Boehringer Ingelheim Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) granted full (traditional) approval of Aptivus® (tipranavir) capsules. The FDA granted accelerated approval to Aptivus in June 2005; accelerated approval is a regulatory process that expedites the approval of therapies for serious or life-threatening illnesses.

Aclasta® (zoledronic acid 5 mg) has received European Union approval as the first once-yearly treatment for women with postmenopausal osteoporosis. The announcement closely follows the recent approval in the US, where the Food and Drug Administration (FDA) approved Aclasta under the brand name Reclast® in August 2007. The European Commission decision applies to all 27 member states, Norway and Iceland.

GlaxoSmithKline (GSK) announced that it has submitted a file on its cervical cancer vaccine, Cervarix™, to the World Health Organization (WHO) for pre-qualification, following the granting of a marketing authorisation approval by regulatory authorities in Europe on 20 September.

Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that Japan's Ministry of Health, Labour and Welfare has approved ELAPRASE, a human enzyme replacement therapy for the treatment of Hunter syndrome, for sale and marketing in Japan. Since its U.S. approval in July 2006, ELAPRASE is now approved for marketing and commercial distribution in 34 countries worldwide.

Pfizer named Dr. Martin Mackay as President of Pfizer Global Research and Development (PGRD); launched an independent, stand-alone biotherapeutics and bioinnovation center under the direction of scientist and entrepreneur Dr. Corey Goodman; and named Dr. Briggs Morrison, who held senior research and development positions at Merck, as its new Head of Clinical Development for the PGRD pipeline.

On Sept. 19th, 2007, the Canadian Patent Office (CIPO) granted an authorisation to the Canadian generic manufacturer Apotex Inc. for the production of a certain volume of APO-TRIOVIR for export into Rwanda. This HIV medicament is a fixed dose combination of three active ingredients, one of which is nevirapine patented for Boehringer Ingelheim.

GlaxoSmithKline (GSK) announced its marketing application for non-prescription orlistat 60mg for weight loss has been accepted for review by the European Agency for the Evaluation of Medicinal Products (EMEA). Orlistat 60 mg was approved for non-prescription sale in the US by the FDA in February 2007 for use by overweight adults in conjunction with a reduced-calorie, low-fat dietand went on sale there in June 2007 under the brand name alli™.