Sentences with phrase «investigational drug study»

Not exact matches

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 SDrug 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 Sdrug 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).

Merck Pharmaceuticals (also manufacturers of the Follistim Pen) selected Pacific Fertility Center as one of about 35 study sites located in the United States to participate in this investigational drug trial in the largest multi-center IVF trial ever undertaken.

Along with the study's co-first authors, Drs. Aayoung Hong and Gatien Moriceau, Lo hypothesized that if they could identify the key tumor cell processes triggered by withdrawal of MAPK inhibitors, then scientists can exploit these process with existing or investigational drugs to trigger the maximal levels of tumor cell death immediately following cessation of the initial therapy.

Crucially, they also help investigators through the paperwork required to win approval from the Food and Drug Adminstration (FDA) to use an investigational drug in a human stDrug Adminstration (FDA) to use an investigational drug in a human stdrug in a human study.

A 12 - week dose of an investigational three - drug hepatitis C combination cleared the virus in 93 percent of patients with liver cirrhosis who hadn't previously been treated, according to a study in the May 5, 2015, issue of The Journal of the American Medical Association.

A study publishing October 1 in Cell Stem Cell reveals why these symptoms arise and tests an investigational drug in mice that could prevent them from developing.

The first trial they revisited, called VAX003, was completed in 2003 and studied an investigational vaccine among intravenous drug users.

An «investigational new drug» application was required by the U.S. Food and Drug Administration to test the pure synthetic (pharmaceutical - grade) resveratrol in the stdrug» application was required by the U.S. Food and Drug Administration to test the pure synthetic (pharmaceutical - grade) resveratrol in the stDrug Administration to test the pure synthetic (pharmaceutical - grade) resveratrol in the study.

Since the mid-1990s, FDA has deemed that organisms used in challenge studies are experimental medicines, and the agency has required researchers to submit Investigational New Drug applications before conducting trials.

A NIH National Cooperative Drug Discovery / Development grant funded the early basic science and discovery of this investigational drug and the Alzheimer's Drug Discovery Foundation and Harrington Discovery Institute helped support some of the key toxicity studies that FDA required, Conn sDrug Discovery / Development grant funded the early basic science and discovery of this investigational drug and the Alzheimer's Drug Discovery Foundation and Harrington Discovery Institute helped support some of the key toxicity studies that FDA required, Conn sdrug and the Alzheimer's Drug Discovery Foundation and Harrington Discovery Institute helped support some of the key toxicity studies that FDA required, Conn sDrug Discovery Foundation and Harrington Discovery Institute helped support some of the key toxicity studies that FDA required, Conn said.

Poly - IC is an investigational drug that has been studied in humans with brain tumors, pancreatic and stomach cancers.

Although this classification was removed a decade later, since 1965, in order to conduct clinical studies of Coley's Toxins, investigators are required to submit an Investigational New Drug (IND) application with the FDA.

The Study will examine an oral investigational drug that may have some effect on the brain changes associated with Alzheimer's disease / The study is designed to find outwhether this investigational drug (or «study drug») can slow down the decline in memory and mental functioStudy will examine an oral investigational drug that may have some effect on the brain changes associated with Alzheimer's disease / The study is designed to find outwhether this investigational drug (or «study drug») can slow down the decline in memory and mental functiostudy is designed to find outwhether this investigational drug (or «study drug») can slow down the decline in memory and mental functiostudy drug») can slow down the decline in memory and mental functioning.

«Investigational» means that the drug is still being evaluated in clinical studies, and has not yet been approved for use by doctors in their everyday practice.

A preliminary study has revealed that an investigational drug may help increase protein levels in babies with spinal muscular atrophy.

The results of long - term safety studies in mice were previously submitted to the Food and Drug Administration to gain permission for a Phase 1 clinical trial under an Investigational New Drug (IND) application.

Vescor, advised by its scientific founders White and Kimmelman, whose research has shown inhibition of autophagy can dramatically impact tumor growth in pre-clinical models, will develop small molecule inhibitors of a number of protein targets at critical nodes of the autophagy cascade, perform investigational new drug (IND) enabling studies, and move these into clinical development.

UNITY recently completed Investigational New Drug (IND) application - enabling studies of UBX0101 and plans to submit an IND application in 2018.

MINNEAPOLIS - A preliminary study suggests that an investigational drug may help increase protein levels in babies with spinal muscular atrophy.

Exclusion Criteria: • Receipt of anticancer medications, anticancer therapies, or investigational drugs within the defined interval before the first administration of study drug.

During her tenure at MHRP, she has served as Director of the Rockville Vaccine Assessment Clinic and also as an investigator in multiple clinical and laboratory - focused protocols, including investigational drug and international studies.

The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab (also known as BMS - 936558).

4/10/2007 National Weight - Loss Study Open At Moores UCSD Cancer Center Nutrition experts at the Moores UCSD Cancer Center and Scripps Clinic in Del Mar are seeking obese men and women to participate in a research study for weight loss employing an investigational combination drug therapy and behavioral modificaStudy Open At Moores UCSD Cancer Center Nutrition experts at the Moores UCSD Cancer Center and Scripps Clinic in Del Mar are seeking obese men and women to participate in a research study for weight loss employing an investigational combination drug therapy and behavioral modificastudy for weight loss employing an investigational combination drug therapy and behavioral modification.

July 14, 2015 Investigational drug prevents life - threatening side effects of kidney disease treatment A yearlong study of more than 300 patients found that the investigational drug patiromer can reduce elevated blood - potassium levels — a common side effect of drugs essential in the treatment of chronic diabetic Investigational drug prevents life - threatening side effects of kidney disease treatment A yearlong study of more than 300 patients found that the investigational drug patiromer can reduce elevated blood - potassium levels — a common side effect of drugs essential in the treatment of chronic diabetic investigational drug patiromer can reduce elevated blood - potassium levels — a common side effect of drugs essential in the treatment of chronic diabetic kidney disease.

But under an «investigational device exemption,» the U.S. Food and Drug Administration granted permission for a five - patient pilot study to see if the procedure could curtail blood flow to the stomach and thereby suppress production of the «hunger hormone» ghrelin.

Dr. Sandra Sargent is starting another clinical study with an investigational drug for atopic dermatitis.

Assisted seven clinical study teams in the execution of clinical trials, including the following activities: developed and maintained tracking tools, prepared minutes from meetings, prepared mailings to investigational sites, assisted with investigational site payments and budget oversight, inputted drug orders, randomized patients, and performed other study specific projects per the needs of the study team

Nurse Researcher Penn Medicine, Hampton, GA 10/2012 — Present • Provide and coordinate clinical care for patients involved in clinical research studies • Ascertain accuracy of data collection and data recording, and handle correlating follow - up • Schedule evaluation screenings and ensure that all participant are made physically and mentally ready for them • Provide patient participants with information on what to expect during clinical trials • Handle administration of investigational drugs, and handle detailed clinical assessments • Study chronic and acute diseases and disorders, and assist in developing new treatment plans • Assist in testing new treatments and medications that may change the way diseases and disorders are perceived • Compile clinical data and review and assess it for reporting purposes