Sentences with phrase «safety trials in»

«The biggest hurdle will be conducting safety trials in the most important target population — women who are pregnant or planning pregnancies,» said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine and president of the Sabin Vaccine Institute.

If the vaccines pass these tests then safety trials in humans would be the next step.

Following successful nonhuman primate studies, Phase I safety trials in humans can begin.

But the new formulation hadn't been through phase I safety trials in humans and so couldn't be used in Ebola patients.

Loomba says that the drug's ability to curb fibrosis, one of the hallmarks of NASH, is encouraging, and he also supports safety trials in people.

He and his colleagues plan further animal studies of the drug and hope to move on to safety trials in people.

The company has begun two safety trials in the US, in people at low risk of infection and in people at high risk, and says it has evidence that the vaccine is safe.

«First embryonic stem cell therapy safety trial in Asian patients.»

By 2007, the drug had been tested on cells and in a phase I clinical safety trial in healthy volunteers.

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.

The program will involve clinical trials testing for safety in humans, followed by a larger trial using non-human primates exposed to Ebola.

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.

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 historic milestone for the drone industry, this week AirMap and Project Wing in a test program led by the Virginia Tech Mid-Atlantic Aviation Partnership, successfully demonstrated an industry - leading solution to safety - critical airspace deconfliction challenges as part of the ongoing NASA - UTM trialIn a historic milestone for the drone industry, this week AirMap and Project Wing in a test program led by the Virginia Tech Mid-Atlantic Aviation Partnership, successfully demonstrated an industry - leading solution to safety - critical airspace deconfliction challenges as part of the ongoing NASA - UTM trialin a test program led by the Virginia Tech Mid-Atlantic Aviation Partnership, successfully demonstrated an industry - leading solution to safety - critical airspace deconfliction challenges as part of the ongoing NASA - UTM trials.

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.

It tells the story of «the guinea pigs»» the people most likely to be research subjects in Phase I trials, which test the safety of a drug under development by giving it to healthy subjects and examining any side effects they experience.

In a public dialogue held by the National Anti-Poverty Commission (NAPC) last August, medical doctors warned that there are not enough data presented to establish safety of Golden Rice to human health thus warranting the disapproval of human feed trials.

In a public dialogue on Golden Rice held by the National Anti-Poverty Commission or NAPC last August, medical doctors has warned that there are not enough data presented to establish safety of Golden Rice to human health thus warranting the discontinuation of human feed trials.

The field trials were permitted by and followed the safety standards of the DA - Bureau of Plant Industry (DA - BPI), the national regulatory authority in the Philippines for biotechnology research and development.

But it is important to note that the Tufts study wasn't a safety trial, because existing research was already available that showed that beta - carotene in Golden Rice was as safe as beta - carotene in other foods.

A third season of multi-location field trials has been completed in the Philippines as part of research to ensure its safety and effectiveness.

A technical briefing focused on event selection, nutritional impact, safety assessment and agronomic data from the GR2E Golden Rice confined field trials in Bangladesh.

Bear in mind that herbs and medications are not a substitute for careful evaluation by a breastfeeding specialist as their safety and efficiency have not been proven in reliable randomized control trials.

Current research includes: co-leading organisational case studies in Birthplace in England, a national study of birth outcomes in home, midwife led, and obstetric led units; investigating the relationship between measures of safety climate and health care quality in A and E and intrapartum care; and conducting nested process evaluations of two trials of obesity in pregnancy behavioural interventions.

As it has been shown that conducting a randomised controlled trial is not possible, the best evidence about the safety of home birth can only come from good quality, routine registrations such as the one we used in our study.

Plenty of respected research supports the safety of planned home birth (most recent large prospective trial published in the British Medical Journal), but for women who need to deliver in a hospital due to a complication, the midwife stays by your side and adopts a doula role.

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 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 safety, impact and effectiveness of a policy of early discharge for healthy mothers and term infants was assessed in one review that included ten randomised trials (Brown 2007).

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.

Larger trials with stricter safety measures have demonstrated that with a cautious protocol, breech birth can be conducted safely in appropriately supported obstetrical units.

And «information regarding safety is lacking» is NOT an endorsement of giving the drug (and yes, in this context hops are a drug) in any context other than a clinical trial.

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Mima doesn't have a strong presence in the U.S. high chair safety testing trials, either.

The widespread assumption of safety has led researchers in fetal behaviour to assure women volunteering for clinical trials that ultrasound exposure of one to one - and - a-half hours (sometimes on more than one occasion) is safe for their unborn babies - yet we know of no follow - up of these exposed children.

The motion notes that the Scottish Premier League is planning to initiate trials and calls on the government to recognise «improvements in stadium design and technology mean that, with rigorous safety specifications, standing areas can be safely introduced».

The safety of the vaccine has been established in large clinical trials and will be continually monitored as it comes into wider use,» Ed Yong, health information manager at the charity told politics.co.uk

In the wake of the collapse of the Tulisa Contostavlos trial, they argue that there are «serious concerns» over the safety of their convictions

The final budget deal, as expected, did not include a range of non-fiscal matters, including extending the statute of limitations in child abuse cases, school safety measures, gun control, relaxing certain criminal bail requirements and any bolstering of ethics and campaign finance laws in reaction to what has become an annual parade of Albany corruption cases, including two major trials this year of people with close ties to Cuomo.

She's «in favor of open discovery,» or requiring prosecutors to turn over evidence to the defense with ample time before trial, as long as no one's safety is jeopardized.

«With an eye toward a significant reduction in the jail population, including increased use of community - based diversion programs, and policing, bail and speedy trial reform, the #CLOSErikers Campaign is advocating for a much smaller, less expensive, fairer and more humane public safety system in NYC,» Martin said.

Alleged N2.3 billion NIMASA Scam: Witness says he shared N121 m on Accused's Instruction The Economic and Financial Crimes Commission, EFCC, Tuesday presented the sixth witness in the ongoing trial of a former Director General of Nigerian Maritime Administration and Safety Agency, NIMASA, Patrick Akpobolokemi and five others for the alleged diversion of over Two Billion -LSB-...]

The safety of all three vaccines was established in large clinical trials before approval by the U.S. Food and Drug Administration.

Not only were there no adverse effects from the transplanted cells — this was primarily a safety trial — but 10 patients showed marked improvements in vision, and the eyesight in another seven seems to have stabilized.

The researchers caution that the booster therapy used in their new study will not be available on the market or even for use in human trials anytime soon; it must await years of animal testing for safety and effectiveness first.

Riscoe says that if ELQ - 300 passes the obligatory safety tests, trials could begin in humans within two years.