Sentences with phrase «efficacy of the drug for»

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 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.

Insurers like Anthem have refused to cover the exorbitantly pricey treatment (around $ 300,000) since the drug's label admits that Exondys hasn't proved its efficacy, making the therapy a roll of the dice for payers and patients alike.

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.

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.

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

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.

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

The time it takes for a new drug to go from bench to prescription pad can be staggering — typically three to six years are needed for development before it's even ready for safety and efficacy testing, according to the Pharmaceutical Research and Manufacturers of America.

The CO-STAR (Hepatitis C Patients on Opioid Substitution Therapy Antiviral Response) trial sought to evaluate the efficacy and safety of elbasvir - grazoprevir for injection drug users.

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.

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.

Andrew Murkin of the University at Buffalo, New York, says Schramm's drugs are so well tailored to block a specific enzyme that there is the potential to lower the dosage needed for efficacy.

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.

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.

Downing and the team evaluated the strength of clinical trial evidence supporting FDA approval decisions for new drugs by characterizing key features of efficacy trials, such as trial size, design duration, and end points.

«These findings do not only contribute to new insights on the effects of anti-estrogen but also the potential of using miRNA for monitoring drug efficacy and for future RNA - based therapy developments.

«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.»

Those traditional statistics jobs aren't going away anytime soon, as long as society continues to need workers who can advance statistics theory, assess drugs» risks and efficacy, or do any of the other things statisticians have done for years.

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.

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

But the three - drug approach has since been fast - tracked for approval, assuming a large - scale efficacy test of 10,000 people confirms positive results at the end of May.

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.

The Phase 2/3 trials will be sponsored by Vtesse, a new biotech company that was formed specifically to evaluate the safety and efficacy of cyclodextrin for the treatment of NPC and ultimately obtain FDA labeling if the drug is effective.

Two new phase III clinical trials investigating the efficacy and safety of bitopertin, a glycine uptake inhibitor considered to be a promising new add - on therapy for treating negative symptoms in schizophrenia, failed to show a benefit of the drug over placebo.

This knowledge may be used to develop new ways for opening the blood - brain - barrier to increase the efficacy of the brain cancer drugs and for the design of treatment regimes that strengthens the integrity of the blood - brain barrier.»

These results provide evidence for the clinical efficacy of more subtype - selective α2AR drugs.

A team at the Wyss Institute for Biologically Inspired Engineering designed a better variant of the widely - used drug erythropoietin (EPO), showing how rational design can improve in vivo efficacy and safety of protein therapeutics, reduce potential side effects, and also accelerate new drug development.

Drugs that target KORs have shown promise as therapeutic candidates because of their efficacy for treating chronic itch and relieving pain.

Improved diagnostic tests are on the horizon, but we need huge efforts to increase their accuracy, use them for active case finding in the community, and eventually make them available in low income countries so as to inform treatment decisions and preserve the efficacy of any new antibiotic drugs for TB,» says lead author of the Commission Professor Keertan Dheda, University of Cape Town.

«It's not feminist to accept a lower standard of drug efficacy and safety for women than for men,» she says.

It costs millions of dollars to develop drugs and get them tested in animals before they can ever be used in clinical trials for safety and efficacy in humans.

After participating in an 8 - week baseline period followed by 12 weeks of brivaracetam treatment, patients became eligible for long - term follow - up to monitor the drug's efficacy and safety.

Changes in these proteins have a great influence on drug efficacy and side effects since they are responsible for the metabolism and transport of many drugs, and are also affected by changes in the intestinal flora.

The group of researchers at the University of Helsinki and Aalto University, Finland, has applied privacy - aware methods for example to predicting cancer drug efficacy using gene expression.

Nor did the article give a hint of the ferocious battle among doctors about the safety and efficacy of tPA: While a number of professional associations endorsed the drug, many others, such as the American Academy of Emergency Medicine, said it should not be considered the standard of care for acute stroke.

«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.

For eventual human application, lowest doses of a drug are always desirable but this must be balanced with efficacy of the compound.

New York, NY and Waltham, MA — September 18, 2007 — The Spinal Muscular Atrophy Foundation and BG Medicine today announced a collaboration to discover plasma biomarkers of drug efficacy for spinal muscular atrophy (SMA), the leading genetic cause of mortality in infants and toddlers.

«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.

He has co-authored more than 100 scientific papers, abstracts, and letters examining the efficacy, safety and effects of drug therapies for cancer.

Preclinical drug efficacy can be evaluated either in a: > prophylactic regimen starting at 3 weeks of age upon disease initiation and lasting for 7 weeks up to the 10th week of age of the animals.