Novartis gains new indication for Diovan®* for the treatment of children and adolescents
The European Commission (EC) has granted Diovan® (valsartan) a new pediatric indication for the treatment of hypertension in children and adolescents 6-18 years of age. Following the Commission's decision, the pediatric indication needs to be implemented through EU National Competent Authorities before Diovan will be available for pediatric use across the European Union (EU), both in the existing tablet formulations as well as a newly developed oral solution.
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Q1/2010: Merck Net Profit After Tax More Than Triples
All four divisions of the Merck Group recorded increases in first-quarter 2010 revenues - most notably the Chemicals divisions - indicating that the company weathered the global economic crisis of 2009 and is now back on track. Merck Group total revenues rose 13% in the first quarter to EUR 2,099 million from EUR 1,859 million in the year-ago quarter as the Chemicals divisions returned to their pre-crisis levels and the Merck Serono prescription drugs division continued on its growth path.
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Roche Group sustained its strong sales growth in the first three months of 2010
Group sales grew 9% in local currencies (6% in Swiss francs; 15% in US dollars) to 12.2 billion Swiss francs. The Pharmaceuticals Division's sales increased 10% in local currencies (6% in Swiss francs; 15% in US dollars) to 9.7 billion Swiss francs, maintaining its above-market growth. The Diagnostics Division also maintained its above-market growth, with sales increasing 9% in local currencies (7% in Swiss francs; 16% in US dollars) to 2.5 billion Swiss francs.
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Nycomed's novel anti-inflammatory therapy Daxas® (roflumilast) recommended for approval in the European Union
Nycomed has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending the approval of Daxas (roflumilast) in the European Union. Daxas® is a proprietary selective phosphodiesterase 4 (PDE4) enzyme inhibitor that has been developed by Nycomed for the treatment of COPD.
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Seroquel XR Recommended For Approval In EU as an Add-On Treatment Of Major Depressive Disorder
AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency (EMA) concluded that the benefit-risk profile of once-daily SEROQUEL XR (quetiapine fumarate) extended-release tablets was positive as an add-on medication for major depressive episodes in major depressive disorder patients who have had sub-optimal response to treatment with other antidepressants.
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The Lancet publishes new data demonstrating the superior efficacy of Victoza® (liraglutide) compared to Januvia® (sitagliptin)
The Lancet published online the results of the first study comparing the once-daily human GLP-1 analogue, Victoza® (liraglutide) with a DPP-4 inhibitor, Januvia®. The 26-week trial showed that Victoza® produced significantly greater reductions in HbA1c, fasting plasma glucose (FPG) and body weight than Januvia®, with similar or better overall treatment satisfaction.[1] In addition, significantly more patients achieved the HbA1c targets of
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GlaxoSmithKline receives conditional marketing authorisation in the EU for Arzerra® (ofatumumab)
GlaxoSmithKline (GSK) and Genmab AS confirmed that the European Commission (EC) has granted a conditional marketing authorisation for Arzerra® (ofatumumab) for the treatment of refractory chronic lymphocytic leukaemia (CLL). Ofatumumab is indicated for the treatment of CLL in patients who are refractory (have not responded) to fludarabine and alemtuzumab.
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