Sentences with phrase «year trial data»

One - year trial data were used to calculate cost - effectiveness for 1 year for the 3 anti-VEGF agents; mathematical modeling was then used to project 10 - year cost - effectiveness results.

Not exact matches

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.

In a decision released by the Baltimore Circuit Court, Judge Martin P. Welch wrote that the 35 - year - old was being granted a new trial because his initial council failed to properly cross-examine an expert from the state about the reliability of cell tower data that seemed to place him at the scene of the crime.

Abernethy said Flatiron's process is similar to a registry trial, but because data from over the years is already available in the database, the trials don't take as long as they might otherwise.

By leveraging the collective will and sociability of the student demographic — while remaining aligned with universities by collecting data and encouraging department collaboration — the jointly reformed Koofers.com gained enough momentum to grow from a one - campus beta trial in 2006 to a 400 - campus platform in 2009 — and a soon - to - be 1,000 - campus platform this year.

Through talking to experts in the field over the past year, Gates said he had identified five areas of need: Understanding better how Alzheimer's unfolds, detecting and diagnosing it earlier, pursuing multiple approaches to trying to halt the disease, making it easier for people to take part in clinical trials of potential new medicines, and using data better.

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).

Juno's setbacks contrast with the biologics license application planned this year by Novartis, and the rolling BLA in progress by Kite Pharma — which on Tuesday reported positive 6 - month trial data for its CAR T - cell lead candidate.

Additional clinical trial data later this year on Tesaro's key drug, Niraparib, which targets advanced solid tumors in ovarian and breast cancers, could help narrow the valuation gap, the people said.

Although Anavex Life Sciences» Alzheimer's disease program should offer up plenty of data to digest this year, its research program is very early stage, and the company's balance sheet is worrisome enough for me to avoid it until placebo - controlled trial results are available.

Most U.S. investors don't realize this, but the China Food and Drug Administration (CFDA) didn't start accepting clinical trial data generated outside the country until the second half of last year.

In its 35th year of existence, the Farming Systems Trial (FST) at Rodale Institute continues to demonstrate, through scientific research data, that organic farming is superior to conventional systems with regard to building, maintaining and replenishing the health of the... Continued

Despite vandalism in one of the five multilocation field trials in August this year, data are being readied for submission to government regulators who will review Golden Rice against international standards for biosafety, according to Antonio Alfonso, coordinator of the biotechnology program of the Philippine Department of Agriculture (DA) and leader of the Golden Rice project at the DA - Philippine Rice Research Institute (DA - PhilRice).

The data was obtained through a multi-center trial whereby over 1000 infants were fed, for their first year of life, either breast milk or infant formula containing high or low levels of protein.

Data derived from two randomized trials with primiparous women from Honduras, one based on low birth weight and the other on normal birth weight infants, show that infants who were exclusively breastfed for six months (vs. four months) began to crawl earlier.5 In addition, the normal birth weight trial showed that babies who were exclusively breastfed for six months were significantly more likely to be walking by one year compared with those who were exclusively breastfed for four months (60 % vs. 39 %).

Primary: number of babies receiving any breast milk at 6 - 8 weeks, as reported in routinely collected data for the 2 pretrial years and 2 trial years

In science news around the world, eastern Asia is experiencing an unprecedented urbanization boom, the European Commission announces a plan to create a unified energy market for the European Union, an external review of the University of Minnesota's clinical trials procedures says the university didn't adequately protect its most vulnerable subjects, a new data repository of the world's oldest fossils is launched, and the Argonne National Laboratory's 24 - year - old Ask A Scientist service closes its virtual doors.

Previous results from the trial have already changed clinical practice — data released last year has led to docetaxel chemotherapy now being part of the standard of care for many men with prostate cancer.

Also published today in Gynecologic Oncology is the end - of - trial data of the Roche Diagnostics ATHENA HPV trial that enrolled more than 47,000 women in a longitudinal, three - year study of Roche's HPV test.

Her team reviewed data from 20 clinical trials in Europe, Australia, New Zealand and Taiwan that involved more than 4,800 children whose mothers either took probiotics during pregnancy or gave probiotics to their babies in the first year.

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 fallout continues from a decision to halt controversial cancer trials at Duke University last year: In an article today, The Cancer Letter is reporting that the U.S. Food and Drug Administration (FDA) is auditing data related to the trials.

Several years ago, for example, poor chemical probe data led researchers to pursue a final stage clinical trial on a cancer drug candidate called iniparib.

The documents represented five years of data from some 1,400 drug trials.

