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Vincent Ronfard, Alain Vertes, Michael May, Anne Dupraz, Mark van Dyke, Yves Bayon
"Evaluating the Past & Present of Regenerative Medicine (RM)" was the first part of an Industry Symposium dedicated to the subject during the 2015 World TERMIS Congress in Boston. This working session presented a critical review of the current RM landscape in Europe and North America with possible projections for the future. Interestingly, the RM development cycle seems to obey the Gartner hype cycle, now at the enlightenment phase, after past exaggerated expectations and discouragements, as suggested by increasing numbers of clinical trials and recent market approvals of RM solutions in both Europe (Glybera & Holoclar® from Chiesi Pharma and Strimvelis® from GSK) and Japan (Remestemcel-L from Mesoblast® )...
October 20, 2016: Tissue Engineering. Part B, Reviews
S Noe, A von Werder, R Iakoubov, H Schneider, M Thaler, P Luppa, B Neu
Purpose: To investigate the kinetics of adrenocorticotropin (ACTH) following oral metyrapone administration and describe differences between ACTH-deficient and non-ACTH-deficient subjects. Methods: Patients from a tertiary endocrine center at a University Hospital in Munich, Germany, were tested for secondary adrenal insufficiency in a regular patient care setting. Metyrapone (Metopirone, HRA Pharma, France) was administered with a dosage of 40 mg/kg bodyweight at 8 a.m. Consecutive levels of ACTH were determined at 0, 60, 120, 180, and 240 min...
October 17, 2016: Experimental and Clinical Endocrinology & Diabetes
M Carmen Crespo, Francesco Visioli
Some epidemiological studies suggest that increased consumption of anthocyanins is associated with lower risk of cardiovascular disease (CVD) and hypertension. Also, high consumption of anthocyanin-rich fruit, such as berries, is associated with a lower risk of developing type 2 diabetes (T2D). In this review, we briefly yet critically assess the available evidence in support of an anti-diabetic role of anthocyanins derived from berries, especially bilberry (Vaccinium myrtillus L., also known as European blueberry, whortleberry, huckleberry and blaeberry) and blueberry (Vaccinium corymbosum, native to the United States)...
October 10, 2016: Current Pharmaceutical Design
Gorden Muduma, Isaac Odeyemi, Richard Fulton Pollock
BACKGROUND: As of 2014, there were approximately 8300 patients with a functioning liver transplant in the UK Transplant Registry, with 880 liver transplants performed in 2013-2014 alone. Tacrolimus, typically used in combination with steroids and mycophenolate mofetil, currently represents the cornerstone of post-transplant immunosuppression in liver transplant recipients. OBJECTIVES: The objective of the present study was to evaluate the cost-effectiveness of prolonged-release (PR) tacrolimus (Advagraf(®), Astellas Pharma Inc...
March 2016: Drugs—Real World Outcomes
Philip Mease, Iain B McInnes
INTRODUCTION: Psoriatic arthritis (PsA) is an immune-mediated chronic inflammatory arthropathy associated with impaired physical function and reduced quality of life. Biologic therapies that target tumor necrosis factor (anti-TNF) have significantly improved clinical outcomes. Partial, non- and transient responses remain common comprising significant unmet clinical need. New therapies with novel modes of action are urgently required. OBJECTIVES: The interleukin (IL)-17 pathway has recently been attributed a critical role in the pathogenesis of spondyloarthritides...
June 2016: Rheumatol Ther
Waroon Khota, Suradej Pholsen, David Higgs, Yimin Cai
Natural lactic acid bacteria (LAB) populations in tropical grasses and their fermentation characteristics on silage prepared with cellulase enzyme and LAB inoculants were studied. A commercial inoculant Lactobacillus plantarum Chikuso 1 (CH), a local selected strain Lactobacillus casei TH14 (TH14), and 2 cellulases, Acremonium cellulase (AC) and Maicelase (MC; Meiji Seika Pharma Co. Ltd., Tokyo, Japan), were used as additives to silage preparation with fresh and wilted (6 h) Guinea grass and Napier grass. Silage was prepared using a laboratory-scale fermentation system...
October 13, 2016: Journal of Dairy Science
Stuart P McElroy, Philip S Jones, Denise V Barrault
With industry increasingly sourcing preclinical drug discovery projects from academia it is important that new academic discoveries are enabled through translation with HTS-ready assays. However, many scientifically interesting, novel molecular targets lack associated high-quality, robust assays suitable for hit finding and development. To bridge this gap, the Scottish Universities Life Sciences Alliance (SULSA) established a fund to develop assays to meet quality criteria such as those of the European Lead Factory...
