Sentences with phrase «efficacy and safety in»

I have enjoyed using Zoetis products over the decades for their efficacy and safety in the dermatologic patients I have treated.

Previously we reported the development of liposome - based vaccines and their efficacy and safety in preclinical mouse models for tauopathy.

The discovery of this new hormone is a potential game - changer in human fertility treatment,» said Gerald Weissmann, M.D., Editor - in - Chief of The FASEB Journal, «but further research is needed to determine its efficacy and safety in humans.»

«If the molecule shows equal efficacy and safety in humans, then this particular «smart» drug design may indeed offer perspectives for metabolic precision medicine,» summarizes Tschöp.

Not exact matches

We are very confident in the safety and efficacy of EpiPen products being produced at the site.»

Actual results and the timing of events could differ materially from those anticipated in the forward - looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: the uncertain timing of, and risks relating to, the executive search process; risks related to the potential failure of eptinezumab to demonstrate safety and efficacy in clinical testing; Alder's ability to conduct clinical trials and studies of eptinezumab sufficient to achieve a positive completion; the availability of data at the expected times; the clinical, therapeutic and commercial value of eptinezumab; risks and uncertainties related to regulatory application, review and approval processes and Alder's compliance with applicable legal and regulatory requirements; risks and uncertainties relating to the manufacture of eptinezumab; Alder's ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with Alder's development and commercialization activities; the sufficiency of Alder's capital and other resources; market competition; changes in economic and business conditions; and other factors discussed under the caption «Risk Factors» in Alder's Annual Report on Form 10 - K for the fiscal year ended December 31, 2017, which was filed with the Securities and Exchange Commission (SEC) on February 26, 2018, and is available on the SEC's website at www.sec.gov.

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.

Detailed 48 - week results from a Phase 3 study evaluating the efficacy and safety of switching from a regimen containing abacavir, dolutegravir and lamivudine (600 / 50/300 mg)(ABC / DTG / 3TC) to Biktarvy, a once - daily single tablet regimen, in virologically suppressed adults with HIV.

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).

Announced a clinical trial collaboration with Pfizer, Inc. (Pfizer) to evaluate the safety and efficacy of the investigational combination of Yescarta and Pfizer's utomilumab, a fully humanized 4 - 1BB agonist monoclonal antibody, in patients with refractory large B - cell lymphoma.

Our forecast for bictegravir starts later than this implied timeline (Q3 2018) but ramps to more than $ 10bn in global sales based on the product's convenience, safety and tolerability and efficacy.

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.

In a March 16 research note, Andrew Fein, an analyst at H.C. Wainwright & Co., reported that OvaScience (OVAS: NASDAQ) shifted its focus back to research and development, after interim data from the first 20 patients in its Phase 1 trial of OvaPrime showed no signs of efficacy despite indicating safety and tolerabilitIn a March 16 research note, Andrew Fein, an analyst at H.C. Wainwright & Co., reported that OvaScience (OVAS: NASDAQ) shifted its focus back to research and development, after interim data from the first 20 patients in its Phase 1 trial of OvaPrime showed no signs of efficacy despite indicating safety and tolerabilitin its Phase 1 trial of OvaPrime showed no signs of efficacy despite indicating safety and tolerability.

But oliceridine's value proposition actually depends on how well it stacks up against morphine from both a safety and efficacy standpoint, which is the secondary endpoint in each trial.

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.

But for those new parents who have been bombarded with misinformation and hearsay regarding the safety and efficacy of sleep training, it's yet another assurance that you can feel confident in the fact that getting your child to sleep through the night is important, safe, and beneficial to your entire family.

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.

The aim of this trial is to evaluate the safety and efficacy of continuous KMC initiated immediately after birth compared to the current recommendation of initiating continuous KMC after stabilization, in improving survival of neonates with birth weight from 1.0 to < 1.8 kg.

The brief includes the analysis of survey data from program participants on child safety in the home, observed parenting practices, parental stress and parenting efficacy, self - reported parenting practices, and rates of child maltreatment.

The DAME trial was a multi-site, randomised controlled trial of antenatal expression of colostrum in late pregnancy for women with diabetes in pregnancy to explore the safety and efficacy for mother, foetus and infant.

