Novartis announces Russian regulatory approval for Gilenya®
The Russian health authority, the Federal Service on Surveillance in Healthcare and Social Development, has granted approval for Gilenya® (fingolimod) 0.5 mg once-daily oral therapy for the treatment of relapsing remitting multiple sclerosis (MS). Approximately 85% of patients with MS are estimated to have the relapsing remitting form at the onset of disease[1]. Russia is the first country to approve Gilenya, providing a new treatment option offering significant efficacy for patients in the convenience of an oral capsule.
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LEVITRA 10mg Orodispersible Tablet for the Treatment of Erectile Dysfunction approved in Europe
The European Commission has approved a new formulation of Levitra® (vardenafil HCI). Levitra 10mg orodispersible tablet will be the first erectile dysfunction (ED) medication available in this novel and convenient formulation. In contrast to other drugs of the same class, Levitra 10mg orodispersible tablet allows men a discreet and convenient intake without water, dissolving on the tongue within seconds with a minty flavour.
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BBC Panorama: "A Risk Worth Taking?" Programme. GlaxoSmithKline Right of Reply Statement
Patient safety is our first priority. We strongly refute any allegation that our actions have put patients at risk. We have carried out an extensive research programme, involving more than 50,000 patients to analyse the safety and benefits of Avandia. All the results from our research programme have been given to the regulatory authorities worldwide and we are fully committed to being open about the results of all our clinical research.
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Reports of narcolepsy in Europe following vaccination with Pandemrix™
GSK initially became aware of possible cases of narcolepsy following vaccination with the adjuvanted H1N1 pandemic vaccine Pandemrix through adverse event reports received by the Swedish Medical Products Agency, and subsequently via media reports in Finland. Information on the individual cases remains limited at present, but GSK is conducting its own investigation in an effort to gather as much additional data as possible regarding the reported cases, and is working closely with key regulatory authorities, including the European Medicines Agency (EMA).
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European Commission Issues Positive Decision for Approval of Seroquel XR
AstraZeneca announced that the European Commission (EC) has issued a positive decision for the approval of once-daily SEROQUEL XR (quetiapine fumarate) Extended Release Tablets as an add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub-optimal response to antidepressant monotherapy.
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Data from Mipomersen Phase 3 Trial in heFH Patients Presented at ESC
Genzyme Corp. (NASDAQ: GENZ) and Isis Pharmaceuticals Inc. (NASDAQ: ISIS) announced that data from the phase 3 study of mipomersen in patients with heterozygous familial hypercholesterolemia (heFH) were presented at the European Society of Cardiology's Congress 2010 in Stockholm, Sweden. The study met its primary endpoint with a 28 percent reduction in LDL-cholesterol, compared with an increase of 5 percent for placebo (p<0.001).
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Global market launch of Daxas® (Roflumilast) kicks off in Germany
Stefan Brinkmann, Managing Director of Nycomed GmbH, kicked off the German market launch of Daxas® (Roflumilast) in Oranienburg today, making Germany the first country to market the medicine. Daxas® is a proprietary selective phosphodiesterase 4 (PDE4) enzyme inhibitor that was developed by Nycomed to treat the progressive, life-threatening lung disease COPD.
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