Sentences with phrase «used in clinical trials of»

For this reason, health authorities require that new infant formulas be tested in piglets before they can be used in clinical trials of human babies.

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.

Besides randomized controlled clinical trials, there are a number of ways researchers can study how a particular cancer treatment is playing out in the real world: there are retrospective studies, observational studies, and even prospective research done using patient registries.

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.

In a clinical trial of more than 600 participants, Empliciti, when used with cancer drug Revlimid and steroid dexamethasone was better at delaying when the cancer worsened than just the two drugs alone.

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.

In fact, one of Marathon's clinical trials that the FDA used as part of its decision - making process was conducted more than 20 years ago, saving the firm plenty of study costs.

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.

«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.

But topping the list is Vertex (VRTX), which has a veritable plethora of HCV drugs in late - stage clinical trials, which are used either alone, or in combination with other drugs.

«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.»

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.

Now that they've demonstrated the significance of insulin signaling in the human mammary gland, they are planning a phase I / II clinical trial with a drug used to control blood sugar in type 2 diabetes to determine whether it improves insulin action in the mammary gland, thus improving milk supply.

Cord blood stem cells can be used to treat dozens of diseases and are being tested in FDA - regulated clinical trials to help people with autism, brain injury, and other conditions.

In addition, there was no effect on breastfeeding duration when the pacifier was introduced at 1 month of age.280 A more recent systematic review found that the highest level of evidence (ie, from clinical trials) does not support an adverse relationship between pacifier use and breastfeeding duration or exclusivity.281 The association between shortened duration of breastfeeding and pacifier use in observational studies likely reflects a number of complex factors such as breastfeeding difficulties or intent to wean.281 A large multicenter, randomized controlled trial of 1021 mothers who were highly motivated to breastfeed were assigned to 2 groups: mothers advised to offer a pacifier after 15 days and mothers advised not to offer a pacifieIn addition, there was no effect on breastfeeding duration when the pacifier was introduced at 1 month of age.280 A more recent systematic review found that the highest level of evidence (ie, from clinical trials) does not support an adverse relationship between pacifier use and breastfeeding duration or exclusivity.281 The association between shortened duration of breastfeeding and pacifier use in observational studies likely reflects a number of complex factors such as breastfeeding difficulties or intent to wean.281 A large multicenter, randomized controlled trial of 1021 mothers who were highly motivated to breastfeed were assigned to 2 groups: mothers advised to offer a pacifier after 15 days and mothers advised not to offer a pacifiein observational studies likely reflects a number of complex factors such as breastfeeding difficulties or intent to wean.281 A large multicenter, randomized controlled trial of 1021 mothers who were highly motivated to breastfeed were assigned to 2 groups: mothers advised to offer a pacifier after 15 days and mothers advised not to offer a pacifier.

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 2002, Home Secretary David Blunkett announced that he might permit the medical use of cannabis if clinical trials of the drug were successful.

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.

Walking through the latest research and clinical trials seeking to restore the mobility, communications and muscle use of soldiers was Dr. Leigh Hochberg, a neurologist and engineer in neurotechnology at Massachusetts General Hospital and a director of the Veterans Affairs Medical Center in Providence, Rhode Island.

It also says that there have been no formal clinical trials of the procedure but that OvaScience are planning to carry out 1000 rounds of IVF around the world this year using Augment, partly to convince the US Food and Drug Administration to approve the treatment in the US.

«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.»

«If you don't use as close to the total physiological system that you can, you're likely to run into troubles,» like being surprised by side effects later on in clinical trials, says William Haseltine, founder and former chairman and CEO of Rockville, Md. — based Human Genome Sciences.

«Most of our samples are consented — that is, the patient is in a clinical trial or has consented to have the sample used in a clinical trial,» Bry says.

In an effort to find out, Stephen P. Juraschek, M.D., Ph.D., research and clinical fellow in general internal medicine at the Johns Hopkins University School of Medicine, and his colleagues used data from the DASH (Dietary Approaches to Stop Hypertension) clinical trial, a widely popular and often - cited study whose results were first published in 199In an effort to find out, Stephen P. Juraschek, M.D., Ph.D., research and clinical fellow in general internal medicine at the Johns Hopkins University School of Medicine, and his colleagues used data from the DASH (Dietary Approaches to Stop Hypertension) clinical trial, a widely popular and often - cited study whose results were first published in 199in general internal medicine at the Johns Hopkins University School of Medicine, and his colleagues used data from the DASH (Dietary Approaches to Stop Hypertension) clinical trial, a widely popular and often - cited study whose results were first published in 199in 1997.

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 one analysis that included 21 randomized clinical trials, investigators found a risk of 138 surgical site infections per 1000 procedures, and the use of sutures coated with the antimicrobial triclosan reduced this by 39.

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.

«If we find that lymphoscintigrams using tilmanocept are at least as good as the conventional radiocolloid tracer in identification and visualization of sentinel nodes, we would like to see a randomised clinical trial involving large numbers of patients,» says Prof de Bree.

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.

The scientists began to use post-transplant cyclophosphamide in clinical trials of fully matched bone marrow transplants in 2004.

Published in the journal Molecular Cancer Therapeutics, the study also found that use of a second inhibitor might improve the effectiveness of these drugs by possibly preventing resistance, and it recommends that clinical trials should be designed to include a second inhibitor.

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

As Scientific American reported earlier this year, more than half of the current cancer clinical trials do incorporate some form of immunotherapy but still oncologists are often only in the early stages of understanding how to use such treatment on a larger scale.

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.

Then, a team led by Robert Lanza, the chief scientific officer of Advanced Cell Technology Inc. in Marlborough, Massachusetts, and his colleagues published the first results ever of a clinical trial using human embryonic stem cells.

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.

The researchers reprogrammed the cells to create induced pluripotent stem cells in an FDA - compliant facility at the Broad Stem Cell Research Center; the use of this facility is an important step in the process as preclinical research moves toward human clinical trials.

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.

The Institute of Medicine, meanwhile, is holding a series of meetings to discuss how technologies like these are used in clinical trials.

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

Tumors typically have a repertoire of molecular defenses they can use to suppress or evade immune attacks, which is why cancer vaccines and immunotherapies have had mixed results in clinical trials to date.

Although most of the shortages affect old, generic drugs, clinical trials often use these staples, either as controls or in combination with experimental medicines, including the genetically targeted drugs that many hope will revolutionize cancer care.