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Mylan Laboratories announced that Mylan Pharmaceuticals received tentative approval from the FDA for its abbreviated new drug application for divalproex sodium extended-release (ER) tablets, 250 and 500 mg.
GlaxoSmithKline's (GSK) kinase inhibitor Tykerb gained FDA approval for use in combination with Roche's oral chemotherapeutic Xeloda for the treatment of advanced metastatic breast cancer -- specifically in tumors that produce an excess of the HER2 protein.
Eli Lilly announced at a recent presentation that it appealed the approvable letter the FDA issued in response to the company's new drug application (NDA) for Arxxant, but that the FDA rejected the appeal.
CeNeRx BioPharma has announced top-line results from a Phase I clinical trial of Tyrima, its lead candidate for the treatment of depression and anxiety.
Obecure has begun a Phase II clinical trial to evaluate the efficacy of the company's OBE101 drug candidate for prevention of weight gain in patients treated with Zyprexa, an antipsychotic medication.
Inflazyme Pharmaceuticals has announced the outcome of a review of the Phase IIb CAPSICS study of IPL512,602, which showed no statistical or clinical difference between patients who received
drug or placebo.
Prima BioMed announced that the final results of its Phase IIa trial of CVac in ovarian cancer exceeded the expectations of the trial, as set by the company's scientific advisory panel in conjunction with the principal investigating oncologist.
Lev Pharmaceuticals announced positive results from the pivotal U.S. Phase III trial of its C1-esterase inhibitor (C1-INH) for the acute treatment of hereditary angioedema (HAE).