• «The Magic Number» teaching concept to help mothers maintain their milk supplies while pumping • Breast massage and compression to help mothers increase breast milk yields and overcome breastfeeding difficulties • New, more - conservative guidelines on the use of galactogogues • Fenugreek, milk volume, and prolactin levels in mothers of preterm infants • The safety and efficacy of placenta consumption as a galactogogue • Preparation, cleaning, and sterilization of breast pump parts • Appropriate use of nipple shields to improve breastfeeding outcomes • The importance of the mother - infant relationship in babies» growth and development

The trial was designed to test the safety and efficacy of omega - 3 — fortified formulas compared with unfortified formulas or breast milk in 288 premature infants.

Safety and efficacy of antenatal milk expressing for women with diabetes in pregnancy: protocol for a randomised controlled trial.

ObjectiveTo evaluate the efficacy and safety of magnesium sulfate in the resolution of vaginal bleeding and contractions in nonsevere placental abruption.

About Hops: From http://www.drugs.com/npp/hops.html «Pregnancy / Lactation Information regarding safety and efficacy in pregnancy and lactation is lacking».

Suksomboon N, Poolsup N, Yuwanakorn A. Systematic review and meta ‐ analysis of the efficacy and safety of chromium supplementation in diabetes.

Women should also understand that there is uncertainty about the safety and efficacy of planned VBAC in pregnancies that go beyond 42 weeks of pregnancy, or those with twins or especially large babies.

«Until we have further evidence on the efficacy of medical cannabis for the treatment of sleep apnea, and until its safety profile is established, patients should discuss proven treatment options with a licensed medical provider at an accredited sleep facility,» said lead author Dr. Kannan Ramar, professor of medicine in the division of pulmonary and critical care medicine at Mayo Clinic in Rochester, Minnesota.

In October, a UNESCO bioethics panel recommended a temporary ban on «engineering of the human germline, at least as long as the safety and efficacy of the procedures are not adequately proven».

Further studies in animal models and patients (with altered TRPM7 channel function) have been initiated, in order to evaluate the efficacy and safety of magnesium as a therapeutic for this disease.

Although gene therapy research has made great strides in recent years, it has yet to be widely deployed, and no CRISPR - edited genes have yet been tested for safety or efficacy in human clinical trials.

«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.

This open label, multicentre, phase 1B trial investigated the safety and efficacy of omaveloxolone in combination with the checkpoint inhibitors ipilimumab or nivolumab.

«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.»

Follow - up data on safety and efficacy has been assessed at up to six years in women age 15 - 26 and the current team of investigators also looked at data on the large cohort of young people two years ago.

Q: Do you mean prominent vaccinologists who believe in the safety and efficacy of today's vaccines?

«The study results elucidate the molecular mechanisms underlying disease progression in multiple sclerosis models, providing a basis for future clinical trials to determine safety and efficacy of these chemical agents in humans with demyelinating disorders,» says Patrizia Casaccia, MD, PhD, Professor of Neuroscience, Genetics and Genomic Sciences at Mount Sinai and senior author of the study.

Boni E. Elewski, M.D., professor of dermatology, is the principal investigator of the Efficacy of Response And Safety of two fixed secUkinumab REgimens in psoriasis (ERASURE) trial, one of two studies in the recent New England Journal of Medicine article «Secukinumab in Plaque Psoriasis — Results of Two Phase 3 Trials.»

It helps to clarify the pre-existing evidence on the effectiveness of these approaches and their side effects in the short term, as well as introducing longer term evidence of efficacy and safety.

«The combined results of ERASURE, along with the FIXTURE trial, are very exciting in terms of the efficacy and safety of secukinumab,» Elewski, co-lead author, said.

Such tests would come under the greatest inspection, information about them would need to be entered in a national database, and manufacturers would have to prove their safety and efficacy to the FDA before they could be sold.

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

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 brochures contain information about toxicology, pharmacology, and animal safety studies used to determine the potential risk a particular therapy may pose to humans, but they also include efficacy studies done in animal models to demonstrate a therapy's potential benefit.

These encouraging results in terms of safety and efficacy are paving the way for a new kind of treatment, not only for Still's disease, but other rare inflammatory diseases, too.

The new study was a prospective, randomized, investigator - blinded study that included more than 250 daptomycin - exposed children, ages 1 to 17, to document safety and efficacy of the antibiotic in treating pediatric skin and skin structure infections.

«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.

In addition, the NFL should convene an independent committee of medical professionals, without ties to the NFL or any of its teams, to evaluate the safety and efficacy of the therapies, establishing a set of criteria for what is considered «safe» and «effective,» the authors said.