Sentences with phrase «further clinical studies»
Further clinical studies have also demonstrated efficacy in the treatment of liver and kidney disease.
http://www.womenlivingnaturally.com/ Not exact matches
Shares of Nektar Therapeutics rose 4.5 % in Tuesday trading as the company's opioid - modifying painkiller proved to have far less abuse potential than conventional opioids in a clinical study.
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).
* MEDICINES360 AND ALLERGAN PRESENT 5 - YEAR TRIAL DATA FROM LARGEST ON - GOING IUS CLINICAL STUDY Source text for Eikon: Further company coverage:
If we are required by the FDA, the EMA, or other regulatory authorities to perform studies in addition to those we currently anticipate, or if there are any delays in completing our clinical trials or the development of our current product candidates, our expenses could increase and our ability to generate revenue could be further delayed.
The strengths of the study include the ability to compare outcomes by the woman's planned place of birth at the start of care in labour, the high participation of midwifery units and trusts in England, the large sample size and statistical power to detect clinically important differences in adverse perinatal outcomes, the minimisation of selection bias through achievement of a high response rate and absence of self selection bias due to non-consent, the ability to compare groups that were similar in terms of identified clinical risk (according to current clinical guidelines) and to further increase the comparability of the groups by conducting an additional analysis restricted to women with no complicating conditions identified at the start of care in labour, and the ability to control for several important potential confounders.
Another strength of the present study is the identification of cow's milk allergy cases through the Special Reimbursement Register, as the requirement for the special reimbursement was based on clinical diagnosis made by a pediatrician and further reviewed against diagnostic criteria by another clinician.
Encourage investigators and funding agencies to pursue studies that further delineate the scientific understandings of lactation and breastfeeding that lead to improved clinical practice in this medical field.216
«Our studies provide promising results in mice, which merit further investigation, such as adjusting the formulation, dose and delivery route of MAOA inhibitors, prior to ultimate clinical application.»
Although the results are encouraging, the authors report limitations to their study and recommend additional investigations related to these and other mTBI biomarkers in blood that will further clarify their utility in clinical management.
«We're excited about this technique, and are seeking funding to pursue further studies and potential clinical translation,» Gu adds.
«We now hope to design larger clinical studies to treat patients» tumors harboring these novel genomic aberrations to further explore the precise extent of clinical benefit for patients with primary or advanced cholangiocarcinoma.»
But given its low cost, availability and safety history further study in a clinical trial to test its effectiveness against Zika virus in humans is merited.»
It will be important to follow this study up to examine these cognitive problems further and in particular to determine how they impact on clinical symptoms and school performance.»
«These results provide the basis for the potential implementation of 5 - LO - inhibitors as stem cell therapeutic agents for a sustained AML cure, although this must be investigated further in preclinical and clinical studies in humans,» explains Dr. Ruthardt.
But he emphasizes the need for further controlled clinical studies to confirm the effect.
In clinical trials, some patients experienced reduced lung function, which Pfizer, on further study, found to be medically insignificant.
«We are very excited to publish this work because we are hoping that a clinical research group will be inspired to take our study findings further in patients,» says Wu.
Weiss cautioned that this proof - of - principle finding is an early step, with many further studies to be done to verify if this approach will be safe and effective in clinical use.
«This vaccine appears to be safe for patients, and elicits a broad anti-tumor immunity — we think it warrants further testing in larger clinical trials,» said study lead author Janos L. Tanyi, MD, an assistant professor of obstetrics and gynecology at Penn Medicine.
«Further studies to clarify the impact and full effects of mTOR signaling are needed in order to support the clinical use of mTOR inhibitors in patients with spinal cord injury,» the authors wrote.
Although further work would be needed to validate the results in humans, the study suggests that a simple blood test along with other clinical indicators could potentially be used to diagnose the disease, the researchers say.
However, the researchers are pursuing further studies to ensure safety, practicality, and efficiency before considering bringing it to a clinical environment.
Further helping to identify the connection between anti-tTG levels and celiac disease, a study in Clinical Gastroenterology and Hepatology reconfirms the recent European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) guidelines, which recognize that the likelihood for celiac disease increases with increasing antibody concentration.
