Sentences with phrase «from clinical trials designed»

Identifying the molecular causes of disease represented a major breakthrough in the history of medicine, moving the discipline from pattern recognition and therapeutic strategies based on syndromic pathophysiology to molecular mechanism and evidence ‐ based therapies derived from clinical trials designed on the basis of molecular mechanism.

Not exact matches

In particular, the complaint alleges that throughout the Class Period, defendants made materially false and / or misleading statements and / or failed to disclose that (1) the trials for GED - 0301 suffered from fatal design defects, such that GED - 0301 had failed to demonstrate meaningful clinical efficacy; (2) the growth of Otezla sales had dramatically slowed during Celgene's third fiscal quarter of 2017; and (3) the clinical and nonclinical pharmacology data in Celgene's new drug application («NDA») for Ozanimod were insufficient to permit a complete review by the FDA, which resulted in the FDA issuing a refusal to file letter to Celgene regarding the NDA.

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.

In those areas that we have mapped, it typically takes us a few hours to go from a mechanism - inspired idea for treating a disease to knowing the companies that might have relevant clinical and preclinical assets to license, the companies from whom a candidate could be commissioned, trial designs and endpoints, competing and complementary agents, current and future standard of care, market size, comparable pricing, financing strategy, and potential acquirers, all meant to enable a thoughtful first - pass assessment of whether an idea could be worth a much deeper assessment.

Although a considerable body of scientific evidence substantiates the positive correlation between curcumin consumption and a reduction in the risk of cancer, the paucity of suitably designed human clinical trials that clearly demonstrate any direct effect of curcumin on cancer markers may prevent Health Canada from approving a cancer risk reduction claim for curcumin within the current regulatory framework.

Although some SIDS experts and policy - makers endorse pacifier use recommendations that are similar to those of the AAP, 272,273 concerns about possible deleterious effects of pacifier use have prevented others from making a recommendation for pacifier use as a risk reduction strategy.274 Although several observational studies275, — , 277 have found a correlation between pacifiers and reduced breastfeeding duration, the results of well - designed randomized clinical trials indicated that pacifiers do not seem to cause shortened breastfeeding duration for term and preterm infants.278, 279 The authors of 1 study reported a small deleterious effect of early pacifier introduction (2 — 5 days after birth) on exclusive breastfeeding at 1 month of age and on overall breastfeeding duration (defined as any breastfeeding), but early pacifier use did not adversely affect exclusive breastfeeding duration.

«It was clear from our findings that many people with IBS should have their vitamin D levels tested, and the data suggests that they may benefit from supplementation with vitamin D. «As a result of this exploratory study, we're now able to design and justify a larger and more definitive clinical trial.»

A statin drug commonly used to lower cholesterol is not effective in reducing the number and severity of flare ups from chronic obstructive pulmonary disease (COPD), according to the results of a large multicenter clinical trial designed and directed by Gerard J. Criner, MD, Director of Pulmonary and Critical Care Medicine at Temple University Hospital in Philadelphia, PA..

Professor Melanie Calvert, from the University of Birmingham, explained, «Researchers face a difficult task in designing effective clinical trials that include PROs.

«Part of what was exciting about the design of this clinical trial is that we decided early on to accept women from a younger and generally sicker population than is typically enrolled in clinical trials,» says Dr. Cristofanilli, who is also a researcher at the Sidney Kimmel Cancer Center at Thomas Jefferson University.

When asked about the ethics of offering a drug to people who may never get the disease it's designed to prevent, Michael Sand, the Boehringer scientist overseeing the clinical trial, acknowledges that psychosis risk prediction is far from perfect.

The aim of the Interdisciplinary Training in Cancer Research training program is to train young scientists to design and conduct research on significant problems in cancer by combining information and approaches from different scientific disciplines, including basic cellular and molecular biology, epidemiology, clinical trials and studies, and behavioral - social sciences.

In the $ 1.47 million, four - year grant called â $ œBiomarkers of Ischemic Outcomes in Intracranial Stenosisâ $ (BIOSIS), Emory researchers are analyzing blood samples from 451 patients from around the country who were enrolled in a study known as SAMMPRIS (Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis), the first randomized, multicenter clinical trial designed to test whether stenting intracranial arteries would prevent recurrent stroke.

