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After Drug Granted Orphan Status Hospitals Left Paying PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest After Drug Granted Orphan Status Hospitals Left Paying articles that have been published worldwide.
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Arginine deiminase is a bacterial enzyme which degrades L-arginine. Some human cancers such as hepatocellular carcinoma (HCC) and melanoma are auxotrophic for arginine. Therefore, PEGylated arginine deiminase (ADI-PEG20) is a good anticancer candidate with antitumor effect. It causes local depletion of L-arginine and growth inhibition in arginine-auxotrophic tumor cells. The FDA and EMA have granted orphan status to this drug.
Rare diseases provide a challenge in the evaluation of new therapies. However, orphan drug development is of increasing interest because of the legislation enabling facilitated support by regulatory agencies through scientific advice, and the protection of the molecules with orphan designation. In the landscape of the rare epilepsies, very few syndromes, namely Dravet syndrome, Lennox-Gastaut syndrome and West syndrome, have been subject to orphan drug development. Despite orphan designations for rare epile...
To compare coverage of orphan and nonorphan drugs, to examine variation in orphan drug coverage across the largest US private plans, and to evaluate factors influencing coverage decisions.
Over the last few years, the share of public spending for orphan drugs (ODs) has increased in several western countries, raising concern on the exemptions granted to this sector with respect to the implementation of health technology assessment (HTA) principles. The aim of this paper is to shed light on both the HTA criteria adopted and the international agreements implemented in the OD regulation, given the new challenges imposed on western countries by a growing number of therapies for rare diseases.
Studies on drug use are limited by the study populations available, which usually only include drug users in treatment settings. Therefore, the knowledge base is limited on drug users not entering treatment for drug use disorder (DUD). Using registers from departments of forensic medicine enables research on decedents with DUD, irrespective of treatment status.
The first methodologic step needed to compare pediatric health outcomes at children's hospitals (CHs) and non-children's hospitals (NCHs) is to classify hospitals into CH and NCH categories. However, there are currently no standardized or validated methods for classifying hospitals. The purpose of this study was to describe a novel and reproducible hospital classification methodology.
The aim of this study was to evaluate surplus drugs left over from medications used via the intravenous and intramuscular routes in a pediatric emergency unit of a tertiary hospital in Turkey and to determine the financial burden imposed by drug wastage.
Hospitals are expected to fulfill a role in the communities they serve by improving the health of the population in the community as mandated in the Affordable Care Act. One way hospitals achieve this is to create partnerships with diverse organizations, such as local public health departments, state/federal agencies, and other health care organizations. The aim of this study is to examine characteristics of hospitals that developed partnerships based on improving population health. This study utilized the ...
Quality, essential in the drug development and approval process, was demonstrated to be a major reason leading to multiple reviews for New Drug Applications (NDAs) submitted to the United States Food and Drug Administration (USFDA). The present study aimed at systematically investigating quality deficiencies described in the first-cycle NDA reviews of the approved drug products to identify the types of concerns and the association between the occurrence of quality deficiencies and the characteristics of the...
While the centrality of withdrawal in the diagnosis of addiction has been decreasing with each successive edition of the Diagnostic and Statistical Manual of Mental Disorders, psychometric and neurobiological evidence provides withdrawal a central role in the development and maintenance of addiction. The current study offers insight into these conflicting positions by using secondary analyses to assess how a history of DSM-assessed withdrawal influences the magnitude of bias in neural reactivity to drug- an...
Pathways can improve the quality of care and outcomes for children with asthma; however, we know little about how to successfully implement pathways across diverse hospital settings. Prior studies of pathways have focused on determining clinical effectiveness and the majority were conducted in children's hospitals. These approaches have left crucial gaps in our understanding of how to successfully implement pathways in community hospitals, where most of the children with asthma are treated nationally.
Drug-resistant staphylococci have been a growing threat to the community and hospitals due to the misuse of antibiotics by humans, industrialisation and lack of novel antimicrobials currently available. Little is known about the prevalence of drug-resistant staphylococci in non-healthcare environments outside hospitals in the London area. Staphylococci can spread via contact with contaminated objects. Traffic light buttons present a fast and easy transmission route for staphylococci.
To examine nursing care left undone and its relationship with the nursing practice environment and perceived quality of nursing care in small Australian rural hospitals.
A cross sectional comparison of drug use indicators using WHO methodology in primary level hospitals participating in an Auditable Pharmaceutical Transactions and Services program versus non-APTS primary hospitals in Southern Ethiopia.
Ethiopian pharmaceutical sector has been facing inaccessibility and unaffordability to key essential medicines due to medicines diversion from the public to private health care facilities, lack of transparency, poor inventory management, and poor dispensing workflow. In an effort to improve the pharmaceutical sector, the government of Ethiopia in 2011 introduced Auditable Pharmaceutical Transactions and Services program. This study intended to compare drug use indicators in auditable and non-auditable prima...
The prevalence of psychotropic drug use in our society is increasing especially in older adults, thereby provoking severe adverse drug reactions (ADR). To identify specific patient risk profiles associated with psychotropic drug use in the situation of polymedication.
Obesity and metabolic syndrome (MetS) are associated with high risk of cardiac dysfunction and heart failure. We assessed the effect of obesity and metabolic health status on left ventricular (LV) structure and function in subjects without overt heart disease.
Irrational use of drugs remains a major challenge especially in developing countries, which contributed to a heavy pharmaceutical expenditure burden. Price regulation has been taken to curb the growth of pharmaceutical expenditures in many countries. This study aimed to investigate the impact of different mark-up drug policies on drug-related expenditures in tertiary public hospitals in Shanghai, China. Data were drawn from the audited financial statement in 24 tertiary public hospitals in Shanghai from Jan...
We study a pay-for-efficiency scheme that encourages hospitals to admit and discharge patients on the same calendar day when clinically appropriate. Since 2010, hospitals in the English NHS are incentivised by a higher price for patients treated as same-day discharge than for overnight stays, despite the former being less costly. We analyse administrative data for patients treated during 2006-2014 for 191 conditions for which same-day discharge is clinically appropriate - of which 32 are incentivised. Using...
The original version of this article contained a mistake in the co-author's conflict of interest statement. Erika von Mutius wishes to add the following disclosures: "E. von Mutius is listed as an inventor on the following patents: publication number EP 1411977, composition containing bacterial antigens used for the prophylaxis and the treatment of allergic diseases, granted on 18 April 2007; publication number EP1637147, stable dust extract for allergy protection, granted on 10 December 2008; publication n...
Although 1-stent with provisional approach is the preferred strategy for the treatment of bifurcation lesions, the optimal treatment strategy according to lesion location is still debatable. This study aimed to identify whether clinical outcomes according to treatment strategy differed between left main (LM) and non-LM bifurcation lesions in the second-generation drug-eluting stent era.
The discovery of novel ligands for orphan G protein-coupled receptors (GPCRs) has had a profound impact on our understanding of human biology, opening new opportunities for research, and ultimately for therapeutic development. Accordingly, enormous efforts have been directed towards the remaining orphan receptors, yet the rate of GPCR deorphanisation has slowed in recent years. Here, we briefly review contemporary deorphanisation methodologies, then highlight our recent integrated computational and experime...
Many ischemic ECG patterns are found in patients with acute left main coronary artery occlusion. We present a patient with dynamic ECG changes that corresponded to changes in his clinical symptoms and hemodynamic status. These changes signify different severity of myocardial ischemia caused by left main coronary artery disease. Take-home Message: Our case with left main coronary artery disease illustrated three distinct ECG patterns with different severity of clinical symptoms signifying varying severity of...