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

08:44 EDT 18th October 2018 | BioPortfolio

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

A checklist for managed access programmes for reimbursement co-designed by Canadian patients and caregivers.

Reimbursement decisions on orphan drugs carry significant uncertainty, and as the amount increases, so does the risk of making a wrong decision, where harms outweigh benefits. Consequently, patients often face limited access to orphan drugs. Managed access programmes (MAPs) are a mechanism for managing risk while enabling access to potentially beneficial drugs. Patients and their caregivers have expressed support for these programmes and see patient input as critical to successful implementation. However, t...

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...

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...

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.

Exploring what shapes injection and non-injection among a sample of marginalized people who use drugs.

Few studies have specifically explored what influences people who use drugs to consume them in certain ways (i.e., smoking, injecting). While a great deal of research has examined the transition from non-injection to injection routes of drug administration, less is known about people who use drugs (PWUD) but have never injected or have stopped injecting. This paper draws on actor-network theory to explore what moves people to inject or not, among both people who currently smoke/sniff drugs (PWSD) and people...

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

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...

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...

Incidence of infantile Pompe disease in the Maroon population of French Guiana.

The aim of this study was to describe the epidemiology of infantile Pompe disease (IPD) in French Guiana, a French overseas territory, by combining a retrospective case records study and a prospective anonymous genotyping in a sample of mothers followed in the two major maternity units of French Guiana.

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...

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

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.

Snakebites in French Guiana: Conclusions of an international symposium.

A workshop on epidemiology and management of snakebites in French Guiana was performed at Cayenne, French Guiana from September 15 to September 16, 2017, under the auspices of the French Regional Health Agency (ARS) and the Pan American Health Organization (PAHO). The activity was attended by experts from France (Angers, Martinique, French Guiana, Guadeloupe, and Paris), Costa Rica, Brazil, Saint Lucia, and Surinam. The epidemiology, clinical manifestations, clinical grading and the management of snakebite ...

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.

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...

Matching optical flow to motor speed in virtual reality while running on a treadmill.

We investigated how visual and kinaesthetic/efferent information is integrated for speed perception in running. Twelve moderately trained to trained subjects ran on a treadmill at three different speeds (8, 10, 12 km/h) in front of a moving virtual scene. They were asked to match the visual speed of the scene to their running speed-i.e., treadmill's speed. For each trial, participants indicated whether the scene was moving slower or faster than they were running. Visual speed was adjusted according to their...

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.

Successes and failures of sixty years of vector control in French Guiana: what is the next step?

Since the 1940s, French Guiana has implemented vector control to contain or eliminate malaria, yellow fever, and, recently, dengue, chikungunya, and Zika. Over time, strategies have evolved depending on the location, efficacy of the methods, development of insecticide resistance, and advances in vector control techniques. This review summarises the history of vector control in French Guiana by reporting the records found in the private archives of the Institute Pasteur in French Guiana and those accessible ...

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...

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