Sentences with phrase «on clinical trials of»

Billions of dollars have been spent on clinical trials of Alzheimer's drugs that target amyloid plaques — the hallmark protein tangles that clog brain cells in people with the memory - robbing disease.

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 questioned.

Not exact matches

Not surprisingly, the spread of diseases (not to mention unhealthy lifestyles that lead to diseases) on a global level is much easier than coordinating care, managing supply chains and clinical trials and rolling out treatments.

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.

Shares of cancer - focused biotech Clovis Oncology soared nearly 50 % in early Monday trading on the strength of clinical trial results for its ovarian cancer treatment Rubraca.

The approval was based on two clinical trials of the device and lowers the barrier of entry for other similar devices, by establishing criteria that classify these systems as moderate risk medical devices, the FDA announced.

Some small studies have suggested that synbiotics could provide benefits to a range of other conditions influenced by the gut microbiome as well, including obesity, diabetes, and non-alcoholic fatty liver disease, but larger - scale clinical trials focusing on each of those conditions are needed.

Earlier this year Merck halted trials on its once - promising Alzheimer's drug after an independent panel of ruled there was «virtually no chance of finding a positive clinical effect.»

A second set claimed that the FDA had seized clinical - trial records of Sarepta Therapeutics (SRPT) on suspicions the results had been «doctored.»

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.

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.

Last year The Ohio State University Wexner Medical Center began clinical trials on the efficacy of SuperBetter to treat traumatic brain injuries, and the University of Pennsylvania Positive Psychology Center greenlighted a randomized controlled user study of the game to treat depression.

It had originally registered the clinical trial in a U.S. government database as «The Effects of SPRINT, a Combination of Natural Ingredients, on Cognition in Healthy Young Volunteer.»

But while thousands of clinical trials on immunotherapy drugs, of which many are predicted to fail, are springing up, the depth of information on neoantigen vaccines is much shallower: Just two studies on neoantigen vaccines for melanoma, recently profiled in Nature, were completed last year in Boston and Germany.

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.

The biotech plans to shed 20 % of its nearly 600 employees in order to secure yearly cost - savings of about $ 21 million — money which can then be used to double down on late - stage clinical trials for its experimental Parkinson's drug.

On average about 99 % of all drugs in clinical trials never actually make it to approval, and drugs are still failing late - stage trials in 2017.

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.

There are about 120 studies ongoing in Israel, including clinical trials looking at the effects of cannabis on autism, epilepsy, psoriasis, and tinnitus.

Solanezumab, a drug developed by Eli Lilly that also acts on the amyloid hypothesis, failed some key clinical trials, though the company is still testing it in the pre-clinical stages of the disease.

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.

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).

HERERA: Merck (NYSE: MRK) was one of the best performing stocks on the blue chip Dow index today, after the drug company «s new type of lung cancer drug performed better than expected in a highly anticipated clinical trial.

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.

The flagship drug of San Diego's MediciNova failed a midstage clinical trial for methamphetamine dependency, casting doubt on prospects for a product it has placed great hopes in.

In 2000 - 10 roughly 80,000 patients took part in clinical trials based on research that was later retracted because of mistakes or improprieties.

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 payments are dependent on reaching certain milestones based on the commencement and outcome of clinical trials.

We may be subject to different or contradictory regulatory requirements in different countries, and different regulatory authorities may not be aligned on the clinical trials necessary to support approval of our product candidates.

Juno Therapeutics is seeking to change the protocol for the Phase II ROCKET clinical trial of its acute lymphoblastic leukemia candidate JCAR015, which the FDA has placed on clinical hold following the deaths of three patients, two of them last week.

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.

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.

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.

However, a recent clinical trial (39) did not find any beneficial effects of short - term (6 wk) dark chocolate and cocoa consumption on cardiovascular outcomes or on neuropsychological tests.

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.

On the heels of a 2013 double - blind clinical trial which showed Axiom Foods» Oryzatein ® plant - based brown rice protein parallels animal - based whey in building and repairing muscle, Oryzatein ® has now become the very first brown rice protein to be granted GRAS approval.

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.

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.

(Culver City, CA April 8, 2014)-- On the heels of a 2013 double - blind clinical trial which proved Axiom Food's Oryzatein ® plant - based brown rice protein equals animal - based whey in building and repairing muscles, Oryzatein has now become the very first brown rice protein to be granted GRAS approval.

The study comes on the heels of a 2013 clinical trial that showed rice protein paralleled whey protein in its ability to build muscle and improve strength and power for the first time.

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.

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.

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.