Sentences with phrase «larger trials involving»

Larger trials involving aducanumab will be carried out and will run until 2022.

Not exact matches

The program will involve clinical trials testing for safety in humans, followed by a larger trial using non-human primates exposed to Ebola.

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).

Another perennial top - finisher, the state's largest trial lawyers» group was involved in issues in 2016 ranging from the Scaffold Law to the expansion of ride - hailing.

Stanford researchers are in the middle of a larger trial (which will involve up to 156 patients) that might provide more definitive answers.

«If we find that lymphoscintigrams using tilmanocept are at least as good as the conventional radiocolloid tracer in identification and visualization of sentinel nodes, we would like to see a randomised clinical trial involving large numbers of patients,» says Prof de Bree.

Together, the trials are part of the largest phase III program in moderate to severe plaque psoriasis completed to date, which involved more than 3,300 patients in more than 35 countries.

That's because a trial like this one is almost without precedent in modern medical research: It involves giving children a vaccine that is almost certain not to benefit them, and that might harm them, all to protect other children from an unlikely scenario — a large - scale anthrax attack.

The team is now calling for a much larger clinical trial, involving one quarter of a million women, to investigate the effect of the screening using HPV testing on cancer rates.

The first reviewed three large trials of multivitamins and 24 trials of single or combined vitamins involving over 400,000 people.

And scientists who conduct human challenge studies, which typically involve a few dozen participants, say they have critical benefits: In addition to saving time and money, they can reveal harm caused by a potential drug or vaccine before it enters large - scale human efficacy trials.

In 2001 the trend reversed: Breast cancer rates initially dipped gradually, but dropped sharply in mid-2002, when many women in the U.S. stopped hormone replacement therapy after the Women's Health Initiative, a large clinical trial involving estrogen - progestin therapy, was stopped after it was determined that the risks — most notably the increased likelihood of developing breast cancer — outweighed the benefits.

If animal tests go well, the next trials will be with humans, a process that involves three stages — one for safety, the next to see if the protein kills cancer in a limited number of people, and the last to turn it loose in a large group.

Becoming compliant with the proposed ruling could, according to one HHS official, drive up the cost of doing large - scale trials or surveys because of the extra work involved in ensuring that projects meet the standards required.

* GRAIL plans to use the money to further develop the technology and to run the large clinical trials (involving hundreds of thousands of subjects) needed to see if screening will be feasible.

Strollo led a large study of the new treatment, a yearlong safety and efficacy trial involving 126 people with moderate to severe obstructive apnea.

Trial studies suggested that fish oil could help, but larger clinical trials proved inconclusive — possibly because the trials involved people with advanced cancers that were difficult to treat.

The current study combines data from five clinical trials involving a total of 1,287 people, including the SWIFT PRIME trial led by Saver, that show these devices improved outcomes for people with acute ischemic strokes due to large vessel blockage.

St. Michael's was the only site outside of the United States involved in the Phase 2 clinical trial for the drug and had the largest number of patients enrolled in the Phase 3 trial.

It is the largest randomized clinical trial of ICD recipients to date, involving a cohort of 2,500 patients worldwide.

Conduct large - scale clinical trials involving high - risk populations to determine the full effectiveness of the vaccine.

Krebs will work on a similar, larger trial later this year involving patients who take high - dose opioids.

Applications involving contracts (such as used for large, multicenter clinical trials) were not included in these analyses.

In a substudy, review outcomes were also compared across different types of clinical research, based in large part on the designations and definitions derived from a number of sources, including a report by Nathan, 14 the Institute of Medicine, 20 the NIH Director's Panel on Clinical Research, 9 the Association of American Medical Colleges and American Medical Association, 21 and the Agency for Healthcare Research and Quality.22 All 3599 R01 applications involving human subjects that were submitted to NIH for the October 2002 council were categorized into 1 of the following: (1) patient - oriented studies of mechanisms of human disease (bench to bedside); (2) clinical trials and other clinical interventions; (3) patient - oriented research focusing on development of new technologies; (4) epidemiological studies; (5) behavioral studies (including studies of normal human behavior); (6) health services research; and (7) use of deidentified human tissue.

Phase 2b trials are larger than phase 2 (sometimes involving thousands of participants), but smaller than a phase 3 study.

Two large - scale trials, each involving upwards of 20,000 people, are still ongoing, said Manson, who is leading one of the studies.

The largest clinical trials, involving thousands of volunteers, were directed by Dr. Terence Anderson, professor of epidemiology at the University of Toronto [6 - 9].

