• Alexza Pharmaceuticals Inc., of Mountain View, Calif., received a Committee for Medicinal Products (CHMP) for Human Use Day 180 Second List of Outstanding Issues from the European Medicines Agency regarding the marketing authorization application for Adasuve (Staccato loxapine). The company said the letter contains no major objections to the application, indicating that the two major objections outlined in the initial 180-day letter have been resolved. Alexza expects to receive the CHMP Day 210 Opinion in December. Adasuve, which is intended to treat schizophrenia or bipolar I disorder, also is under review in the U.S.

• Bio-Matrix Scientific Group Inc., of San Diego, said its subsidiary, Regen BioPharma, contracted Cascade Life Sciences Inc., also of San Diego, to research the safety and efficacy of Regen's HemaXellerate product using mice models for testing. Results will provide the safety profile data required for filing an investigational new drug application, anticipated later this quarter. HemaXellerate is designed to deliver a population of endothelial cells to restore blood production in patients with hematological conditions.

• Ligand Pharmaceuticals Inc., of San Diego, said partner GlaxoSmithKline plc, of London, received FDA approval to expand the use of Promacta (eltrombopag) for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy. Promacta in combination with interferon-based therapy has been shown to improve a patient's chance of achieving a sustained virologic response or viral cure. Shares of Ligand (NASDAQ:LGND) gained $2.40, or 14.4 percent, to close Monday at $19.07.

• Orexo AB, of Uppsala, Sweden, said the FDA accepted for review its new drug application for Zubsolv, a sublingual formulation of buprenorphine and naloxone, and set a PDUFA date of July l6, 2013. Zubsolv was developed as an alternative treatment option to Suboxone for use in opioid dependence.