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Aastrom Biosciences announced that its proprietary Tissue Repair Cells (TRCs) have been granted orphan drug designation by the FDA for use in the treatment of dilated cardiomyopathy (DCM).
BioSante Pharmaceuticals has announced positive results from a dose-ranging preclinical study demonstrating that its calcium phosphate nanoparticle-based vaccine adjuvant, BioVant, may serve as a vaccine adjuvant for the development of an effective vaccine against H5N1 avian flu.
Hollis-Eden Pharmaceuticals has presented data showing that HE3286, an orally bioavailable small-molecule compound, produced a statistically significant reduction in disease in a rodent model of established arthritis.
Athenagen has completed a Phase I clinical study of ATG3, the company's topical eyedrop therapy for neovascular or wet age-related macular degeneration (AMD).
Actelion announced that its Phase II proof-of-concept study in patients with primary insomnia receiving Orexin-OX1/OX2 receptor antagonist ACT-078573 has met its primary endpoint, an improvement in sleep efficiency measured by polysomnography.
GTx announced that a per-protocol interim safety review by an independent data safety monitoring board (DSMB) recommended that the company continue its two pivotal Phase III clinical trials of Acapodene (toremifene citrate).
Columbia Laboratories announced that its Phase III clinical trial of progesterone for the prevention of preterm birth for women with a previous preterm birth earlier than 35 weeks of gestation did not meet its primary endpoint, a reduction in the incidence of preterm birth at week 32, or secondary endpoints, a reduction at weeks 28, 35 and 37.
Mylan Laboratories announced that the FDA has granted final approval for Mylan Technologies' supplemental abbreviated new drug application for its 12 micrograms/hour fentanyl transdermal system. This product is shipping immediately.