Sentences with phrase «safety trials with»

The vaccine from the Mount Sinai researchers is entering the first human safety trials with drugmaker GlaxoSmithKline.

«The global stem - cell and regenerative medicine community will be awaiting the results of this safety trial with much anticipation.»

Additionally, long - term follow up in the Phase 1 safety trial with annual MRI scans through five years post-injection of AST - OPC1 has shown no evidence of adverse changes in any of the subjects treated with AST - OPC1.

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.

As with many new biologics - based technologies, there have been a number of clinical setbacks for these companies (for instance, Juno's trials have been rocked by safety issues).

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.

Random control trials with regards to home birth verses hospital delivery are not ethical, and the methodological challenges of attempting to compare the safety of home and hospital birth are exceptionally tricky which is why the home birth debate has yet to be resolved.

There is also a lot of information on the internet about baby bedding safety, about trials and testing carried out by independent research groups on certain items, and about possible dangers (including Sudden Infant Death Syndrome) associated with some baby bedding products.

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 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.

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 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.

But Ms Kelly maintained the trial on the M4 around Birmingham had shown safety is not compromised by opening the hard shoulder to regular traffic, with the motorway closely monitored by CCTV.

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.

The clinical trial is designed to assess safety and activity of escalating doses of the special cells (AST - OPC1) for individuals with a complete cervical spinal cord injury.

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

A phase I clinical trial for a Zika vaccine which began in August 2016 in partnership with the Wistar Institute and Inovio / GeneOne Pharmaceuticals aims to discover the safety and effectiveness of a DNA vaccine for Zika.

From here, we'll be optimizing the delivery system, evaluating the approach in more severe models of DMD, and assessing efficiency and safety in larger animals with the eventual goal of getting into clinical trials.»

«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.

In general, the researchers found liraglutide 3 mg to have a safety profile that was similar to that found in previous clinical trials of the drug in individuals with Type 2 diabetes treated with lower doses.

With A3AR drugs demonstrating good safety profiles in clinical trials as anti-inflammatory and anti-cancer agents, Salvemini and colleagues are enthusiastic about the potential of these new drugs to treat chronic pain in patients.

«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.

Nonetheless, this July, the FDA suspended enrollment in Glaxo's large clinical trial comparing the safety of Avandia with that of a competing diabetes drug and may halt the study altogether.

It typically takes many years to initiate such trials because of the stringent safety testing that must be done before testing in humans begins, but Reynolds said it may be possible to move faster as the therapy only involves modifying a patient's dietary intake and supplementing with a medium - chain triglyceride oil, both of which have no known side effects.

Dr. Hemila concludes that given the low cost and safety of vitamin C and the consistency of positive findings in three randomized trials on EIB, it seems reasonable for physically active people to test vitamin C on an individual basis if they have respiratory symptoms such as cough associated with exercise.

They are launching a clinical trial to evaluate the safety of their approach and gauge its effectiveness in patients with lymphoma, a cancer of the lymphatic system.

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 logical substitution was a medication called abraxane, but there were insufficient safety data on combining that with other drugs used in the trial.

A second randomized trial on the use of the sun - safety mobile app Solar Cell showed some improvement and was associated with greater sun protection, according to an article published online by JAMA Dermatology.

«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.

«Not only do we believe that high - quality, randomized clinical trials are necessary to determine the safety of the Lariat device for off - label procedures, but our analysis raises broader issues with the FDA 510 (k) clearance protocol for medical devices,» said study senior author Jay Giri, MD, MPH, assistant professor in the Cardiovascular Medicine Division at Penn. «We believe there needs to be a method for reassessing the safety of a device that has been cleared for one use but is being frequently used for a different purpose in real - world practice.»

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.

«Many adenovirus vaccine trials are moving forward for HIV, malaria and TB with promising results and very few residual safety concerns,» he said.

If animal tests go well, the next trials will be with humans, a process that involves three stages — one for safety, the next to see if the protein kills cancer in a limited number of people, and the last to turn it loose in a large group.

Further trials are planned to document the efficacy and safety of the combination in patients infected with the other HCV genotypes and in particularly vulnerable groups, to enable a public health approach to the treatment of hepatitis C.

Wyss - Coray was critical of this trial, but Alkahest, a company he co-founded, recently completed its own more rigorous small safety trial on 18 Alzheimer's patients with «no adverse side effects.»

In a phase 1b clinical trial with 21 patients, researchers tested the safety and efficacy of combining the immunotherapy drug pembrolizumab with an oncolytic virus called T - VEC.

The data safety monitoring board of the trial, as mandated by the study protocol, continues to monitor outcomes in patients with a Recurrence Score of 11 to 25 randomized to chemo - endocrine therapy or endocrine therapy alone.

A clinical trial in the Republic of Korea for patients with degenerative eye diseases is the first to test the safety of an embryonic stem cell therapy for people of Asian descent.

He and colleagues are collaborating with the Sanford Burnham Prebys Medical Discovery Institute to design new assays to discover the next generation of CRF receptor - 1 antagonists for testing in early phase human safety trials.

To address that debate, Kojic's study, dubbed «AIDS Clinical Trials Group Protocol 5240,» measured the safety and immune system response of the vaccine in HIV - positive women aged 13 to 45 with a wide range of immune statuses.

Clinical trials in dogs are similar to those done in humans, with safety protections in place to minimize harm.

A clinical trial investigating a treatment for blindness is under way this winter to evaluate the safety and efficacy of replacing diseased eye cells with stem cells.

Between legal expenses and the high - security field trials needed to comply with European safety laws — not to mention the risk that field trials will be destroyed — bringing a product to market can cost over $ 100 million, making developing GMOs so expensive only profit - driven agribusiness can afford it.