Sentences with phrase «on clinical trial data»

Their report set intake levels based only on clinical trial data.

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.

And Marathon barely did any actual clinical legwork to get the drug cleared for Duchenne — it relied on 1990 - era clinical trial data before tacking on just enough study material to win an approval that doesn't even address the root cause of the disease.

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.

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).

Additional clinical trial data later this year on Tesaro's key drug, Niraparib, which targets advanced solid tumors in ovarian and breast cancers, could help narrow the valuation gap, the people said.

After Abbott, he co-founded DCVC company BlueTalon, which was initially focused on enterprise data security for data - driven clinical trial design and population health management.

Pharmaceuticals: Reflects Canada's existing regimes, systems and laws on: patent linkage; protection for clinical trial data; and early working exceptions.

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.

The FDA reviews more liver health data and approves duloxetine for depression and diabetic neuropathy (pain), based on another set of clinical trials.

The result will be corresponding data representations for clinical and trial data, both based on the RIM.

Rather than create drastic salt policies based on conflicting data, Alderman and his colleague Hillel Cohen propose that the government sponsor a large, controlled clinical trial to see what happens to people who follow low - salt diets over time.

We were the first to put up a clinical trial registry with all our data on a website.

The authors do note that this large study can not definitively prove cause and effect; nonetheless, the findings are strongly consistent with «a wealth of existing observational and clinical trial data to support health benefits of nut consumption on many chronic diseases.»

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.

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.

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.

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.

Among the new voluntary efforts by pharmaceutical companies to post clinical trial data, the Association of the British Pharmaceutical Industry, one of the trade groups behind last week's proposal, will recommend that its members post trial results on a World Health Organization (WHO) global trials database that WHO hopes to establish in July.

An investigation into how patient outcomes are assessed in clinical trials has revealed a worrying lack of consistency, raising concerns about funding being wasted on the acquisition of poor quality data.

The lab is also working with the Breast Oncology Program at UCSF to make this data part of an adaptive clinical trial called I - SPY, which lets researchers identify the most effective therapies based on patient molecular profiling, and is collaborating with members of the UCSF Institute for Computational Health Sciences (ICHS) to put these and other public data into a centralized database that clinicians can access through an app to help make the most appropriate treatment decisions.

Eslick hopes that by collecting information on people's self - experiments over a long period of time, he'll have enough useful data to warrant the deployment of a traditional clinical trial to investigate the most successful interventions for psoriasis.

Partnering with the U.S. Food and Drug Administration allowed Doebele and colleagues to access clinical trial data describing initial tumor response, PFS and OS for 305 patients with stage IIIb or IV non-small cell lung cancer on trials of ALK inhibitors and 355 similar patients on trials of immunotherapies directed at PD - 1.

It's also moving ahead with plans to post clinical trial data on its Web site for all to see.

The researchers then tested their scoring method using data on 688 AML patients in three different clinical trials, In each of these groups, patients with low scores (methylation patterns similar to normal HSCs) had approximately twice the median survival time of patients with high scores.

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.

Clinical trials on improvised nasal naloxone kits are underway, but no data on levels of naloxone absorbed have been published.

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.»

Offsetting any such savings, according to CSDD, are higher costs due to the increased complexity of clinical trials, a greater focus on chronic and degenerative diseases, and tests for insurers seeking comparative drug effectiveness data.

The US Food and Drug Administration should consider approving the French «abortion pill» mifepristone (RU486) on the basis of European data, rather than waiting for clinical trials in the US, according to a panel of experts convened by the US National Academy of Sciences.

The Johns Hopkins team tested ImmunoMap's ability to correlate immune responses on receptor sequencing data from T - cells in the tumors of 34 patients with cancer enrolled in a nationwide clinical trial of the immunotherapy drug nivolumab.

The one time a compound she worked on entered a clinical trial, she says, the team was very careful, checking and double - checking their toxicology data.

«These results enable us to determine whether potential treatments will be effective against patients» symptoms by testing them first in healthy volunteers and defining the best doses based on objective physiological data before conducting costly clinical trials,» said Jeffrey Lieberman, MD, the Lawrence C. Kolb Professor and Chairman of the Department of Psychiatry at CUMC, and Principal Investigator of this study.

For the study, Baron performed an analysis of data from a 2010 clinical trial (by the same group of Northwestern researchers on the current paper) that demonstrated the ability of aerobic exercise to improve sleep, mood and vitality over a 16 - week period in middle - age - to - older adults with insomnia.

In 2011 Yale's Open Data Access (YODA) Project reached an agreement with medical device maker Medtronic to act as an intermediary for releasing all data on clinical trials of a controversial bone - growth protein whose safety had been questioData Access (YODA) Project reached an agreement with medical device maker Medtronic to act as an intermediary for releasing all data on clinical trials of a controversial bone - growth protein whose safety had been questiodata on clinical trials of a controversial bone - growth protein whose safety had been questioned.

«Our data argue for developing new clinical trials focused specifically on using these T memory cells, in order to determine if it would indeed be better than current therapeutic options,» said Dr. Snyder.

The FDA granted the approval in August on an accelerated basis, after only 24 weeks of data collection during a clinical trial.

Dr. Younossi stressed that while these preliminary results are encouraging, he plans to conduct further research to examine data outside of the clinical trial setting in order to evaluate the real - world consequences of a hepatitis C cure on work productivity and associated economic gains.

When Glaxo settled the suit, it denied having suppressed data and consented to posting results of all its clinical trials online — including its data on Avandia.

The ICMJE, whose membership includes the editors of The Journal of the American Medical Association (JAMA), The Lancet and the New England Medical Journal, announced the proposal one year after a report by the Institute of Medicine called on stakeholders to address the key challenges associated with sharing clinical trial data so as to «foster a culture in which data sharing is the expected norm» [2].

«Despite the limitations of a single arm, non-randomized study, we infer from these data that Interferon ß - 1a treatment is worth further consideration for the treatment of Ebola virus disease,» said Dr. Fish, who is also a Professor in the Department of Immunology at the University of Toronto, noting that the decision to undertake the clinical trial was based on previous preliminary scientific data, and on the fact that no currently approved antivirals exist to treat Ebola.

Piller and Bronshtein's work, and the follow - up pieces that came out of this investigation, applied real pressure on the government to fortify its efforts to improve clinical trial data reporting.

Here we review the data on anti — PD - 1 monoclonal antibodies to date and discuss ongoing and future clinical trials.

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

Together these data will support future efforts to conduct Phase I clinical trials in humans and constitute significant progress on the pathway toward a vaccine for falciparum malaria.

Building on clinical data from several single - agent immunotherapy clinical trials, and by engaging scientists with unique and complementary expertise from eight institutions and three industry partners, the BEAT - HIV Collaboratory's central mission will be to develop and test innovative combined immunotherapy strategies to eradicate and / or permanently suppress HIV replication in the absence of ART.

We have commenced a series of clinical trials designed to obtain safety and efficacy data on Epidiolex to provide to the FDA and other regulatory authorities around the world, which is necessary to be considered for approval as a prescription medicine.

Having previously published data on a variety of experimental mAbs against AS species in animal models -LRB-[16,20]; possibly [21]-RRB-, Prothena's Dale Schenk presented new data on additional experimental antibodies at SENS Research Foundation's Rejuvenation Biotechnology 2014 conference, roughly contemporaneous to its publication, [22] along with information specific to the humanized candidate PRX002, which is now being advanced into clinical trials.

It derived from careful evaluation of nearly 40 years of published data on stroke - related care, clinical trial results, scientific guidelines and input from professional organizations.