As expected, Celgene Corp. finished its rolling new drug application for Revlimid, asking for the FDA's approval based on Phase II data with the compound for myelodysplastic syndromes (MDS) in transfusion-dependent patients with a 5q-deletion chromosomal abnormality. (BioWorld Today)
Taking aim at relapsed ovarian cancer patients considered incurable, Madrid, Spain-based PharmaMar SA is starting a Phase III trial with Yondelis (trabectedin), a compound first isolated from marine tunicates. (BioWorld International)
A spate of news at the start of this year regarding therapies for pulmonary arterial hypertension (PAH) threw fresh light on the disorder - and might put eventual pressure on the Swiss firm Actelion Ltd., which markets the only approved oral therapy: Tracleer (bosentan), the dual endothelin receptor antagonist given market clearance by the FDA in 2001.
Adding weight to the old superstition that bad news comes in sets of three, Biogen Idec Inc. and Elan Corp. plc reported that another case of progressive multifocal leukoencephalopathy (PML) has turned up in a patient given Tysabri. (BioWorld Today)