GlaxoSmithKline update: A (H1N1) influenza vaccine development
GSK is committed to supporting governments and health authorities around the world to respond to the emergence of the new A (H1N1) influenza strain. Since the outbreak, the company has been in continuous discussions with governments and public health authorities, including the WHO, the US Centers for Disease Control and Prevention, the US Department of Health and Human Services and the European Centre for Disease Prevention and Control to help develop appropriate options to respond to the emergence of the new A (H1N1) influenza strain.
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Qlaira® - innovative estradiol-based oral contraceptive available in Europe
Bayer Schering Pharma AG, Germany, is starting the European roll-out of its new oral contraceptive Qlaira® (estradiol valerate/dienogest). From May 15, 2009, Qlaira® will be available in several European countries, including Germany. More European countries will follow from autumn 2009 onwards.
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Roche provides additional donation of 5.65 million packs of Tamiflu to WHO
Roche has announced a new donation to the World Health Organization (WHO) of 5.65 million courses of treatment of the antiviral drug Tamiflu (oseltamivir). This donation includes:
Replenishment of the Regional Stockpile of 2 million treatment courses of Tamiflu to be held by the WHO and used to address regional outbreaks,
Replenishment of the Rapid Response Stockpile of 3 million treatment courses of Tamiflu to be held by Roche and deployed under the direction of the WHO,
Establishment of a new pediatric stockpile of 650,000 treatment courses of Tamiflu small (30mg and 45mg) capsules.
Sanofi-aventis builds a New Vaccine Manufacturing Facility in France with an investment of 350 million euros
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY), the world's leading vaccine manufacturer, officially launched the construction of a new Sanofi Pasteur vaccine manufacturing center in Neuville-sur-Saône, France, in a ceremony attended by Gérard Collomb, Senator and Mayor of Lyon, Christopher A. Viehbacher, Chief Executive Officer of sanofi-aventis, Dr. Elias A. Zerhouni, Science and Technology Adviser for sanofi-aventis.
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AstraZeneca Announces Top Line Results From Pivotal Phase III Study for BRILINTA
AstraZeneca has announced top line results from the phase III trial, PLATO (A Study of Platelet Inhibition and Patient Outcomes), which demonstrate that BRILINTA (ticagrelor), the investigational oral antiplatelet treatment for acute coronary syndromes (ACS), has achieved a statistically significant primary efficacy endpoint versus clopidogrel, in the prevention of cardiovascular (CV) events in patients with ACS.
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Nycomed files European marketing authorisation application for Daxas®
Nycomed has announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) for Daxas® as a once-daily oral treatment for patients with COPD associated with chronic bronchitis. The MAA submission is based on encouraging results from four Phase III trials of Daxas (roflumilast) in the treatment of symptomatic COPD. Two pivotal 12-month studies met their primary endpoints, showing effects on exacerbation rates and pulmonary function (FEV1).
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Glivec® approved in EU as first post-surgery therapy
Glivec® (imatinib)* received approval from the European Commission (EC) to become the first and only treatment available in Europe to reduce the risk of recurrence in adult patients who are at significant risk of relapse following surgery to remove gastrointestinal stromal tumors (GIST).
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