Results of ASSET (Anglo-Scandinavian Study of Early Thrombolysis) mortality study published in the Sept. 3 issue of The Lancet show overall one month fatality rates with TPA at 7.2% versus 9.8% with placebo in the 5,009 patient study, representing a relative reduction of 26% (95% confidence interval 11-39%). "The 26% reduction of fatality rate is similar to that seen in the ISAM, GISSI, and ISIS-2 trials for streptokinase (12%, 18% and 21%, respectively, or 16%, 20%, and an estimated 27% for patients treated within 6 hours of onset)," the investigators observed. "The effect on 6 month mortality in ASSET will be described later but, by analogy with the late results of GISSI, it seems likely that the difference between groups observed at one month will remain unchanged".
You may also be interested in...
Roche/Genentech oncology partnering maintained a robust dealmaking pace through the pandemic, keeping the percentage of partnered R&D programs at about 50% of the cancer drug pipeline.
To mitigate pandemic disruption of component supply chains, the US FDA said it will downgrade some post-approval change categories for sterile drug container closure systems. The downgrade will cover drugs in shortage and those used to treat COVID-19.
“This is truly uncharted territory because we’ve never had this situation,” says CHPA regulatory VP David Spangle. Asking Congress instead to instruct FDA to first determine a safe daily limit would be a threatening precedent for the supplement market, says CRN CEO Steve Mister. “That really turns DSHEA on its head.”