Sentences with phrase «for use in clinical trials»

As Head of Project Leader Unit, Nicolas is in charge of the pharmaceutical development and subsequent production of vaccines - for use in clinical trials - directly funded by the European Vaccine Initiative (EVI), and European projects funded from other sources coordinated by EVI.

The SMA Foundation and RBM are continuing to analyze these results and plan to create a specific panel of biomarker assays for use in clinical trials exploring new treatments for SMA.

It bars a researcher from receiving drugs for use in clinical trials — in effect, preventing that investigator from administering experimental drugs to patients.

Decitabine is approved by the U.S. Food and Drug Administration to treat myelodysplastic syndromes and leukemia, and for use in clinical trials for several types of solid - tumour cancers including colorectal.

«Our compound is very specific for the target, but the next step is to rigorously establish if it's safe for use in clinical trials,» says Stanford.

Brendan Kennedy, the cofounder of Privateer Holdings, which owns various marijuana companies like Marley Natural and Canadian pharmaceutical - grade cannabis producer Tilray, explains how Tilray is already exporting marijuana to countries like Croatia and Australia for use in clinical trials.

As we'll see later on, this has already contributed to their receiving FDA - approval for use in a clinical trial.

Not exact matches

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.

Beginning in January 2017, IBM employees in the U.S. will be able to use Watson supercomputer technology to help find the most effective oncology drugs and clinical trials for their specific cancers, IBM announced.

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

Intarcia has completed several late - stage clinical trials in which it uses the pump to deliver a glucose - controlling drug continuously for months — an idea, that if successful (and approved by the FDA) could significantly help patients with type 2 diabetes, fewer than half of whom maintain the recommended glycemic levels.

The biotech plans to shed 20 % of its nearly 600 employees in order to secure yearly cost - savings of about $ 21 million — money which can then be used to double down on late - stage clinical trials for its experimental Parkinson's drug.

Through talking to experts in the field over the past year, Gates said he had identified five areas of need: Understanding better how Alzheimer's unfolds, detecting and diagnosing it earlier, pursuing multiple approaches to trying to halt the disease, making it easier for people to take part in clinical trials of potential new medicines, and using data better.

«Stakeholder interest in the initiative and the upcoming IEEE Blockchain for Clinical Trials Forum is strong, and we encourage even broader participation and input from vested healthcare and regulatory partners in order to identify pertinent issues and more viable use cases that can help us advance industry - wide adoption,» said Tim Mackey, co-chair of the IEEE - Standards Association Supply Chain / Clinical Trials Industry Connections Program.

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.

Cambridge, MA — March 30, 2017 — Aura Biosciences, a biotechnology company developing a new class of therapies to target and selectively destroy cancer cells using viral nanoparticle conjugates, announced today that it has enrolled and dosed the first patient in its Phase 1b clinical trial of light - activated AU - 011, an investigational, first - in - class targeted therapy in development for the treatment of ocular melanoma, a rare and life - threatening disease.

To achieve this goal, several approaches are envisaged: identifying small populations with severe disease where a medicine's benefit - risk balance could be favorable; making more use of real - world data where appropriate to support clinical trial data; and involving health technology assessment bodies early in development to increase the chance that medicines will be recommended for payment and ultimately covered by national healthcare systems.

«We chose to use Axiom Foods» Oryzatein ® ingredient,» said CEO of Growing Naturals, David Janow, «because it is the only 90 % brown rice protein isolate that is made with a proprietary enzyme fractioning method and was shown in a clinical trial for the first time to equal animal - based whey protein in building and maintaining muscle.»

(Culver City, CA August 27, 2013)-- After Oryzatein ® was recognized as the first plant - based rice protein to equal animal - based whey protein for muscle building and repair in a clinical trial published last month, an «Oryzatein ® Inside» endicia is being provided to manufacturers who use the ingredient in their food products.

Throughout 2017, ongoing clinical trials in regenerative medicine using cord blood have offered hope to families facing life - changing medical conditions, such as cerebral palsy and autism.1 For some of these families, banking their baby's cord blood with ViaCord gave them the opportunity to participate in this groundbreaking research.

We searched ClinicalTrials.gov (30 June 2016) and the WHO International Clinical Trials Registry Platform (ICTRP)(1 July 2016) for unpublished, planned and ongoing trial reports using the terms given in Appendix 1.

While they were able to block DOT1L directly using an inhibitor substance currently being tested in a clinical trial for a different type of leukemia, a direct drug - based inhibition of MLL proved impossible.

To use genomics resources to benefit patients, consider research hospitals that do clinical trials, he advises; to turn discoveries into diagnostic tools and medicines, look for opportunities in the life science industry.

«Thus, we hope that its potential as a powerful therapeutic agent for the treatment of autoimmune diseases will facilitate its use in future clinical trials.»

AAV is in use in many late - stage clinical trials in the United States, and has already been approved for use in one gene therapy drug in the European Union.

