Amgen Inc. (Nasdaq: AMGN) announced that the U.S. Food and Drug Administration (FDA) has approved Prolia(TM) (denosumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

Novo Nordisk today announced that it has received approval of the price of Victoza®, a once-daily human GLP-1 analogue for the treatment of type 2 diabetes, from Japan's Central Social Insurance Medical Council (Chuikyo), the advisory committee to the Minister of Health, Labour and Welfare.

AstraZeneca has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the new drug application for AXANUM (aspirin/esomeprazole magnesium) tablets.

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Nichi-Iko Pharmaceutical Co., Ltd. (Nichi-Iko) (Osaka Stock Exchange and Nagoya Stock Exchange: NIK) have signed an agreement to establish a new joint venture, called sanofi-aventis Nichi-Iko K.K., in order to develop a generic business in Japan.

Novartis announced that the US Food and Drug Administration (FDA) has extended by three months, to September 2010, its review period for the regulatory approval of FTY720 (fingolimod).

Results of the clinical study CALYPSO, published online by The Journal of Clinical Oncology, show that patients in this study with platinum-sensitive relapsed ovarian cancer experienced longer progression-free survival than patients taking the current standard of care.

Genzyme Corporation (Nasdaq: GENZ) announced that the FDA has granted U.S. marketing approval for Lumizyme™ (alglucosidase alfa), produced at the 4000 liter (L) bioreactor scale at its manufacturing facility in Geel, Belgium.