Sentences with phrase «safety and efficacy data»

Prepare solicitations and provide technical review (including safety and efficacy data) of proposals for avian influenza, classical swine fever, Rift valley fever, and other vaccines.

We have commenced a series of clinical trials designed to obtain safety and efficacy data on Epidiolex to provide to the FDA and other regulatory authorities around the world, which is necessary to be considered for approval as a prescription medicine.

«I think the big question now is how do we do this while gathering sufficient safety and efficacy data to be confident that we are doing good,» Farrar says.

«Despite the increased quality risks and the lack of safety and efficacy data for non-FDA regulated custom - compounded bioidentical hormones, their use by menopausal women is higher than expected and appears to be continuing to grow,» said lead researcher JoAnn Pinkerton, MD, a professor of obstetrics and gynecology at the University of Virginia Health System, Charlottesville.

Rwanda will present safety and efficacy data on 50 patients at the American Urology Association in May 2011, and a randomized, controlled trial with 150 participants, designed to compare PrePex with the conventional surgical method is currently ongoing.

If you dig and read studies examining the actual safety and efficacy data about the various vaccines, it is clear that vaccination prevents the development of a strong natural immune system.

Presentations will highlight the short and long - term effects of Ingrezza on tardive dyskinesia symptoms by body region, long term safety and efficacy data from the KINECT 4 phase 3 open label study and also from RE-KINECT (real - world screening study of patients with possible TD).

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.

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).

Not exact matches

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.

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 tolerability.

Reflecting on the evidence, the study's authors wrote, «Despite the media attention and perceived benefits of these therapies, there are still limited data as to efficacy and long - term safety.

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.

«It's important for us to finish what we started... and to make sure we get the data, the safety and efficacy that's necessary to support the approval and licensure of therapeutics and vaccines,» Disbrow said.

«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.

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

Robotic rectal cancer surgery is gaining popularity, but limited data are available regarding 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.

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.

«These data reinforce and support the safety and efficacy we have shared in previous studies.

The largest CBD study presented efficacy and safety data on GW Pharmaceutical's investigational medicine, Epidiolex (cannabidiol) from open - label Expanded Access programs at 16 sites.

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.

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

The goals of Cohort B, for which survival data are not yet complete, were, primarily, to prove pembrolizumab's safety and, secondarily, to explore its efficacy as a first - line treatment.

In January 2013, the American Society for Reproductive Medicine declared the technique of oocyte cryopreservation (egg freezing) no longer experimental, although it called for «more widespread clinic - specific data on the safety and efficacy of oocyte cryopreservation... before universal donor oocyte banking can be recommended.»

[NIAID Director Anthony] Fauci says $ 56 million of the total would go toward a larger efficacy trial in Liberia, which would include both the NIAID / GSK [GlaxoSmithKline] vaccine and another made by NewLink Genetics of Ames, Iowa (pending more data from ongoing safety trials).»

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.

Susan Gould Fogerite, director of research for the Institute for Complementary and Alternative Medicine in the School of Health Related Professions, said that although there is widespread evidence that yoga is being used as a form of exercise by those with MS, much of the feedback has been anecdotal and there isn't much empirical data regarding its safety and efficacy.

A total of 347 patients (155 treated with vitamin E, 192 not treated with vitamin E) were included in the analysis which compared data from three clinical trials that investigated the efficacy and safety of vitamin E as a treatment for NASH: the PIVENS, TONIC and FLINT trials.

Medical schools have resisted the introduction of a specific phytotherapy curriculum, preferring to wait for more data on efficacy and safety.

An HFEA spokesperson says that the agency is waiting for further experiments on the safety and efficacy of mitochondrial replacement (including data from Herbert's team) before approving what could be the world's first mitochondrial replacement in humans.

Adam R. Glassman, M.S., of the Jaeb Center for Health Research, Tampa, Fla., and colleagues examined the incremental cost - effectiveness ratios (ICERs) of aflibercept, bevacizumab, and ranibizumab for the treatment of DME with an analysis of efficacy, safety, and resource utilization data at 1 - year follow - up from the Diabetic Retinopathy Clinical Research (DRCR) Network Comparative Effectiveness Trial.

Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Syndax's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes.

Since there is no vaccine or specific approved treatment for Ebola virus disease (EVD), there is a «moral obligation» to collect and share all data generated, to understand the safety and efficacy of any intervention, and to evaluate promising interventions to inform future research, says Dr. Eleanor Fish, the senior author and senior scientist in the Toronto General Hospital Research Institute (TGHRI).

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.

Data from these studies indicate the safety and efficacy of Celvive's therapeutic approach.

Along with our nonprofit partners, this program aims to collect, organize, and validate massive amounts of data generated by clinical trials across our global trial network sites in order to generate novel insights into biomarkers for safety and efficacy, novel treatment strategies, and personalization of treatment regimens.

At the International Society for Stem Cell Research 2017 Annual Meeting (June 14 - 17, 2017; Boston, USA), Asterias Biotherapeutics, Inc (CA, USA) will present new 9 - month efficacy and safety data from their ongoing SCiStar Phase I / IIa trial of human embryonic stem cell - derived oligodendrocyte progenitor cells.

«The ASGCT decision to include a presentation on AST - OPC1 in its Presidential Symposium signifies the ground - breaking nature of our program, and reflects the encouraging efficacy and safety data we have seen to date in patients with severe spinal cord injuries that have been treated with AST - OPC1,» commented Steve Cartt, President and Chief Executive Officer of Asterias.

Asterias Biotherapeutics, Inc will present new 9 - month efficacy and safety data from their ongoing Phase I / IIa trial for OPC - 1 in a workshop and poster presentation.

AST - VAC1 (antigen - presenting autologous dendritic cells) is an autologous cancer immunotherapy with promising efficacy and safety data from a Phase 2 study in Acute Myeloid Leukemia (AML).

In this presentation, we discuss data from studies conducted with academic, clinical, and industry collaborators that demonstrates the utility of the system as a more predictive, human - relevant alternative for efficacy and safety testing of new chemical entitites.

Published new efficacy and safety data from preclinical studies of AST - OPC1 in the peer - reviewed journal «Stem Cells Translational Medicine.»

PD01A in Phase I: Early Evidence of Safety and Hints of Efficacy The animal data reviewed above were published in June of 2014, [15] long after they had evidently been completed (see e.g. [11]-RRB-.

«It is exciting to be directly involved in creating an innovative clinical trial infrastructure that will yield important efficacy and safety data on novel asthma interventions,» says Dr. Jain, «I look forward to participating in this work and seeing how it directly impacts asthma patients.»

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.

Unfortunately, very few clinical trials are performed with children; thus, there is limited data with which to assess safety and efficacy.

Home / NEWS & MEDIA / pivotal data demonstrating efficacy and safety of apoquel ® published in veterinary dermatology

Kiefer said that veterinarians should consider the following before working with companies that offer stem cells: what data they have provided demonstrating the efficacy and safety of their product, whether they rely on publications by other companies or groups and whether their product is an equivalent product.