The company plans to proceed into a pivotal Phase IIb study for late-stage pancreatic cancer and said German authorities have indicated the study could be sufficient to file for marketing authorization in the European Union

The company plans to proceed into a pivotal Phase IIb study for late-stage pancreatic cancer and said German authorities have indicated the study could be sufficient to file for marketing authorization in the European Union

The European Union FP7 Health Program has awarded a grant of $8.5 million to Opsona Therapeutics Ltd., of Dublin, Ireland, to advance its candidate OPN-305 for solid organ transplantation, focusing on delayed graft function

The European Union FP7 Health Program has awarded a grant of $8.5 million to Opsona Therapeutics Ltd., of Dublin, Ireland, to advance its candidate OPN-305 for solid organ transplantation, focusing on delayed graft function

Biovista Inc., of Charlottesville, Va., said its European Union affiliate has been awarded a $500,000 grant for R&D in personalized medicine as part of the "p-medicine" project, a four-year effort under the European Community's 7th Framework Programme

All other rights, including North American and European Union, were acquired from New York-based Pfizer Inc...and European Union in patients with recurrent lymphomas and – in combination with doxorubicin – sarcoma patients. (See BioWorld Today, April 20, 2009

plc, of Dublin, Ireland, and Biogen Idec Inc., of Weston, Mass., for the European Union

plc, of Dublin, Ireland, for the European Union

The agreement would give Compass rights in the Americas, the European Union and some other territories

MorphoSys AG, of Martinsried, Germany, signed a manufacturing agreement with Boehringer Ingelheim GmbH, of Ingelheim, Germany, to cover the process of developing and manufacturing additional clinical material for MorphoSys' anti-CD19 antibody MOR208 and other drug candidates...In other news, the FDA has approved Oxford BioMedica plc's investigational new drug application for StarGen, a gene-based treatment for Stargardt disease

Cytos Biotechnology Ltd., of Zurich, Switzerland, received European Union funding to work in a consortium, known as VECTORIE, to prevent and treat infections caused by emerging viral pathogens in Europe...The partnership is funded by the Eurostars program of the European Union

Cytos Biotechnology Ltd., of Zurich, Switzerland, received European Union funding to work in a consortium, known as VECTORIE, to prevent and treat infections caused by emerging viral pathogens in Europe...The partnership is funded by the Eurostars program of the European Union

In other news, Diamyd said its Phase III European Union study of antigen-based therapy Diamyd completed the 15-month visit

Digna Biotech SL, of Madrid, Spain, and the Centro de Investigacion Medica Aplicada de la Universidad de Navarra said the European Union finalized a €3.3 million (US$4.5 million) grant to AIPGENE consortium and, as members of the consortium, Digna and CIMA will receive €500,000 and €800,000, respectively, for the clinical development of a gene therapy product for acute intermittent porphyria

Digna Biotech SL, of Madrid, Spain, and the Centro de Investigacion Medica Aplicada de la Universidad de Navarra said the European Union finalized a €3.3 million (US$4.5 million) grant to AIPGENE consortium and, as members of the consortium, Digna and CIMA will receive €500,000 and €800,000, respectively, for the clinical development of a gene therapy product for acute intermittent porphyria

Omeros Corp., of Seattle, said the European Medicines Agency (EMA) confirmed that OMS103HP is eligible to be submitted for marketing approval in the European Union through the EMA centralized procedure

The European Union awarded a grant of €3.3 million (US$4.5 million) to the Aipgene consortium for the development of a gene therapy product, AMT-0210 for acute intermittent porphyria

The European Union awarded a grant of €3.3 million (US$4.5 million) to the Aipgene consortium for the development of a gene therapy product, AMT-0210 for acute intermittent porphyria

Based on positive feedback from the agencies, Pluristem said it is now in a position to advance toward two clinical studies with its PLX-PAD cells: a joint FDA-EMA Phase II/III study of PLX-PAD for critical limb ischemia and a Phase II study for intermittent claudication under the FDA and the Paul Ehrlich Institute, the German competent authority in the European Union