Sentences with phrase «completed than trials»

Not exact matches

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.

Intarcia has completed several late - stage clinical trials in which it uses the pump to deliver a glucose - controlling drug continuously for months — an idea, that if successful (and approved by the FDA) could significantly help patients with type 2 diabetes, fewer than half of whom maintain the recommended glycemic levels.

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).

Dr. Newman added that rival CAR T cell therapy developer Kite Pharma was still likelier to generate more revenue than Juno with KTE - C19, which last week completed patient enrollment in the Phase II portion of the ZUMA - 1 trial in patients with diffuse large B - cell lymphoma.

Such trials should be conducted in varied populations and settings and include longer periods of restricted exposure to pacifiers than have been examined thus far.13 Until such studies can be completed, it is important that breastfeeding support and education be incorporated into prenatal obstetric and early pediatric patient encounters.

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.

Rather than beginning his pivotal trial by the end of last year, he now predicts it won't start until spring 2017 and won't be completed until that year's end.

Amit Patel, a cardiac surgeon and researcher at the University of Pittsburgh, has completed three clinical trials in Asia and South America that included more than 100 heart - failure patients.

Harvard University researchers reviewed the more than 550 pediatric clinical trials that were registered with the U.S. federal government over a three - year period between 2008 and 2011 and found that more than 40 percent were never finished or that they were completed but never published even five years later.

However, completed trials sponsored by industry were less likely to be published than trials sponsored by academia.

If you're a medic who has completed junior training and a career in clinical research appeals to you more than general medicine, a useful first step would be to apply for clinical research jobs in a phase 1 trial at a research hospital.

Now scientists in Nigeria and Britain have completed a placebo - controlled trial in more than 3500 people which shows that ivermectin reduces the incidence of optic nerve disease caused by the worm Onchocerca volvulus (The Lancet, vol 341, 16 January 1993, p 130).

If it cranks up production to full capacity before the those trials are complete, the company could have 230,000 doses available in April, and then could steadily increase capacity to produce more than 1 million doses a month by December 2015.

Final results of a cohort from a phase II monotherapy trial of quizartinib in acute myeloid leukemia patients showed that more than half of patients 60 years of age and older who harbored an internal tandem duplication in the FMS - like tyrosine kinase 3 had a composite complete remission.

Once those trials are complete, that's what helps to decide if a drug is going to be approved, if a new combination is better than the existing drug, whether perhaps an existing drug could be used for a new indication.

Four participants more than 3 months post right - sided stroke completed 10 walking trials (5 with and 5 without stimulator) at baseline and after 4 weeks of using a commercial device (WalkAide, Innovative Neurotronics, Austin TX).

In addition, patients who received Rydapt in combination with chemotherapy in the trial went longer (median 8.2 months) without certain complications (failure to achieve complete remission within 60 days of starting treatment, progression of leukemia or death) than patients who received chemotherapy alone (median three months).

I actually don't know what that is, but it's clearly significantly harder than 55 % of VO2max, because two thirds of the subjects (who were trained, recreationally competitive cyclists) were unable to complete the trial at that level and had to lower the power to 50 % Wmax during the later stages of the trial.

More than 2500 students in Years 3 and 5 and 1500 students in Years 7 and 9 took part in the research trials, completing numeracy or reading online tests.

