PubMed Journals Articles About "French Industry Welcomes Moves Speed Access Innovative Drugs" RSS

05:30 EST 19th December 2018 | BioPortfolio

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Showing "French Industry Welcomes Moves Speed Access Innovative Drugs" PubMed Articles 1–25 of 12,000+

Exploring the Tiers of Rooted Phylogenetic Network Space Using Tail Moves.

Popular methods for exploring the space of rooted phylogenetic trees use rearrangement moves such as rooted Nearest Neighbour Interchange (rNNI) and rooted Subtree Prune and Regraft (rSPR). Recently, these moves were generalized to rooted phylogenetic networks, which are a more suitable representation of reticulate evolutionary histories, and it was shown that any two rooted phylogenetic networks of the same complexity are connected by a sequence of either rSPR or rNNI moves. Here, we show that this is poss...

The patient's safety and access to experimental drugs after the termination of clinical trials: regulations and trends.

Participants' rights and safety must be guaranteed not only while a clinical trial is being conducted but also when a clinical trial finishes. The criteria for post-trial access to experimental drugs, however, are unclear in various countries. The objectives of this study were (i) to ascertain if there were regulations or guidelines related to patients' access to drugs after the end of clinical trials in the countries selected in the study and (ii) to analyze trends in post-trial access in countries classif...

Impact of Brexit on UK and EU Drug Regulation and Patient Access.

The chronology of U.K. leaving the European Union Is presented together with its implications for medicines regulation, including the move of the European Medicines Agency from London to Amsterdam, The legal and political options for the UK and the EU are discussed, which at the time of writing (October 2018) are both uncertain, Of importance is the response of the pharmaceutical industry and the possible consequences for UK patients, including delays in access to innovative medicines and an increase in dru...

Highly Innovative Drug Program in the Czech Republic: Description and Pharmacoeconomic Results-Cost-Effectiveness and Budget Impact Analyses.

Highly innovative drugs (HIDs) can be granted 2 to 3years of temporary reimbursement (TR) to provide timely patient access and to collect real-world evidence through registries in the Czech Republic. A TR applicant does not need to comply with cost-effectiveness (CE) requirements and the willingness-to-pay threshold. It is only when mandatory transition to permanent reimbursement (PR) status occurs does the drug need to comply with CE and willingness-to-pay requirements.

Little to lose and no other options: Ethical issues in efforts to facilitate expanded access to investigational drugs.

Today, public and private bodies around the world are trying to facilitate and increase expanded access to unapproved, investigational drugs for patients with unmet medical needs.

A preference for visual speed during smooth pursuit eye movement.

Does the preference for visual speed extend to motion perception when the eye moves? Current evidence from psychophysics and neuroscience is limited to small patches of image motion and stationary fixation. Active observers, however, are more likely to use large patches of retinal flow and extraretinal signals accompanying eye movement to judge motion. We therefore investigated whether speed remains a primary dimension during smooth pursuit using a "discrimination-contour" technique. Our results showed that...

Meteorite fragment, deadly floods and French open-access push.

Progress in Inherited Retinal Disease Drug Discovery and Development: A Foundation's Perspective.

Ophthalmic drug discovery and development has enjoyed a recent renaissance, with a major shift away from reformulating old systemic drugs for ocular use to de novo discovery of drugs for specific ocular disease targets. This shift, coupled with a revolution in molecular biology and genetic sequencing, has uncovered an unprecedented number and variety of novel targets for therapeutic intervention in eye disease. With such a treasure chest of new science to pursue, it also creates a new challenge for translat...

Improving Expanded Access in the United States: The Role of the Institutional Review Board.

The FDA allows patients with a serious or immediately life-threatening illness to use investigational medical products outside of clinical trials through its "expanded access" program. In response to criticism that the process to apply for expanded access is too onerous, numerous changes have been made over the last few years. These have been largely focused on the FDA and the pharmaceutical industry, while institutional review boards (IRBs)-which must approve expanded access protocols, except in emergencie...

U-BIOPRED: evaluation of the value of a public-private partnership to industry.

Unbiased Biomarkers for the Prediction of Respiratory Disease Outcomes (U-BIOPRED) was initiated in the first year of the Innovative Medicines Initiative (IMI). It was an ambitious plan to tackle the understanding of asthma through an integration of clinical and multi-'omics approaches that necessitated the bringing together of industry, academic, and patient representatives because it was too large to be managed by any one of the partners in isolation. It was a novel experience for all concerned. In this r...

Co-creation to scale up provision of simplified high-quality comprehensive abortion care in East Central and Southern Africa.

Universal access to comprehensive abortion care (CAC) is a reproductive right and is essential to reduce preventable maternal mortality and morbidity. In East Africa, abortion rates are consistently high, and the vast majority of all abortions are unsafe, significantly contributing to unnecessary mortality and morbidity. The current debate article reflects and summarises key action points required to continue to speed the implementation of and expand access to CAC in the East, Central, and Southern African ...

Ensuring Justice in Access to Investigational Neurological Drugs.

Patients who suffer from life-threatening illnesses or are stricken with conditions that could result in serious morbidity who have exhausted all appropriate treatments may choose to try, through the Food and Drug Administration's expanded access program, an investigational drug or device in development. The program has succeeded for decades in allowing patients to access potentially helpful but still experimental agents. Nevertheless, the administration of investigational drugs outside of clinical trials r...

