Sentences with phrase «drug efficacy studies»

Not exact matches

Topics included: early reporting on inaccuracies in the articles of The New York Times's Judith Miller that built support for the invasion of Iraq; the media campaign to destroy UN chief Kofi Annan and undermine confidence in multilateral solutions; revelations by George Bush's biographer that as far back as 1999 then - presidential candidate Bush already spoke of wanting to invade Iraq; the real reason Bush was grounded during his National Guard days — as recounted by the widow of the pilot who replaced him; an article published throughout the world that highlighted the West's lack of resolve to seriously pursue the genocidal fugitive Bosnian Serb leader Radovan Karadzic, responsible for the largest number of European civilian deaths since World War II; several investigations of allegations by former members concerning the practices of Scientology; corruption in the leadership of the nation's largest police union; a well - connected humanitarian relief organization operating as a cover for unauthorized US covert intervention abroad; detailed evidence that a powerful congressional critic of Bill Clinton and Al Gore for financial irregularities and personal improprieties had his own track record of far more serious transgressions; a look at the practices and values of top Democratic operative and the clients they represent when out of power in Washington; the murky international interests that fueled both George W. Bush's and Hillary Clinton's presidential campaigns; the efficacy of various proposed solutions to the failed war on drugs; the poor - quality televised news program for teens (with lots of advertising) that has quietly seeped into many of America's public schools; an early exploration of deceptive practices by the credit card industry; a study of ecosystem destruction in Irian Jaya, one of the world's last substantial rain forests.

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 SDrug 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 Sdrug 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).

They have a vested interest in publishing studies that promote the use of their medications and failing to publish study results that call the efficacy or safety of their drugs into question.

BY NATHAN RILEY Outraged that Mayor Bill de Blasio continues to sit on a city health department study into the efficacy of establishing safe places for drug users to pursue their high — facilities that are in place all over Europe with proven track records of reducing fatal overdoses — protestors sat down in the middle of Broadway across from City Hall bringing downtown traffic to a halt.

The limited number of marijuana studies are inconclusive regarding the drug's safety and efficacy.

To find the answers, further study on this difference will be needed to gain a better understanding of susceptibility to disease, efficacy of drugs and even the course of normal development among all individuals, not just between men and women.

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.

The main objective of this study was to verify the safety of the drug and to confirm its efficacy on the clinical manifestations of the disease.

The determination of each efficacy level was also based on the rigor and quantity of published studies on the drug class: to be in Level A, for example, a class of drugs must have been supported by at least two «Class I» studies — well - designed, double - blind, randomized, placebo - controlled clinical trials.

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.

With the initial contract of $ 24.9 million over the next 18 months, Mapp Pharmaceutical will manufacture a small amount of the drug for early - stage clinical studies to demonstrate its safety and efficacy in people.

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.

Exploiting the same pre-clinical model used for their studies, the researchers are testing the efficacy of this kind of drug candidates against cancer stem cells, and the possibility of identifying combination regimens with standard chemotherapies with minimized toxic effects, with the perspective of their possible application for the treatment of human breast cancer.

During that time, the FDA granted 22 drugs Accelerated Approval and ordered 38 post-approval studies to confirm the safety and efficacy of these drugs.

«Further prospective studies are warranted for teens between 10 and 18 years of age to determine the most appropriate Vancomycin dosing to maximize drug efficacy and reduce the risk of Vancomycin induced renal toxicity.»

The study, «Anti-TNF drives regulatory T cell expansion by paradoxically promoting membrane TNF - TNF - RII binding in rheumatoid arthritis,» which will be published online June 6 in The Journal of Experimental Medicine, may help explain the divergent efficacies of different TNF - targeting drugs.

Although other drug developers, including Pfizer, had already dropped FAAH inhibitors because of disappointing efficacy studies, most of the molecules were shown to be safe, as the U.S. Food and Drug Administration confirmed in August 2drug developers, including Pfizer, had already dropped FAAH inhibitors because of disappointing efficacy studies, most of the molecules were shown to be safe, as the U.S. Food and Drug Administration confirmed in August 2Drug Administration confirmed in August 2016.

The analysis, which comprised a total of 3 344 patients, shows that the two studied drugs are clearly superior to placebo with respect to antidepressant efficacy also in patients who have not experienced any side effects.

A new study led by University of Kentucky researchers suggests a new approach to develop highly - potent drugs which could overcome current shortcomings of low drug efficacy and multi-drug resistance in the treatment of cancer as well as viral and bacterial infections.

The data obtained from this study provide a basis for more rapid, cost - effective clinical trials to evaluate new influenza drugs or to determine the efficacy of candidate vaccines for both seasonal and pandemic influenza.

Led by Bavari and Travis Warren, Ph.D., the USAMRIID team performed a series of studies involving a lethal challenge with Marburg virus in nonhuman primates to determine the efficacious dose and regimen of AVI - 7288, as well as to characterize the drug exposures in animals that produced efficacy.

Pharmacogenomics — the study of how genes affect responses to drugs — is becoming more important in drug - development research and clinical trials, with a view toward decreasing side effects and increasing the efficiency and efficacy of drugs in patients with the right genetic profiles.

In the first study of the drug lorcaserin in the human brain, the research revealed the mechanism underlying the drug's efficacy and provides insight into which individuals may benefit most from the medication.

