Business & Industry News Channel
Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Afinitor® (everolimus) tablets for the treatment of unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumors (NET) of pancreatic origin in adults with progressive disease. If approved, everolimus will be the first mTOR inhibitor available for these patients. 
GlaxoSmithKline (GSK) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended an update to the product label for the H1N1 influenza vaccine, Pandemrix. Based on a review of currently available information on an increased number of reported cases of narcolepsy among children and adolescents in a small number of European countries, the CHMP confirmed that the overall benefit-risk balance for Pandemrix remains positive. 
Roche (SIX: RO, ROG; OTCQX: RHHBY) has signed an agreement under which it will acquire 100 percent of mtm laboratories AG (mtm), a privately-held company based in Heidelberg, Germany. mtm is a global leader in developing in vitro diagnostics with a focus on early detection and diagnosis of cervical cancer, the largest early detection market in oncology. mtm will become part of Roche's Tissue Diagnostics (Ventana Medical Systems, Inc.) business unit. Under the terms of the agreement, Roche will pay mtm shareholders an upfront payment of approximately 130 million EUR as well as up to approximately 60 million EUR upon reaching performance-related milestones. Novartis' net sales rose 27% (+19% cc) to USD 14.9 billion. Currency benefited sales by 8% as the US dollar weakened against most currencies. Recently launched products grew 46% over the previous-year quarter, contributing USD 3.8 billion to total net sales for the Group. Pharmaceuticals net sales grew 10% (+2% cc) to USD 8.3 billion, driven by 8 percentage points of volume growth, partly offset by a negative pricing impact of 1 percentage points and the negative impact of generic entries and product divestments of 5 percentage points. GlaxoSmithKline (GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) announced that the European Commission (EC) has granted marketing authorisation for Benlysta®(belimumab) 10mg/kg as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus (SLE), with a high degree of disease activity (e.g. positive anti-dsDNA and low complement), despite standard therapy(1). 
Novo Nordisk has been granted approval by the European Commission for the new prefilled insulin pen - FlexTouch®. The approval is for NovoRapid® (insulin aspart) and Levemir® (insulin detemir) - both modern insulins currently delivered in FlexPen®. FlexTouch® is the latest prefilled delivery system from Novo Nordisk which offers a new insulin injection experience for users. Current insulin pens require users to inject their insulin in a traditional way - using the force of their thumb to push the button. For some patients this can be difficult. Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the European Commission has extended the existing Avastin (bevacizumab) metastatic breast cancer label to include combination with Xeloda (capecitabine). The European Commission had recently confirmed the approval of Avastin in combination with paclitaxel chemotherapy for women with metastatic breast cancer in the first-line setting. This new extension provides an additional first-line treatment option for women in whom treatment with other chemotherapies (including taxanes or anthracyclines) is not considered appropriate.