Sentences with phrase «drug safety and efficacy»

However, drug safety and efficacy beyond 1 year of total treatment have not been established.

In the future, such reprogrammed skin cells could be used to test both drug safety and efficacy for an individual patient with, for example, Alzheimer's disease.

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.

Not exact matches

Although the FDA can't dictate prices or reject therapies over pricing concerns (they can only focus on safety and efficacy), the agency can encourage more competition through moves like this (as well as speedier approval pathways) which could spur drug makers to produce products that ultimately lower costs for patients — a goal cited by FDA Commissioner Scott Gottlieb in announcing the list.

Boehringer Ingelheim stepped away from flibanserin after the FDA rejected the drug due to concerns about its efficacy and safety; Goldstein persuaded the Whiteheads to step in.

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).

If large - scale trials can replicate safety and efficacy results, the drug could be approved for legal use by 2021.

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.

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

The new administration is taking shape and may potentially include an FDA commissioner who has argued the agency should consider safety when evaluating new drugs and devices and efficacy only after the drug has been legalized.

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.

If a food was being marketed as a drug, it needed to prove safety and efficacy, something no food maker wanted to do.

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

The U.S. Food and Drug Administration prepares to weigh the safety and efficacy of new flab fighters

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.

«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 U.S. Food and Drug Administration recently banned TCC from soaps because of questions about its safety and efficacy.

«If nanoparticles are carrying a drug to deliver, different uptake could mean different therapeutic efficacy and other important differences, such as safety, in clinical data.»

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.

To address this challenge, our research group is using nanoparticles not only to deliver more chemotherapy drugs to the target site within cancer cells, but also to compromise the function of the efflux pumps and thereby significantly improve safety and efficacy of cancer therapy.»

The drug was voluntarily withdrawn in 2010 following questions about its safety and efficacy.

Continuous data collection off of organ mimics is what we need to measure efficacy and safety of drugs during long - duration experiments.

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.

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.

«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.

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.

Animal scientist Matt Wheeler at the University of Illinois, Urbana / Champaign, says this demonstration of safety and efficacy is the first step before any scientific review boards or the U.S. Food and Drug Administration will allow human consumption of the milk.

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 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.

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.

The technology has led to few approved drugs owing to safety problems and a lack of efficacy.

Goldman says the IMI also provides a platform for agencies such as the U.S. Food and Drug Administration and the European Medicines Agency to discuss novel regulatory approaches to getting drugs to patients quickly while ensuring safety and efficacy.

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.

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.

But pharmacometrics — the modeling and statistical analysis of drug metabolism data — touts a more tailored, predictive approach to safety and efficacy.

Scientists poured scorn on the decision, contending it puts patients at risk and undermines the authority of the Brazilian Health Surveillance Agency (the equivalent of the U.S. Food and Drug Administration) to regulate research and approval of new drugs based on internationally accepted safety and efficacy protocols.

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.

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.

The complaint also says that the widely cited paper «was biased» in favor of the drug's efficacy and safety and that Amsterdam felt that Penn colleague Laszlo Gyulai «misappropriated» his data.

«We can also use these models to test the efficacy and safety of new cancer treatment therapies and cancer drugs.»

Like most smart drug enthusiasts, Tony attests to their efficacy and safety with unquestioning zeal.

They explain that psychiatric drugs are rigorously examined for efficacy and safety and while the evidence base is «imperfect,» research shows that psychiatric drugs are more beneficial than harmful.

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.

To get through the FDA's demanding approval process, drug companies must demonstrate their product's safety and efficacy in costly randomized clinical trials.

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.

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.

After the success of a new drug treatment in adults with hepatitis C infection, a Saint Louis University pediatric researcher is testing the safety and efficacy of the medications in children.

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

Alice Klein notes some clinicians» concerns about the safety and efficacy of biosimilar versions of biological drugs compared with the...