• Almirall SA, of Barcelona, Spain, said the European Committee for Medicinal Products for Human Use issued a positive opinion for Eklira Genuair (aclidinium) as a maintenance bronchodilator treatment to relieve symptoms in adults with chronic obstructive pulmonary disease. Almirall recently signed a deal granting Menarini Group, of Florence, Italy, rights across a majority of European Union member states, as well as Russia, Turkey and other CIS countries, where it will market the drug as Bretaris Genuair. The deal excludes the UK, the Netherlands and the Nordic countries.

• Bristol-Myers Squibb Co., of Princeton, N.J., said it helped form the International Immuno-Oncology Network, a global collaboration between industry and academia aimed at furthering the scientific understanding of immune-oncology, which focuses on the potential of harnessing the intelligence of the body's own immune system to fight cancer. In addition to BMS, the collaboration comprises 10 cancer-research institutions, including the Dana-Farber Cancer Institute, Johns Hopkins Kimmel Cancer Center and Memorial Sloan-Kettering Cancer Center.

• CSL Behring Ltd., of King of Prussia, Pa., said the FDA accepted for review its biologics license application for a human 4-factor prothrombin complex concentrate for the urgent reversal of vitamin K-antagonist therapy (i.e. warfarin) in patients with acute major bleeding.

• Eisai Inc., of Woodcliff Lake, N.J., said the European Committee for Medicinal Products for Human Use issued a positive opinion for Fycompa (perampanel) as an adjunctive treatment of partial-onset seizures, with or without secondarily generalized seizures, in patients with epilepsy, age 12 years and older. Perampanel is an AMPA receptor antagonist. Full European Commission approval is anticipated in three months.

• Janssen Therapeutics, of Titusville, N.J., a division of Johnson & Johnson, said the FDA issued a complete response letter for its supplemental new drug application for an 800-mg tablet of HIV protease inhibitor Prezista (darunavir). The company said it will respond to the agency as quickly as possible and does not expect additional trials will be required.