October 5, 2016: Drug Discovery Today
Naheed Sayeed-Desta, Ajay Babu Pazhayattil, Jordan Collins, Shu Chen, Marzena Ingram, Jana Spes
The paper introduces evaluation methodologies and associated statistical approaches for process validation lifecycle Stage 3A. The assessment tools proposed can be applied to newly developed and launched small molecule as well as bio-pharma products, where substantial process and product knowledge has been gathered. The following elements may be included in Stage 3A: number of 3A batch determination; evaluation of critical material attributes, critical process parameters, critical quality attributes; in vivo in vitro correlation; estimation of inherent process variability (IPV) and PaCS index; process capability and quality dashboard (PCQd); and enhanced control strategy...
October 6, 2016: AAPS PharmSciTech
Linda Stein Gold, John Villumsen, Monika Rosen
INTRODUCTION: Good treatment adherence is important in the effective management of psoriasis and is related to both the frequency of applications and the amount of product used versus the recommended dose. The efficacy and safety of fixed combination calcipotriol 50 µg/g (Cal) and betamethasone 0.5 mg/g as dipropionate (BD) in the treatment of psoriasis is well established; an aerosol foam formulation has been developed to enhance adherence. This subanalysis from the Phase III PSO-FAST study evaluates the amount of Cal/BD foam used during treatment and the association between the extent and severity of baseline disease...
October 6, 2016: Dermatology and Therapy
Philipp Klahn, Mark Brönstrup
The development of bacterial resistance against current antibiotic drugs necessitates a continuous renewal of the arsenal of efficacious drugs. This imperative has not been met by the output of antibiotic research and development of the past decades for various reasons, including the declining efforts of large pharma companies in this area. Moreover, the majority of novel antibiotics are chemical derivatives of existing structures that represent mostly step innovations, implying that the available chemical space may be exhausted...
October 5, 2016: Current Topics in Microbiology and Immunology
Valentino Antonio Pironti, Meng-Chuan Lai, Ulrich Müller, Edward Thomas Bullmore, Barbara Jacquelyn Sahakian
BACKGROUND: Attention-deficit hyperactivity disorder (ADHD) shows clear, albeit heterogeneous, cognitive dysfunctions. However, personality traits are not well understood in adults with ADHD, and it is unclear whether they are predisposing factors or phenotypical facets of the condition. AIMS: To assess whether personality traits of impulsivity, sensation seeking and sensitivity to punishment and reward are predisposing factors for ADHD or aspects of the clinical phenotype...
July 2016: BJPsych Open
Gin S Malhi, Yulisha Byrow, Frederick Cassidy, Andrea Cipriani, Koen Demyttenaere, Mark A Frye, Michael Gitlin, Sidney H Kennedy, Terence A Ketter, Raymond W Lam, Rupert McShane, Alex J Mitchell, Michael J Ostacher, Sakina J Rizvi, Michael E Thase, Mauricio Tohen
SUMMARY: The appeal of ketamine - in promptly ameliorating depressive symptoms even in those with non-response - has led to a dramatic increase in its off-label use. Initial promising results await robust corroboration and key questions remain, particularly concerning its long-term administration. It is, therefore, timely to review the opinions of mood disorder experts worldwide pertaining to ketamine's potential as an option for treating depression and provide a synthesis of perspectives - derived from evidence and clinical experience - and to consider strategies for future investigations...
May 2016: BJPsych Open
Béatrice Cochener
PURPOSE: To analyze the clinical outcomes after implantation of an extended range of vision intraocular lens (IOL), the Tecnis Symfony, in a routine clinical setting. SETTING: Forty clinical sites in Finland, France, Germany, Norway, Spain, Sweden, and the United Kingdom. DESIGN: Prospective case series. METHODS: The study comprised 411 patients who had bilateral implantation of the extended range of vision IOL, with intended micro-monovision in 1 group (monovision group) and intended emmetropia in the other group (non-monovision group)...
September 2016: Journal of Cataract and Refractive Surgery
Antonello Santini, Ettore Novellino
Growing attention is nowadays given to the possible preventive/alternative ways to avoid illness onset. Lifestyle change and proper food habits are taking over the conventional pharmaceutical based approach especially for chronic pathologies. Nutraceuticals propose themselves as a key tool to prevent and cure some pathologic conditions. This is leading the research to develop new formulations based on these pharma-foods addressed in a specific way to prevent and cure health issues, which, in turn, will have an impact on the therapy-related cost to be sustained by any National Health Organization...
