• Cephalon Inc., of Frazer, Pa., presented results from a Phase IV trial of Nuvigil (armodafinil) tablets [C-IV] with 383 people with excessive sleepiness associated with shift work disorder that showed improvement in the shift-workers' overall clinical condition late in their shifts (i.e., 4 a.m. to 8 a.m.), including the commute home, compared to placebo. Results were presented at the Society of General Internal Medicine's 34th Annual Meeting in Phoenix. Nuvigil is indicated to improve wakefulness in patients with excessive sleepiness associated with shift work disorder, treated obstructive sleep apnea or narcolepsy.

• Millennium, of Cambridge, Mass., a unit of the Takeda Oncology Co., said results of a randomized Phase III trial that investigated the effect of consolidation with single-agent Velcade (bortezomib) for Injection in newly diagnosed multiple myeloma patients after autologous stem cell transplant showed significant improvements in response rates and progression-free survival, while the overall survival rate was 87 percent in both arms after a median follow-up of 27 months. The data were presented at the 13th International Myeloma Workshop in Paris. Velcade is approved for the treatment of patients with multiple myeloma and the treatment of patients with mantle cell lymphoma who have already received other treatments.

• Pacira Pharmaceuticals Inc., of Parsippany, N.J., presented new Phase III data at the Society for Ambulatory Anesthesia 26th Annual Meeting in San Antonio that the company said demonstrated the utility of Exparel in the treatment of postsurgical pain after augmentation mammoplasty. The company also said that it presented new Phase I and preclinical data on Exparel at the American Society of Regional Anesthesia and Pain Medicine 36th Annual Regional Anesthesia Meeting and Workshops in Las Vegas. Exparel is a bupivacaine-based product and has completed Phase III development for postoperative analgesia by infiltration. The FDA has assigned a PDUFA date of July 28.