Results from the first randomized controlled European clinical trial of GlaxoSmithKline's ($GSK) pneumococcal conjugate vaccine show it's highly effective when it comes to preventing invasive pneumococcal disease in infants younger than age 2.
As clinical trials get more and more complex, Pharmaceutical Product Development has reached out to technology consultancies Tessella and Berry Consultants to use FACTS, adaptive trial software that lets study designers simulate trials in their early planning stages.
Earlier this year, 10 of the biggest names in drug development joined forces to streamline outsourcing R&D, and the resulting nonprofit is creating a huge database of global clinical trial sites.
The study, which tested the formulation as a once-a-day therapy, missed its main goal of changing seizure frequency compared with placebo.
AcelRx Pharmaceuticals shares got a big boost this morning after the biotech announced that its post-operative pain therapy--the Sufentanil NanoTab PCA (patient-controlled analgesia) System--was not only not inferior to the standard IV morphine but also beat it on a key measurement score while gaining kudos from nurses and patients.
The open R&D movement just took another step forward. A trio of pharma giants--J&J, Merck and Eli Lilly--has reportedly begun to create a "one-stop" database to help streamline their work with clinical trial sites worldwide, enlisting direct input from an international network of more than 100,000 investigators.
Tranzyme--named a Fierce 15 company back in 2005--has had a rough run these past two years. The company was forced to offer a big discount when it went public in 2011. And the failure of the GI drug program in the spring triggered a meltdown in its share price.
CRA Holdings, the parent company of Clinical Research Advantage, has agreed to buy Radiant Research, expanding its number of trial sites and study capabilities.
After impressing analysts with topline results last month, Abbott revealed that its triple-combo of antiviral drugs offered slightly better efficacy when given with ribavirin than without in its Phase IIb "Aviator" study. Check out more coverage from the American Association for the Study of Liver Diseases' meeting in Boston >>
Ken Getz, assistant professor at Tufts Center for the Study of Drug Development, has come out with a new analysis showing that one in 5 procedures performed in "later" stage drug development is done in pursuit of "supplementary secondary, tertiary, and exploratory endpoints." And it isn't cheap, adding an average cost of $1.1 million per trial spent in pursuit of "extraneous data."