• Janssen Biotech Inc., of Horsham, Pa., a unit of Johnson & Johnson, said it submitted a supplemental biologics license application to the FDA and a Type II Variation to the European Medicines Agency requesting approval of Simponi (golimumab) in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy. Simponi, a subcutaneously administered antitumor necrosis factor-alpha therapy, previously gained approval for moderately to severely active rheumatoid arthritis.

• Laboratorios del Dr. Esteve SA, of Barcelona, Spain, said data published in the British Journal of Pharmacology showed that sigma-1 receptor (S1R) antagonist E-52862 demonstrated a direct relationship between drug of E-52862, levels of the drug interacting with the S1R in the brain and analgesic activity in preclinical models. The pain-relieving effect of the drug also was maintained with repeated treatment. E-52862 is in Phase II testing.