Sentences with phrase «on clinical trials with»

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.

With a critical mass of 450,000 patients annually among them, the six centers have agreed to combine their efforts on planning clinical trials in immunotherapy, recruit patients quickly, and share the information learned — which could be the single biggest factor in speeding up drug development.

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.

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.

Investors, however, are focused on quarterly results and often have little patience with clinical trial setbacks and the years - long process of developing drugs.

Ritual's non-GMO, gluten - free, sugar - free, dairy - free, and dye - free vegan vitamins contain just nine ingredients, the origins of which are listed on the company's website, along with details of where each vitamin was manufactured and the clinical trials that influenced its dosage.

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).

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.

For the second time in 5 months, Juno Therapeutics has put a clinical hold on a Phase II trial of JCAR015 in adult patients with relapsed or refractory B - cell acute lymphoblastic leukemia due to patient deaths.

The event was filled with updates on clinical trials and research.

More details on a pivotal clinical trial mixed with a bullish analyst report send shares screamin...

Most biotechs would have shuttered a clinical program that showed absolutely no efficacy whatsoever in a late - stage trial, but Novavax has instead doubled down on RSV by going forth with its phase 3 trial of the RSV F vaccine for infants via maternal immunization, and begun planning for another trial in older adults that's reportedly on track to kick off in 2018.

The future of research into the potential health benefits of cocoa should focus on the mechanisms and active compounds, with well defined clinical trials key to this burgeoning segment, says a new review by Nestlé.

With China expected to experience rapid growth in clinical trials over the short term, the Australian industry needs to remain competitive by focusing on quality factors as a differentiator.

In this randomized, double - blind clinical trial, virgin coconut oil was the clear winner: «among pediatric patients with mild to moderate AD, topical application of virgin coconut oil for eight weeks was superior to that of mineral oil based on clinical (SCORAD) and instrumental (TEWL, skin capacitance) assessments.»

While this is not really a surprise, since similar research and trials with wounds on people has shown the healing benefits of using medical grade manuka honey, this is the first time a clinical trial has been done on horses.

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.

Before the sack, Richardson's performance against Clowney is an offer any NFL GM would spend first - round money on: when applied on roughly one - third of called offensive plays in a single game, Tiny Richardson can nullify a premier pass - rushing defensive end with single coverage with a 95.4 percent success rate in clinical trials.

With a recent clinical trial showing a 110 % improvement in skin elasticity in just 8 weeks, Osmosis Pür Medical Skincare's Catalyst AC - 11 DNA Repair Serum is now one of the most powerful age reversing serums on the market right now.

«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.

The PhD course focuses on various aspects of human (donor) milk, with as main study a randomized clinical trial towards the effects of human donor milk in very low birth weight infants (the Early Nutrition Study).

Help your patients with food allergies with educational materials and find information on food allergy clinical trials.

While anecdotal and clinical experience supports improvement in milk production for women with insulin resistance who start or resume metformin, Vanky and colleagues (Vanky, Nordskar, Leithe, Hjorth - Hansen, Martinussen, & Carlsen, 2012) reported after a randomized, controlled trial that metformin had no effect on breast changes / size increase in pregnancy or breastfeeding in women who were obese.

Reduction of unnecessary intake of water and herbal teas on breast - fed infants: a randomized clinical trial with adolescent mothers and grandmothers

Influence of counseling sessions on the prevalence of breastfeeding in the first year of life: a randomized clinical trial with adolescent mothers and grandmothers

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.

Based on Han's presentation to the Depression Club, the group decided to move forward with a clinical trial in patients.

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.

Based on results of the current study described in a report online June 18 in the journal Cancer Cell, Johns Hopkins researchers say they are planning a phase I clinical trial to test the paclitaxel - fostamatinib combination therapy in patients with recurrent advanced ovarian cancer.

«First clinical trial on HER -2-negative breast cancer with nintedanib shows promising results.»

Lanza says that this time, he aims to do things right: direct good science focused on treating disease, publish in reputable journals with rigorous peer - review processes and work with high - quality collaborators and clinical centres for its trials.

Effect of Prehospital Induction of Mild Hypothermia on Survival and Neurological Status Among Adults With Cardiac Arrest A Randomized Clinical Trial.

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.

Ophthalmologists at 10 sites nationwide tested the ring in a phase 2 clinical trial on patients with glaucoma or ocular hypertension.

With neuroimaging, a neuroscientist can watch a drug's interaction with its receptor and judge its probability of success long before embarking on expensive late phase clinical triWith neuroimaging, a neuroscientist can watch a drug's interaction with its receptor and judge its probability of success long before embarking on expensive late phase clinical triwith its receptor and judge its probability of success long before embarking on expensive late phase clinical trials.

In a head - to - head clinical trial comparing standard chemotherapy with the immunotherapy drug nivolumab, researchers found that people with squamous - non-small cell lung cancer who received nivolumab lived, on average, 3.2 months longer than those receiving chemotherapy.

The TOPCAT trial is the first randomized, double - blind trial to assess the effect of spironolactone on clinical outcomes in these patients with heart failure and preserved ejection fraction.

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.

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.

Several clinical trials have tested whether taking vitamin D as a supplement has an effect on asthma attacks, symptoms and lung function in children and adults with asthma.

«There are multiple clinical trials going on right now with other members of the thiopeptide class.»

Focus on courses that provide you with broadly applicable tools: information technology, informatics, drug development, clinical trials, medicinal chemistry, operations management, and regulatory affairs are obvious choices.

The researchers hope to be able to start a controlled clinical trial to test the drug's efficacy on patients with aortic aneurysm.

Clinical trials of such tissue on patients with Parkinson's disease could start by 1999, he says.

It's kind of heartbreaking to hear these extraordinary innovators pick apart each other's work as they race to finish their various devices, complete clinical trials big enough to gain FDA approval and ramp up production with sufficient support personnel to help diabetics actually strap one on by 2017 or 2018.

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

All groups of both species showed improvement over the course of 10 to 12 trials, but the healthy participants consistently reached the target with a more economic route, the team reports on today in the Journal of Clinical Investigation.