Sentences with phrase «safety trial involving»
The current HTTRx safety trial involves patients with early symptoms of Huntington's disease.
https://en.hdbuzz.net/ Not exact matches
The program will involve clinical trials testing for safety in humans, followed by a larger trial using non-human primates exposed to Ebola.
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).
It typically takes many years to initiate such trials because of the stringent safety testing that must be done before testing in humans begins, but Reynolds said it may be possible to move faster as the therapy only involves modifying a patient's dietary intake and supplementing with a medium - chain triglyceride oil, both of which have no known side effects.
If animal tests go well, the next trials will be with humans, a process that involves three stages — one for safety, the next to see if the protein kills cancer in a limited number of people, and the last to turn it loose in a large group.
«The promising safety results of these early trials set the stage for additional HCQ trials in different cancers, and trials involving new autophagy inhibitors that are being developed by pharmaceutical companies,» said Amaravadi.
The study, which will involve 16 000 women, could be under way before a similar trial in Britain, which has become entangled in a controversy over the drug's safety.
Strollo led a large study of the new treatment, a yearlong safety and efficacy trial involving 126 people with moderate to severe obstructive apnea.
«It is exciting to be directly involved in creating an innovative clinical trial infrastructure that will yield important efficacy and safety data on novel asthma interventions,» says Dr. Jain, «I look forward to participating in this work and seeing how it directly impacts asthma patients.»
The approval process involves several steps including preclinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, and FDA review and approval of the application.
The UK's aviation safety agency, the CAA, will be involved in helping work out safety rules for flying the drones beyond line of sight and the government, as well as those of other countries watching, will be using the outcome of these trials to refine drone regulations.
Witnesses often are reluctant to testify in criminal trials, either because they fear for their safety or because they simply don't want to be involved.
Successfully defended an international tree care company in multiple trials before the Occupational Health and Safety Commission involving workplace deaths and the applicability of logging regulations to an employer engaged in arborist work.
Most trials involve testing for the safety of various interventions, and the effectiveness of treatments or medicines.