VOICE - ACTIVATED TOUCH - SCREEN NAVIGATION SYSTEM - inc: pinch - to - zoom capability, SiriusXM Traffic and Travel Link w / a 5 - year prepaid subscription, SiriusXM audio and data services each require a subscription sold separately, or as a package, by SiriusXM Radio Inc, If you decide to continue service after your trial, the subscription plan you choose will automatically renew thereafter and you will be charged according to your chosen payment method at then - current rates, Fees and taxes apply, To cancel you must call SiriusXM at 1-866-635-2349, See SiriusXM Customer Agreement for complete terms at www.siriusxm.com, All fees and programming subject to change, Sirius, XM and all related marks and logos are trademarks of Sirius XM Radio Inc, SAFE & SMART PACKAGE - inc: Adaptive Cruise Control, Blind Spot Info System w / Cross-Traffic Alert, Pre-Collision Assist w / Pedestrian Detection, automatic emergency braking and forward collision warning w / brake support, Memory Driver Seat, Mirrors & Ambient Lighting, 3 settings, Lane Keeping Alert, Automatic High Beam, Rain - Sensing Windshield Wipers, RADIO: SHAKER PRO AUDIO SYSTEM - inc: 12 - speakers and subwoofer in trunk, HD Radio, MAGNERIDE DAMPING SYSTEM, FRONT LICENSE PLATE BRACKET - inc: Standard in states where required by law, EQUIPMENT GROUP 200A, ENHANCED SECURITY PACKAGE - inc: electronic - locking center console and electronic steering column lock, Active Anti-Theft System, Wheel Locking Kit, ECOBOOST PERFORMANCE PACKAGE - inc: black painted strut tower brace, performance rear wing, unique chassis tuning, unique electronic power assisted steering, unique anti-lock brakes, stability control tuning and upsized rear sway bar, Larger Brake Rotors, 4 - piston fixed calipers, Engine Spun Aluminum Instrument Panel, Gauge Pack (Oil Pressure and Boost), Wheels: 19» x 9» Ebony Black - Painted Aluminum Low gloss, 3.55 TORSEN Limited Slip Rear Axle, HD Front Springs, Larger Radiator, Tires: P255 / 40R19 Summer - Only Designed to optimize driving dynamics and provide superior performance on wet and dry roads, High performance summer tires wear faster than non-performance tires, Ford does not recommend using summer tires when temperatures drop to approximately 45 deg F (7 deg C) or below or in snow / ice conditions, CARBON SPORT INTERIOR PACKAGE - inc: Alcantara door inserts, Alcantara seat inserts, carbon fiber instrument panel and carbon fiber shift knob, Wireless Streaming.

Unfortunately, the company seems more interested in making money than in completing the necessary clinical trials.

Renovo's chief executive, Mark Ferguson, said the company has completed trials on more than 1,500 people.

There are harder trophies including the Scaring on Schedule silver trophy for completing the time trial mode in less than 90 minutes and the A Glitchy World gold trophy for activating all of the secret glitched objects which consist of tapping on a particular object in order for it to grow and spin as it is continually tapped to intentionally make the entire screen glitch.

Other standouts of this ilk include Kirby Air Ride, the one button racer whose City Trial mode is still a complete blast to play with friends; Pokémon Colosseum, a unique take on the world with its themes of corruption and the ability to technically «steal» Pokémon; and Super Mario Sunshine which saw Mario utilizing a water pack more than his trademark jumping to explore one of the finest examples of a 3D platforming world in modern memory.

The downloadable game offers more than 100 pre-built levels, over 300 medals, a Randomizer puzzle mode, a Time Trial mode, an auto - complete feature for skipping up to three difficult levels a day, multiplayer modes using either multiple DSi systems or a single DSi, and even a Colorblind Mode that differentiates the blocks with symbols for players who difficulty telling certain colors apart.

Where a trial in court might take 4 to 6 years from start to finish, securities arbitrations can be completed in less than a year, at less than 1/2 the cost.

Put simply, these trial courts are faced with lengthy dockets with the pressure of trying to complete them in a sitting, often litigated by unrepresented defendants with little experience or knowledge of the substantive and procedural law, some quite upset about the perceived injustice in their case, in a crowded courtroom with perhaps less than ideal staffing or facilities.

Adding insult to injury, when their trials do complete, self - represented parties usually achieve worse results than they would have had with counsel.

After a two - week trial and less than an hour of deliberations, the jury returned a complete defense verdict for our client, finding no conspiracy.

- Lead trial and appellate counsel in obtaining and upholding complete defense jury verdict against claim for more than $ 90 million in oil and gas farmout contract damages.

The trial comes more than seven years after U.S. regulators first examined how LIBOR rates were set, and a global investigation which led to 21 individuals charged, some of the world's leading banks being fined around $ 9 billion and a «complete overhaul» of the regulatory regime.

I recently completed a divorce case in which all issues other than child custody settled in the middle of trial.

That means police and prosecutors must ensure it takes no more than 18 months from the laying of a charge to complete a trial in provincial court, and 30 months for serious, often more complex cases in superior trial courts.

Now, if you aren't a complete idiot, you are well aware that Miller knows more about federal civil trial practice than any other living human.

The fundamental basis of the right guaranteed by art 6.3 (c) is that the legal representation should be conducive to a fair trial, rather than conferring complete freedom to an individual defendant to choose the lawyer by whom to be represented.

In clinical trials, for example, teens who complete Liberty's online teenSMART course have up to 30 percent fewer collisions one year afterwards than teens who didn't take the training.

«This trial took more than 15 years to complete, because we wanted to know about the long - term effects of surgery,» Halliday said in a statement.