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PubMed Journals Articles About "Overcoming Hurdles Bringing ATMPs European Market" RSS

07:17 EST 7th December 2019 | BioPortfolio

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Showing "Overcoming hurdles bringing ATMPs European market" PubMed Articles 1–25 of 8,400+

Horses for courses: an approach to the qualification of clinical trial sites and investigators in ATMPs.

The advanced therapy medicinal products (ATMPs) landscape is entirely different from classical drug development. Academia has been the major source of ATMP development, and academic hospitals act as trial sites for the clinical testing of ATMPs, including early academic-led trials as well as industry-sponsored trials that pursue the full developmental pathway to market authorization. The recent breakthrough developments in some ATMPs, such as genetically engineered immune cells, have confronted academic hos...


Total disc replacement for lumbar degenerative disc disease: single centre 20 years experience.

To report clinical and radiographic outcomes, rate of complications and influence on spinal alignment on long-term follow-up (FU) of patients who underwent lumbar total disc arthroplasty (TDR), bringing some evidence to determine the profile of the most well-suited patients for TDR.

An empirical study on asymmetric jump diffusion for option and annuity pricing.

In this paper, we present a method to estimate the market parameters modelled by an asymmetric jump diffusion process. The method proposed is based on Kou's jump diffusion model while the market parameters refer to the market drift, the market volatility, the jump intensity on market price, and the rate of jump occurrence in a consistent manner throughout the entire paper. The model captures the asymmetric nature of the price fluctuation during up trend markets and down trend markets. The results are compar...


Artificial Intelligence for Clinical Trial Design.

Clinical trials consume the latter half of the 10 to 15 year, 1.5-2.0 billion USD, development cycle for bringing a single new drug to market. Hence, a failed trial sinks not only the investment into the trial itself but also the preclinical development costs, rendering the loss per failed clinical trial at 800 million to 1.4 billion USD. Suboptimal patient cohort selection and recruiting techniques, paired with the inability to monitor patients effectively during trials, are two of the main causes for high...

Impact of market misallocations on green TFP: evidence from countries along the Belt and Road.

Based on the idea of a "Community of Human Destiny," the Chinese government proposed the "Belt and Road" initiative, and clearly proposed to promote green development and strengthen ecological environmental protection. However, a considerable number of countries are resource-rich economies with serious market misallocations. Using the stochastic frontier analysis (SFA) combined with the directional distance function (DDF) framework, this paper measures the green total factor productivity (GTFP) and its item...

With or without U(K): A pre-Brexit network analysis of the EU ETS.

The European Emission Trading System (EU ETS) is commonly regarded as the key pillar of the European climate policy and as the main unifying tool to create a unique carbon price all over Europe. The UK has always played a crucial role in the EU ETS, being one of the most active national registry and a crucial hub for the exchange of allowances in the market. Brexit, therefore, could deeply modify the number and directions of such exchanges as well as the centrality of the other countries in this system. To ...

The heterogeneous effects of exchange rate and stock market on CO2 emission allowance price in China: A panel quantile regression approach.

This paper studies the heterogeneous effects of exchange rate and stock market on carbon emission allowance price in four emissions trading scheme pilots in China. We employ a panel quantile regression model, which can describe both individual and distributional heterogeneity. The empirical results illustrate that the effects of explanatory variables on carbon emission allowance price is heterogeneous along the whole quantiles. Specifically, exchange rate has a negative effect on carbon emission allowance p...

Lymphocyte infiltration predicts survival in chemotherapy-naïve, triple negative breast cancer, and identifies patients with intrinsically good prognosis: Have we been bringing owls to Athens?

Biosimilars: A Value Proposition.

Biosimilars are biological agents that effectively replicate original reference products. The main driver of their development is the promise of bringing competition into the marketplace, and consequently contributing to the sustainability of healthcare systems. By reducing financial barriers to biological therapies, biosimilars play a part in budgetary redistribution and, hence, in increasing patients' access to treatment. They also foster innovation and deliver other non-price-driven advantages. However, ...

Shifting paradigms revisited: biotechnology and the pharmaceutical sciences.

In 2003 Crommelin et al. published an article titled: 'Shifting paradigms: biopharmaceuticals versus low molecular weight drugs' (https://doi.org/10.1016/S0378-5173(03)00376-4). In the current commentary, 16 years later, we discuss pharmaceutically relevant aspects of the evolution of biologics since then. First, we discuss the increasing repertoire of biologics, in particular the rapidly growing monoclonal antibody family and the advent of advanced therapy medicinal products (ATMPs). Next, we discuss trend...

The analysis of medical market in Russia in 2016-2018: main economic indices and research results.

The article presents the main indicators of development of Russian medical market in 2016-2018. The basic data concerning main activities in market of medical services and goods, key figures on patterns and trends of market of medical sphere, pricing policy, organizational forms of medical institutions is presented. The conclusions on the research oт supply and demand in medical market are made. The conclusions related to forecasting and planning of development of Russian medical market in Russia, its pers...

Nickel dermatitis from earrings 15 years after EU directive implementation: a clinical-epidemiological study and a market survey in Rome, Italy.

Nickel (Ni) dermatitis remains a highly prevalent allergic condition in Italy. There is a continuous need for clinical and epidemiological surveillance to evaluate whether or not European Ni Directive has been effective in contact allergy prevention.

