Sentences with phrase «efficacy data for»

«Despite the increased quality risks and the lack of safety and efficacy data for non-FDA regulated custom - compounded bioidentical hormones, their use by menopausal women is higher than expected and appears to be continuing to grow,» said lead researcher JoAnn Pinkerton, MD, a professor of obstetrics and gynecology at the University of Virginia Health System, Charlottesville.

Full efficacy data for the 2017 - 2018 flu season are still being compiled, but pEpitope has predicted it will be around 19 percent against H3N2, the type of influenza A that infected most people in the U.S. in each of the past two years.

Not exact matches

In particular, the complaint alleges that throughout the Class Period, defendants made materially false and / or misleading statements and / or failed to disclose that (1) the trials for GED - 0301 suffered from fatal design defects, such that GED - 0301 had failed to demonstrate meaningful clinical efficacy; (2) the growth of Otezla sales had dramatically slowed during Celgene's third fiscal quarter of 2017; and (3) the clinical and nonclinical pharmacology data in Celgene's new drug application («NDA») for Ozanimod were insufficient to permit a complete review by the FDA, which resulted in the FDA issuing a refusal to file letter to Celgene regarding the NDA.

These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.

Actual results and the timing of events could differ materially from those anticipated in the forward - looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: the uncertain timing of, and risks relating to, the executive search process; risks related to the potential failure of eptinezumab to demonstrate safety and efficacy in clinical testing; Alder's ability to conduct clinical trials and studies of eptinezumab sufficient to achieve a positive completion; the availability of data at the expected times; the clinical, therapeutic and commercial value of eptinezumab; risks and uncertainties related to regulatory application, review and approval processes and Alder's compliance with applicable legal and regulatory requirements; risks and uncertainties relating to the manufacture of eptinezumab; Alder's ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with Alder's development and commercialization activities; the sufficiency of Alder's capital and other resources; market competition; changes in economic and business conditions; and other factors discussed under the caption «Risk Factors» in Alder's Annual Report on Form 10 - K for the fiscal year ended December 31, 2017, which was filed with the Securities and Exchange Commission (SEC) on February 26, 2018, and is available on the SEC's website at www.sec.gov.

The ongoing American Heart Association (AHA) meeting in New Orleans is producing a deluge of data — including some promising prospects for a class of next - generation cholesterol drugs that have been slow to take off so far in the U.S. So - called PCSK9 inhibitors have shown tremendous efficacy in lowering LDL - C, or «bad» cholesterol.

These risks and uncertainties include: Gilead's ability to achieve its anticipated full year 2018 financial results; Gilead's ability to sustain growth in revenues for its antiviral and other programs; the risk that private and public payers may be reluctant to provide, or continue to provide, coverage or reimbursement for new products, including Vosevi, Yescarta, Epclusa, Harvoni, Genvoya, Odefsey, Descovy, Biktarvy and Vemlidy ®; austerity measures in European countries that may increase the amount of discount required on Gilead's products; an increase in discounts, chargebacks and rebates due to ongoing contracts and future negotiations with commercial and government payers; a larger than anticipated shift in payer mix to more highly discounted payer segments and geographic regions and decreases in treatment duration; availability of funding for state AIDS Drug Assistance Programs (ADAPs); continued fluctuations in ADAP purchases driven by federal and state grant cycles which may not mirror patient demand and may cause fluctuations in Gilead's earnings; market share and price erosion caused by the introduction of generic versions of Viread and Truvada, an uncertain global macroeconomic environment; and potential amendments to the Affordable Care Act or other government action that could have the effect of lowering prices or reducing the number of insured patients; the possibility of unfavorable results from clinical trials involving investigational compounds; Gilead's ability to initiate clinical trials in its currently anticipated timeframes; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead's earnings; Kite's ability to develop and commercialize cell therapies utilizing the zinc finger nuclease technology platform and realize the benefits of the Sangamo partnership; Gilead's ability to submit new drug applications for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the SEC).

We do this by conducting clinical trials in which we collect safety and efficacy data about our experimental drugs with the goal of submitting those data to regulatory authorities, like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), so that these experimental drugs can be approved for use by patients.

This account of awareness is empirical because it is based on the immediate experience of the causal efficacy of the physical world; it is radically empirical because it claims to sense, in addition to the data for the five senses, the objective embodiments of values, and it senses these values «intuitively» — that is, physically by, for example, a sense of aversion or a sense of attraction.

Furthermore, precisely as paradigmatically exemplified in the life process of Jesus, they function as a physical datum, with direct causal efficacy, for all subsequent history.

When we speak of the double efficacy of the risen Christ as ideal and as objective datum for present becoming, we might do better to speak of a «triple efficacy» of the love of Christ, for that faith, love, and communion with God which are Christ's find innumerable, if only partial, echoes in the lives of individual believers and in that system of relationships which they comprise within the world.

This includes the objective form according to which feelings of causal efficacy prehend past actual occasions, the subjective form — how the occasion prehends — and the subjective aim of the present concrescence — how it wants to be a datum for future becomings.