Access to Dermatological Care with an Innovative Online Model for Psoriasis Management: Results from a Randomized Controlled Trial.

Many patients with chronic skin diseases lack regular access to dermatologists in the United States and suffer poor clinical outcomes.

Comprehension of Top 200 Prescribed Drugs in the US as a Resource for Pharmacy Teaching, Training and Practice.

Pharmacists have access to a plethora of information related to drugs. Online compendia concerning top 200 prescribed drugs are readily-accessible, comparatively-easy to search. While these resources provide some information about the commonly prescribed drugs, they lack in furnishing in-depth knowledge to pharmacy students, pharmacists and other healthcare professionals. The aim of this paper is to present the relevant details of top 200 most prescribed drugs in the United States. The names and therapeutic...

Non-steroids anti-inflammatory drugs and risk of peritonsillar abscess in pharyngitis: a French longitudinal study in primary care.

The safety of non-steroids anti-inflammatory drugs (NSAIDs) in the context of pharyngitis is doubtful with contradictory results in the literature.

French comment on article The size, morphology, site, and access score predicts critical outcomes of endoscopic mucosal resection in the colon.

Access to care for people with alcohol use disorder in France: a mixed-method cross-sectional study protocol (ASIA).

Alcohol use disorder (AUD) is a major public health concern worldwide. In France, only 10% of people with AUD (PWAUD) receive medical care. General practitioners (GP) are one of the main entry points for AUD care. The present ongoing study, entitled ASIA (Access to Care and Indifference toward Alcohol, in French), aims to improve knowledge about factors associated with access to care for AUD by exploring related GP and PWAUD practices, experiences and perceptions.

Miracle of haemophilia drugs: Personal views about a few main players.

In the second decade of the third millennium there have been dramatic developments pertaining to the availability of highly innovative drugs for hemophilia care, notwithstanding a satisfactory previous scenario.

Implications of Medical Tourism.

Medical tourism is an emerging industry that facilitates travel to another country for people who seek medical, surgical, or dental care that is unavailable or more affordable than in their home countries. Rapid advances in electronic communication and the ease of international travel have fueled the growth of this industry. More than half of medical travelers are women, especially for services related to cosmetic or reproductive conditions. Medical tourism creates both opportunities and challenges for nurs...

Evaluation of Attitudes Toward Same-Sex Parenting in the Italian Context: Adaptation of a French Questionnaire.

This study investigated the psychometric properties of the Italian version of a French scale to detect attitudes toward same-sex parenting. The Italian sample was split into two subsamples. On one, exploratory factor analysis (EFA) was conducted to detect the factor structure of the Italian scale, and on the other, confirmatory factor analysis (CFA) was run to find the data's best fit model. The scales' internal consistency was evaluated using Cronbach's alpha. The questionnaire's convergent validity was al...

Trends and Patterns of Antidepressant Use in French Children and Adolescents From 2009 to 2016: A Population-Based Study in the French Health Insurance Database.

Over the last decade, the use of antidepressants (ATDs) in children and adolescents has markedly increased in several occidental countries, but recent data in French children are missing. This study aimed to assess trends of ATD use in French children (6-11 years) and adolescents (12-17 years) and to characterize changes in ATD prescribing patterns from 2009 to 2016.

Modelling stroking parameters in competitive sprint swimming: Understanding inter- and intra-lap variability to assess pacing management.

This study investigated the inter- and intra-lap variability in stroking parameters during sprint competition to gain insight into the race management of speed (S), stroke length (SL), stroke rate (SR) and stroke index (SI) in relation to gender. The stroking parameters of 32 male and 32 female finalists in the 2015 World Championships and French Championships were analysed during 50-m and 100-m freestyle events. Using a video-derived two-dimensional direct linear transformation system, the biological coeff...

Weighing of evidence by health technology assessment bodies: retrospective study of reimbursement recommendations for conditionally approved drugs.

This study assessed whether five health technology assessment (HTA) bodies in Europe were more negative about drugs with a conditional marketing authorisation (CMA) that are approved without controlled studies compared to CMA drugs that are approved based on controlled studies. HTA recommendations were categorized into positive, restricted and negative. A total of 92 HTA recommendations were available for 27 drugs. 30/62 (48%) and 17/30 (57%) of recommendations were negative for drugs with and without contr...

Semi-autonomous vehicles: Usage-based data evidences of what could be expected from eliminating speed limit violations.

The use of advanced driver assistance systems and the transition towards semi-autonomous vehicles are expected to contribute to a lower frequency of motor accidents and to have a significant impact for the automobile insurance industry, as rating methods must be revised to ensure that risks are correctly measured. Telematics information and usage-based insurance research are analyzed to identify the effect of driving patterns on the risk of accident. This is used as a starting point for addressing risk quan...

Quantitative assessment of dietary supplement intake in 77,000 French adults: impact on nutritional intake inadequacy and excessive intake.

Dietary supplements (DS) are largely consumed in Western countries without demonstrating their nutritional benefits and safety in the general population. The aims, in a large population-based study of French adults, were: (1) to compare the prevalence of nutrient intake inadequacy and the proportion of individuals exceeding tolerable upper intake levels (UL) between DS users and non-users, and (2) to quantify the extent of potentially "at-risk" DS use practices (e.g., DS/drugs contraindicated association or...

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