Sentences with phrase «larger safety study»
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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).
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In addition, the LEAP study design excluded 9.1 % of the infants who were screened (76 of 834) because large wheals (greater than 4 mm in diameter) developed after the skin - prick test21 that were probably associated with peanut allergy; the safety and effectiveness of early peanut consumption in that population remain unknown.
If sugar substitutes are used, such as aspartame or saccharin, consumers can be assured they have gone though large scale studies to validate safety, and have gained approval from regulatory industries worldwide, including the Australian food regulator FSANZ.
The study adds to the body of large cohort studies of planned home births that have reported on the relative safety of home versus hospital births.
As far as we know, this is the largest study into the safety of home birth.
The most amazing epidemiological study on the safety of formula has been going on for decades, it's called «a large proportion of full term humans in the developed world», and there is currently no hard data that there are dangers, or even visible trends associated with formula.
A new study from the Family Online Safety Institute (FOSI) reveals that the large majority of parents believe technology has a positive effect on their child's future, career and life skills (78 %) and creativity (64 %).
In order to assess the efficiency and safety of domperidone, researchers Catherine Paul et al. analyzed both the limited studies available on maternal and infant exposure to the stimulant as well as larger studies focused on its use in gastrointestinal disorder treatment.
Before trying this remedy for your baby's thrush, you should be aware of a recent study raising concerns about the safety of using gentian violet for treating thrush as it may cause cancer in animals if used in large amounts.
Our study adds to the body of large cohort studies of planned home births that have reported on the relative safety of home versus hospital birth.
Washington, D.C. — A new study from the Family Online Safety Institute (FOSI) reveals that the large majority of parents believe technology has a positive effect on their child's future, career and life skills (78 %) and creativity (64 %).
On the same day that Carmen Fariña was named the new schools chancellor — and said that school safety had «improved by and large» — the departing Bloomberg administration quietly released a two - year - old study showing that nearly a third of LGBT students in city schools reported having been bullied.
«American effort reduced risky opioid prescriptions for veterans, study finds: Reductions in highest doses through computer «dashboard» and prioritizing painkiller safety suggests other large health systems could do the same.»
Nonetheless, this July, the FDA suspended enrollment in Glaxo's large clinical trial comparing the safety of Avandia with that of a competing diabetes drug and may halt the study altogether.
However, safety concerns remain because large scale effectiveness studies are lacking.
The largest urban health systems, which serve as safety nets for large patient populations with lower socioeconomic status and greater likelihood to speak English as a second language, do worse on government patient satisfaction scores than smaller, non-urban hospitals likely to serve white customers with higher education levels, according to a new study by Mount Sinai researchers published this month in the Journal of Hospital Medicine.
According to Dunbar, the next logical step would be to take evinacumab into larger clinical trials to study its safety, effectiveness, and optimal dosing.
Whereas the reasons for the effect remain unclear, a large study led by Devanand suggests «safety and nutritional issues associated with the loss of smell» — the inability to smell smoke, for example, and lack of interest in food from loss of taste — could be contributors.
For example, the results of one study, known as UPLIFT, one of four large - scale studies conducted in 2008, demonstrated the effectiveness and safety of a drug called Spirivain about 6,000 patients with respiratory disease.
Following the success of this preliminary safety and feasibility study, more patients are being recruited for a larger clinical trial of the procedure to test the efficacy and durability of the procedure.
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.
Future pre-clinical work will require additional optimization, large - scale mouse studies and rigorous safety analysis, the researchers emphasize.
«While Massachusetts safety - net hospitals (many of which are minority - serving) received large cuts in payments with the idea that other hospitals would assume the care of previously uninsured patients, this study demonstrates the importance of securing the future of safety - net and minority - serving hospitals through policy - based interventions to assure the continued care of vulnerable and underserved patient populations.»
Using data and follow - up from the first and largest studies of TAVR safety, the research team found that the biologic valves used in a TAVR procedure, as well as those used in open heart surgery, continue to perform well up to five years after implantation.
