Top Regulatory News Stories – Week Ending July 13, 2018

Eagle Pharmaceuticals announced that the U.S. FDA has granted seven years of orphan drug exclusivity in the U.S., for BENDEKA™ (bendamustine hydrochloride injection, or bendamustine HCI), a liquid, low-volume and short-time 10-minute infusion formulation of bendamustine hydrochloride. https://www.biospace.com/article/releases/fda-grants-eagle-seven-year-orphan-drug-exclusivity-for-bendeka-bendamustine-hydrochloride-injection-/?s=95 OBI Pharma, Inc. announced that the FDA has granted Orphan Drug Designation for OBI-3424 for the Treatment[…]