Additional clinical trial data later this year on Tesaro's key drug, Niraparib, which targets advanced solid tumors in ovarian and breast cancers, could help narrow the valuation gap, the people said.
Not exact matches
The documentation ranges across the whole spectrum of drug development: Investigators» brochures provide information on all that is currently known about the medicine and so need periodic updating; accurate and concise protocols are required to ensure that
trials are performed effectively;
clinical trial reports (generally from phase II and III studies) present the information gathered from the
trials; higher level documents provide summaries of efficacy and safety
data from
clinical trial programmes; expert reports provide critical interpretation of the results; and response documents clarify any points that are not clear to the regulatory agencies or provide
additional analyses or supporting
data for any items of concern.
Having previously published
data on a variety of experimental mAbs against AS species in animal models -LRB-[16,20]; possibly [21]-RRB-, Prothena's Dale Schenk presented new
data on
additional experimental antibodies at SENS Research Foundation's Rejuvenation Biotechnology 2014 conference, roughly contemporaneous to its publication, [22] along with information specific to the humanized candidate PRX002, which is now being advanced into
clinical trials.
Potential cardioprotection was based on generally supportive
data on lipid levels in intermediate outcome
clinical trials,
trials in nonhuman primates, and a large body of observational studies suggesting a 40 % to 50 % reduction in risk among users of either estrogen alone or, less frequently, combined estrogen and progestin.2 - 5 Hip fracture was designated as a secondary outcome, supported by observational
data as well as
clinical trials showing benefit for bone mineral density.6, 7 Invasive breast cancer was designated as a primary adverse outcome based on observational
data.3, 8
Additional clinical outcomes chosen as secondary outcomes that may plausibly be affected by hormone therapy include other cardiovascular diseases; endometrial, colorectal, and other cancers; and other fractures.3, 6,9