Factory Inspection May Be To Blame In Biocon’s Recent FDA Rejection
Read about the biggest pharmaceutical developments and pricing stories from the past week in KHN's Prescription Drug Watch roundup.
FiercePharma:
Biocon Hit With FDA Rejection For Avastin Biosimilar
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)
FiercePharma:
Sun Recalls Generic For High Blood Pressure After Failed Test
Generics giant Sun Pharma has found itself at the center of another nationwide recall in the U.S. (Becker, 2/14)
FiercePharma:
Leo Pharma Scores In Phase 3 Trial For JAK Inhibitor Cream
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)
New England Journal of Medicine:
Azithromycin To Prevent Sepsis Or Death In Women Planning A Vaginal Birth
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)
