Sentences with phrase «safety and efficacy at»

The same year, the FDA approved the start of the first human clinical trial of this vaccine that demonstrated its safety and efficacy at inducing an immune response against the virus.

But he cautioned that the treatment used represented very high dosages, and that researchers need to test its safety and efficacy at lower levels.

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.

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).

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 tolerability.

Our Bloomingdale facility is at the heart of our manufacturing and distribution network and strongly supports our ability to achieve consistent levels of product quality, efficacy, and safety, as well as our ability to meet increasing consumer demand.

Thus, you can set your mind at rest that its safety and efficacy are certificated.

The workshop, which took place on the August 28 - 29, 2017, was aimed at educating the Herbal Manufacturers on «Specifications for Herbal Products» with the aim of improving the overall quality, efficacy and product safety on the market.

«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».

«We also needed to look at long - term efficacy, safety and immunogenicity,» he says.

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.

«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.

It's about determining efficacy (how well it works and how much is needed) and safety (at what level might the compound produce adverse effects), a risk - benefit curve.

Following a systematic review of case reports and an FDA safety database, researchers at the Perelman School of Medicine at the University of Pennsylvania are calling for formal controlled investigations into the safety and efficacy of off - label use of the Lariat device, which has never been approved for treatment of this condition.

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.

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.

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.

1) Facilitate safe off - label use of existing vaccines — Support collaboration between the zoological community and conservationists in the field to determine the safety as well as efficacy of existing distemper vaccines that could be, at a minimum, administered opportunistically to endangered wild carnivores whenever they are being handled (e.g. during radio - collaring exercises or when being translocated to mitigate human - wildlife conflict).

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.

«While we have a long way to go in demonstrating the safety and efficacy of this technique, this case represents a significant first step,» said Christopher J. Hartnick, M.D., lead investigator of the study and director of the pediatric otolaryngology division at Mass..

The ADvance Trial, using a device from Functional Neuromodulation, Inc., is aimed at evaluating the safety, efficacy and tolerability of DBS in this patient population.

The standard pharmaceutical development path for products that target pathogens moves slowly from studying safety, dosing, and biological responses in hundreds of people to an expensive efficacy trial with thousands of participants at high risk of becoming naturally infected.

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.

«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.

At the meeting, GlaxoSmithKline (GSK) of Rixensart, Belgium, which has the vaccine furthest in development, spelled out how it might scale up production in parallel with the safety and efficacy trials now under way so that the product could be ready for wider distribution by April if warranted.

At Merck Frosst Canada, I have been an integral part of the discovery of a new molecule, the testing of its mechanism of action, the validation of its safety and efficacy in Phase IIb and III clinical trials, the market approval of the resulting product, and the subsequent management of patients and their disease.

«We are at a point in our research where we have validated the efficacy of this combination treatment approach in preclinical animal models, and we now need to define its safety through toxicology and pharmacology studies,» says Fisher, Thelma Newmeyer Corman Endowed Chair in Cancer Research and co-leader of the Cancer Molecular Genetics research program at VCU Massey, chairman of VCU School of Medicine's Department of Human and Molecular Genetics and director of the VCU Institute of Molecular Medicine.

The CoreValve US Pivotal was a prospective, non-randomized single - arm, multicenter trial to determine the safety and efficacy of self - expanding TAVR at two - years in patients at extreme risk for surgery.

Efficacy and safety outcomes at two years were also examined.

These results highlight the challenges that physicians, patients, and policymakers face when safety and efficacy results are at odds with cost - effectiveness results,» the researchers write.

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.

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.

The A4 study was designed to evaluate safety, tolerability and efficacy of Solanezumab in older individuals who have normal thinking and memory function but who may be at risk for developing dementia related to Alzheimer's disease (AD) in the future.

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 full paper that this statement is in response to can be found at: Niederberger et al. 2018 Safety and efficacy of immunotherapy with the recombinant B - cell epitope — based grass pollen vaccine BM32.

PD01A: Promising Animal Efficacy; Initial Human Safety and Hints of Disease Modification At the time of our last post on α - synuclein vaccines, AFFiRiS had published several papers about the AFFITOME immnotherapy discovery platform [8 - 11] and had even begun their first Phase I trial of PD01A, but had kept nearly silent on many of the most elementary aspects of the vaccine.

The drug was approved based on efficacy and safety results from a phase III trial presented earlier this year at the 2015 American Society of Clinical Oncology Annual Meeting.

METHODS: Three hundred seventy - two patients with mild to moderate AD were randomized to receive IM injections of AN1792 or placebo (4:1) at baseline and at months 1, 3, 6, 9, and 12 in a multicenter Phase II safety, tolerability, and pilot efficacy study.

«Wyss - Coray formed a start - up company, Alkahest in Menlo Park, California, and in September 2014 it began a randomized, placebo - controlled, double - blind trial at Stanford, testing the safety and efficacy of using young plasma to treat Alzheimer's disease.

The phase II part of a phase Ib / II study (ClinicalTrials.gov identifier: NCT02263508; MASTERKEY - 265)[24] assessing the safety and efficacy of T - VEC in combination with the PD - 1 — blocking antibody pembrolizumab in previously untreated, unresected stage IIIB / IV melanoma is evaluating confirmed ORR by irRECIST at week 24.

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.

Importantly, IMGN632 was effective at concentrations well below those that affected normal bone marrow cells, suggesting the potential for efficacy in AML patients with reduced likelihood of myelosuppressive side effects and favorable safety profile.

Sidney Wolfe, MD, director of the Health Research Group at the consumer advocacy group Public Citizen, notes that weight - loss products have a dismal history in terms of safety and efficacy.

Looking at the published science, and particularly the long - term safety and efficacy of fasting, there are a number of reasons to be concerned with this fad approach to weight loss and metabolic health.

Looking at the published science, and particularly the long - term safety and efficacy of fasting, there are a number of reasons to be concerned with this approach to weight loss and metabolic health.

We research and choose our partnerships here at the kitchen table for quality, safety, efficacy, and environmentalism.