Sentences with phrase «efficacy of drugs in»

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.

Neurologist Malcolm MacLeod of the Centre for Clinical Brain Sciences at the University of Edinburgh and his colleagues combed through papers reporting the efficacy of drugs in eight animal disease models and checked whether the authors reported four measures that are widely acknowledged to reduce the risk of bias.

The only remaining need for the live virus was to test the efficacy of drugs in vitro, it said.

This group was to demonstrate the efficacy of this drug in preventing heartworm infections; its high efficacy was clearly demonstrated.

Not exact matches

In particular, the complaint alleges that throughout the Class Period, defendants made materially false and / or misleading statements and / or failed to disclose that (1) the trials for GED - 0301 suffered from fatal design defects, such that GED - 0301 had failed to demonstrate meaningful clinical efficacy; (2) the growth of Otezla sales had dramatically slowed during Celgene's third fiscal quarter of 2017; and (3) the clinical and nonclinical pharmacology data in Celgene's new drug application («NDA») for Ozanimod were insufficient to permit a complete review by the FDA, which resulted in the FDA issuing a refusal to file letter to Celgene regarding the NDIn particular, the complaint alleges that throughout the Class Period, defendants made materially false and / or misleading statements and / or failed to disclose that (1) the trials for GED - 0301 suffered from fatal design defects, such that GED - 0301 had failed to demonstrate meaningful clinical efficacy; (2) the growth of Otezla sales had dramatically slowed during Celgene's third fiscal quarter of 2017; and (3) the clinical and nonclinical pharmacology data in Celgene's new drug application («NDA») for Ozanimod were insufficient to permit a complete review by the FDA, which resulted in the FDA issuing a refusal to file letter to Celgene regarding the NDin Celgene's new drug application («NDA») for Ozanimod were insufficient to permit a complete review by the FDA, which resulted in the FDA issuing a refusal to file letter to Celgene regarding the NDin the FDA issuing a refusal to file letter to Celgene regarding the NDA.

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.

Rather, it's the no - holds - barred sales practices that Alexion allegedly engaged in — which, in some cases, reportedly led to salespeople bullying doctors into prescribing the drug for patients even when the efficacy of the treatment was unclear.

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.

The ongoing American Heart Association (AHA) meeting in New Orleans is producing a deluge of data — including some promising prospects for a class of next - generation cholesterol drugs that have been slow to take off so far in the U.S. So - called PCSK9 inhibitors have shown tremendous efficacy in lowering LDL - C, or «bad» cholesterol.

Immuno - oncology drugs have proven promising and effective for many patients; but they also don't produce a response in a sizable chunk of the patient pool and may eventually wane in efficacy.

Researchers at Israel's Technion Institute of Technology are experimenting with a nanoparticle «barcode» system in order to trace the efficacy of cancer drugs.

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).

We do this by conducting clinical trials in which we collect safety and efficacy data about our experimental drugs with the goal of submitting those data to regulatory authorities, like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), so that these experimental drugs can be approved for use by patients.

The technology measures the stage of disease, rate of progression of disease, drug efficacy, and drug toxicity in several cancers and Alzheimer's disease.

A stroke drug invented at The Scripps Research Institute has shown signs of safety and efficacy in a mid-stage clinical trial.

The agency ordered the commercial pulled after just a few days because it was «false and misleading,» «overstates the efficacy of the drug product» and «may result in serious consequences, including death.»

In the argument for the spiritual efficacy of drugs, much is made of feeling or failing to feel God's presence.

There are two things, safety and efficacy — you do not talk about safety and efficacy in food, you only talk about these in terms of drugs.

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.

«This phase III trial will be noteworthy for being the first prostate cancer trial to assess a biomarker, namely AR - V7 in circulating tumour cells, as a predictor of response at the same time as testing the efficacy of the drug,» Prof Taplin will conclude.

