FDA boosts efforts to deliver clinical trial findings to public
WASHINGTON Following the passage of the Food and Drug Amendments Act of 2007, the Food and Drug Administration has been beefing up the system to disseminate data from clinical trials to the public.
Under the act, data from more clinical trials must be submitted to the FDA’s official reporting Web site, www.clinicaltrials.gov. Scientists leading clinical trials have 21 days after enrolling their first test subjects to post registration information, 30 days to post information after making any changes to the study and a year to post the results of the study after it?s finished.
Shopko donates school supplies to Green Bay area elementary school
GREEN BAY, Wis. An elementary school in Green Bay received a variety of school supplies from a locally headquartered retail chain.
Shopko announced Oct. 2 that it had donated the supplies to Sunrise River Elementary, which serves students in second through fifth grade. The supplies included basic items from the school’s required supply list.
Shopko operates stores throughout the Midwest and West.
ARCA Biopharma makes unprecedented payment to Aeolus following FDA approval of bucindolol
NEW YORK Aeolus Pharmaceuticals announced Friday that it had received a $175,000 milestone payment from ARCA Biopharma following the Food and Drug Administration’s acceptance of an approval application for a cardiovascular drug.
Aeolus said the drug, bucindolol, could be the first genetically targeted cardiovascular therapy. CPEC, a company owned jointly by Aeolus and Indevus Pharmaceuticals, licensed all rights to bucindolol to ARCA.
“ARCA’s success in demonstrating the potential benefits of bucindolol in treating heart failure in patients is encouraging,” Aeolus president and chief executive officer John McManus said in a statement. “We look forward to an expeditious review and hope for a positive outcome.”