• Baxter International Inc., of Deerfield, Ill., said it submitted a marketing authorization application to the European Medicines Agency for Rixubis, (recombinant Factor IX [nonacog gamma]) to treat and prevent bleeding in patients with hemophilia B. The drug was approved by the FDA in June to control and prevent bleeding episodes, manage perioperative events and prevent or reduce the frequency of bleeding episodes in adults with hemophilia B.

• Johnson & Johnson, of New Brunswick, N.J., is facing a lawsuit filed by the AIDS Healthcare Foundation (AHF) in California against J&J and its subsidiaries alleging the companies failed to satisfy their obligations with respect to drugs they sold to AHF under the 340B Program, a federal drug discount program for safety net health care providers. The lawsuit, filed in the Superior Court of California, County of Los Angeles, Central District, cited violations of California’s unfair competition law, breach of contract as a third-party beneficiary, negligence, unjust enrichment and breach of covenant of good faith and fair dealing. AHF said it is entitled to relief based on statutory, contractual and equitable theories, citing J&J’s significant control of the AIDS drug market through Prezista (darnavir), Intelence (etravirine), Endurant and Procrit (epoetin alfa).