Amgen announced primary results of a pivotal Phase 3 trial ('147) demonstrating that XGEVA(TM) (denosumab) significantly increased bone metastasis-free survival for more than four months in men with castrate-resistant metastatic prostate cancer that has not yet spread to bone. Full results of the '147 study were presented for the first time today in a late-breaking plenary session at the American Urological Association (AUA) 2011 Annual Meeting in Washington, D.C.

Shire plc, the global specialty biopharmaceutical company, today announced the appointment of two senior Research & Development executives to its Specialty Pharmaceuticals business. Lawson Macartney, DVM, PhD, FRCPath, has been appointed Senior Vice President of the Emerging Business Unit and Mario Saltarelli, MD, PhD, has been named Senior Vice President of Clinical Development and Medical Affairs.

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.

Lycera Corporation, a biopharmaceutical company pioneering innovative approaches to developing novel oral medicines to treat autoimmune diseases, announced that it has entered into an exclusive research collaboration with Merck to discover, develop and commercialize small molecules that target T-helper 17 (Th17) cells, key mediators of inflammation. The collaboration will focus on developing drug candidates that have the potential to treat major autoimmune diseases such as rheumatoid arthritis, psoriasis, inflammatory bowel disease and multiple sclerosis.

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).

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