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https://www.readbyqxmd.com/read/27931985/impact-of-regulatory-measures-on-antipsychotics-drug-consumption-in-castilla-y-le%C3%A3-n-spain
#1
L H Martín Arias, C Treceño Lobato, S Pérez García, P García Ortega, M Sáinz Gil, R Sanz Fadrique, A Carvajal García-Pando
OBJECTIVES: Antipsychotics are currently used to treat different diseases; even some off-labelled conditions are treated with this medication. Consumption and cost of antipsychotic drugs sharply increased in Spain after second-generation drugs were marketed; several regulatory measures were adopted to curb this trend. The aim of this study was to examine the impact of these measures upon the use and cost of antipsychotics. STUDY DESIGN: Study of drug use (SDU) from 1995 to 2012...
December 2016: Public Health
https://www.readbyqxmd.com/read/27928726/evaluating-the-safety-profile-of-non-active-implantable-medical-devices-compared-with-medicines
#2
REVIEW
Josep Pane, Preciosa M Coloma, Katia M C Verhamme, Miriam C J M Sturkenboom, Irene Rebollo
Recent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our objectives were to compare the current processes and methodologies for the assessment of NAIMD safety profiles with those for medicines, identify potential gaps, and make recommendations for the adoption of new methodologies for the ongoing benefit-risk monitoring of these devices throughout their entire life cycle...
December 7, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/27928427/alprostadil-cream-in-the-treatment-of-erectile-dysfunction-clinical-evidence-and-experience
#3
REVIEW
Béatrice Cuzin
Erectile dysfunction (ED) is a very common disorder with a deep impact on quality of life on both patients and partners. Several options are available for treating ED: oral pharmacotherapy with phosphodiesterase 5 (PDE5) inhibitors currently represents the first-line option for many patients with ED. Alprostadil, a prostaglandin, has been marketed for many years as a urethral stick and an intracavernous injection for the treatment of ED. It is now available in the form of a cream (Vitaros/Virirec), a noninvasive treatment which combines an active drug (alprostadil, a synthetic prostaglandin E1) with a skin enhancer improving its local absorption directly at the site of action...
August 2016: Therapeutic Advances in Urology
https://www.readbyqxmd.com/read/27928192/approvals-submission-and-important-labeling-changes-for-us-marketed-pharmaceuticals
#4
(no author information available yet)
This monthly feature will help readers keep current on new drug, new indications, dosage forms and safety-related changes in labeling or use. Efforts have been made to assure the accuracy of this information; however, if there are any questions, please let us know at jgeneral@ku.edu.
November 2016: Hospital Pharmacy
https://www.readbyqxmd.com/read/27927231/identification-of-a-potent-small-molecule-capable-of-regulating-polyploidization-megakaryocyte-maturation-and-platelet-production
#5
Nick Huang, Mabel Lou, Hua Liu, Cecilia Avila, Yupo Ma
BACKGROUND: Megakaryocytic cell maturation involves polyploidization, and megakaryocyte (MK) ploidy correlates with their maturation and platelet production. Retardation of MK maturation is closely associated with poor MK engraftment after cord blood transplantation and neonatal thrombocytopenia. Despite the high prevalence of thrombocytopenia in a range of setting that affect infants to adults, there are still very limited modalities of treatment. METHODS: Human CD34(+) cells were isolated from cord blood or bone marrow samples acquired from consenting patients...
December 8, 2016: Journal of Hematology & Oncology
https://www.readbyqxmd.com/read/27926729/intracellular-allosteric-antagonism-of-the-ccr9-receptor
#6
Christine Oswald, Mathieu Rappas, James Kean, Andrew S Doré, James C Errey, Kirstie Bennett, Francesca Deflorian, John A Christopher, Ali Jazayeri, Jonathan S Mason, Miles Congreve, Robert M Cooke, Fiona H Marshall
Chemokines and their G-protein-coupled receptors play a diverse role in immune defence by controlling the migration, activation and survival of immune cells. They are also involved in viral entry, tumour growth and metastasis and hence are important drug targets in a wide range of diseases. Despite very significant efforts by the pharmaceutical industry to develop drugs, with over 50 small-molecule drugs directed at the family entering clinical development, only two compounds have reached the market: maraviroc (CCR5) for HIV infection and plerixafor (CXCR4) for stem-cell mobilization...
