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YM BioSciences announced that the independent data safety monitoring board (DSMB) for the company's pivotal Phase III trial of tesmilifene in patients with metastatic or recurrent breast cancer has notified the company that the milestone of 320 events required for the third interim analysis in its pivotal Phase III trial has occurred.
Actelion announced that initial results from the double-blind, placebo-controlled, multicenter EARLY study indicate that six months of treatment with the dual endothelin receptor antagonist Tracleer (bosentan) showed a significant reduction in pulmonary vascular resistance, a strong trend toward improved exercise capacity and a significant delay in the time to clinical worsening.
Shire announced that the European Commission has granted a marketing authorization for the use of Elaprase (idursulfase) for the long-term treatment of patients with Hunter syndrome.
Biopure announced it has received a provisional opinion letter from the UK Commission on Human Medicines containing comments and questions based on its review of the company's marketing authorization application for Hemopure (hemoglobin glutamer 250 (bovine)) for the treatment of acutely anemic adult orthopedic surgery patients under 80 years of age.
Humanetics announced that the FDA has cleared its request to begin Phase I trials under an investigational new drug application for BIO 300, a radiation countermeasure.
Chelsea Therapeutics International has reported the preliminary results of a European Phase IIb trial of Droxidopa, an orally available synthetic amino acid for the treatment of neurogenic orthostatic hypotension, a disorder resulting from a deficient release of norepinephrine, the neurotransmitter used by sympathetic autonomic nerves to send signals to the blood vessels and the heart.
Aegerion Pharmaceuticals has announced the publication of positive results from a second Phase II clinical trial of its lead cholesterol-lowering compound, AEGR-733, in the New England Journal of Medicine (NEJM).
Ark Therapeutics announced it has held a meeting with the FDA at which the agency agreed that a single Phase III trial will be acceptable for the basis of a marketing approval of Trinam, the company's gene therapy to prevent blood vessels from becoming blocked in kidney dialysis patients who have undergone vascular access graft surgery.