BioAlliance Pharma S.A. (Euronext:BIO) gained €0.08 to €3.30 last week after FDA accepted for review an NDA for Sitavig acyclovir Lauriad to treat recurrent orofacial herpes. The PDUFA date is undisclosed. BioAlliance submitted the application in 1Q12; a 10-month standard review would place the PDUFA date around year end. The product is also under review in Europe, where it is known as Sitavir.
CSL Ltd. (ASX:CSL) gained A$0.71 to A$37.18 last week after FDA accepted for review a BLA for 4-factor prothrombin complex concentrate (PCC) for the reversal of vitamin K antagonist therapy, including warfarin, in patients with acute major bleeding.