Getting Alzheimer's drugs to market requires long and costly clinical studies, which some experts say have failed thus far because experimental drugs were tested too late in the disease process.
However, they caution that because of the limited number of participants, further larger studies will be needed in general clinical settings to confirm the value of this audiovisual distraction tool.
Garet Lahvis was a 4th - year assistant professor of surgery at the University of Wisconsin (UW), Madison, when his department chair told him that his studies of social motivation and communication in mice — research with implications for autism and drug addiction — had moved too far from the department's focus on clinical plastic surgery and that the department would have to let him go.
Further research incorporating patient outcomes and data from actual clinical interactions is warranted to clarify the effect of clinician implicit bias on the provision of health care and outcomes,» the study concludes.
The researchers call for additional larger scale, multi-center clinical studies to further confirm the findings and determine the most effective and personalized treatment protocols.
The study is investigator led and has therefore focused on clinical need, targeting patients with progressive multiple sclerosis in whom most disability is incurred... The study also reports a predominant effect on neurodegenerative rather than inflammatory outcomes, suggesting a novel mechanism of action that might be suitable as combination treatment with immunomodulatory treatments... Further phase 3 studies to measure the effect of simvastatin on sustained disability, particularly in patients with non-relapsing secondary progressive and primary progressive multiple sclerosis, are clearly needed, but this trial represents a promising point from which to develop trials of progressive disease.»
Clinical Psychologist and lead author of the study, Dr Thomas Richardson, says: «There may be a «vicious cycle» for these students, where negative attitudes towards eating increase the risk of financial difficulties in the short term, and those difficulties further exacerbate negative eating attitudes in the longer term.»
In an accompanying editorial, Dr. Timothy E. Morey of University of Florida points out the need for further studies to test the advantages of the new proliposomal formulation, especially in clinical situations where its properties may be most useful.
«Our research group plans to conduct further studies to identify and understand the gap between current antibiotic prescribing practices in the community and clinical practice guidelines,» Durkin said.
This feature would be critical for clinical uses, such as transplanting stem cells — with their defects corrected — back into patients, but the researchers emphasize that years of further study remain before such treatments might be possible.
That's true of both population - level studies looking at marijuana's potential harms, as well as clinical studies looking for benefits, although the report notes that there have been far more population studies than clinical studies.
If these preclinical studies are successful, the researchers plan to further develop their CAR T cell therapy and test its safety and efficacy for different types of metastatic cancer in upcoming clinical trials.
Further study in clinical trials is necessary, but the study provides a promising new find in a type of cancer with no current targeted options, Chan said.
Further study of the relationships between the clinical assays for CTX and PINP as well as physiological and pre-analytical factors contributing to variability in BTM concentrations is required.
Clinical studies thus far have failed to identify an effective treatment strategy when a combination of targets controlling aspects of neuroprotection, neuroinflammation, and neuroregeneration is needed.
Looking ahead, this newly generated mouse model offers far - reaching scope to study the molecular bases of hydrocephalus, a fairly common clinical condition in humans, where the causes are often unknown.
Although further studies are necessary, potential clinical applications of the team's finding would involve developing methods or drugs that prevent Mtb from entering M - cells.
«Overall, our studies show a new therapeutic strategy for the treatment of chronic inflammatory pain that deserves further study for its potential use in clinical medicine,» says the professor of the University of Valencia.
So far, the studies of diabetic ulcers and rheumatoid arthritis mentioned above are the only methods to show evidence of clinical effectiveness in human patients.
They urge further studies to assess the clinical outcomes of opioid use by under - 65 disabled workers and factors associated with chronic opioid use.
«Further studies are needed to determine the clinical importance and long - term consequences of these findings.»
The new study should prompt further clinical research.
Melton and his colleagues are already working with Evotec, a company in Hamburg, Germany, and Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, to further study betatrophin and possibly move it toward clinical trials.
The findings, which come from a study appearing in an upcoming issue of the Clinical Journal of the American Society of Nephrology (CJASN), provide further evidence that many of the donated kidneys that are discarded are in fact suitable for use.
«Further studies are needed to assess long - term associations with clinical outcomes,» the authors write.
He cautions that the study is years from a clinical application, but says, «most studies so far have concentrated on bacterial factors.