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https://www.readbyqxmd.com/read/29350568/abp-980-promising-trastuzumab-biosimilar-for-her2-positive-breast-cancer
#1
Elisavet Paplomata, Rita Nahta
Approval of the HER2-targeted antibody trastuzumab dramatically improved outcomes for patients with HER2-positive breast cancer. Multiple trastuzumab biosimilars, including ABP 980, are in clinical development. Biosimilars are not identical to the reference biologic, but exhibit equivalence and safety in analytical and clinical studies. Areas covered: A brief introduction to trastuzumab, overview of trastuzumab biosimilars, and detailed review of ABP 980 preclinical and clinical studies are included. We searched PubMed and 2016-2017 ASCO and ESMO conference proceedings for "ABP 980" or "trastuzumab biosimilar"...
January 19, 2018: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/29349812/drug-promotion-practices-a-review
#2
Nilan T Jacob
Over the years, the pharmaceutical industry has been at the forefront of research and innovation in drug discovery and development. The process of drug discovery extending from pre-clinical studies to multi-centric clinical trials and post-marketing phase is a costly affair running into billions of dollars. On the flip side, not all investigational molecules clear the trial phases and get approved; which puts pressure on the manufacturers to maximise the profit from approved drugs. It is in this key area, the practice of drug promotion plays its role...
January 18, 2018: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29349524/-qualification-and-classification-of-medical-apps-what-should-be-noted-and-what-is-bfarm-s-contribution
#3
REVIEW
Nicole Rämsch-Günther, Sylvia Stern, Wolfgang Lauer
Smartphones and tablets with their nearly unlimited number of different applications have become an integral part of everyday life. Thus, mobile devices and applications have also found their way into the healthcare sector.For developers, manufacturers, or users as well, it is often difficult to decide whether a mobile health application is a medical device.In this context, it is extremely important for manufacturers to decide at an early stage of the development whether the product is to be introduced into the market as a medical device and is therefore subject to the legislation on medical devices...
January 18, 2018: Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
https://www.readbyqxmd.com/read/29325516/brucellosis-remains-a-neglected-disease-in-the-developing-world-a-call-for-interdisciplinary-action
#4
K A Franc, R C Krecek, B N Häsler, A M Arenas-Gamboa
BACKGROUND: Brucellosis is an endemic zoonotic disease in most of the developing world that causes devastating losses to the livestock industry and small-scale livestock holders. Infected animals exhibit clinical signs that are of economic significance to stakeholders and include reduced fertility, abortion, poor weight gain, lost draught power, and a substantial decline in milk production. In humans, brucellosis typically manifests as a variety of non-specific clinical signs. Chronicity and recurring febrile conditions, as well as devastating complications in pregnant women are common sequelae...
January 11, 2018: BMC Public Health
https://www.readbyqxmd.com/read/29316910/determinants-of-new-drugs-prescription-in-the-swiss-healthcare-market
#5
Anne Decollogny, Romain Piaget-Rossel, Patrick Taffé, Yves Eggli
BACKGROUND: Drug markets are very complex and, while many new drugs are registered each year, little is known about what drives the prescription of these new drugs. This study attempts to lift the veil from this important subject by analyzing simultaneously the impact of several variables on the prescription of novelty. METHODS: Data provided by four Swiss sickness funds were analyzed. These data included information about more than 470,000 insured, notably their drug intake...
January 9, 2018: BMC Health Services Research
https://www.readbyqxmd.com/read/29313499/telecommunications-companies-and-health-in-west-africa-the-issues
#6
R Ankri, M-H Maroune
West Africa still faces important public health issues today: improving the health infrastructure, compensating for the lack of medical personnel, and bringing the rural "lost-to-follow-up" population into an inclusive healthcare system. At the same time, the boom in the mobile telephone market is providing important business opportunities for telecommunications companies in this field, leading to the rapid propagation of eHealth solutions. Thus, the telecom companies' technical innovations enable the creation of digital health solutions adapted to the specific needs of the West African market...
