Sentences with phrase «on clinical trials at»

Not exact matches

In December, Tehrani signed a deal with GlaxoSmithKline that will allow the pharmaceutical giant to test at least four of its drug candidates on a Zymeworks - designed platform, which combines a computer simulation with a way of engineering protein molecules and allows products to be refined before they move to expensive clinical trials.
«Watson is able to give us faster, better matching of patients to potential clinical trials that our oncologists wouldn't have otherwise be able to see — and I sit with our oncologists who work on this kind of thing,» Christopher Ross, CIO at the Mayo Clinic, told MobiHealthNews in an interview.
The striking example I focused on then was the cancer drug Avastin, developed by Genentech (now Roche)-- which, at the time, had been studied in at least 400 completed human clinical trials for various cancers.
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.
Some retrospective studies and preclinical work have indicated that it might also lower a person's risk of cancer, though at least one clinical trial wasn't able to show that it had any protective effect on esophageal cancer.
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.
There are about 120 studies ongoing in Israel, including clinical trials looking at the effects of cannabis on autism, epilepsy, psoriasis, and tinnitus.
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).
The Blockchain for Clinical Trials Forum will take place on February 12 at the Orlando Science Center in Florida and will bring together prominent healthcare industry stakeholders.
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.
A March 28, 2018, research note by JMP Securities analyst Michael King indicated that at the recent International Symposium on Amyloidosis in Japan, Alnylam Pharmaceuticals Inc. (ALNY: NASDAQ) reported multiple sets of results of clinical trials, separately evaluating its investigational RNA interference (RNAi) therapeutics patisiran and ALN - TTRsc02.
«There's more emphasis now and there will be more emphasis because of the Affordable Care Act [on] offering mental health services in primary care settings,» suggests Curry, who is about to start a clinical trial looking at the effects of cognitive behavior therapy for adolescents with depression and substance abuse problems.
However, the home atmosphere was described at trial by a clinical psychologist as «having taken on the flavor of an «armed camp.»»
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.
The Effect of Timing of Cord Clamping on Neonatal Venous Hematocrit Values and Clinical Outcome at Term: A Randomized, Controlled Trial José M. Ceriani Cernadas, Guillermo Carroli, Liliana Pellegrini, Lucas Otaño, Marina Ferreira, Carolina Ricci, Ofelia Casas, Daniel Giordano and Jaime Lardizábal Pediatrics 2006; 117; 779 - 786; originally published online Mar 27, 2006; DOI: 10.1542 / peds.2005 - 1156 Download file in 380 kb - 10 pages The online version of this article, along with updated information and services, is located on the World Wide Web at: http://www.pediatrics.org/cgi/content/full/117/4/e779 Background: The umbilical cord is usually clamped immediately after birth.
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.
Sawyers conducted some of the first, dramatically successful clinical trials on Gleevec, which inhibits specific enzymes at play in certain cancers, particularly CML.
Results of the Phase II clinical trial were presented Feb. 23 at the 2016 Conference on Retroviruses and Opportunistic Infections (CROI) in Boston.
«It will be very exciting to see if the study can move to a clinical trial soon,» said Alex Agelidis, a graduate student at UIC and co-author on the paper.
Tash, now at the University of Kansas Medical Center in Kansas City, and colleagues began with an anticancer drug that, during clinical trials, severely cut down on sperm production.
Between 2011 and 2014, he conducted three such transplants at Karolinska University Hospital, four in cooperation with the Kuban State Medical University in Krasnodar, as part of a formal clinical trial, and one — on a toddler born without a trachea — in Illinois.
Ophthalmologists at 10 sites nationwide tested the ring in a phase 2 clinical trial on patients with glaucoma or ocular hypertension.
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 trialAt 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 trialat a university hospital — and concurrently works on four research projects, from fundamental science to clinical trials.
Findings were presented at the WCLC are based on the updated results of 12 lung cancer patients enrolled in the clinical trial with pembro and irinotecan or gemcitabine with or without vinorelbine or docetaxel.
Although the analysis found pulses had little impact on «second meal food intake,» the amount of food someone eats at his or her next meal, these findings support longer term clinical trials that have shown a weight loss benefit of dietary pulses.
A somewhat obscure study on statistical methods published in 2009 by medical statistician Ying Lu at Stanford University, California in a specialty journal on clinical trials, was downloaded 2000 times in early August, making it the hottest paper among Stanford University's 5439 registered users.
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.»
The team plans to present the results on 4 November at the 10th Clinical Trials on Alzheimer's Disease conference in Boston, Massachusetts.
«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.»
The German biotech CureVac, for example, has brought mRNA - based vaccines for rabies and cancer to clinical trials, and Karikó now heads a research team at BioNTech in Mainz, Germany, that focuses on mRNA - based drugs.
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.
The determination of each efficacy level was also based on the rigor and quantity of published studies on the drug class: to be in Level A, for example, a class of drugs must have been supported by at least two «Class I» studies — well - designed, double - blind, randomized, placebo - controlled clinical trials.
Sean Morrison, Professor and Director of the Children's Medical Center Research Institute at UT Southwestern Medical Center in the United States, who is not an author on the paper, added: «Patients are ultimately not helped by therapies that are not based on sound science and that are not tested in systematic clinical trials.
«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.
The GP asked him whether he felt his eczema improved in sunny weather and when the teacher said yes, he was referred to a clinical researcher at the local hospital who was starting a trial into the effects of light on skin conditions, including eczema.
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.
In 1996, when RMP - 7 was first used on brain cancer patients in a Phase 1 clinical trial at UCLA, it was found to be safe, with virtually no side effects.
The results of this study were first released in late 2016 at the international Clinical Trials on Alzheimer's Disease meeting in San Diego.
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.
The supplement they took has yet to be proved in large clinical trials, while scientists who have studied it have been caught in the cross fire between converts, willing to take the supplement on faith and anecdotal evidence alone, and skeptics who look askance at all alternative medicine.
«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.
The two drug combination «reveals the possibilities of combining an immune signaling molecule with taking the brakes off at the same time,» said F. Stephen Hodi, MD, first author on the clinical trial report.
The study included 124 newly diagnosed patients at 25 clinical trial sites in the U.S. Two - thirds of the patients were treated with ICT - 107, an experimental vaccine based on immune system cells called dendritic cells that were exposed to six synthetic proteins, or antigens, known to be involved in GBM development.
Li Ying, a retired chemist at the Chinese Academy of Sciences Institute of Materia Medica in Shanghai, who worked on the synthesis of artemisinin derivatives, wrote in an article in 2008 that Tu's method of extraction and purification yielded crystals containing artemisinin mixed with other chemicals, giving rise to toxicity in clinical trials.
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.
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.
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.
It's essential that people feel they are in a safe, comfortable setting with someone who can oversee the experience, says Alicia Danforth, a clinical psychologist at the Harbor — UCLA Medical Center in Torrance, California, who is involved in MAPS - sponsored trials studying MDMA's effects on social anxiety in adults with autism.
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