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Baxter International has announced results from a preliminary evaluation of its Phase I/II clinical trial of whole-virus H5N1 influenza candidate vaccine.
Micromet and Serono have reported the outcome of two Phase II trials testing the activity of adecatumumab (MT201) in metastatic breast cancer and in prostate cancer.
Spectrum Pharmaceuticals has announced that its double-blinded, randomized, placebo-controlled, multicenter, dose-ranging Phase II trial with ozarelix in patients suffering from benign prostatic hypertrophy (BPH) met the primary endpoint.
Johnson & Johnson (J&J) Pharmaceutical Research and Development has announced that doripenem, an investigational carbapenem antibiotic in Phase III trials, achieved a high clinical cure rate of 83 percent in patients with intra-abdominal infections.
Novalar Pharmaceuticals has announced that NV-101, a local dental anesthetic reversal agent, was well-tolerated and met its primary endpoints in two Phase III studies.
Perrigo announced that it has been granted tentative approval from the FDA for its abbreviated new drug application for ciclopirox topical solution, 8 percent.
Alfacell announced it has completed the non-clinical section of the rolling submission of a new drug application (NDA) in preparation for its submission to the FDA for its lead anticancer compound, Onconase (ranpirnase).
VIVUS has submitted a new drug application to the FDA for its investigational estradiol drug, EvaMist, being developed for the treatment of vasomotor symptoms associated with menopause.
GlaxoSmithKline (GSK) announced that the supplemental new drug application for its anticoagulant product Arixtra (fondaparinux sodium) Injection has been accepted for priority review by the FDA.