November 1, 2017: Médecine et Santé Tropicales
https://www.readbyqxmd.com/read/29306457/cost-effectiveness-of-pcsk9-inhibition-in-addition-to-standard-lipid-lowering-therapy-in-patients-at-high-risk-for-vascular-disease
#7
Manon C Stam-Slob, Yolanda van der Graaf, Anthonius de Boer, Jacoba P Greving, Frank L J Visseren
BACKGROUND: As proprotein convertase subtilisin-kexin type 9 (PCSK9) monoclonal antibodies are entering the market, we assessed the cost-effectiveness of PCSK9 inhibition added to standard lipid-lowering therapy in patient groups at high risk for major adverse cardiovascular events (MACE). METHODS: A lifetime Markov Model was designed to estimate healthcare costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs) for PCSK9 inhibition added to standard therapy in patients with Familial Hypercholesterolemia (FH), patients with vascular disease at high MACE recurrence risk, and patients with vascular disease with diabetes mellitus...
February 15, 2018: International Journal of Cardiology
https://www.readbyqxmd.com/read/29304996/-what-did-maxwell-s-equations-really-have-to-do-with-edison-s-invention-addressing-the-complexity-of-developing-clinical-interventions-for-skeletal-muscle-disease
#8
Jonathan Dando
To reach the healthcare market and have a medical intervention reimbursed in any format carries high risk and very low success rates. Even when all regulatory hurdles have been surpassed, there is no guarantee that the product will be purchased; a different body makes that decision using criteria typically unknown to early-stage innovators and intervention developers. In the context of skeletal muscle diseases, the field is at a crossroads; accurate diagnoses are difficult to obtain, patient management and monitoring are equally difficult, cures are evasive, and disease progression is not well enough understood in the human to identify clear targets (irrespective of whether the specific muscle disease is rare or frequent because the progression is slow and the tissue large)...
2018: Current Topics in Developmental Biology
https://www.readbyqxmd.com/read/29303821/sustained-hospital-performance-on-hospital-consumer-assessment-of-healthcare-providers-and-systems-survey-measures-what-are-the-determinants
#9
Mona Al-Amin, Melody K Schiaffino, Sinyoung Park, Jeffrey Harman
This study examines hospital characteristics associated with sustained superior performance on Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) measures. We classified hospitals as sustainers if they remained in the top 25th percentile of overall patient ratings of inpatient experience from 2009 through 2013. We classified hospital characteristics as modifiable or unmodifiable. Modifiable characteristics are operational measures that hospitals can change to improve performance; these characteristics include registered nurse (RN) staffing levels, presence of hospitalists, and level of physician integration...
January 2018: Journal of Healthcare Management / American College of Healthcare Executives
https://www.readbyqxmd.com/read/29296563/single-repeated-dose-toxicity-and-genotoxicity-assessment-of-herb-formula-kiom2012h
#10
Hwayong Park, Youn-Hwan Hwang, Jin Yeul Ma
Background: Traditional medicine and herbal prescriptions are becoming more popular, and they account for a large share of the world's healthcare research studies, developments, and market demands. Increasing scientific evidence of the substantive efficacies such as preventive health keeping pharmaceutical materials and dietary supplements can be found elsewhere. Above all, safety should be the critical premise for considering developmental materials such as pharmaceuticals without side effects and toxicity...