A new letter, published yesterday in The New England Journal of Medicine, brings together data from the five - year Conflict of Interest Notification Study backed by the National Heart, Lung and Blood Institute, along with broader reports on conflict of interest in medicine released by the Institute of Medicine (IOM) and the Association of American Medical Colleges (AAMC) to examine the practical goals and challenges of presenting this information to possible trial participants.

Once the investigators reported their landmark data in 2011, all infected study participants were offered the opportunity to begin antiretroviral therapy right away, and the trial continued for another four years, concluding this spring.

He analyzed the data of the randomized trial (Alpha - Tocopherol Beta - Carotene Cancer Prevention [ATBC] Study) which was conducted in Finland between 1985 - 1993 and included male smokers aged from 50 to 69 years.

«Initial data from TAILORx breast cancer trial published: TAILORx trial finds 99 percent of women with low Oncotype DX ® Recurrence Score ® are free of breast cancer recurrence after 5 years of hormone therapy alone.»

Analysis of data from nine randomised trials involving 6756 patients (1729 older than 80 years of age) showed that alteplase treatment significantly increased the odds of a good stroke outcome (no significant disability 3 - 6 months after stroke), with faster treatment offering the best chance of recovery.

«With data from the trial reported in JAMA, evidence now supports a 2 - dose schedule in adolescents (aged 9 to 14 years) for all 3 licensed HPV vaccines.»

RIAT invites researchers with unpublished trials to either commit to publish within a year or provide public access to their data, allowing independent investigators to become «restorative authors.»

It took several years of trial and error at shows before he was confident enough of his methods to begin collecting data.

They reviewed data from 80 trials involving 205,401 children aged six months to twelve years, mostly in low and middle income countries.

Last year, the European Medicines Agency (EMA) in London changed its rules to make public the massive amounts of clinical trial data that it receives as part of marketing applications.

But the Anglo - French trial, known as Concorde, has lasted for three years and has more data than all the previous trials put together.

Moreover, clinical trial data suggest that a considerable proportion of patients receiving anti-TNF-alpha therapy may become resistant to treatment in the first few years.

Cholera expert David Sack of Johns Hopkins University in Baltimore, Maryland, doubts that immunity wanes as quickly as the data suggest — vaccine trials indicate it may last several years.

Fried and Koch's data could, in principle, help Berger make the leap to clinical trials in humans in years to come.

«Five - year survival data: Brentuximab vedotin may be curative in some with Hodgkin lymphoma: Phase II trial suggests therapy should be standard of care for patients facing relapsed or treatment - resistant Hodgkin lymphoma.»

The ICMJE, whose membership includes the editors of The Journal of the American Medical Association (JAMA), The Lancet and the New England Medical Journal, announced the proposal one year after a report by the Institute of Medicine called on stakeholders to address the key challenges associated with sharing clinical trial data so as to «foster a culture in which data sharing is the expected norm» [2].

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.

Data from the trial on 29 patients presented in June of this year showed that 24 % of the patients achieved a partial response, 14 % a minimal response, and another 24 % had stable disease.

The expansion of the network allows for more than 50,000 new patients each year to have the opportunity to donate their tissue and clinical data to the network, and potentially help them be matched with ongoing clinical trials with the best chance to help them.

Dear readers, as you know I have been collecting cell therapy clinical trials data for several years now.

It derived from careful evaluation of nearly 40 years of published data on stroke - related care, clinical trial results, scientific guidelines and input from professional organizations.

STAMPEDE is also the only randomized trial with 5 - year data that included patients with only mild obesity or merely overweight.

Terry: Because I'm also a researcher and I write grants, get funding, do clinical trials, and every year, we have 2 research days, one for the Department of Medicine and one for the College of Medicine, where my lab presents our data, and so my colleagues have seen the progress with other progressive MS folks and the remarkable results that we are showing.

In this 8 - year trial, involving 41,186 particpants of the Black Women's Health Study, research data confirmed inverse associations between magnesium, calcium and major food sources in relation to type 2 diabetes that had already been reported in predominantly white populations.

Irate that columnist George Will had questioned the benefits of early childhood education in a throwaway line in paragraph 15 of an op - ed, Heckman wrote, «Those benefits, quoted by President Obama this year, come from my evidence - based analysis of more than 30 years of data from the Perry Preschool program... It is as good a trial for effectiveness as those we currently rely on to evaluate prescription and over-the-counter drugs.»

That year, Congress authorized trial assessments at the state level in order to provide data allowing states to compare themselves with one another and with other nations in international comparisons.