New Levitra® formulation submitted for registration in the EU
Bayer Schering Pharma AG has submitted an application for registration of a new formulation of Levitra® (vardenafil HCI) in the European Union (EU). This new formulation is an orodispersible tablet containing 10mg vardenafil. In contrast to other drugs of the same class used for the treatment of erectile dysfunction, Levitra orodispersible tablet allows men a discreet and convenient intake without water, dissolving on the tongue within seconds.
Nycomed reports sustained momentum in the second quarter 2009, with total net turnover increasing by 0.5% to €786.9 million excluding the impact of the Sepracor execution payment received in the first half of 2008. This performance is driven by Nycomed's Key Products. Pantoprazole turnover in Europe dropped only moderately after loosing patent protection in May.
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that a Phase III study of Avastin (bevacizumab) in combination with a range of chemotherapies met its primary endpoint of increasing the time women with previously treated advanced HER2 negative breast cancer lived without the disease getting worse (progression-free survival or PFS) compared to chemotherapy alone.
GSK issued an update on its progress to develop a vaccine against the Pandemic (H1N1) 2009 influenza virus, and announced that it has commenced the clinical development programme for its adjuvanted pandemic vaccine. Enrolment into this first study has been completed.
The European Commission (EC) has approved Afinitor® (everolimus) tablets for the treatment of patients with advanced renal cell carcinoma (RCC) whose disease progressed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy. Nearly 40% of all RCC patients have advanced cancer at time of diagnosis, meaning that their tumors have spread outside of the kidneys[1]. Standard initial treatment for these patients may include VEGF-targeted therapies[2].
Genzyme Corporation (Nasdaq: GENZ) announced that the European Commission has granted marketing authorization for Mozobil® (plerixafor injection), providing a significant new option for patients with the blood cancers lymphoma and multiple myeloma who require an autologous stem cell transplant.