December 2017: Integrative Medicine Research
https://www.readbyqxmd.com/read/29290173/comparison-of-specialty-medication-use-for-common-chronic-inflammatory-diseases-among-health-exchange-and-other-commercially-insured-members
#11
Xiaoxue Chen, Santosh Gautam, Alexander Ruggieri, Thomas Richards, Andrea Devries, Gosia Sylwestrzak
BACKGROUND: The Affordable Care Act of 2010 allows the purchase of health insurance through special marketplaces called "health exchanges." The majority of individuals enrolling in the exchanges were previously uninsured, older, and sicker than other commercially insured members. Early evidence also suggests that exchange plan members use more costly specialty drugs compared with other commercially insured members. OBJECTIVES: To (a) examine patient characteristics and specialty drug use for common chronic inflammatory diseases (CIDs) among exchange plan members compared with other commercially insured members and (b) explore variations in specialty drug use within exchange plans by metal tiers (bronze, silver, gold, and platinum), as well as across local markets...
January 2018: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29289932/vaccination-marketing-by-private-healthcare-sector-glaring-malpractices
#12
Vipin Vashistha
The editorial by Jesani and Johari in this journal raises some contentious yet relevant ethical issues pertaining to vaccination practices in India. Vaccination is one of the most important preventive measures against infectious diseases. The eradication of smallpox in the 70s and near eradication of polio are testimony to this. The Government of India (GoI) has recently added a few new vaccines in its Universal Immunisation Programme (UIP), one of the largest public health programmes across the globe. The number of vaccines delivered through this public health programme has doubled from six in 1985 to twelve in 2017...
December 21, 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/29284477/disparities-in-the-use-of-mobile-phone-for-seeking-childbirth-services-among-women-in-the-urban-areas-bangladesh-urban-health-survey
#13
Ghose Bishwajit, Md Rakibul Hoque, Sanni Yaya
BACKGROUND: In Bangladesh, similar to its other South Asian counterparts, shortage of health workers along with inadequate infrastructure constitute some of the major obstacles for the equitable provision of reproductive healthcare services, particularly among the marginalized and underserved neighbourhoods. However, given the rapidly expanding broadband communication and mobile phone market in the country, the application of eHealth and mHealth technologies offer a window of opportunities to minimise the impact of socioeconomic barriers and promote the utilization of maternal healthcare services thereby...
December 29, 2017: BMC Medical Informatics and Decision Making
https://www.readbyqxmd.com/read/29284064/policies-for-biosimilar-uptake-in-europe-an-overview
#14
Evelien Moorkens, Arnold G Vulto, Isabelle Huys, Pieter Dylst, Brian Godman, Simon Keuerleber, Barbara Claus, Maria Dimitrova, Guenka Petrova, Ljiljana Sović-Brkičić, Juraj Slabý, Robin Šebesta, Ott Laius, Allan Karr, Morgane Beck, Jaana E Martikainen, Gisbert W Selke, Susan Spillane, Laura McCullagh, Gianluca Trifirò, Patricia Vella Bonanno, Asbjørn Mack, Antra Fogele, Anita Viksna, Magdalena Władysiuk, Helder Mota-Filipe, Dmitry Meshkov, Marija Kalaba, Simona Mencej Bedrač, Jurij Fürst, Corrine Zara, Peter Skiöld, Einar Magnússon, Steven Simoens
BACKGROUND: Across European countries, differences exist in biosimilar policies, leading to variations in uptake of biosimilars and divergences in savings all over Europe. OBJECTIVES: The aim of this article is to provide an overview of different initiatives and policies that may influence the uptake of biosimilars in different European countries. Recommendations will be formulated on how to create sustainable uptake. METHODS: An overview of policies on biosimilars was obtained via a questionnaire, supplemented with relevant articles...
2017: PloS One
https://www.readbyqxmd.com/read/29282055/knowledge-attitudes-and-practices-of-community-pharmacists-on-generic-medicines-in-palestine-a-cross-sectional-study
#15
Naser Y Shraim, Tasneem A Al Taha, Rawan F Qawasmeh, Hiba N Jarrar, Maram A N Shtaya, Lama A Shayeb, Waleed M Sweileh
BACKGROUND: Generic substitution in several countries has become a common practice. Besides, it is considered as a major cost minimizing strategy meant to contain pharmaceutical expenditure without compromising healthcare quality. However, the safety and quality issues of generic products are of top concerns of general practitioners and health work professionals. This study aimed to investigate community pharmacist's knowledge, attitudes and practices toward generic medicines in Palestine...
