Abstral received a positive opinion last month from the Committee for Medicinal Products for Human Use of the European Medicines Agency recommending approval

The decision was based on a list of outstanding issues received following review of the filing by the Committee for Medicinal Products for Human Use, which indicated that the opinion of the committee is that the application currently is not approvable

The decision was based on a list of outstanding issues received following review of the filing by the Committee for Medicinal Products for Human Use, which indicated that the opinion of the committee is that the application currently is not approvable

Omrix Biopharmaceuticals Inc., of New York, said it has received a positive opinion for Evicel Fibrin Sealant (human) from the European Committee for Medicinal Products for Human Use

However, the Committee for Medicinal Products for Human Use of the European Medicines Agency has informally advised the company that it would not support a positive opinion at this time

This approval follows a positive opinion from the EMEA Committee for Medicinal Products for Human Use in April

IDM Pharma Inc., of Irvine, Calif., said the European Committee for Medicinal Products for Human Use (CHMP) requested additional Phase III data analyses of osteosarcoma drug mifamurtide (L-MTP-PE

ProStrakan plc, of Lalshiels, Scotland, said the European Union's Committee for Medicinal Products for Human Use has issued a positive opinion for its Abstral cancer pain product

ProStrakan plc, of Lalshiels, Scotland, said the European Union's Committee for Medicinal Products for Human Use has issued a positive opinion for its Abstral cancer pain product

UCB SA, of Brussels, Belgium, said the European Committee for Medicinal Products for Human Use issued a positive opinion for lacosamide - proposed trade name Vimpat - as an adjunctive treatment of partial onset seizures with or without secondary generalization in epilepsy patients, 16 years and older

The company opted to pull the application after the Committee for Medicinal Products for Human Use said data, obtained from a single-arm Phase II trial, do not allow it to conclude on a positive benefit-risk balance

The company opted to pull the application after the Committee for Medicinal Products for Human Use said data, obtained from a single-arm Phase II trial, do not allow it to conclude on a positive benefit-risk balance

Merck KGaA, of Darmstadt, Germany, received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) to broaden the use of Erbitux (cetuximab) to include patients with KRAS wild-type tumors

Amgen Inc., of Thousand Oaks, Calif., said the European Committee for Medicinal Products for Human Use has requested Amgen and other erythropoiesis-stimulating agent (ESA) marketing authorization holders to participate in a closed meeting of the Scientific Advisory Group on Oncology May 15

UCB SA, of Brussels, Belgium, said the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended that the European Commission grant a marketing authorization for its Neupro drug for the treatment of restless legs syndrome in adults

UCB SA, of Brussels, Belgium, said the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended that the European Commission grant a marketing authorization for its Neupro drug for the treatment of restless legs syndrome in adults

CV Therapeutics Inc., of Palo Alto, Calif., said the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of ranolazine in the European Union for the treatment of chronic angina

The approval follows the initial positive opinion issued in February by the Committee for Medicinal Products for Human Use of the European Medicines Evaluation Agency

UCB SA, of Brussels, Belgium, said the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has rejected its appeal following CHMP refusal of a marketing authorization application for Cimzia (certolizumab pegol) in Crohn's disease