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AstraZeneca announced that the European Commission has granted marketing authorisation for the oral anti-cancer drug, IRESSA for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK (epidermal growth factor receptor-tyrosine kinase) across all lines of therapy. 
H. Lundbeck A/S (LUN.CO; LUN DC) has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for Serdolect® (sertindole) for the treatment of schizophrenia. 
The US Food and Drug Administration (FDA) has approved Ilaris® (canakinumab) for the treatment of children and adults with cryopyrin-associated periodic syndrome (CAPS), which includes a number of rare but life-long auto-inflammatory disorders with debilitating symptoms and limited treatment options[1],[2],[3],[4]. 
Nycomed received marketing authorisation from the European Commission for five applications: PANTOZOL Control®, PANTOLOC Control®, PANTECTA Control®, SOMAC Control® and CONTROLOC Control®. This new OTC medication is intended for short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults as a medicinal product not subject to medical prescription. 
Genzyme Corporation (Nasdaq: GENZ) announced that the European Commission has approved Renvela® (sevelamer carbonate) for the control of serum phosphorus in patients with chronic kidney disease (CKD). The approval includes patients not on dialysis with serum phosphorus levels ≥ 1.78 mmol/L (5.5 mg/dL), and covers both the tablet and powder formulations. 
Abbott (NYSE: ABT) has announced the launch of the sixth-generation Emboshield NAV6(TM) Embolic Protection System for use in carotid artery stenting procedures. Carotid artery stenting provides a minimally invasive treatment alternative to conventional open carotid artery surgery for patients who are at high risk for surgery. 
Takeda Pharmaceutical Company Limited ("Takeda") has reviewed the development strategy for the Marketing Authorization Applications (MAAs) for its investigational compounds, alogliptin and alogliptin/ACTOS (generic name: pioglitazone HCl), in Europe, and accordingly, has initiated an additional long-term clinical study for alogliptin. 
Amgen Inc. (Nasdaq: AMGN) released the results of a new study comparing Nplate(R) (romiplostim) to the medical standard of care (SOC) in non-splenectomised adult patients with chronic immune thrombocytopenic purpura (ITP). Chronic ITP is a serious autoimmune disorder characterised by low platelet counts in the blood (thrombocytopenia), which can lead to serious bleeding events. Financial
Product
- IRESSA (Gefitinib) Receives Marketing Authorisation in Europe
- AstraZeneca Development Partner, Pozen, Inc., Submits New Drug Application for PN400
- Lundbeck receives FDA Complete Response Letter on Serdolect® for the treatment of schizophrenia
- New biological therapy Ilaris® approved in US
- Nycomed receives Marketing Authorization for Pantoprazole 20mg OTC from European Commission
Clinical Trials
- Lu AA24530 shows positive results in major depressive disorder phase II study
- Schering-Plough Announces Phase II and III Data for Corifollitropin Alfa
- Pfizer Discontinues Phase 3 Trial of Sutent® in Metastatic Colorectal Cancer
- Sutent Significantly Improved Progression-Free Survival
- Abbott Initiates Trial of Next-Generation XIENCE PRIME(TM) Drug Eluting Stent
Corporate
- Graceway Pharmaceuticals Acquires Early-stage Dermatological Molecules from Pfizer
- Bayer files patent infringement lawsuit against Teva
- Bayer Schering Pharma Extends Research Portfolio in the Field of Cancer-Related Targets
- Novo Nordisk reaches settlement with the Danish authorities regarding Oil-for-Food activities
- GSK and Chroma Therapeutics form alliance to develop novel macrophage-targeted drugs