If the European Commission adopts the CHMP's recommendation, Pixuvri would be approved for marketing in the 27 member countries of the European Union, as well as the European Economic Area

Alexza is working with partner Grupo Ferrer International Inc., of Barcelona, Spain, to develop Adasuve in the European Union and other territories

Intercell AG, of Vienna, Austria, said it completed a pivotal Phase III study of its Japanese encephalitis vaccine, Ixiaro/Jespect, in 1,869 children in the Philippines and a second Phase III study in the European Union, U.S

Navidea Biopharmaceuticals Inc. (formerly Neoprobe Corp.), of Dublin, Ohio, plans to file a marketing authorization application in the European Union by year-end for the radiopharmaceutical Lymphoseek (99mTc tilmanocept for injection

Telormedix SA, of Bioggio, Switzerland, said it was elected as a member of a collaborative research program dubbed TIMER (targeting novel mechanisms of resolution in inflammation), which is funded with €3 million (US$3.9 million) from the European Union to establish a robust collaboration comprising a team of European universities and research institutions

Amarin plans to use proceeds to fund the commercial launch of triglyceride-lowering compound AMR101 (ethyl icosapentate) and the patient enrollment in a cardiovascular outcomes study of the compound...Vibativ was approved in Europe last year for the treatment of adults with nosocomial pneumonia, including ventilator-associated pneumonia, known or suspected to be caused by methicillin-resistant Staphylococcus aureus (MRSA) when other alternatives aren't suitable

That designation would provide 10 years of marketing exclusivity in the European Union upon approval

Enkam Pharmaceuticals A/S, of Copenhagen, Denmark, said the European Union awarded a €6 million grant (US$7.84 million) to a consortium led by Enkam to fund clinical studies of the company's lead product in treating Alzheimer's disease

Final approval, which would allow products manufactured at the facility to be distributed in the European Union, is expected in the first quarter of 2012

Alexion Pharmaceuticals Inc., of Cheshire, Conn., said the European Commission extended the therapeutic indication for Soliris (eculizumab) in the European Union to include pediatric and adult patients with atypical hemolytic uremic syndrome (aHUS

ViroPharma anticipates launching Plenadren in the European Union in about one year. (See BioWorld Today, Oct. 28, 2011

That designation confers clinical and regulatory incentives and would guarantee 10 years of marketing exclusivity in the European Union upon approval

That designation confers clinical and regulatory incentives and would guarantee 10 years of marketing exclusivity in the European Union upon approval

Celldex Therapeutics Inc., of Needham, Mass., said the European Medicines Agency granted orphan drug designation in the European Union for rindopepimut (CDX-110) for the treatment of glioblastoma

and orphan medicinal product designation from the European Medicines Authority in the European Union for follicular lymphoma and mantle cell lymphoma

Xigris, approved by the FDA in November 2001 and licensed in the European Union in 2002, remains the only product approved specifically for patients at high risk of death from severe sepsis and joins a long list of failed sepsis drugs

The five-year, $54.5 million European research initiative was launched Oct. 1 with funding from the European Union and collaborating organizations

Ligand Pharmaceuticals Inc., of La Jolla, Calif., said it signed a global licensing deal with Chiva Pharmaceuticals Inc., of Los Altos Hills, Calif., for Fablyn (lasofoxifene), a selective estrogen receptor modulator, approved in the European Union in 2009 to treat osteoporosis in postmenopausal women at increased risk of fracture

The partnership will receive funding from the European Union as part of the Eurostars program aimed at supporting innovation within the EU