It will allow patients with Gaucher's disease in France to receive treatment with taliglucerase alfa before marketing authorization for the product is granted in the European Union

Sanofi will have exclusive marketing rights for North America, European Union and Japan, subject to Glenmark's right to co-promote the products in the U.S

Cell Therapeutics Inc., of Seattle, met with and received encouraging feedback from the rapporteurs and the European Medicines Agency's medical reviewers regarding a proposed filing of a marketing authorization application for pixantrone in the European Union to treat relapsed/refractory aggressive non-Hodgkin's lymphoma

The European Union Committee for Orphan Medicinal Products concurrently granted IMGN901 orphan medicinal product designation for the treatment of MCC

registration of Posidur (bupivacaine), an investigational drug for postsurgical pain, while Nycomed will oversee development in the European Union and other countries

It was approved in the European Union under the trade name MabThera in June 1998, and is also cleared for NHL in various other settings. (See BioWorld Today, Dec. 1, 1997

Pfizer has the exclusive rights to commercialize Xiaflex in the 27 member countries of the European Union and 19 other European and Eurasian countries, and is primarily responsible for regulatory activities there

GenWay received nonexclusive rights to distribute RPC's Onko-Sure in vitro diagnostic cancer test in the European Union, Middle East (excluding Israel), UK, and Russia

Basilea Pharmaceutica Ltd., of Basel, Switzerland, said Toctino (alitretinoin) was recommended for regulatory approval under the repeat-use procedure in 13 additional European Union member states, as well as in Norway and Iceland

Basilea Pharmaceutica Ltd., of Basel, Switzerland, said Toctino (alitretinoin) was recommended for regulatory approval under the repeat-use procedure in 13 additional European Union member states, as well as in Norway and Iceland

Dynavax said the updated European Union GMP manufacturing license will help the firm meet the initial commercial production demands for the anticipated launch of Heplisav...Osteologix Inc., of Glen Allen, Va., said it expects to file a marketing application in 2011 in the European Union for its second-generation strontium therapy NB S101 (strontium malonate) for postmenopausal osteoporosis

Funds are expected to support work on the company's SIMPLE Antibody engine and to build a preclinical antibody portfolio...The firms have been working together since early 2005 to discover and develop therapies for schizophrenia and other central nervous system diseases based on the calcineurin pathway

The drug was developed as a similar biological product to Neupogen (filgrastim), the G-CSF drug marketed by Thousand Oaks, Calif.-based Amgen Inc., and already has been launched in several European Union markets as TevaGrastim

3,4-DAP previously received orphan drug designation in the European Union, and EU regulators adopted a positive opinion in October recommending approval of amifampridine phosphate for LEMS

Cerimon Pharmaceuticals Inc., of San Francisco, has acquired exclusive rights to develop and commercialize its once-daily topical diclofenac sodium patch in Europe, including most countries in the European Union, Turkey, Switzerland, Norway, the Balkan countries and Iceland

Celvapan H1N1 is the first cell culture-based and non-adjuvanted pandemic influenza vaccine to receive marketing authorization in the European Union

Ceplene is approved in the European Union for the remission maintenance and prevention of relapse in patients with AML in first remission

That would give the drug, based on Clavis' Lipid Vector Technology, 10 years of marketing exclusivity upon approval in the European Union...plc, of Dublin, Ireland, Biogen Idec Inc., of Cambridge, Mass., and saw their shares nicked in early trading Thursday after the European Medicines Agency reported another case of progressive multifocal leukoencephalopathy linked to multiple sclerosis drug Tysabri (natalizumab) in the European Union

That would give the drug, based on Clavis' Lipid Vector Technology, 10 years of marketing exclusivity upon approval in the European Union