For Whitehead, conceptual reversion is the «positive conceptual prehension of relevant alternatives» (PR 381)-- as in Hume's famous example of imagining the missing shade of blue — because there is a novel conceptual feeling whose data are different from, but relevant to, those extrapolated from feelings of causal efficacy by the operation of «conceptual reproduction» (PR 380f).

For, (a) neither conceptual feelings nor those of causal efficacy are per se reflectively conscious judgments, and (b) perception in its most basic level of causal efficacy is both «form» (meaning) and «matter» (experiential data), and the «main characteristic» of these feelings is their «enormous emotional significance» (Al 276).

«It's important for us to finish what we started... and to make sure we get the data, the safety and efficacy that's necessary to support the approval and licensure of therapeutics and vaccines,» Disbrow said.

The self - efficacy scale, for example, can be used as either a reflection tool or as a tool to collect data across time to document changes in scientists» self - efficacy that would be expected to result from science communication training programmes.

Respondents in this year's survey pointed to five main causes of the field's less than favorable reputation: drug and product recalls such as the withdrawal of Avandia; safety issues such as the discovery of problems with raw material from China used in medical products; scandals, including evidence that pharmaceutical companies have failed to release data from trials whose results cast doubts on their drugs» safety and efficacy; lawsuits brought against companies that failed to warn patients of problems with their products; and ethical issues such as kickbacks for physicians promoting specific medications.

The documentation ranges across the whole spectrum of drug development: Investigators» brochures provide information on all that is currently known about the medicine and so need periodic updating; accurate and concise protocols are required to ensure that trials are performed effectively; clinical trial reports (generally from phase II and III studies) present the information gathered from the trials; higher level documents provide summaries of efficacy and safety data from clinical trial programmes; expert reports provide critical interpretation of the results; and response documents clarify any points that are not clear to the regulatory agencies or provide additional analyses or supporting data for any items of concern.

The authors performed a systematic literature search for data on e-cigarettes» mechanism of action, their emissions, how they are seen by groups of potential users, their efficacy in smoking cessation, and their addiction potential.

The goals of Cohort B, for which survival data are not yet complete, were, primarily, to prove pembrolizumab's safety and, secondarily, to explore its efficacy as a first - line treatment.

In January 2013, the American Society for Reproductive Medicine declared the technique of oocyte cryopreservation (egg freezing) no longer experimental, although it called for «more widespread clinic - specific data on the safety and efficacy of oocyte cryopreservation... before universal donor oocyte banking can be recommended.»

What's really necessary, Dr. Gaillard says, is real data on efficacy for each of the medications commonly prescribed to pediatric epilepsy patients — a marked vacuum in research that prevents doctors from using evidence - based reasoning when making medication choices.

The data obtained from this study provide a basis for more rapid, cost - effective clinical trials to evaluate new influenza drugs or to determine the efficacy of candidate vaccines for both seasonal and pandemic influenza.

Susan Gould Fogerite, director of research for the Institute for Complementary and Alternative Medicine in the School of Health Related Professions, said that although there is widespread evidence that yoga is being used as a form of exercise by those with MS, much of the feedback has been anecdotal and there isn't much empirical data regarding its safety and efficacy.

A pooled analysis of data from two randomised trials comparing vitamin E versus placebo, and the placebo group from another trial comparing vitamin E use versus non-use, demonstrates that the efficacy of vitamin E is comparable to other treatments for NASH, including pioglitazone, metformin and obeticholic acid.

However, no data existed to compare the addition of these treatment approaches to usual medical care for OA or for the long - term efficacy of this holistic approach.

A total of 347 patients (155 treated with vitamin E, 192 not treated with vitamin E) were included in the analysis which compared data from three clinical trials that investigated the efficacy and safety of vitamin E as a treatment for NASH: the PIVENS, TONIC and FLINT trials.

Medical schools have resisted the introduction of a specific phytotherapy curriculum, preferring to wait for more data on efficacy and safety.

An HFEA spokesperson says that the agency is waiting for further experiments on the safety and efficacy of mitochondrial replacement (including data from Herbert's team) before approving what could be the world's first mitochondrial replacement in humans.

Adam R. Glassman, M.S., of the Jaeb Center for Health Research, Tampa, Fla., and colleagues examined the incremental cost - effectiveness ratios (ICERs) of aflibercept, bevacizumab, and ranibizumab for the treatment of DME with an analysis of efficacy, safety, and resource utilization data at 1 - year follow - up from the Diabetic Retinopathy Clinical Research (DRCR) Network Comparative Effectiveness Trial.

Since there is no vaccine or specific approved treatment for Ebola virus disease (EVD), there is a «moral obligation» to collect and share all data generated, to understand the safety and efficacy of any intervention, and to evaluate promising interventions to inform future research, says Dr. Eleanor Fish, the senior author and senior scientist in the Toronto General Hospital Research Institute (TGHRI).

