Sentences with phrase «of efficacy data»

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).

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.

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.

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).

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.»

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.

The very function of the phase of presentational immediacy is to provide a representation or mapping of the datum, which is dimly discerned at the level of causal efficacy.

In such cases the sensory datum complete with the feeling of bodily efficacy is present.

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.»

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.

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.

Feelings of causal efficacy give us, as Merleau - Ponty appreciated in Whitehead, the infrastructure behind the presentation of sense data.

First, in terms of their origin in the second phase of concrescence, ideas emerge as data of conceptual feelings — pried out of immanence in feelings of causal efficacy as the objects of feelings of conceptual reproduction and reversion.

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.

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).

If you dig and read studies examining the actual safety and efficacy data about the various vaccines, it is clear that vaccination prevents the development of a strong natural immune system.

Reflecting on the evidence, the study's authors wrote, «Despite the media attention and perceived benefits of these therapies, there are still limited data as to efficacy and long - term safety.

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.

Data about the efficacy of home visiting programs have been accumulating over the past three decades.

Despite this shift in practice, there are limited data evaluating the efficacy of «nutrient - fortified» donor milk compared with preterm formula.

Its role in the initiation of labour is poorly understood and data examining its efficacy within a clinical trial are limited.

And New York State Senator Brad Hoylman announced there would be a public forum on June 14 at the Senate Hearing Room «to assess the efficacy of New York State's Hate Crimes Law, how state and local government agencies are implementing and enforcing the Law, and whether amendments should be considered to expand the data collection, statistical reporting, law enforcement training requirements and / or otherwise further the Law's goals.»

«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.

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.

The disagreement exposes a rift between those scientists who accept only clinical trials as proof of efficacy and those who accept observational data.

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.

Follow - up data on safety and efficacy has been assessed at up to six years in women age 15 - 26 and the current team of investigators also looked at data on the large cohort of young people two years ago.

Continuous data collection off of organ mimics is what we need to measure efficacy and safety of drugs during long - duration experiments.

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.

Three studies presented at the American Epilepsy Society's 69th Annual Meeting in Philadelphia highlight emerging efficacy and safety data of Epidiolex, a pharmaceutical liquid formulation of cannabidiol, which is currently undergoing U.S. Food and Drug Administration (FDA) authorized Phase 3 pivotal clinical trials in the United States and across the globe by GW Pharmaceuticals.

Gaff, who calls herself a mathematical ecoepidemiologist, at Old Dominion University in Norfolk, Va., is one of the few people collecting real field data on the efficacy of tick - slaying robots...

«I really worry about this study — I think it's flawed,» says Peter Snyder, a neurologist who studies ageing at Brown University's Alpert Medical School in Providence, R.I. Snyder agrees that data supporting the efficacy of brain training are sparse.

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.

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.

But pharmacometrics — the modeling and statistical analysis of drug metabolism data — touts a more tailored, predictive approach to safety and efficacy.

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.»

[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.