[NIAID Director Anthony] Fauci says $ 56 million of the total would go toward a larger efficacy trial in Liberia, which would include both the NIAID / GSK [GlaxoSmithKline] vaccine and another made by NewLink Genetics of Ames, Iowa (pending more data from
ongoing safety trials).»
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 SEC).
In a historic milestone for the drone industry, this week AirMap and Project Wing in a test program led by the Virginia Tech Mid-Atlantic Aviation Partnership, successfully demonstrated an industry - leading solution to
safety - critical airspace deconfliction challenges as part of the
ongoing NASA - UTM
trials.
Alleged N2.3 billion NIMASA Scam: Witness says he shared N121 m on Accused's Instruction The Economic and Financial Crimes Commission, EFCC, Tuesday presented the sixth witness in the
ongoing trial of a former Director General of Nigerian Maritime Administration and
Safety Agency, NIMASA, Patrick Akpobolokemi and five others for the alleged diversion of over Two Billion -LSB-...]
Rwanda will present
safety and efficacy data on 50 patients at the American Urology Association in May 2011, and a randomized, controlled
trial with 150 participants, designed to compare PrePex with the conventional surgical method is currently
ongoing.
The drug has already demonstrated
safety in nonhuman primate
trials, and the cardiovascular research might even be able to skip ahead to a larger phase II
trial based on
safety data from the
ongoing phase I studies, Leeper suggests.
At the International Society for Stem Cell Research 2017 Annual Meeting (June 14 - 17, 2017; Boston, USA), Asterias Biotherapeutics, Inc (CA, USA) will present new 9 - month efficacy and
safety data from their
ongoing SCiStar Phase I / IIa
trial of human embryonic stem cell - derived oligodendrocyte progenitor cells.
The first clinical
trial was a
safety study in Australia, followed by an
ongoing efficacy study in Peru to evaluate the ability to treat patients with malaria.
Asterias Biotherapeutics, Inc will present new 9 - month efficacy and
safety data from their
ongoing Phase I / IIa
trial for OPC - 1 in a workshop and poster presentation.
Prothena announced the dosing of the first Phase Ia subject on April 8, 2014; they appear to have been successful in recruiting subjects and to have quickly derived favorable
safety signals, as they announced the dosing of the first PD volunteer in the Phase Ib
trial on July 31, 2014, «based upon
safety and tolerability observed to date in the
ongoing study in healthy volunteers.»
The Phase 1/2
trial called STEP ONE, or
Safety, Tolerability, and Efficacy of VC - 01 Combination Product in Type One Diabetes, is
ongoing.
Researchers hope that if the
ongoing preliminary studies prove the
safety and effectiveness of these drugs for certain treatments, the government will step in to fund larger
trials.
In it they conclude that the literature available and preliminary results from
ongoing trials, suggest the
safety and feasibility of the ketogenic diet in GBM's.
Dr. Powers completed a clinical drug
safety trial for the use of Advantage Multi for Cats (Bayer) in domestic ferrets, and has conducted several other research studies while at Carolina Veterinary Specialists, including an investigation into the metabolism of the anticonvulsant drug phenobarbital in African grey parrots and
ongoing studies investigating a newly characterized intestinal parasite of cockatiels, Spironucleus meleagridis.