December 7, 2016: Nature
https://www.readbyqxmd.com/read/27926652/hysteroscopic-sterilization-with-essure-summary-of-the-u-s-food-and-drug-administration-actions-and-policy-implications-for-postmarketing-surveillance
#7
Jessica R Walter, Comeron W Ghobadi, Emily Hayman, Shuai Xu
In September 2015, the U.S. Food and Drug Administration (FDA) convened a meeting of the Obstetrics and Gynecology Advisory Board Committee to address the sudden increase of patient-reported adverse events surrounding Essure, a Class III device offering a less invasive method for permanent female sterilization. After a review of the premarketing and postmarketing data and existing scientific literature, the FDA concluded there was insufficient evidence to remove the device from the market. However, the FDA did release a new guidance document requiring a black box warning for the device and ordered a new postmarketing study comparing Essure's safety and efficacy with laparoscopic tubal sterilization...
December 2, 2016: Obstetrics and Gynecology
https://www.readbyqxmd.com/read/27925221/pharmacokinetic-pharmacodynamic-evaluation-of-grapiprant-in-a-carrageenan-induced-inflammatory-pain-model-in-the-rabbit
#8
V De Vito, M Salvadori, A Poapolathep, H Owen, R Rychshanova, M Giorgi
Grapiprant is the novel selective EP4 receptor inhibitor recently issued on the veterinary market for dogs affected by osteoarthritis. The aim of this study was twofold: to evaluate the pharmacokinetics and the pharmacodynamics of grapiprant in the induced inflammatory pain model in the rabbit after a single IV injection of 2 mg/kg; to compare the thermal antinociception effect after 2 mg/kg IV grapiprant, with that generated by 0.5 mg/kg meloxicam SC injected. Rabbits (n = 12) were randomly assigned to two crossover studies (single-dose, two-period crossover)...
December 7, 2016: Journal of Veterinary Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27924981/hts-ftir-spectroscopy-allows-the-classification-of-polyphenols-according-to-their-differential-effects-on-the-mda-mb-231-breast-cancer-cell-line
#9
A Mignolet, V Mathieu, E Goormaghtigh
Breast cancer is a major public health issue among women in the world. Meanwhile new anticancer treatments struggle more and more to be accepted in the pharmaceutical market and research costs still increase. There is therefore a need to find new treatments and new screening methods to test them more quickly and efficiently. Among natural compounds, an increasing interest has been given to polyphenols as they can take action at the different stages of carcinogenesis, from tumour initiation to metastasis formation, by disturbing multiple cellular signalling pathways...
December 7, 2016: Analyst
https://www.readbyqxmd.com/read/27924754/relevance-of-randomised-controlled-trials-in-oncology
#10
REVIEW
Ian F Tannock, Eitan Amir, Christopher M Booth, Saroj Niraula, Alberto Ocana, Bostjan Seruga, Arnoud J Templeton, Francisco Vera-Badillo
Well-designed randomised controlled trials (RCTs) can prevent bias in the comparison of treatments and provide a sound basis for changes in clinical practice. However, the design and reporting of many RCTs can render their results of little relevance to clinical practice. In this Personal View, we discuss the limitations of RCT data and suggest some ways to improve the clinical relevance of RCTs in the everyday management of patients with cancer. RCTs should ask questions of clinical rather than commercial interest, avoid non-validated surrogate endpoints in registration trials, and have entry criteria that allow inclusion of all patients who are fit to receive treatment...
December 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27922751/new-therapies-for-asthma-and-copd
#11
Nicholas J Gross, Peter J Barnes
Asthma and COPD (chronic obstructive pulmonary disease) are two common diseases for which current treatments are less than optimal and for which new drugs are greatly needed. Better understanding of the cellular and molecular mechanisms of these diseases has identified new targets for therapy and several new drugs are in development. Although most new treatments on the market are improvements in existing classes of drug or new combination of treatments, the clinicaltrials.gov website indicates 50 and 100 new medications for both asthma and COPD and many of these are entirely new...