The team's next step will be to complete studies showing safety of SW033291 - related compounds in larger animals, a required part of the pathway to secure approval from the U.S. Food and Drug Administration for trials in humans.
«Two years after the tragedy in Newtown, our study of public support for two dozen specific gun policies found a large majority of Americans continue to favor a range of gun - safety policies,» says lead study author Colleen Barry, PhD, MPP, an associate professor at the Johns Hopkins Bloomberg School of Public Health.
The drug has already demonstrated safety in nonhuman primate trials, and the cardiovascular research might even be able to skip ahead to a larger phase II trial based on safety data from the ongoing phase I studies, Leeper suggests.
It is one of the largest studies to date to look at the safety of ARV use during pregnancy.
Promising outcomes of preliminary studies in patients in Southeast Asia and parts of Western and Central Africa led the World Health Organization to make the recommendation, but safety and efficacy have not yet been proven in large - scale clinical trials.
No large - scale, long - term studies have been conducted to examine the effectiveness and safety of custom - compounded MHT.
Our study is one of the largest to explore the efficacy and safety of anti-TNF therapy in a large independent cohort of JDM patients.»
Strollo led a large study of the new treatment, a yearlong safety and efficacy trial involving 126 people with moderate to severe obstructive apnea.
«We're looking forward to longer - term results to come in the next five years from various ongoing observational studies,» Dr. Arterburn said: The Utah Obesity Study, the Michigan Bariatric Surgery Collaborative, and large cohorts from Veterans Affairs health system and the HMO Research Network (including Group Health) and should yield important long - term information comparing the efficacy, safety, and costs of surgical and non-surgical care for severe obesity.
The development track will begin with a Phase I trial to test the vaccine regimen's safety and immunogenicity and depending on those study results, a larger efficacy study will follow.
In a pilot study, these investigators examined the safety and feasibility of the protocol in a large number of patients from different institutions, and identified predictors of the clinical response to the treatment.
There is a shortage of high - quality evidence demonstrating the safety and effectiveness of long - term opioid therapy for the management of chronic pain, and to date, no large - scale studies have assessed strategies for managing and reducing chronic opioid use in real - world clinical settings.
As partner of TRANSVAC, IRTA will provide access to their animal facilities (CReSA) to carry out safety and immunogenicity studies of new candidate vaccines and / or of novel vaccination (administration) strategies in pigs, ferrets and other large animal species.
The study was the largest yet focused on the safety and efficacy of proactive antibiotic therapy to prevent infections in pediatric ALL patients during induction therapy.
In the meantime, some patients will continue to use marijuana even though large studies havent tested its safety and efficacy.
Researchers hope that if the ongoing preliminary studies prove the safety and effectiveness of these drugs for certain treatments, the government will step in to fund larger trials.
The researchers added that larger studies are also needed to evaluate the long - term safety and effectiveness of the medication.
But according to the American Congress of Obstetricians and Gynecologists (ACOG), there have been no large long - term clinical trials that have studied the safety and effectiveness of Bioidentical hormones.
«CHAMPAIGN, Ill. — Yerba maté tea - based beverages contained the largest antioxidant and polyphenol content among tea - based and non-tea-based drink in a recent study published in the Comprehensive Reviews in Food Science and Food Safety (doi 10.1111/j.1541-4337.2010.00111.x).
The large, ongoing French E3N study is providing valuable safety data for users of bioidentical hormones, most recently on estrogen, progesterone and the risk of stroke.
, «Yerba maté tea - based beverages contained the largest antioxidant and poly - phenol content among tea - based and non-tea-based drink in a recent study published in the Comprehensive Reviews in Food Science and Food Safety.
There were also significant concerns about data tampering in the RECORD study, one of the largest trials that had «proved» its safety.
A large scale study of the assessment of the social environment of middle and secondary schools: the validity and utility of teachers» ratings of school climate, cultural pluralism, and safety problems for understanding school effects and school improvement.
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