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ActivBiotics has begun enrolling patients into a Phase II study examining the effect of rifalazil, a potent anti-chlamydial antibiotic, on atherosclerotic changes in the carotid artery.
Ariad Pharmaceuticals announced that the Phase III clinical trial of oral AP23573, its novel mTOR inhibitor, will be conducted in patients with metastatic soft-tissue and bone sarcomas by the Sarcoma Alliance for Research through Collaboration in cooperation with other cancer research groups.
Halozyme Therapeutics and Baxter Healthcare announced the presentation of results from a Phase IIIb trial showing that subcutaneous administration of morphine with Hylenex recombinant (hyaluronidase human injection) accelerated the time to maximal blood levels of morphine by 33 percent versus morphine with placebo, and appeared to be safe and well tolerated.
According to pivotal Phase III research published in the Feb. 15 issue of New England Journal of Medicine, children under 5 immunized with MedImmune's FluMist (influenza virus vaccine live, intranasal) reported 55 percent fewer cases of influenza compared with children who received the flu shot.
Advancis Pharmaceutical announced that it has received a refusal-to-file letter from the FDA for its once-daily amoxicillin PULSYS new drug application (NDA).
Somaxon Pharmaceuticals has announced it plans to file a new drug application (NDA) with the FDA for its insomnia drug Silenor in the third quarter of 2007.
Rigel Pharmaceuticals announced that its partner Merck Serono has begun enrolling patients in a Phase I study evaluating the safety and tolerability of R763, a highly potent, orally available, multi-Aurora kinase inhibitor, for the treatment of patients with hematological malignancies.
InSite Vision has announced top-line results from its Phase I safety study of AzaSite Plus (ISV-502), a combination antibiotic/corticosteroid product formulated in DuraSite.