In evaluating the adaptogenic properties of Siberian ginseng, a large study reviewed the results of a number of clinical trials involving 2,100 healthy men and women ages 19 to 72.

However, no large controlled trials involving yogurt or other probiotics have been conducted.

One part of the study is to include the first large randomised control trial of mindfulness training involving nearly 6,000 students and running for five years.

The Clinical Trials Office (CTO) at The Ohio State University College of Veterinary Medicine continues to be the largest and most comprehensive center for clinical trials involving client owned animals in the United STrials Office (CTO) at The Ohio State University College of Veterinary Medicine continues to be the largest and most comprehensive center for clinical trials involving client owned animals in the United Strials involving client owned animals in the United States.

Like many large trials, the case often involved a lot of work done after court hours.

With nearly 20 years» experience as a trial lawyer and respected prosecutor, as well as more than a decade heading large government agencies, Stu offers enormous experience, judgment, and credibility to clients, particularly those with matters involving state and local government.

If you have been involved in an accident with a large truck or have lost a loved one in a collision with a semi, the San Diego truck accident lawyers at Gomez Trial Attorneys can help.

Lightfoot represented the defendants in a series of toxic tort cases involving PCB contamination in Anniston, Alabama, which spawned two different downstream lake class actions, numerous consolidated mass tort actions and resulted in the largest and longest - running trial in Alabama history.

Lightfoot attorneys represented the defendants in a toxic tort case involving PCB contamination, which resulted in the largest and longest - running trial in Alabama history.

When a case involving a large vehicle crash goes to trial, it is critical to present a strong accident re-enactment to the jury.

Notable mandates: Acting for the Government of Newfoundland and Labrador regarding the development and financing of the Muskrat Falls Hydroelectric Project, also known as the «Lower Churchill Project»; acting for the Government of Newfoundland and Labrador concerning the development and operation of the Hebron offshore oilfield project and the Hibernia South oilfield expansion project; acting for developers and placing financing on new hotel developments in downtown St. John's; defending class action claims involving product liability and taxation issues at a certification hearing and a common issues trial and appeal; acting for mining corporations involved in large - scale mine development projects in Labrador

Paul has been involved in some of the highest profile reported court cases and investigations over the last 25 years, including the Lockerbie trial, the largest class action in the UK in the pharmaceutical sector, the Shard of Glass litigation, the Oil for Food Programme investigation, the BTA Bank v Ablyazov case, the split capital trust investment litigation, the worldwide deep vein thrombosis litigation, and some of the leading cases in the field of aviation law.

As a full - time litigator, Scott has been involved in the trial of some of the largest cases taken to trial at Keesal, Young & Logan.

Orr & Brown LLP devotes a large part of its trial practice to cases involving car accidents, truck accidents, motorcycle accidents, and bicycle accidents.

Our experienced team of trial lawyers, paralegals, and nurses have worked together to handle these cases, which can involve some of the world's largest, high - profile companies.

After more than six years of litigation which involved two trials and multiple parties, including the country of Brazil, Browne Greene helped secure ownership of the world's largest emerald for his clients.

He successfully guides clients through tax issues in connection with taxable and tax - free acquisitions, dispositions, spin - offs and other restructurings involving domestic and foreign entities; negotiates large case settlements with IRS Appeals Offices throughout the country; and has litigated cases at the trial and appellate court levels.

Extensive bankruptcy trial successes involving private litigants and governmental and regulatory organizations; our bankruptcy litigators are particularly skilled at effective and efficient case development, trial preparation and trial, giving our clients a significant strategic advantage in fast - paced and evolving large restructurings

Highlights of his work with the dispute resolution team include acting for a company in a High Court trial involving a large pension fund and Heathrow Airport Ltd, and assisting on several litigation matters for a major high street bank.

Won the second largest damage verdict in California after an 11 - week jury trial involving breach of contract claims against a large shopping center redevelopment.

We have also represented some of the nation's largest law firms in complex, high - exposure cases involving claims arising from the conduct of trials, real estate transactions, private employment matters, fee disputes, commercial transactions and bank representations.

Connie, in conjunction with other lawyers in the firm, is frequently involved in defending larger personal injury cases transferred to Bernard LLP on a «short fuse» basis, i.e. in the last few months or even weeks before the scheduled trial, with very successful results.

Floyd's clients have included The McGraw - Hill Companies in a large number of litigations around the country involving claims against its subsidiary, Standard & Poor's Financial Services LLC, The New York Times in the Pentagon Papers case and others, ABC, NBC, CBS, CNN, Time Magazine, Business Week, The Nation, Reader's Digest, Hearst, AIG, and others in trials, appeals and investigations.