Sentences with phrase «other clinical trials for»

In September that trial and three other clinical trials for related immune disorders in the United States were suspended.

Not exact matches

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.

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.

GUMC says its researchers are now planning larger clinical trials with nilotinib for patients with Parkinson's and other similar diseases including Alzheimer's disease, likely to begin in 2016.

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).

Juno asserted that the clinical hold on the ROCKET trial did not affect plans for its other CD19 - directed CAR T - cell product candidates, including JCAR017, for which the company has launched two clinical trials now recruiting patients.

Other PMT - derived programs — for example, Project SafeCare in Oklahoma — have also shown significant promise for reducing child maltreatment in randomized clinical trials at the state and local level.

We searched the following databases to 18 February 2016: the Cochrane Central Register of Controlled Trials (CENTRAL)(the Cochrane Library), MEDLINE including In - Process & Other Non-Indexed Citations (OVID), Embase (OVID), PsycINFO (OVID), and CINAHL (EBSCO); the metaRegister of Controlled Trials (mRCT), ClinicalTrials.gov (clinicaltrials.gov), and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP)(apps.who.int / trialsearch /) for ongoing tTrials (CENTRAL)(the Cochrane Library), MEDLINE including In - Process & Other Non-Indexed Citations (OVID), Embase (OVID), PsycINFO (OVID), and CINAHL (EBSCO); the metaRegister of Controlled Trials (mRCT), ClinicalTrials.gov (clinicaltrials.gov), and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP)(apps.who.int / trialsearch /) for ongoing tTrials (mRCT), ClinicalTrials.gov (clinicaltrials.gov), and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP)(apps.who.int / trialsearch /) for ongoing tTrials Registry Platform (WHO ICTRP)(apps.who.int / trialsearch /) for ongoing trialstrials.

To learn more about these clinical trials and others that are available at Floating Hospital for Children, please e-mail the Pediatric Clinical Trials Office at pediatrictrials@tuftsmedicalcenclinical trials and others that are available at Floating Hospital for Children, please e-mail the Pediatric Clinical Trials Office at pediatrictrials@tuftsmedicalcentetrials and others that are available at Floating Hospital for Children, please e-mail the Pediatric Clinical Trials Office at pediatrictrials@tuftsmedicalcenClinical Trials Office at pediatrictrials@tuftsmedicalcenteTrials Office at [email protected].

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.

AstraZeneca's AKT inhibitor is currently in clinical trials for prostate, breast and other cancers.

After years of false starts, a new generation of DNA vaccines and medicines for HIV, influenza and other stubborn illnesses is now in clinical trials

Redberg and others have also criticized the CTT for not releasing the raw data of clinical trials, which would allow other independent researchers to mine the data for adverse reactions.

Other reasons for testing tau drugs in PSP patients have more to do with clinical trial practicalities.

Several JAK2 inhibitors have already been approved by the FDA or are currently in clinical trials for the treatment of other cancers.

«Every day, most of us take for granted that when we will to move, we can move any part of our body with precision and control in multiple directions and those with traumatic spinal cord injury or any other form of paralysis can not,» said Benjamin Walter, associate professor of Neurology at Case Western Reserve School of Medicine, Clinical PI of the Cleveland BrainGate2 trial and medical director of the Deep Brain Stimulation Program at UH Cleveland Medical Center.

Now a University of Colorado Cancer Center study published online ahead of print in the journal Oncogene offers compelling evidence explaining this failure and offering a possible strategy for the use of retinoic acid or other retinoids against some breast cancers: Because early clinical trials are often offered to patients who have already tried other more established therapies, breast cancer cells may have been pushed past an important tipping point that offers retinoic acid resistance.

It also has a preliminary program to make other blood proteins, such as alpha - 1 anti trypsin, and a clinical trial in the U.S. for ATryn.

Critical factors to achieve a higher level of information sharing include: a) the development and adoption of global data interchange standards that are harmonized between health care and clinical trials; b) the use of technology that is more acceptable to users; c) clarification of and adherence to regulatory requirements for health care and clinical trials; d) implementation of new technologies that are being employed by other industries to facilitate data interchange, specifically the use of the eXtensible Markup Language or XML.

In 2012, the NHMRC provided almost A$ 3 million in research funding for clinical trials for people with chronic diseases, among many other projects.

