Sentences with phrase «on clinical trials led»

Based primarily on clinical trials led by Arjun V. Balar, MD, assistant professor of medicine and director of the Genitourinary Medical Oncology Program, the FDA approved atezolizumab (Tecentriq ®) and pembrolizumab (Keytruda ®) as first - line treatments for these particularly frail patients with advanced bladder cancer in early 2017.

Results of the first 12 women enrolled at Johns Hopkins on a clinical trial led by Trimble are reported online in the Jan. 27 issue of Science Translational Medicine.

Not exact matches

Not surprisingly, the spread of diseases (not to mention unhealthy lifestyles that lead to diseases) on a global level is much easier than coordinating care, managing supply chains and clinical trials and rolling out treatments.

Following a devastating clinical trial setback earlier this month for its lead experimental product, a cannabidiol gel, in epilepsy, the firm reported another trial failure on Monday for the product in treating knee pain due to osteoarthritis.

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.

Motif has successfully concluded a second phase III clinical trial on its lead drug, iclaprim and is preparing for regulatory...

Given the clinical trial results underpinning a new drug application for Kite Pharma's lead candidate, which the Food and Drug Administration is currently reviewing, I'd say there's a solid chance Gilead can squeeze out a return on its investment.

He has published seminal works on blood pressure management through his role in the BPLTTC and played leading roles in a series of trials that define the clinical management of patients with diabetes and chronic kidney disease.

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.

Eating about 3/4 cup (130 grams) each day of these foods known as pulses led to a weight loss of 0.34 kilograms (just over half a pound), in a systematic review and meta - analysis of all available clinical trials on the effects of eating pulses.

Also in this issue, how single - person medical experiments, alternatives to big clinical trials, are leading to breakthroughs on a small scale.

«We are pleased to have demonstrated such a potent and durable immune response to the vaccine,» said the study's lead author, Sita Awasthi, PhD, a research associate professor of Infectious Diseases at Penn. «If found effective in clinical trials, the vaccine will have a huge impact on reducing the overall prevalence of genital herpes infections and could reduce new HIV infections as well, especially in high - burden regions of sub-Saharan Africa.»

Biden has also been talking to Los Angeles, California, oncologist and billionaire Patrick Soon - Shiong, who on 11 January announced an industry - led moonshot aimed at testing in clinical trials combinations of cancer immunotherapy drugs, one of most promising new cancer treatments in recent years.

Several years ago, for example, poor chemical probe data led researchers to pursue a final stage clinical trial on a cancer drug candidate called iniparib.

According to lead author Mr James Oliver of the Arthritis Research UK, Centre for Genetics and Genomics, Centre for Musculoskeletal Research, University of Manchester, UK, «in current clinical practice, RA drugs are administered on a trial and error basis; there are no clinical biomarkers of response to guide treatment decisions.

The study is investigator led and has therefore focused on clinical need, targeting patients with progressive multiple sclerosis in whom most disability is incurred... The study also reports a predominant effect on neurodegenerative rather than inflammatory outcomes, suggesting a novel mechanism of action that might be suitable as combination treatment with immunomodulatory treatments... Further phase 3 studies to measure the effect of simvastatin on sustained disability, particularly in patients with non-relapsing secondary progressive and primary progressive multiple sclerosis, are clearly needed, but this trial represents a promising point from which to develop trials of progressive disease.»

One report, focusing on clinical trial patients with advanced kidney cancer treated with checkpoint inhibitors, is from scientists at Dana - Farber Cancer Institute and the Broad Institute of MIT and Harvard, led by Eliezer Van Allen, MD, of Dana - Farber and the Broad, and Toni Choueiri, MD, director of the Lank Center for Genitourinary Oncology at Dana - Farber.

Appel and Sacks led three earlier clinical trials that tested ways to reduce the risk of cardiovascular disease and diabetes, providing volunteers with carefully designed diets and measuring the effects on key health indicators.

While the finding does not directly lead to a test for immunotherapy response yet, Choueiri said, «We intend to look at these specific genomic alterations in larger, randomized controlled trials, and we hope that one day these findings will be the impetus for prospective clinical trials based on these alterations.»

Based on results from this and previous studies, pemetrexed and gemcitabine were included in a St. Jude - led multicenter clinical trial of children and adolescents newly diagnosed with medulloblastoma.

NCCC's leading pancreatic cancer research experts highlight groundbreaking research projects and clinical trials underway for this challenging cancer, and offer thoughts on what the future holds.

Learn more about how we are delivering on our commitment to leading medicine from the earliest phase of discovery in a lab to the testing new drugs or therapies in clinical trials.

Franziska Michor (Dana - Farber Cancer Institute)-- Research done at the computational biology and bioinformatics laboratory of Dr. Michor has led to the first clinical trials based on the evolutionary mathematical modeling of cancer.

Key figures share their perspectives on a controversy that led to the suspension of Ebola vaccine clinical trials in Ghana.

This experimental vaccine regimen is based on the one tested in the U.S. Military HIV Research Program - led RV144 clinical trial in Thailand — the first study to demonstrate that a vaccine can protect people from HIV infection.

He led Daiichi Sankyo's international research unit focused on early oncology therapeutic programs, strategy and development, and was accountable for development activities from post-target identification basic science research to first - in - man trials and proof - of - clinical concept.

Based on our findings, the occurrence of cancer is much higher in adults over 75 years of age compared with the proportion of patients in this age group who enroll in clinical trials,» said lead study author Bindu Kanapuru, MD, medical officer in the Division of Hematology Products, Office of Hematology and Oncology Products in the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research, who presented the results at the 59th American Society of Hematology (ASH) Annual Meeting and Exposition, held December 9 — 12 in Atlanta.