Now a University of Colorado Cancer Center study published online ahead of print in the journal Oncogene offers compelling evidence explaining this failure and offering a possible strategy for the use of retinoic acid or other retinoids against some breast cancers: Because early clinical trials are often offered to patients who have already tried other more established therapies, breast cancer cells may have been pushed past an important tipping point that offers retinoic acid resistance.

In this new study and for the first time, scientists used functional magnetic resonance imaging (fMRI) combined with a standard clinical trial design to derive an unbiased brain - based neurological marker to predict analgesia associated with placebo treatment in patients with chronic knee osteoarthritis paiIn this new study and for the first time, scientists used functional magnetic resonance imaging (fMRI) combined with a standard clinical trial design to derive an unbiased brain - based neurological marker to predict analgesia associated with placebo treatment in patients with chronic knee osteoarthritis paiin patients with chronic knee osteoarthritis pain.

This project includes a trial at Duke University that tests the idea of capturing clinical trial data in a single source and sharing the data using standard protocols, with direct implications for future research procedures and health care quality.

Two of the drugs are investigational and approved by the Food and Drug Administration (FDA) for use in people as part of clinical trials; the third drug is FDA - approved to treat rheumatoid arthritis.

U.S. biotechnology company Circe Biomedical has had similar success, she said, showing in an ongoing clinical trial of a similar device using pig liver cells that six out of 36 patients have completely recovered without the need for transplant.

«UDCA has been in clinical use for decades and thus could be advanced to the clinic rapidly if it proves beneficial in clinical trials.»

Researchers who conduct animal studies often don't use simple safeguards against biases that have become standard in human clinical trials — or at least they don't report doing so in their scientific papers, making it impossible for readers to ascertain the quality of the work, an analysis of more than 2500 journal articles shows.

One new paper, for instance, examines the use of statistics in medical clinical trials.

The CRISPR / Cas9 platform for Duchenne developed by the UCLA scientists is not yet available in clinical trials and has not been approved by the FDA for use in humans.

People working in biomanufacturing need to be prepared for inspections by the US Food and Drug Administration and the European Medical Evaluation Agency designed to ensure that mass - produced proteins are of the same quality as those used in clinical trials.

Their results, published this week in the journal Biomedical Optics Express, from The Optical Society (OSA), may yield a cheaper and less invasive initial screening test for colon cancer that could complement colonoscopy, though further clinical trials will need to demonstrate the safety and effectiveness of the blood test before it is routinely used.

A non-hormonal option for male contraception is preferable to hormonal treatments currently in clinical trials, because the types of hormones that make men infertile have more severe side effects than those used in the female pill.

Monica Bertagnolli, chief of the Division of Surgical Oncology at Brigham and Women's Hospital and chair of the Alliance for Clinical Trials in Oncology, a nationwide effort to test new therapies, says she was thrilled that the president used the word «cure» in his speech at all.

In a randomized, controlled clinical trial — the first of its kind — a multi-institution research team reports that daptomycin, part of a new class of antibiotics currently approved only for use in adults, is effective and well - tolerated in childreIn a randomized, controlled clinical trial — the first of its kind — a multi-institution research team reports that daptomycin, part of a new class of antibiotics currently approved only for use in adults, is effective and well - tolerated in childrein adults, is effective and well - tolerated in childrein children.

While MEK inhibitors are part of treatment protocols for melanoma, palbociclib is entering clinical trials for use in melanoma populations.

However, it's not routinely used outside of clinical trials — in large part because it costs between # 4,000 (US$ 5,700) and # 7,000 for each recipient.

The team is optimistic about CGP3466B because it has already been shown to be nontoxic and nonaddictive in phase I clinical trials that explored its use for Lou Gehrig's and Parkinson's diseases — though it did not prove effective in treating those conditions.

«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.»

During interviews for this article, neither McGlashan nor McGorry backed the use of antipsychotics in prevention outside of clinical trials.

CDC based its decision for children under 10 to receive two doses on preliminary data from clinical trials of the vaccines being used in the United States, but he said more complete data should emerge soon.

«Our gene therapy protocol is not yet ready for clinical trials — we need to tweak it a bit more — but in the not - too - distant future we think it could be developed for therapeutic use in humans,» says Jeffrey Holt, PhD, a scientist in the Department of Otolaryngology and F.M. Kirby Neurobiology Center at Boston Children's and an associate professor of Otolaryngology at Harvard Medical School.

«However, given that IGF - 1 is approved for human use in people who are deficient in this hormone, a clinical trial of IGF - 1 in lithium - resistant bipolar disorder patients is warranted.»

Meanwhile, his research teams are moving several other novel therapies toward clinical trials, each of which has potential for use in the synergistic model of cancer treatment that Black believes will offer the best hope for his patients.

Muotri said the findings show it is possible to more effectively stratify ASD individuals for clinical trials by identifying persons who are likely to be more responsive to specific therapies using their «mini-brains» in a dish.

AAV viral particles are in clinical trials for other purposes, making the researchers optimistic that this CRISPR delivery method could be used in humans, although more studies are needed.