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NeoPharm has announced that the pivotal Phase III PRECISE trial evaluating cintredekin besudotox (IL13-PE38QQR) for the treatment of recurrent glioblastoma multiforme (GBM) did not meet the efficacy endpoint at 215 deaths, which was a statistically significant difference, or separation, in the overall survival curves compared with Gliadel Wafer.
Nuvelo and Bayer HealthCare have announced top-line data demonstrating that the Phase III clinical trial of alfimeprase in acute peripheral arterial occlusion (PAO), known as NAPA-2, did not meet its primary endpoint of avoiding open vascular surgery within 30 days of treatment.
Sanofi-aventis has announced that the FDA has accepted the company's complete response to the February approvable letter for its new drug application (NDA) for Acomplia (rimonabant).
Eli Lilly has submitted a new drug application (NDA) to the FDA for Evista (raloxifene HCl) for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and postmenopausal women at high risk for breast cancer.
Epix Pharmaceuticals has presented data from three randomized, placebo-controlled, Phase I clinical trials of PRX-08066, a novel serotonin 5-HT2B receptor antagonist.
Nastech Pharmaceutical has announced results from a placebo-controlled, dose-escalation, crossover, Phase I study comparing its proprietary insulin nasal spray formulation with NovoLog insulin aspart injection and Exubera inhalation powder in healthy subjects.
NicOx has announced results from a Phase I pharmacodynamic clinical study that compared naproxcinod with naproxen using ambulatory blood pressure monitoring (ABPM), which demonstrated a differentiated and favorable 24-hour blood pressure profile for naproxcinod, in hypertensive subjects.
MethylGene, along with its partner Pharmion, have initiated a Phase II clinical trial with its isotype-specific histone deacetylase (HDAC) inhibitor product candidate, MGCD0103, in patients with high-risk myelodysplastic syndromes (MDS) or relapsed or refractory acute myelogenous leukemia (AML).