«The work will have direct implications for designing clinical trials using oncolytic viruses, not only for brain tumors, but for other solid tumors.»

The compound is now in phase II clinical trials for diabetic nephropathy and is being explored in other fibrotic diseases.

Two are in clinical trials — one to treat gout and the other for leukemia.

One of these CDK2 inhibitors, kenpaullone, was more effective than four other compounds that are currently in clinical trials for treating hearing loss.

No wonder the team from Penn has been besieged by entreaties for entry into clinical trials and other sorts of help.

A health - agency windfall includes funding for two promising clinical trials, one focusing on prevention and the other on early treatment

«Our research paves the way for future clinical trials that screen for AIM2 expression in colon cancer and possibly other cancers to identify patients who may potentially benefit from personalized anti-Akt therapy,» Wilson said.

This improvement could be a significant result, as there are currently no approved pharmaceutical therapies for traumatic brain injury (TBI), and recently completed clinical trials have not demonstrated any benefit of other tested neuro - protective interventions.

Meanwhile, his research teams are moving several other novel therapies toward clinical trials, each of which has potential for use in the synergistic model of cancer treatment that Black believes will offer the best hope for his patients.

The immunotherapy drug pembrolizumab — already FDA - approved for other forms of cancer - has been found to be effective in patients with metastatic triple negative breast cancer, according to an international clinical trial led by NYU Langone's Perlmutter Cancer Center.

AG1295 won't work inside the body because it can't get to the marrow, but Small says his team has already identified other FLT3 inhibitors potentially useful for patients, and clinical trials are just around the corner.

AAV viral particles are in clinical trials for other purposes, making the researchers optimistic that this CRISPR delivery method could be used in humans, although more studies are needed.

Another limitation is that bioRxiv is for life sciences, not medicine, so it will not publish clinical trials or other research that is «medically relevant,» Inglis says.

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.

Long - term use of mifepristone has been studied in clinical trials for other tumors, with minimal adverse effects reported after years of usage.

A few other drugs, including a THI derivative and an unrelated drug now in clinical trials for rheumatoid arthritis, also showed beneficial effects in fruit flies.

Wender and others are also pursuing clinical trials for bryostatin 1 as a drug for HIV.

A drug used for decades to treat high blood pressure and other conditions has shown promise in a small clinical trial for autism.

Double - blind clinical trials, the gold standard for research studies in medicine, have never been conducted to investigate the effects of marijuana's terpenes or its cannabinoids other than THC.

«Our work not only holds potential for developing cells for treatment of other areas of the eye, but could set the stage for future human clinical trials of anterior eye transplantation to restore visual function.»

The team envisions that in the future, deaf people might benefit from gene therapy similar to the approaches currently being tested in clinical trials for other diseases.

«The research lays the groundwork for possible clinical trials to address the behavioral aspects of anorexia nervosa and other neuropsychiatric diseases with compulsive behavioral components,» he said.

The impetus for the plan is evidence from recent clinical trials showing that treating people with HIV earlier not only reduces the likelihood of disease progression but also lowers the chances that they will infect others.

Studies are underway, and similar to the glioma therapy development, I am working to develop clinical trials for brain metastasis, together with medical oncologists Mansoor Saleh, M.D., Andres Forero, M.D., and others at UAB.»

They then soaked tiny collagen sponges (which are made from the same protein found in dentin) in various drugs known to stimulate Wnt signaling, including tideglusib, a compound that has been investigated in clinical trials for its potential to treat Alzheimer's and other neurological disorders.

Vaccine developers are trying to improve vaccines for transplant recipients and other people with a weak immune system, and the samples used in this study came from a clinical trial of different versions of a flu vaccine in patients on immune - suppressive drugs.

Streamlining the regulatory process for developing genetic and other treatments for rare diseases, recognizing the time - consuming difficulty of acquiring a critical mass of patients for clinical trials for disorders affecting very few people.

«Our next step is to see how long we can extend the cycling pattern, and test some of the STAT3 inhibitors currently in clinical trials for other indications such as cancer, as this could accelerate testing in humans,» added Sacco.

In fact, the researchers point out that phase 1 clinical trials are already underway for compounds targeting this gene in other cancers, meaning that the time needed to apply a similar strategy to mucosal melanoma could be dramatically shorter than if they had to start from scratch.