Sentences with phrase «on clinical trials from»

Until today, the regimen outlined on mifepristone's label was based on clinical trials from way back in the «90s.

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.

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.

Researchers from the Sichuan University in Chengdu inserted the re-engineered cells into a lung cancer patient participating in a clinical trial at the West China Hospital on October 28th, according to Nature.

By printing multiple lung airways — or any other afflicted organ — from a human patient and testing drugs on them, pharma companies can bypass the ethically challenged practice of testing on animals and proceed to human clinical trials with greater confidence the drugs will actually work, according to Wadsworth.

It can be everything from an über - helpful call - center rep to an oncology adviser, recommending cancer treatments on the basis of a patient's genetic profile and thousands of clinical trials and medical journal articles it has analyzed.

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).

* MEDICINES360 AND ALLERGAN PRESENT 5 - YEAR TRIAL DATA FROM LARGEST ON - GOING IUS CLINICAL STUDY Source text for Eikon: Further company coverage:

Athenex, which raised $ 68 million from a secondary stock offering during the quarter, finished the year with $ 51 million in cash and short - term investments, down from $ 69 million in September as the company spent heavily on clinical trials for the drugs it is developing and absorbed higher licensing fees at its specialty drug business, which has added 12 new drugs to its stable of products.

That's because it costs on average, $ 1.2 billion dollars to bring a new drug to market — from the time it is a twinkle in a scientist's eye, through a decade or more of lab research, to clinical trials and finally FDA approval.

The 2nd International Congress on Advances in Food Chemistry and Technology will exhibit the products and services from commercial and non-commercial organizations like Drug manufactures, Clinical Trial Sites, Management Consultants, Chemists, Pharmacists, Business delegates and Equipment Manufacturers.

The 12 week clinical study from the US of 303 participants is the first prospective, randomised clinical trial to directly compare the effects of water and diet beverages on weight loss within a behavioural weight loss program.

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.

MuscleTech ® researchers reviewed numerous clinical trials on whey peptides, and the science shows that whey peptides can promote rapid recovery from exercise.

Collectively, the evidence from longitudinal research, clinical trials, and neurodevelopmental research is beginning to provide a compelling case for the view that breastfeeding may have longer - term effects on individual cognitive ability and educational achievement.

The «unexpected deaths» were based on data from an industry - funded, academic - researcher - run clinical trial described in two papers published in 1999 and 2000.

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 pacifier.

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.

Cole is the first Democrat to publicly announce a bid against Collins, whose fifth year in Congress has been marked by controversy over his investment in an Australian biotech company that critics said could have benefited from his work on a bill aimed at speeding clinical trials of new drugs.

Findings from the clinical trial now appear as an «article in press» on the Journal of the American College of Surgeons website in advance of print.

On November 1, 2016, the entire SPIRE clinical trials program was stopped when the sponsor, Pfizer, who manufactures bococizumab, discontinued the development of the drug when initial results from the LDL cholesterol lowering trials indicated that some trial participants had developed anti-drug antibodies, an immunologic response to the drug.

AveXis, Inc., a clinical - stage gene therapy company developing treatments for patients suffering from rare and life - threatening neurological genetic diseases, announced in July 2016 that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the treatment based on preliminary clinical results from the trial of AVXS - 101.

The company had identified a molecule, CGP3466B, that in laboratory tests protected neurons from degeneration by inhibiting apoptosis, and had tested it in clinical trials on patients with Parkinson's disease and amyotrophic lateral sclerosis, or ALS.

At the moment, though, he is employed as a full - time clinician at a university hospital — and concurrently works on four research projects, from fundamental science to clinical trials.

The clinical trial received ethical approval from the hospital's review board on July 6.

Although no clinical trials involving therapies derived from iPS cells are on the books, researchers are currently testing drugs on them.

These techniques include: human tissue created by reprogramming cells from people with the relevant disease (dubbed «patient in a dish»); «body on a chip» devices, where human tissue samples on a silicon chip are linked by a circulating blood substitute; many computer modelling approaches, such as virtual organs, virtual patients and virtual clinical trials; and microdosing studies, where tiny doses of drugs given to volunteers allow scientists to study their metabolism in humans, safely and with unsurpassed accuracy.