Scientific assessments in European food law: Making it future-proof.

European food laws increasingly use scientific evidence to protect consumers from hazards and to prevent the use of misleading information. In this article, the use of risk assessment in European food law is analysed and the implications of the recently adopted adjustments to the EU's General Food Law are reviewed. The risk analysis cycle that has been implemented in many authorisation decisions of the European Commission has resulted in the increased level of public health protection since 2002. The food l...

Classification of position management strategies at the order-book level and their influences on future market-price formation.

Financial prices fluctuate as a results of the market impact of the flow of transactions between traders. Reciprocally, several studies of market microstructure have shown how decisions of individual traders or banks, implemented in their trading strategies, are affected by historical market information. However, little is known about the detailed processes of how such trading strategies at the micro level recursively affect future market information at the macro level. Using a special fined-grained dataset...

Will I Need to Move to Get My First Job?: Geographic Relocation and Other Trends in the Pathology Job Market.

There is an ongoing perception that the pathology job market is poor, which may be discouraging medical students from pursuing the specialty. Academic pathologists believe that jobs are available but relocation may be necessary.

Sleep assessment devices: types, market analysis, and a critical view on accuracy and validation.

: Sleep assessment devices are essential for the detection, diagnosis, and monitoring of sleep disorders. This paper provides a state-of-the-art review and comparison of sleep assessment devices and a market analysis.: Hardware devices are classified into contact and contactless devices. For each group, the underlying technologies are presented, paying special attention to their limitations. A systematic literature review has been carried out by comparing the most important validation studies of sleep track...

The unexpected consequences of generic entry.

Generic drugs are sold at a fraction of the original brand price. Yet, generic entry typically produces a drop in the quantity market share of the molecule losing exclusivity. This effect is economically and statistically significant for a large dataset covering hundreds of prescription drugs sold in the US during the period 1994Q1-2003Q4. This paper proposes the first systematic analysis of what appears to be a market anomaly. We propose a model to characterize the market equilibrium before and after gener...

Cannabis and youth protection in Colorado's commercial adult-use market: A qualitative investigation.

Arguments both for and against the legalization of cannabis often include the issue of youth protection. At the time of writing 5-years after the implementation of the Coloradan recreational cannabis market (CRCM), no statistically significant increase in consumption had been identified. This paper aimed to provide a thick descriptive account of youth prevention objectives stipulated in the pre-implementation phase of the CRCM and compare these with the real-world experience of regulators and other stakehol...

New Psychoactive Substances: A Matter of Time.

In the last few years, a wide range of new psychoactive substances (NPS) have been produced and marketed to elude the controlled substance lists. These molecules enter the traditional illegal and web market with poor knowledge about their toxicity, mechanism of action, metabolism, abuse potential so that they are directly tested by the consumers. This perspective highlights the main issues connected with NPS: the celerity they enter and leave the market once included in the banning laws to be substituted by...

Financial Neutrality Should Replace the Iranian Paid Donor Market.

The article by Feizi and Moeindarbari, two Iranian economists, in this issue [1] serves to put another nail in the coffin in the once touted, but much overrated, so-called Iranian system of paid "regulated" organ donation. The Iranian "market" (the authors' term) was not a result of a strategic plan to address the needs of patients with end stage organ failure; rather, it was a result of the desperate needs of these patients with end stage kidney disease at the time of the catastrophic war between Iran and ...

ADHD and later-life labor market outcomes in the United States.

This study analyzes the relation between attention-deficit hyperactivity disorder (ADHD) and later-life labor market outcomes in the United States and whether these relationships are mediated by educational attainment. To overcome endogeneity concerns in the estimation of these relationships, we exploit the polygenic risk score (PRS) for ADHD in a cohort where the diagnosis of and treatment for ADHD were generally not available. We find that an increase in the PRS for ADHD reduces the likelihood of employme...

Privacy hurdles thwart Facebook democracy research.

Gene transfer to skeletal muscle using hydrodynamic limb vein injection: current applications, hurdles and possible optimizations.

This review focuses on gene transfer to skeletal muscle using hydrodynamic limb vein injection, with current applications, hurdles and possible optimizations.

Comparative Physicochemical and Biological Characterisation of the Similar Biological Medicinal Product Teriparatide and Its Reference Medicinal Product.

In January 2017, the European Commission approved Terrosa (company code RGB-10) as one of the first biosimilar medicinal products of teriparatide for the same indications as for the reference medicinal product Forsteo (Lilly France S.A.S.), which has been on the market in the European Union since 2003. The active pharmaceutical ingredient of the reference medicinal product is the biologically active 1-34 fragment of the endogenous human parathyroid hormone [PTH(1-34)]. It is one of the three bone anabolic a...

Anomaly detection in Bitcoin market via price return analysis.

The Bitcoin market becomes the focus of the economic market since its birth, and it has attracted wide attention from both academia and industry. Due to the absence of regulations in the Bitcoin market, it may be easier to bring some kinds of illegal behaviors. Thus, it raises an interesting question: Is there abnormity or illegal behavior in Bitcoin platforms? To answer this question, we investigate the abnormity in five leading Bitcoin platforms. By analyzing the financial index, i.e. the normalized logar...


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