December 6, 2016: American Journal of Respiratory and Critical Care Medicine
https://www.readbyqxmd.com/read/27922739/tyrosine-kinase-aurora-kinase-and-leucine-aminopeptidase-as-attractive-drug-targets-in-anticancer-therapy-characterisation-of-their-inhibitors
#12
Joanna Ziemska, Jolanta Solecka
Cancers are the leading cause of deaths all over the world. Available anticancer agents used in clinics exhibit low therapeutic index and usually high toxicity. Wide spreading drug resistance of cancer cells induce a demanding need to search for new drug targets. Currently, many on-going studies on novel compounds with potent anticancer activity, high selectivity as well as new modes of action are conducted. In this work, we describe in details three enzyme groups, which are at present of extensive interest to medical researchers and pharmaceutical companies...
2016: Roczniki Państwowego Zakładu Higieny
https://www.readbyqxmd.com/read/27922703/robotkirurgi-p%C3%A3-bred-front-%C3%A2-utan-evidensbaserad-grund-tekniken-anv%C3%A3-nds-allt-mer-trots-att-den-%C3%A3-r-dyr-och-att-vetenskapliga-bevis-f%C3%A3-r-patientnytta-saknas
#13
Henrik Sjövall, Josefine Persson
Robot-assisted surgery on a broad front - without evidence for being cost-effective Robot-assisted surgery is currently heavily marketed. The HTA centre in Region Västra Götaland has produced five HTA reports regarding use of robot-assisted surgery in different clinical situations (prostatic cancer, benign gynaecological surgery, pediatric pyeloplasty and fundoplication, and rectal cancer), finding weak evidence for a patient value. The current report by Per Carlsson et al confirms that robot-assisted surgery indeed leads to increased costs that are not balanced by augmented patient value, i...
November 29, 2016: Läkartidningen
https://www.readbyqxmd.com/read/27921260/development-of-oral-flexible-tablet-oft-formulation-for-pediatric-and-geriatric-patients-a-novel-age-appropriate-formulation-platform
#14
Prabagaran Chandrasekaran, Ruckmani Kandasamy
Development of palatable formulations for pediatric and geriatric patients involves various challenges. However, an innovative development with beneficial characteristics of marketed formulations in a single formulation platform was attempted. The goal of this research was to develop solid oral flexible tablets (OFTs) as a platform for pediatrics and geriatrics as oral delivery is the most convenient and widely used mode of drug administration. For this purpose, a flexible tablet formulation using cetirizine hydrochloride as model stability labile class 1 and 3 drug as per the Biopharmaceutical Classification System was developed...
December 5, 2016: AAPS PharmSciTech
https://www.readbyqxmd.com/read/27920893/antibody-drug-conjugates-and-other-nanomedicines-the-frontier-of-gynaecological-cancer-treatment
#15
REVIEW
David Howard, Jetzabel Garcia-Parra, Gareth D Healey, Cynthia Amakiri, Lavinia Margarit, Lewis W Francis, Deyarina Gonzalez, R Steven Conlan
Gynaecological cancers: malignancies of the cervix, uterus, ovaries, vagina and vulva, are responsible for over 1.1 million new cancer cases and almost half a million deaths annually. Ovarian cancer in particular is difficult to treat due to often being diagnosed at a late stage, and the incidence of uterine and vulvar malignancies are both on the rise. The field of nanomedicine is beginning to introduce drugs into the clinic for oncological applications exemplified by the liposomal drugs, Doxil and Myocet, the nanoparticle, Abraxane and antibody-drug conjugates (ADCs), Kadcyla and Adcetris...
