Morning Briefing
Summaries of health policy coverage from major news organizations
Factory Inspection May Be To Blame In Biocon's Recent FDA Rejection
Biocon’s recent biosimilar track record at the FDA isn’t looking so hot. Following an insulin copycat slap-down last month, Biocon on Sunday revealed (PDF) a complete response letter from the FDA on a proposed biosim to Roche's Avastin. (Kansteiner, 2/13)
Generics giant Sun Pharma has found itself at the center of another nationwide recall in the U.S. (Becker, 2/14)
Watch out, Incyte: Leo Pharma’s topical JAK inhibitor is catching up. In a late-stage trial in moderate to severe chronic hand eczema, Leo Pharma's delgocitinib cream met its primary and secondary endpoints, the Danish dermatology specialist said Friday. (Becker, 2/13)
The use of azithromycin reduces maternal infection in women during planned cesarean delivery, but its effect on those with planned vaginal delivery is unknown. Data are needed on whether an intrapartum oral dose of azithromycin would reduce maternal and offspring sepsis or death. (Tita, M.D., Ph.D., et al, 2/9)