September 29, 2016: British Journal of Pharmacology
David B Clifford, Tarek A Yousry, Eugene O Major
The interplay between each of the stakeholder's responsibilities and desires clearly has resulted in continued widespread use of natalizumab with substantial risks and an ongoing quest for better risk mitigation. In the United States, regulatory actions codified the process of risk acceptance-and risk transfer-by escalating monitoring and information transfer to physicians and patients. Management of medication-related risks is a core function of regulatory agencies such as the Food and Drug Administration (FDA), European Medicines Agency (EMA), and the medical community...
September 27, 2016: Multiple Sclerosis: Clinical and Laboratory Research
Erling Thom
Postpartum effluvium is a well-known clinical fact. However, following some minor research activities in the 1960s, very little has happened on the research front of the subject. It was hypothesized that postpartum hair loss might be a manifestation of a change in the hair growth cycle occurring normally during pregnancy. Recently, new research has been published trying to explain the mechanism of action behind this frequently occurring hair growth disruption, and to develop a functional treatment schedule and regime...
September 23, 2016: Journal of Cosmetic Dermatology
Steffen Leth, Mariane H Schleimann, Sara K Nissen, Jesper F Højen, Rikke Olesen, Mette E Graversen, Sofie Jørgensen, Anne Sofie Kjær, Paul W Denton, Alejandra Mørk, Maja A Sommerfelt, Kim Krogsgaard, Lars Østergaard, Thomas A Rasmussen, Martin Tolstrup, Ole Schmeltz Søgaard
BACKGROUND: Immune priming before reversal of latency might be a component of a functional HIV cure. To assess this concept, we assessed if therapeutic HIV immunisation followed by latency reversal would affect measures of viral transcription, plasma viraemia, and reservoir size in patients with HIV on suppressive antiretroviral therapy. METHODS: In this single-arm, phase 1B/2A trial, we recruited adults treated at the Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark (aged ≥18 years) with successfully treated HIV-1 with plasma RNA loads of less than 50 copies per mL for the previous year and CD4 counts of at least 500 cells per μL...
October 2016: Lancet HIV
Maria Gurevich, Usra Leedham, Amy Brown-Bowers, Nicole Cormier, Zara Mercer
Contemporary social theorists emphasise the cultural quest for authenticity under conditions of increasing artificiality. Within this context, the body is commonly treated as an 'unfinished' surface requiring ongoing transformation to fulfil identity obligations. In this paper, we examine one such identity authentication project in the form of marketing of men's sexuopharmaceuticals. We use online pharmaceutical advertising for four approved sexuopharmaceuticals (Viagra, Cialis, STAXYN and Stendra) to describe the ideal neoliberal consumer...
September 21, 2016: Culture, Health & Sexuality
William Wei Lim Chin, Angelika Joos
: Over the past two decades, there has been growing concern over the lack of proper medication for children. This review attempts to evaluate the current progress of EU Pediatric Regulation made since 2007. The lack of properly evaluated pediatric medication has for long been a source of concern in the European Union. The drugs that were used in the past were often not properly evaluated, and dosage was arbitrarily calculated. Therefore, it was necessary to establish the Pediatric Regulation (EC no...
September 19, 2016: European Journal of Pediatrics
Felicia Cosman, Daria B Crittenden, Jonathan D Adachi, Neil Binkley, Edward Czerwinski, Serge Ferrari, Lorenz C Hofbauer, Edith Lau, E Michael Lewiecki, Akimitsu Miyauchi, Cristiano A F Zerbini, Cassandra E Milmont, Li Chen, Judy Maddox, Paul D Meisner, Cesar Libanati, Andreas Grauer
Background Romosozumab, a monoclonal antibody that binds sclerostin, increases bone formation and decreases bone resorption. Methods We enrolled 7180 postmenopausal women who had a T score of -2.5 to -3.5 at the total hip or femoral neck. Patients were randomly assigned to receive subcutaneous injections of romosozumab (at a dose of 210 mg) or placebo monthly for 12 months; thereafter, patients in each group received denosumab for 12 months, at a dose of 60 mg, administered subcutaneously every 6 months. The coprimary end points were the cumulative incidences of new vertebral fractures at 12 months and 24 months...
September 18, 2016: New England Journal of Medicine
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