Biostatisticians and bioinformaticians must have a high level of understanding of the research question being asked, and design the trial accordingly with the information available, setting reasonable expectations for a new treatment based on input from the clinical investigator.

The data from extensive laboratory studies on correlates of risk of HIV infection will be used in one aspect of the clinical trial design.

Dr. Leo Stamatatos, an immunologist in Fred Hutch's Vaccine and Infectious Disease Division, has received funding from the National Institutes of Health to begin manufacturing an HIV vaccine candidate designed to stimulate the production of broadly neutralizing antibodies and to test the experimental vaccine in human clinical trials.

The positive safety profile to date, the evidence supporting engraftment of the cells post-implantation, and the improvements we are seeing in upper extremity motor function highlight the promising findings coming from this Phase 1 / 2a clinical trial, which will guide us as we work to design future studies.

A new analysis of clinical data from the TRACK - HD and COHORT studies proposes a way to design of clinical trials designed to delay the onset of HD, rather than treating symptoms after they occur.

Our program is collaborating with researchers around the globe to dissect the results from this trial to inform basic research and design future clinical trials to translate a scientific milestone into an eventual public health tool.

As one of the of the center's research projects, Dr. Kent P. Hymel, a child abuse pediatrician at Penn State Children's Hospital, will lead eight pediatric intensive care units from across the country in a randomized clinical trial designed to assess the impact of a novel screening tool for pediatric abusive head trauma.

Informed by knowledge drawn from clinical trials, researchers design and implement novel diagnostic and treatment protocols benefiting patients.

The company is currently focused on conducting the clinical trials necessary for regulatory approval and commercialization of advanced hormone therapy, pharmaceutical products designed to alleviate the symptoms of and reduce the health risks resulting from menopause - related hormone deficiencies, including hot flashes, osteoporosis, and vaginal dryness.

Clinical trials are often designed from preliminary data that show the new treatment may be effective in laboratory studies.

She plans to seek certification from the American College of Veterinary Clinical Pathologists and ultimately wants to design and coordinate clinical trials that deliver new tools to veteriClinical Pathologists and ultimately wants to design and coordinate clinical trials that deliver new tools to vetericlinical trials that deliver new tools to veterinarians.

Physiomesh Flexible Composite Mesh is a type of synthetic hernia mesh designed to support the surrounding tissue after a hernia repair surgery first cleared by the United States Food and Drug Administration (FDA) in April of 2010 and withdrawn from the market in May of 2016 after medical professionals expressed concern over results from a clinical trial.

As a graduate student from China, specializing in highly technical design of clinical drug trials, she had little connection to America's long - running debate...

The program was designed as a multicentre trial, and includes referrals from both clinical and community samples (JIGSAW Youth Mental Health Services in Geelong, Deakin University, and Drummond Street Services in Carlton).

Several elements of this important, well designed, clinical trial by Maude - Griffin et al are noteworthy from a clinical perspective.

Because the present study was designed to be an effectiveness trial and prior studies noted earlier showed that attrition before 12 sessions from child treatment is common in actual clinical settings, parents were given the choice of attending 6 two - hour meetings each of which covered two sessions or the standard 12 one - hour session procedure.

Fortunately, conducting randomized trials over the decades, intervention researchers have produced numerous manual - guided, evidence - based treatments (EBTs) for depression, anxiety, and conduct in youth.2 Unfortunately, these treatments have not been incorporated into most everyday clinical practice.3 - 5 A common view is that the complexity and comorbidity of many clinically referred youths, whose problems and treatment needs can shift during treatment, may pose problems for EBT protocols, which are typically designed for single or homogeneous clusters of disorders, developed and tested with recruited youths who differ from patients seen in everyday clinical practice, and involve a predetermined sequence of prescribed session contents, limiting their flexibility.3 - 8 Indeed, trials testing these protocols against usual care for young patients in clinical practice have produced mixed findings, with EBTs often failing to outperform usual care.7, 9