December 28, 2017: BMC Health Services Research
https://www.readbyqxmd.com/read/29278756/decentralised-manufacturing-of-cell-and-gene-therapy-products-learning-from-other-healthcare-sectors
#16
REVIEW
Richard P Harrison, Steven Ruck, Qasim A Rafiq, Nicholas Medcalf
Decentralised or 'redistributed' manufacturing represents an attractive choice for production of some cell and gene therapies (CGTs), in particular personalised therapies. Decentralised manufacturing splits production into various locations or regions and in doing so, imposes organisational changes on the structure of a company. This confers a significant advantage by democratising supply, creating jobs without geographical restriction to the central hub and allowing a more flexible response to external pressures and demands...
December 23, 2017: Biotechnology Advances
https://www.readbyqxmd.com/read/29277310/mechanism-of-intranasal-drug-delivery-directly-to-the-brain
#17
REVIEW
Tyler P Crowe, M Heather West Greenlee, Anumantha G Kanthasamy, Walter H Hsu
Neurological diseases are becoming increasingly prominent worldwide due to rapidly aging populations, which greatly contributes to increasing healthcare costs. The development of neuroprotective drugs has so far proven exceptionally difficult due to the blood-brain barrier. One novel approach to address this challenge is to administer drugs intranasally to noninvasively bypass the blood-brain barrier. The intranasal route can thus transport drugs directly to the brain from the nasal cavity along the olfactory and trigeminal nerves...
December 22, 2017: Life Sciences
https://www.readbyqxmd.com/read/29275969/mobile-applications-in-children-with-cerebral-palsy
#18
M Rodríguez Mariblanca, R Cano de la Cuerda
INTRODUCTION: Cerebral palsy (CP) is one of the most common developmental disorders. Technological development has enabled a transformation of the healthcare sector, which can offer more individualised, participatory, and preventive services. Within this context of new technology applied to the healthcare sector, mobile applications, or apps, constitute a very promising tool for the management of children with CP. OBJECTIVE: The purpose of this article is to perform a systematic review of the information published about various mobile applications either directly related to CP or with potential to be useful in the context of the disease, and to describe, analyse, and classify these applications...
December 21, 2017: Neurología: Publicación Oficial de la Sociedad Española de Neurología
https://www.readbyqxmd.com/read/29274225/personal-support-workers-in-canada-the-new-precariat
#19
Katherine Zagrodney, Mike Saks
There has been much recent discussion internationally about the emergence in modern society of a new class of workers - the precariat - with a common consciousness based on features such as low wages, insecurity, short-term jobs, minority status and restricted rights. This paper critically explores the extent to which the growing, large-scale group of personal support workers (PSWs) can be viewed as part of a new precariat in terms of their position in the healthcare labour market. Drawing on currently available empirical data, this issue is examined particularly with reference to PSWs in Canada - drawing out some of the implications for government health policy in this sphere...
November 2017: Healthcare Policy, Politiques de Santé
https://www.readbyqxmd.com/read/29273068/exploring-patient-and-family-involvement-in-the-lifecycle-of-an-orphan-drug-a-scoping-review
#20
REVIEW
Andrea Young, Devidas Menon, Jackie Street, Walla Al-Hertani, Tania Stafinski
BACKGROUND: Patients and their families have become more active in healthcare systems and research. The value of patient involvement is particularly relevant in the area of rare diseases, where patients face delayed diagnoses and limited access to effective therapies due to the high level of uncertainty in market approval and reimbursement decisions. It has been suggested that patient involvement may help to reduce some of these uncertainties. This review explored existing and proposed roles for patients, families, and patient organizations at each stage of the lifecycle of therapies for rare diseases (i...
December 22, 2017: Orphanet Journal of Rare Diseases
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