December 6, 2016: Interface Focus
https://www.readbyqxmd.com/read/27920499/smart-nanocrystals-of-artemether-fabrication-characterization-and-comparative-in-vitro-and-in-vivo-antimalarial-evaluation
#16
Syed Muhammad Hassan Shah, Farhat Ullah, Shahzeb Khan, Syed Muhammad Mukarram Shah, Marcel de Matas, Zahid Hussain, Muhammad Usman Minhas, Naser M AbdEl-Salam, Khaled Hafez Assi, Mohammad Isreb
Artemether (ARTM) is a very effective antimalarial drug with poor solubility and consequently low bioavailability. Smart nanocrystals of ARTM with particle size of 161±1.5 nm and polydispersity index of 0.172±0.01 were produced in <1 hour using a wet milling technology, Dena(®) DM-100. The crystallinity of the processed ARTM was confirmed using differential scanning calorimetry and powder X-ray diffraction. The saturation solubility of the ARTM nanocrystals was substantially increased to 900 µg/mL compared to the raw ARTM in water (145...
2016: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/27919207/safety-and-effectiveness-of-24-week-treatment-with-iguratimod-a-new-oral-disease-modifying-antirheumatic-drug-for-patients-with-rheumatoid-arthritis-interim-analysis-of-a-postmarketing-surveillance-study-of-2679-patients-in-japan
#17
Tsuneyo Mimori, Masayoshi Harigai, Tatsuya Atsumi, Takao Fujii, Masataka Kuwana, Hiroaki Matsuno, Shigeki Momohara, Syuji Takei, Naoto Tamura, Yoshinari Takasaki, Satoshi Ikeuchi, Satoru Kushimoto, Takao Koike
OBJECTIVE: To determine the real-world safety and effectiveness of iguratimod (IGU) for rheumatoid arthritis (RA), a 52-week, Japanese, postmarketing surveillance study was conducted. An interim analysis at week 24 was performed. METHODS: This study included all RA patients who received IGU following its introduction to the market. All adverse events (AEs) and adverse drug reactions (ADRs) were collected. Effectiveness was evaluated by the change in Disease Activity Score 28-C-reactive protein (DAS28-CRP) from baseline to week 24...
December 6, 2016: Modern Rheumatology
https://www.readbyqxmd.com/read/27917369/management-of-multiple-myeloma-and-usage-of-bortezomib-perspective-from-india-and-ukraine
#18
Amit Garg, Mykhaylo Morgunskyy, Yogesh Belagali, Namita Gupta, Shyam Prasad Akku
Novel treatment strategies have remarkably improved the multiple myeloma (MM) patients' survival, with associated increased costs. A joint panel meet of international experts from India and Ukraine was held in New Delhi on May 19, 2016 focusing on MM management, bortezomib role, unmet medical needs, and current challenges. The health-care system for oncology in India is majorly private vs. government-based in Ukraine. In India, electrophoresis, serum-free light chain assays, bone marrow tests, and X-rays are available modes of diagnosis...
2016: Frontiers in Oncology
https://www.readbyqxmd.com/read/27917126/perspectives-for-the-use-of-social-media-in-e-pharmamarketing
#19
Magdalena Syrkiewicz-Świtała, Piotr Romaniuk, Ewa Ptak
The Internet has become a common and global medium. It contains vast information resources and a wide range of communication instruments. One of the communication channels are social media, which increasingly are also used in the business field. Social media combined with mobile technology introduced new challenges to marketing activity. This trend is also observed on specific and highly regulated drug market. The aim of this article is to describe the perspectives for the use of social media in e-pharmamarketing...
2016: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/27916504/the-state-of-play-and-future-of-antibody-therapeutics
#20
REVIEW
Zehra Elgundi, Mouhamad Reslan, Esteban Cruz, Vicki Sifniotis, Veysel Kayser
It has been over four decades since the development of monoclonal antibodies (mAbs) using a hybridoma cell line was first reported. Since then more than thirty therapeutic antibodies have been marketed, mostly as oncology, autoimmune and inflammatory therapeutics. While antibodies are very efficient, their cost-effectiveness has always been discussed owing to their high costs, accumulating to more than one billion dollars from preclinical development through to market approval. Because of this, therapeutic antibodies are inaccessible to some patients in both developed and developing countries...
December 1, 2016: Advanced Drug Delivery Reviews
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