In addition, risks associated with the usability, therapeutic efficacy and market share of medicinal substances are usually realized only in the final stages of drug developmenIn addition, risks associated with the usability, therapeutic efficacy and market share of medicinal substances are usually realized only in the final stages of drug developmenin the final stages of drug development.

«I believe in the 21st century, the classic public health measures that are critical can be complemented by the addition of rapid diagnostics; by the development of vaccines, assessment of safety and efficacy and then deployment; and by the development of drugs.

The three - armed trial evaluated the efficacy of chiropractic spinal manipulative therapy (CSMT) in the treatment of migraine versus placebo (sham chiropractic) and control (usual drug treatment).

The researchers hope that ultimately human trials will prove the efficacy of the OH14 compound in sensitising tumour cells and cancer stem cells to existing drug - based therapies thus disabling tumours from seeding new growth after treatment.

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.

Schlom, of the National Cancer Institute, says the next challenge for researchers is to find ways to combine different immunotherapy drugs into single treatments and measure their efficacy in clinical trials.

The research team, Heller says, has already begun experiments to further explore the implications of these results, which include looking at differences in this pathway between cells taken from allergic and healthy individuals, and testing the efficacy of an inhalable drug that mimics the function of GRB1 and p70S6K to shut off the development of M2 macrophages in the lungs of mice.

Some geochemists even hope that, as techniques improve, there could be applications in diagnosing diseases and measuring the efficacy of drugs on individuals.

«So we bought the rights to the drug and started working with Professor Gabay to assess its safety and efficacy in a clinical trial,» explains Andrew Sleight, CEO of AB2 Bio Ltd., the Lake Geneva startup that has the World Wide license of the drug.

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.

To demonstrate the chip's efficacy in modeling disease, the team doped different regions of the brain with the drug Phencyclidine hydrochloride — commonly known as PCP — which simulates schizophrenia.

In broad terms, a regulatory writer assists in the production of the clinical documentation required by these national regulatory agencies when assessing the safety and efficacy of drugIn broad terms, a regulatory writer assists in the production of the clinical documentation required by these national regulatory agencies when assessing the safety and efficacy of drugin the production of the clinical documentation required by these national regulatory agencies when assessing the safety and efficacy of drugs.

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.

There is no evidence that patients have suffered harm from these drugs; the FDA says it has detected no increase in reports of side effects or lack of efficacy among Cetero - tested medications.

And if it somehow did, Africa is much better equipped to deal with than it was in the 1980s when chloroquine resistance hit, WHO experts say, with strong national malaria programs in place and increased monitoring of drug efficacy.

Theoretically, it may be possible to enhance the efficacy of these drugs based on our findings, but if so it's in the future.»

The drug as well as the physical contact of the microneedles with the scar tissue contributes to the efficacy of the device, leading to the cessation of scar tissue growth and a considerable reduction of keloids as demonstrated in laboratory cultures and experiments with animals.

In a phase 1b clinical trial with 21 patients, researchers tested the safety and efficacy of combining the immunotherapy drug pembrolizumab with an oncolytic virus called T - VEC.

This shortcoming makes it difficult to accurately monitor whether a patient is improving or declining and also confuses the approval of new antidepressant drugs, because the scale is a benchmark in judging their efficacy during clinical trials.

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 program works by connecting computer - generated drug profiles — including mechanisms of action, clinical efficacy, and side effects — with information about how a molecule may interact with human proteins in specific diseases, such as ovarian cancer.

The authors urge utmost caution in the dosage of drugs targeting BACE1 in order to achieve a therapeutic window that balances both safety and efficacy.

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.

Conventional drug discovery remains a hit - and - miss affair and Hunter believes the 50 percent failure rates seen for experimental compounds in mid - and late - stage clinical trials due to lack of efficacy is unsustainable, forcing a shift to AI.

After hearing about his work, several other companies, including Pfizer, Bayer, and Eli Lily, decided to examine the effects of different genetic variants on the efficacy and safety of drugs they had in development.

For instance, drug companies have manipulated research in ways that have led to questionable science supporting questionable claims of a drug's efficacy.

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.