Results from recent clinical trials and studies in animals suggest that a class of anti-cancer drugs called angiogenesis inhibitors may be able to temporarily reduce interstitial pressure and improve the efficacy of chemotherapy and radiation treatments.

Indeed, this study shows that the therapeutic efficacy of a new drug that is currently in clinical trial depends on Sestrin1.

The results of a study published in the New England Journal of Medicine, comparing the efficacy of various drugs in treating diabetic macular degeneration, are now being analyzed in more detail at the Vienna Reading Center of MedUni Vienna.

«Future research will focus on optimizing the candidate therapies discovered by our team in this study as well as developing biomarkers that can be used to test the efficacy of other potentially promising drugs,» says Dr. Rothstein

«We are exploring alternative directions for developing this compound, including potential use of the animal efficacy rule,» Cihlar said, referring to a regulatory mechanism under which the U.S. Food and Drug Administration may consider efficacy findings from adequate and well - controlled animal studies of a drug in cases where it is not feasible or ethical to conduct human triDrug Administration may consider efficacy findings from adequate and well - controlled animal studies of a drug in cases where it is not feasible or ethical to conduct human tridrug in cases where it is not feasible or ethical to conduct human trials.

A Houston Methodist team led by Mauro Ferrari, PhD and Jenny Chang, MD has received funding from the U.S. Department of Defense to complete preclinical efficacy studies and a future clinical trial testing a breast cancer precision drug.

Early results from a phase I, first in - human study indicate that a potential new class of drugs, RNA interference (RNAi) drugs, can be safely administered in humans, according to a researcher who presented data on the safety and preliminary efficacy of TKM - 080301 at the AACR Annual Meeting 2013, held in Washington, D.C., April 6 - 10.

«The circadian clock regulates certain signaling pathways that are key for minimizing drug toxicity in normal tissues and increasing anticancer therapeutic drug efficacy,» said Shobhan Gaddameedhi, PhD, College of Pharmacy, Washington State University, Pullman, Washington, and senior author of this study.

The purpose of this study is to examine the response to and clinical efficacy of a new drug, «BAN2401», in subjects with Early Alzheimer's Disease.

With the availability of this remarkable tool, it's hard to understand why so many researchers continue to use grain - based chow diets in nutrition studies and even, as we shall see, in studies that are not necessarily nutrition - oriented, such as drug and compound efficacy studies, or behavioral studies.

In addition, the knowledge must be imparted to scientists studying the efficacy of drugs on a variety of diseases that may be affected by compounds in soy.

Monies have gone to fund such projects as a postdoctoral fellow studying familial hypercholesterolemia, evaluating the efficacy and safety of a new drug for congenital hyperinsulinism, and identifying molecular targets for Pitt - Hopkins Syndrome treatments.

BOSTON, Mass. — Emulate, Inc. announced today that it has formed a strategic partnership with F Hoffman La - Roche AG (Roche) that will use Emulate's Human Emulation System across R&D programs to enable more human - relevant studies that will lead to earlier and better prediction of safety and efficacy of drug candidates.

In a normal efficacy study, the researchers start with the assumption that the drug doesn't work, and allow themselves to be «surprised» if the statistical analysis shows that the drug has worked much better than expected.

So, regulators and drug developers are looking at ways to import data collected in early studies — which are used to initially assess drug safety and efficacy — into the Phase 3 studies that the FDA uses to determine whether drugs should make it onto the market.

The approval process involves several steps including preclinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, and FDA review and approval of the applicatDrug Application by the manufacturer of the drug, and FDA review and approval of the applicatdrug, and FDA review and approval of the application.

Being able to measure the navigational impairment caused by Alzheimer's disease in both species gives us the potential to directly compare results across species, including studies of drug efficacy.

Most therapeutic research involving the testing of new drugs is conducted in highly regulated phases that study dosage, safety, efficacy and long - term side effects:

The efficacy of methods was not compared in the study, nor were the costs over time of individual drugs calculated, as dosages and prices vary widely.

In multiple studies, Turmeric's Curcumin's efficacy has even been compared to anti-inflammatory pharmaceutical drugs [3].

Two human studies showed no decreased efficacy of 2 chemo drugs.

A lot of this is somewhat like what goes on in the medical business: Small, poorly controlled studies are used to proclaim the efficacy of some new drug or treatment.

It is important that additional efficacy studies such as this one are undertaken with multitraumatised families (for example, domestic violence, drug abuse, economic hardship, community violence, etc).

The main purpose of this study was to improve mood and behavior disorders in RTT patients with venlafaxine (SNRI), and compare the results with citalopram (SSRIs) during 6 - 8 weeks, to determine which drug offered greater efficacy and fewer side effects, as well as to compare them to risperidone, and to correlate cortisol levels in saliva with stress and drug response.

This study (NIDA #R01DA025616) is a randomized clinical trial (RCT) that will compare an experimental treatment (OutPatient Treatment for Adolescents) to an «active placebo» on key indices (drug use; mental health; behavioral, school, peer, and family functioning; and consumer satisfaction) from pre-treatment through 18 months in order to evaluate its efficacy for youth referred to outpatient treatment of co-occurring substance use and internalizing problems.

Abstract: This study examined relationships among language use, mindfulness, and substance - use treatment outcomes in the context of an efficacy trial of mindfulness - based relapse prevention (MBRP) for adults with alcohol and other drug use (AOD) disorders.