A final decision from the European Commission is expected within the next few months...A final decision from the European Commission is expected in about two months

Regenx Biosciences LLC, of Washington, said it received a grant award from the European Commission's (EC) Seventh Framework Program as part of the MEUSIX consortium

Pfizer Inc., of New York, said the European Commission granted conditional marketing authorization for Bosulif (bosutinib) for the treatment of adult patients with chronic phase, accelerated phase and blast phase Philadelphia chromosome-positive chronic myelogenous leukemia previously treated with one or more tyrosine kinase inhibitors and for whom Gleevec (imatinib, Novartis AG), Tasigna (nilotinib, Novartis AG) and Sprycel (dasatinib, Bristol-Myers Squibb Co.) are not considered appropriate

Mast Therapeutics Inc., of San Diego, said the European Commission designated MST-188 (purified poloxamer 188) as an orphan medicinal product for the treatment of sickle cell disease

Astellas Pharma Inc., of Tokyo, said the European Commission approved expanded options for pre-treatment prior to use of Qutenza (8 percent capsaicin patch

Astellas Pharma Inc., of Tokyo, said the European Commission approved expanded options for pre-treatment prior to use of Qutenza (8 percent capsaicin patch

In other news, Biotie and partner H. Lundbeck A/S, of Copenhagen, Denmark, said they received marketing authorization from the European Commission for Selincro (nalmefene), an opioid system modulator, for the reduction of alcohol consumption in adults with alcohol dependence

Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., may receive an additional royalty stream with the European Commission approval of Basel, Switzerland-based Novartis AG's Ilaris (canakinumab/ACZ885) for gouty arthritis

Biotie Therapies Corp., of Turku, Finland, and partner H. Lundbeck A/S, of Copenhagen, Denmark, said they received marketing authorization from the European Commission for Selincro (nalmefene), an opioid system modulator, for the reduction of alcohol consumption in adults with alcohol dependence

Alexza Pharmaceuticals Inc., of Mountain View, Calif., and Grupo Ferrer Internacional SA, of Barcelona, Spain, said the European Commission granted marketing authorization for Adasuve (Staccato loxapine

Intercell AG, of Vienna, Austria, said the pediatric indication for Ixiaro, a vaccine to protect against Japanese encephalitis (JE), was granted marketing authorization by the European Medicines Agency and the European Commission

Prolor Biotech Inc., of Ness-Ziona, Israel, received orphan drug designation from the European Commission and the European Medicines Agency for hGH-CTP, a longer-acting human growth hormone being developed for growth hormone deficiency

Intercell AG, of Vienna, Austria, said the pediatric indication for Ixiaro, a vaccine to protect against Japanese encephalitis (JE), was granted marketing authorization by the European Medicines Agency and the European Commission

Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., and Sanofi SA, of Paris, said the European Commission granted marketing authorization in the European Union for Zaltrap (ziv-aflibercept) for infusion in combination with irinotecan/5-fluorouracil/folinic acid (Folfiri) chemotherapy in metastatic colorectal cancer that is resistant to or has progressed after an oxaliplatin-containing regimen...Xenon Pharmaceuticals Inc., of Vancouver, British Columbia, received a milestone payment from uniQure BV

Johnson & Johnson, of New Brunswick, N.J., said unit Janssen R&D Ireland reported that the European Commission approved Prezista (darunavir) 800-mg tablet, allowing HIV patients once-daily darunavir treatment

Janssen-Cilag International NV, of Beerse, Belgium, a unit of Johnson & Johnson, said the European Commission approved an extension for once-daily Zytiga (abiraterone acetate), expanding the indication to include its use, in combination with prednisone or prednisolone, for the treatment of metastatic castration-resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated

Janssen-Cilag International NV, of Beerse, Belgium, a unit of Johnson & Johnson, said the European Commission approved an extension for once-daily Zytiga (abiraterone acetate), expanding the indication to include its use, in combination with prednisone or prednisolone, for the treatment of metastatic castration-resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated

Pfizer Inc., of New York, said the European Commission approved expanding the use of pneumococcal conjugate vaccine Prevener 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) to older children and adolescents, ages 6 to 17, for active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by vaccine-type Streptococcus pneumoniae

Savient Pharmaceuticals Inc., of Bridgewater, N.J., said the European Commission granted marketing authorization to Krystexxa (pegloticase) for the treatment of severe debilitating chronic tophaceous gout in adults who may also have erosive joint involvement and who have failed to normalize serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom those medications are contraindicated