Sentences with phrase «efficacy trials in»

Efficacy trials in Brazil, Panama, and the Cayman Islands showed that this approach has helped reduce the Aedes aegypti population by more than 90 percent, Oxitec said.

[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 next steps are to move ahead with a larger efficacy trial in West Africa.»

Thailand Clinical Trials Development Trial MHRP, in collaboration with the P5, is planning an efficacy trial in a high - risk population of men who have sex with men (MSM) to hopefully improve upon the RV144 result and extend its relevance to at - risk populations to achieve the greatest public health impact.

This malaria vaccine is being evaluated in a Phase 2 efficacy trial in children at this site.

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 NDIn 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 NDin 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 NDin the FDA issuing a refusal to file letter to Celgene regarding the NDA.

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.

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).

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.

«The positive efficacy results observed in the pivotal phase 3 clinical trials indicate that sarecycline can be an effective treatment option for patients with moderate to severe acne,» said Allergan R&D chief David Nicholson in a statement.

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.

Most biotechs would have shuttered a clinical program that showed absolutely no efficacy whatsoever in a late - stage trial, but Novavax has instead doubled down on RSV by going forth with its phase 3 trial of the RSV F vaccine for infants via maternal immunization, and begun planning for another trial in older adults that's reportedly on track to kick off in 2018.

Efficacy of tart cherry juice in reducing muscle pain during running: a randomized controlled trial.

A systematic review of the efficacy of herbal galactagogues published in the Journal on Lactation found five trials that showed an increase in breast milk production.

The efficacy of malunggay (moringa oleifera) given to near term pregnant women in inducing early postpartum breast milk production - a double blind randomized clinical trial.

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.

In the third trial of the nurse home visitor program, nurse - visited, 6 - month - old infants born to mothers with low psychological resources (i.e., maternal IQ, mental health, and sense of efficacy) displayed fewer aberrant emotional expressions (e.g., low levels of affect and lack of social referencing of mother) associated with child maltreatment.18

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 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.

A randomized trial assessing the efficacy of peer counseling on exclusive breastfeeding in a predominantly Latina low - income community

In recent years, medical researchers have proven its efficacy in clinical trialIn recent years, medical researchers have proven its efficacy in clinical trialin clinical trials.

Although professional lactation support can improve the duration of overall breast feeding, its effect in improving exclusive breast feeding is unclear.11 18 22 Thus far, studies that report improvement of rates of exclusive breastfeeding have involved mainly community based peer counselling strategies.23 24 25 Even then, a randomised trial in the UK recently cast doubt on the efficacy of this approach.26 There are current recommendations from NICE for the UK - wide implementation of the baby friendly initiative.4 5 6 The 2006 NICE costing report on routine postnatal care of women and their babies estimates that efforts to improve rates of breast feeding will result in substantial cost savings for the NHS.6

The efficacy of these treatments for other anxiety disorders in children and adolescents has been supported by multiple randomized controlled trials (e.g., Walkup et al., 2008).

Its role in the initiation of labour is poorly understood and data examining its efficacy within a clinical trial are limited.

Efficacy of an online breastfeeding tutorial and maternal needs assessment in increasing breastmilk - only feeding in a pediatric practice: results of a randomized controlled trial

«A future clinical trial for NMN will tell us if it has any efficacy in humans.»

«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.

Thomas Smith, who studies the epidemiology of malaria at the Swiss Tropical Institute in Basel, says it may be premature to say exactly what the efficacy is based on this early data from the trial, which is still ongoing.

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.

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

The three - armed trial evaluated the efficacy of chiropractic spinal manipulative therapy (CSMT) in the treatment of migraine versus placebo (sham chiropractic) and control (usual drug treatment).

«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.

If it appears safe, Inovio plans to test its efficacy in field trials among Zika - affected populations in the Caribbean later this year, says Inovio CEO Joseph Kim.

«Randomized trials have confirmed the value of radiation dose escalation for prostate tumors, and the potential benefits of larger radiation doses in fewer fractions, are expected to increase the therapeutic efficacy for men with prostate cancer,» said Anders Widmark, MD, a professor of radiation sciences at Umeå University in Umeå, Sweden and lead author of the study.

She has created toxin - smothering antibodies that have been shown to be safe in humans by Caprion Pharmaceuticals, paving the way for efficacy trials.

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.»

«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.

Previous clinical trials of creatine in symptomatic HD patients have been limited in scale, involved daily doses of 10 grams or less, and did not provide evidence of potential efficacy.

More than 5,000 people in Guinea received the vaccine in a trial to gauge its efficacy.

The company plans in October to conduct a separate test specifically to study the seasonal flu vaccine's effectiveness among 480 elderly participants (a demographic often encouraged to get seasonal flu shots), and Phase III efficacy trials across a larger set of demographics are scheduled to begin early next year.

The researchers hope that ultimately human trials will prove the efficacy of the OH14 compound in sensitising tumour cells and cancer stem cells to existing drug - based therapies thus disabling tumours from seeding new growth after treatment.

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.

And scientists who conduct human challenge studies, which typically involve a few dozen participants, say they have critical benefits: In addition to saving time and money, they can reveal harm caused by a potential drug or vaccine before it enters large - scale human efficacy trials.

Only a clinical trial that combines azacitidine with the blinded addition of either vitamin C or a placebo will give the true answer as to whether or not vitamin C increases the efficacy of azacitidine in patients.