GlaxoSmithKline announces Swiss approval of Duodart®
GlaxoSmithKline (GSK) announced that the Swiss regulatory authority, Swissmedic, has granted approval for Duodart®, a fixed dose combination (FDC) of dutasteride (0.5mg) and tamsulosin (0.4mg). Dutasteride and tamsulosin FDC is indicated for the treatment of men with moderate-to-severe symptoms of Benign Prostatic Hyperplasia (BPH) and reduction in the risk of acute urinary retention (AUR) and surgery in patients with moderate-to-severe symptoms of BPH(1). 
Novartis announced that the European Commission (EC) granted a Marketing Authorization for Menveo® (Meningococcal Group A, C, W135 and Y conjugate vaccine) in all 27 European member states. Menveo is indicated for the active immunization of adolescents (from 11 years of age) and adults at risk of exposure to Neisseria meningitidis groups A, C, W135 and Y, to prevent invasive disease. Menveo is the first conjugate vaccine commercially available in Europe that helps protect against four major groups of meningococcal disease. 
Pfizer Inc. (NYSE: PFE) and Medivation, Inc. (NASDAQ: MDVN) announced results from two Phase 3 trials of the investigational drug dimebon (latrepirdine*) in patients with Alzheimer's disease (AD). In the CONNECTION trial, dimebon did not meet its co-primary or secondary efficacy endpoints compared to placebo. Co-primary endpoints were measures of cognition and global function. 
Nycomed was on track in 2009, with strong growth in Key Products and most emerging markets. Pantoprazole sales were resilient after the loss of exclusivity in May in 12 European countries, as a result of a tailored approach to each region. The pipeline portfolio progressed strongly. Daxas® was submitted to EMEA and the FDA for approval, and positive Phase III trial data were presented in September and published in the medical journal The Lancet. 
2009 was operationally one of the strongest years for the Bayer Group. "We were successful in a difficult environment, and we are optimistic for the future," said Werner Wenning, Chairman of the Board of Management, on Friday at the Financial News Conference in Leverkusen. Earnings before interest, taxes, depreciation and amortization (EBITDA) before special items came in at EUR 6,472 million, the third-highest level in Bayer's history. 
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced the topline results from a global phase III trial investigating the use of Avastin (bevacizumab) in combination with Xeloda (capecitabine) or fluorouracil and cisplatin chemotherapy in patients with inoperable, advanced or metastatic gastric cancer (stomach cancer). The study, known as AVAGAST, did not meet its primary endpoint of extending overall survival in patients treated with Avastin in combination with chemotherapy compared to the same chemotherapy plus placebo. 
Sanofi Pasteur, the vaccines division of sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced that its adjuvanted A(H1N1) monovalent influenza vaccine, Humenza®, has received a positive opinion from Europe's Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA).