King Pharmaceuticals®, Inc. and Acura Pharmaceuticals, Inc. announced that King has submitted a New Drug Application (NDA) for ACUROX® (oxycodone HCl) Tablets to the U.S. Food and Drug Administration (FDA), including a request for priority review classification. ACUROX® is an immediate release tablet containing oxycodone HCl intended for the relief of moderate to severe pain. ACUROX® utilizes Acura’s patented Aversion® Technology which is designed to deter opioid abuse by intravenous injection of dissolved tablets and nasal snorting of crushed tablets. ACUROX® does not contain niacin. A separate NDA submission for ACUROX® with Niacin Tablets is subject to an FDA Complete Response Letter. Further details on the response to this FDA action letter will be provided at a later date.

Pfizer Inc. announced that a significantly higher proportion of patients with newly diagnosed chronic myeloid leukemia who were treated with bosutinib (39 percent) experienced a major molecular response (MMR), a secondary endpoint, compared with patients treated with imatinib (26 percent) in the intent-to-treat (ITT) population (p=0.002).

Optimer Pharmaceuticals, Inc.announced that it has completed the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for fidaxomicin to treat patients with Clostridium difficile infection (CDI) and to prevent recurrences of CDI. It is the most common cause of diarrhea in the hospital, and according to the CDC contributes to 15,000-30,000 deaths each year, a number that surpasses Methicillin-resistant Staphylococcus aureus (MRSA).

Amgen announced that it has won the Best New Drug awardfor Prolia(TM) (denosumab), a novel treatment approved in the United States (U.S.) for women with postmenopausal osteoporosis at high risk for fracture, at the2010 Scrip Awards ceremony Nov. 4 in London. Named one of TIME's Top 10 Medical Breakthroughs of 2009, Prolia is the first treatment specifically designed to target osteoclasts, the cells that break down bone.

Scientists working at the European Molecular Biology Laboratory in Grenoble, France have developed a new technique that enables them to introduce up to 15 fluorescent markers to a mammalian cell in one go. They say their findings could help speed up drug development and screening.

New data demonstrated that antibodies induced by Novartis Vaccines investigational, four component, Meningococcal Serogroup B Vaccine (4CMenB) killed the majority of a collection of geographically and genetically diverse meningococcal serogroup B (MenB) strains. The strain coverage research findings were recently published in the Proceedings of the National Academy of Sciences.

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