For example, Matt Krause, director of human resources at CV Therapeutics, says, «Our research programs include multiple, cutting - edge cardiovascular product candidates in various stages of clinical trials and preclinical programs, all of which rely heavily on the contributions from our many B.S. - and M.S. - level scientists.»

Previous research has largely focused on dietary components and which diet would be best to lower the risk of obesity and type 2 diabetes, but so far there is no clear evidence from epidemiological or clinical trial data that a specific diet is optimal for long - term weight - loss or lowering the risk of diabetes.

To help make that happen, the research team recently won a grant from MIT's Deshpande Center for Technological Innovation to develop a business plan for a startup that could work on commercializing the technology and performing clinical trials.

The documentation ranges across the whole spectrum of drug development: Investigators» brochures provide information on all that is currently known about the medicine and so need periodic updating; accurate and concise protocols are required to ensure that trials are performed effectively; clinical trial reports (generally from phase II and III studies) present the information gathered from the trials; higher level documents provide summaries of efficacy and safety data from clinical trial programmes; expert reports provide critical interpretation of the results; and response documents clarify any points that are not clear to the regulatory agencies or provide additional analyses or supporting data for any items of concern.

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.

«The CASTLE - AF clinical trial represents a landmark in the history of cardiovascular medicine because of its potential impact on our patients who are suffering from heart failure,» said James Fang, M.D., Chief of Cardiovascular Medicine at the University of Utah Health.

If you treat a patient on the basis of data from clinical trials, you ought to be sure that the patient actually is a member of the population sampled to perform the trial.

Today's catch phrase is «evidence - based medicine,» and that «evidence» typically takes the form of results from clinical trials, in which potential treatments are tested on large groups of people.

Researchers, Dr Abi Rose and Dr Andy Jones, from the University's Addiction Research Team conducted a meta - analysis on all 12 clinical trials comparing baclofen with placebo on at least one of the described drinking outcomes, craving, anxiety, or depression.

Related sites PhRMA announcement of clinical trials policy National Institutes of Health - funded clinical trials registry Statement from medical journals on clinical trials disclosure

For example, if you and your fellow postdocs would like to learn about career opportunities in industry and biotech, you'll need to invite a variety of companies focusing on areas ranging from clinical trials to biotech start - ups to big pharma.

Most clinical trials show that cutting out 1,000 milligrams of sodium from a diet, a relatively large amount, results in only a small drop in blood pressure on average, Cohen says.

The first - of - its - kind study found the dual treatments to be safe and elicit a clinical response in patients, according to new results from a phase I trial to be presented at the AACR Annual Meeting 2015 on April 19.

«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.

White and colleagues will work with other collaborators at the Cancer Institute to develop early - phase patient clinical trials based on the findings from this study in the near future.

«[T] he visit also comes as the White House awaits action from Congress on a nearly $ 6.2 billion emergency appropriations request to continue fighting [Ebola] in West Africa and to move candidate vaccines through clinical trials.

In collaboration with Vertex, HUB has tested ivacaftor on organoids grown from CF patients who had taken part in a clinical trial of that drug.

The Mayo task force found no evidence from clinical trials to recommend treating people only on the basis of age in the absence of risk factors, high cholesterol or inflammation.

Apart from the loss of time, money and resources, these failures are also «tragic because we have so little clinical trial information on children to begin with,» says Florence Bourgeois, an assistant professor of pediatrics and emergency medicine at Harvard Medical School, who co-authored the study.

A new study by researchers from the University of Chicago Medicine, based on a 6 - month clinical trial, finds that use of a CGM is cost - effective for adult patients with type 1 diabetes when compared to daily use of test strips.

Neither result on its own was very convincing, so a team of European researchers combined the data, similar to the way medical researchers cull information from independent clinical trials, to look for rare side effects.

Further clinical trials are on - going internationally, and we hope to include data from them in a future analysis to determine whether the promise of today's results is confirmed in an even larger and more diverse group of patients.»

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.»