Sentences with phrase «efficacy data from»

Presentations will highlight the short and long - term effects of Ingrezza on tardive dyskinesia symptoms by body region, long term safety and efficacy data from the KINECT 4 phase 3 open label study and also from RE-KINECT (real - world screening study of patients with possible TD).

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).

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.

But my specific point is that while everybody is busy telling you that «kids don't use email» or «email is dead» I have actual data from portfolio company's CEO showing the efficacy of email as a communication and marketing channel.

Once she can start aggregating data from her patients with data from other doctors who are using the app, she will have a huge number of data points that she can use to track everything from the efficacy of the surgery in certain patient populations, to which doctors might get the best outcomes.

In a March 16 research note, Andrew Fein, an analyst at H.C. Wainwright & Co., reported that OvaScience (OVAS: NASDAQ) shifted its focus back to research and development, after interim data from the first 20 patients in its Phase 1 trial of OvaPrime showed no signs of efficacy despite indicating safety and tolerability.

In contrast stands the more basic perception in the mode of causal efficacy; which «is our general sense of existence, as one item among others in an efficacious external world» and «of derivation from an immediate past, and of passage to an immediate future»; its data «are vague, not to be controlled, heavy with emotion.»

Sometimes, especially when he is speaking pre-systematically and citing examples from ordinary experience, Whitehead seems to claim that causal efficacy merely discloses relations among the data of presentational immediacy and to indicate that «something is going on in nature and some things are affecting other things.»

One may then speculate that the emotional character of the experience in the cells in the grass are somewhat replicated in the emotional component of their prehension in the mode of causal efficacy from which the sense datum, green, arises visually.

He explains that «According to this account, perception in its primary form is consciousness of the causal efficacy of the external world by reason of which the percipient is a concrescence from a definitely constituted datum.

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).

The brief includes the analysis of survey data from program participants on child safety in the home, observed parenting practices, parental stress and parenting efficacy, self - reported parenting practices, and rates of child maltreatment.

Thomas Smith, who studies the epidemiology of malaria at the Swiss Tropical Institute in Basel, says it may be premature to say exactly what the efficacy is based on this early data from the trial, which is still ongoing.

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 largest CBD study presented efficacy and safety data on GW Pharmaceutical's investigational medicine, Epidiolex (cannabidiol) from open - label Expanded Access programs at 16 sites.

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.

Shadi Yaghi, M.D., of Brown University, Providence, R.I., and colleagues analyzed data from 10 stroke centers across the United States to understand the natural history of thrombolysis - related sICH and to focus on the efficacy of various treatments used.

[NIAID Director Anthony] Fauci says $ 56 million of the total would go toward a larger efficacy trial in Liberia, which would include both the NIAID / GSK [GlaxoSmithKline] vaccine and another made by NewLink Genetics of Ames, Iowa (pending more data from ongoing safety trials).»

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.

In order to examine the «placebo breaking the blind» theory, a research group at the Sahlgrenska Academy in Gothenburg, Sweden, has now analyzed data from the clinical trials that were once undertaken to establish the antidepressant efficacy of two of the most commonly used SSRIs, paroxetine and citalopram.

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.

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.

Because MVA was never tested in a real outbreak, data on its efficacy will have to come from animal studies.

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.

In a few weeks, meeting participants learned, enough data may be available from small phase I trials of a vaccine jointly made by the U.S. National Institute of Allergy and Infectious Diseases and GlaxoSmithKline (GSK) that began in September to launch efficacy studies.

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.

While the data from this research demonstrate continued symptomatic improvement six months after treatment, more research is needed to show efficacy at one year and beyond, added Bagla.

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.

In order to examine the «placebo breaking the blind» theory, a research group at the Sahlgrenska Academy, has now analyzed data from the clinical trials that were once undertaken to establish the antidepressant efficacy of two of the most commonly used SSRIs, paroxetine and citalopram.

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

Early results from a phase I, first in - human study indicate that a potential new class of drugs, RNA interference (RNAi) drugs, can be safely administered in humans, according to a researcher who presented data on the safety and preliminary efficacy of TKM - 080301 at the AACR Annual Meeting 2013, held in Washington, D.C., April 6 - 10.

Data from these studies indicate the safety and efficacy of Celvive's therapeutic approach.

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.

AST - VAC1 (antigen - presenting autologous dendritic cells) is an autologous cancer immunotherapy with promising efficacy and safety data from a Phase 2 study in Acute Myeloid Leukemia (AML).

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.

Published new efficacy and safety data from preclinical studies of AST - OPC1 in the peer - reviewed journal «Stem Cells Translational Medicine.»

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.

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.

During the training seminar, teachers try out the process using real data from other Efficacy schools around the country.

From analyses of quantitative and qualitative data, findings indicated an increase in students» science achievement and self - efficacy for learning science after their engagement in a computer - enhanced PBL environment; however, no significant changes were seen in their attitude toward science.

Responding to Whitehurst and Chingos» call for more research on textbook efficacy, we have recently undertaken a project [vii] using data from California to investigate the impact of textbooks on student achievement.

From Teacher Efficacy and Evaluation to the NYS P - 12 Common Core Learning Standards (CCLS) and Data Driven Instruction, New York State Teacher Centers are here.

To determine the efficacy of the use of data from student test scores, particularly in the form of Value - Added Measures (VAMs), to evaluate and to make key personnel decisions about classroom teachers.

(Using Data to Inform Decisions: How Teachers Use Data to Inform Practice and Improve Student Performance in Mathematics - Results from a Randomized Experiment of Program Efficacy.

Dr. Marc Hernandez, an expert on literacy assessments from the University of Chicago, also attended the meeting and commented on the efficacy of assessment data informed instruction.