FDA approves Bayer’s drug for hemophilia in children
NEW YORK The Food and Drug Administration has approved Bayer HealthCare’s Kogenate FS (antihemophilic factor [recombinant]) to reduce bleeding episodes and joint damage in children with hemophilia A, the Bayer subsidiary announced Friday.
The company said the approval provides children with the only factor VIII treatment that the FDA has deemed safe and effective for routine protective treatment, recommended by the National Hemophilia Foundation’s Medical and Scientific Advisory Council.
Hemophilia A, also known as factor VIII deficiency or classic hemophilia, affects about one-in-5,000 males born in the United States.
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.”