raynowska, Rachel Nolan, Steven L Galetta, Raju Kapoor, Ralph Benedict, Glenn Phillips, Nicholas LaRocca, Lynn Hudson, Richard Rudick
Low-contrast letter acuity (LCLA) has emerged as the leading outcome measure to assess visual disability in multiple sclerosis (MS) research. As visual dysfunction is one of the most common manifestations of MS, sensitive visual outcome measures are important in examining the effect of treatment. Low-contrast acuity captures visual loss not seen in high-contrast visual acuity (HCVA) measurements. These issues are addressed by the MS Outcome Assessments Consortium (MSOAC), including representatives from advocacy organizations, Food and Drug Administration (FDA), European Medicines Agency (EMA), National Institute of Neurological Disorders and Stroke (NINDS), academic institutions, and industry partners along with persons living with MS...
February 1, 2017: Multiple Sclerosis: Clinical and Laboratory Research
https://www.readbyqxmd.com/read/28193191/effective-inhibition-of-mers-cov-infection-by-resveratrol
#16
Shih-Chao Lin, Chi-Tang Ho, Wen-Ho Chuo, Shiming Li, Tony T Wang, Chi-Chen Lin
BACKGROUND: Middle East Respiratory Syndrome coronavirus (MERS-CoV) is an emerging viral pathogen that causes severe morbidity and mortality. Up to date, there is no approved or licensed vaccine or antiviral medicines can be used to treat MERS-CoV-infected patients. Here, we analyzed the antiviral activities of resveratrol, a natural compound found in grape seeds and skin and in red wine, against MERS-CoV infection. METHODS: We performed MTT and neutral red uptake assays to assess the survival rates of MERS-infected Vero E6 cells...
February 13, 2017: BMC Infectious Diseases
https://www.readbyqxmd.com/read/28192937/amplification-and-quantification-of-an-antisense-oligonucleotide-from-target-microrna-using-programmable-dna-and-a-biological-nanopore
#17
Moe Hiratani, Masayuki Ohara, Ryuji Kawano
This paper describes a strategy for autonomous diagnoses of cancers using microRNA (miRNA) and therapy for tumor cells by DNA computing techniques and nanopore measurement. Theranostics, which involves the combination of diagnosis and therapy, has emerged as an approach for personalized medicine or point-of-care cancer diagnostics. DNA computing will become a potent tool for theranostics because it functions completely autonomously without the need for external regulations. However, conventional theranostics using DNA computing involves a one-to-one reaction in which a single input molecule generates a single output molecule; the concentration of the antisense drug is insufficient for the therapy in this type of reaction...
February 9, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/28185142/print-me-an-organ-ethical-and-regulatory-issues-emerging-from-3d-bioprinting-in-medicine
#18
Frederic Gilbert, Cathal D O'Connell, Tajanka Mladenovska, Susan Dodds
Recent developments of three-dimensional printing of biomaterials (3D bioprinting) in medicine have been portrayed as demonstrating the potential to transform some medical treatments, including providing new responses to organ damage or organ failure. However, beyond the hype and before 3D bioprinted organs are ready to be transplanted into humans, several important ethical concerns and regulatory questions need to be addressed. This article starts by raising general ethical concerns associated with the use of bioprinting in medicine, then it focuses on more particular ethical issues related to experimental testing on humans, and the lack of current international regulatory directives to guide these experiments...
February 9, 2017: Science and Engineering Ethics
https://www.readbyqxmd.com/read/28170173/the-3rs-of-cell-therapy
#19
Arnold I Caplan, Chris Mason, Brock Reeve
The 3Rs for a good education are "reading, 'riting, and 'rithmetic." The basis for good health care solutions for the emergent field of cell therapy in the future will also involve 3Rs: regulation, reimbursement, and realization of value. The business models in this new field of cell therapy will involve these 3Rs. This article brings forth realities facing this new industry for its approaches to provide curative health care solutions. Stem Cells Translational Medicine 2017;6:17-21.
January 2017: Stem Cells Translational Medicine
https://www.readbyqxmd.com/read/28159720/biphasic-calcium-phosphate-ceramics-for-bone-reconstruction-a-review-of-biological-response
#20
REVIEW
J M Bouler, P Pilet, O Gauthier, E Verron
Autologous bone graft is considered as the gold standard in bone reconstructive surgery. However, the quantity of bone available is limited and the harvesting procedure requires a second surgical site resulting in severe complications. Due to these limits, scientists and clinicians have considered alternatives to autologous bone graft. Calcium phosphates (CaPs) biomaterials including biphasic calcium phosphate (BCP) ceramics have proven efficacy in numerous clinical indications. Their specific physico-chemical properties (HA/TCP ratio, dual porosity and subsequent interconnected architecture) control (regulate/condition) the progressive resorption and the bone substitution process...
January 31, 2017: Acta Biomaterialia
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