In recent years, researchers have developed so - called «senolytic» drugs that wipe out senescent cells in aging mice and mouse models of age - related disease, exploiting the high dependence of these cells on specific biochemical survival pathways.9, 10 In these studies, senolytic drugs have restored exercise capacity9 and formation of new blood and immune precursor cells11 in aging mice to near youthful norms, and prevented or treated mouse models of diseases of aging like osteoarthritis, 12 fibrotic lung disease, 13 hair loss, 14 atherosclerosis, 15,16 and age - related diseases of the heart itself.9 UNITY Biotechnology is leading a growing charge toward the clinic, with human clinical trials expected to begin in 2019.

His research on OX40 / OX40L interactions controlling the generation and activity of Th2 cells is cited by the Foundation as one of their major breakthroughs, and led to clinical trials of antagonists of OX40L in asthma.

The clinical consortium is led by AFFiRiS itself, and in addition to the PD booster trial, it is now recruiting for a separate Phase I trial of the α - synuclein vaccine against MSA, a synucleinopathy differentiated from PD or LBD based on the cell populations affected, the regional concentration of AS neuropathology, and the spectrum of movement and other symptoms.

This first - of - a-kind clinical trial builds on nearly three decades of research led by collaborative teams at Nationwide Children's and Ohio State's University College of Medicine.

They expect to move their lead candidate UBX0101 into human clinical trials for osteoarthritis sometime in 2018, and move on to other clinical indications after that.

MHRP, which led the RV144 trial with the Thai Ministry of Public Health, initiated follow - on clinical studies to conduct intensive immunogenicity research.

Dr. Jain proposed the design for the adaptive clinical trial platform and will lead the center's quantitative effort on design development and the analysis of the various types of data that will be generated in these multi-year adaptive trials.

«We think this clinical trial offers great hope based on what we have observed in prior studies,» said the study's lead investigator, Robert Vonderheide, M.D., DPhil, director of the Abramson Cancer Center of the University of Pennsylvania.

There is an urgent need to collaborate on clinical trials and translational research and to unite leading experts.

May 3, 2006 deCODE genetics (Nasdaq: DCGN) today announced that it has reached an agreement with the US Food and Drug Administration (FDA) on the design of its Phase III clinical trial for DG031, deCODE's lead developmental compound for the prevention of heart attack...

The Johns Hopkins Kimmel Cancer Center is one of 11 Lead Academic Organization sites of the National Cancer Institute's Experimental Therapeutics Clinical Trials Network (ETCTN), which supports the evaluation of early phase clinical trials on experimental thClinical Trials Network (ETCTN), which supports the evaluation of early phase clinical trials on experimental therTrials Network (ETCTN), which supports the evaluation of early phase clinical trials on experimental thclinical trials on experimental thertrials on experimental therapies.

Funding provided by the Cancer Center Support Grant (CCSG) supports several types of pilot projects (1) highly innovative pilot projects focusing on proof - of - concept or translational research; (2) preliminary collaborative investigations that lead to multi-investigator grant awards or clinical trial; (3) projects that closely align with the Cancer Center's strategic plan and enhance key initiatives; and (4) pilot funding for junior investigators to jump - start independent projects or for more senior investigators looking to study a novel idea derived from discovery.

Lead Investigator, Professor Gary Anderson, Director of the University's Lung Health Research Centre, welcomes the collaboration to work on the protein that will lead to clinical trials for treating astLead Investigator, Professor Gary Anderson, Director of the University's Lung Health Research Centre, welcomes the collaboration to work on the protein that will lead to clinical trials for treating astlead to clinical trials for treating asthma.

The UK has been leading conversations on clinical trial transparency and can not afford to be left behind when it comes to regulation.

Establishment of a collaboration with the European Lung Cancer Working Party which led to a phase II study on patients with refractory or relapsing small cell lung cancer (clinical trial # 1081 - http://www.elcwp.org/).

At Roswell Park, along with his translational lab research, Dr. Koya leads an NIH funded prospective clinical trial based on an immune - modulator - enhanced TCR - engineered T cell transfer for metastatic cancer patients.

Peta leads worldwide research into psychological trials into new therapies in the area of obesity and weight management, focussed on Clinical EFT.

One of her most significant contributions in her life has been to lead a world - first randomized clinical trial investigating the effectiveness of EFT on food cravings in overweight and obese adults (SEE RESEARCH).

There are precedents that parallel our apparently paradoxical finding.36, 37 In a β - amyloid immunization trial among those with probable Alzheimer disease, immunization led to significant clinical benefit, reduced β - amyloid load, and reduced brain volume.36 The investigators hypothesized that removal of β - amyloid and / or other protein constituents from brain tissue may have caused cerebral fluid shifts, resulting in brain volume reductions on magnetic resonance imaging.

Researchers in the on - going clinical trial, led by Dr. Sara Thomasy, hope that once the CED - causing gene is identified and isolated, they will be able to create a genetic test to allow breeders to avoid producing dogs with CED.

UC Davis veterinarians, led by Drs. Mathieu Spriet and Pablo Espinosa, are making breakthroughs in their discoveries of the diagnostic capabilities of positron emission tomography (PET) through a clinical trial and other research focused on advancing the clinical applications of this new modality.

UC Davis veterinarians, led by Drs. Mathieu Spriet and Pablo Espinosa, are continuing to see successes in their discoveries of the diagnostic capabilities of PET through this clinical trial and other research focused on advancing the clinical applications of this new modality.

Her research focuses on local chemotherapy treatment for brain tumors, including a potentially ground - breaking drug that has led to a clinical trial.