White MT, Verity R, Griffin JT, et al.White MT, Verity R, Griffin JT, Asante KP, Owusu - Agyei S, Greenwood B, Drakeley C, Gesase S, Lusingu J, Ansong D, Adjei S, Agbenyega T, Ogutu B, Otieno L, Otieno W, Agnandji ST, Lell B, Kremsner P, Hoffman I, Martinson F, Kamthunzu P, Tinto H, Valea I, Sorgho H, Oneko M, Otieno K, Hamel MJ, Salim N, Mtoro A, Abdulla S, Aide P, Sacarlal J, Aponte JJ, Njuguna P, Marsh K, Bejon P, Riley EM, Ghani AC close, 2015, Immunogenicity of the RTS, S / AS01 malaria vaccine and implications for duration of vaccine efficacy: secondary analysis of data from a phase 3 randomised controlled trial, Lancet Infectious Diseases, Vol: 15, ISSN: 1473 - 3099, Pages: 1450 - 1458

Only four provided data for positive outcomes or adverse effects, and none provided any data on efficacy beyond the end of treatment.

An yet, while we can question the evidence for the actual efficacy of most performance enhancers currently used, tDCS in particular stands out in calling for more data.

Along with our nonprofit partners, this program aims to collect, organize, and validate massive amounts of data generated by clinical trials across our global trial network sites in order to generate novel insights into biomarkers for safety and efficacy, novel treatment strategies, and personalization of treatment regimens.

At the International Society for Stem Cell Research 2017 Annual Meeting (June 14 - 17, 2017; Boston, USA), Asterias Biotherapeutics, Inc (CA, USA) will present new 9 - month efficacy and safety data from their ongoing SCiStar Phase I / IIa trial of human embryonic stem cell - derived oligodendrocyte progenitor cells.

Asterias Biotherapeutics, Inc will present new 9 - month efficacy and safety data from their ongoing Phase I / IIa trial for OPC - 1 in a workshop and poster presentation.

In this presentation, we discuss data from studies conducted with academic, clinical, and industry collaborators that demonstrates the utility of the system as a more predictive, human - relevant alternative for efficacy and safety testing of new chemical entitites.

Title: Combining efficacy and completion rates with no data imputation: a composite approach with greater sensitivity for the statistical evaluation of active comparisons in antipsychotic Trials Author: J. Rabinowitz et al..

We have commenced a series of clinical trials designed to obtain safety and efficacy data on Epidiolex to provide to the FDA and other regulatory authorities around the world, which is necessary to be considered for approval as a prescription medicine.

AFF 1: Preclinical Efficacy Data AFF 1 was then tested for preclinical efficacy in two models of human synucleinopathy: mThy1 - AS mice, and also PDGF - AS mice expressing WT human AS under the PDGF - β promoter — a model with closer neuropathological and metabolic resemblance to LBD Efficacy Data AFF 1 was then tested for preclinical efficacy in two models of human synucleinopathy: mThy1 - AS mice, and also PDGF - AS mice expressing WT human AS under the PDGF - β promoter — a model with closer neuropathological and metabolic resemblance to LBD efficacy in two models of human synucleinopathy: mThy1 - AS mice, and also PDGF - AS mice expressing WT human AS under the PDGF - β promoter — a model with closer neuropathological and metabolic resemblance to LBD than PD.

Using data from the AHRQ report, the Institute for Clinical and Economic Review (ICER, 2011) conducted a cost - effectiveness modeling study, assuming that transcranial electrical stimulation and electroconvulsive therapy have equivalent efficacy.

Our data show, for the first time, the efficacy of ES - derived CD45 + HPCs to engraft in allogenic recipients without the use of immunosuppressive agents, there by protecting cardiac allografts from rejection.

Structured Abstract Introduction: The analysis of pharmaceutical industry data indicates that the major reason for drug candidates failing in late stage clinical development is lack of efficacy, with a high proportion of these due to erroneous hypotheses about target to disease linkage.

«These data highlight and provide even more evidence as to the efficacy of the vaccine in preventing HPV infections and related diseases,» said Fred Wyand, a spokesman for the American Sexual Health Association / National Cervical Cancer Coalition.

The objective of the testing for Berkey Water Filter was to establish preliminary data regarding the efficacy of viral removal or inactivation from clean water.

Beyond efficacy, safety data are critical for the therapeutic application of fasting but are sorely lacking.

Kane argues that a system of efficacy networks, making it easier for district leaders to pilot and evaluate initiatives with their own data, would be better integrated with the way local leaders make decisions.

That way, our clients can provide their funders and accreditors with the statistics they need to demonstrate the efficacy of their courses without having to hire a psychometrician to analyze the data for them.

Topics of discussion will include: • Setting goals and identifying criteria to evaluate programs for efficacy, standards - alignment, and student growth • How to build teacher capacity using data - informed instruction and intentional organizational support structures • Scaling beyond intervention; increasing district - wide adoption and usage of personalized learning programs All K - 12 administrators and educators are encouraged to attend.