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Approvals (EMEA, Total)
First treatment in more than a decade
07-06-2010 |  21:05 hs.
The European Medicines Agency cleared Nycomed A/S to market Chronic Obstructive Pulmonary Disease drug, Daxas (Roflumilast) in Europe. It´s the first new type of treatment for the disease in over a decade

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06-23-2010 |  15:31 hs.
The European Medicines Agency (EMEA) cleared GlaxoSmithKline Plc. oral cancer drug Tyverb (Lapatinib or Tykerb) in combination with an aromatase inhibitor in post menopausal breast cancer patients with the correct genetic profile or tumors overexpress HER2 for whom chemotherapy is currently not intended.

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06-04-2010 |  15:38 hs.
AstraZeneca Plc. Submitted documentation for European regulators approval, for combined drug Axanum, indicated for patients that need aspirin (Acetylsaicylic Acid) but are at risk of developing ASA-associated gastric and/or duodenal ulcers.

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05-20-2010 |  19:04 hs.
Teva Pharmaceuticals Industries Ltd. said that Health Canada cleared generic version of the world´s top seller drug Lipitor.

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04-27-2010 |  16:25 hs.
The European Medicines Agency authorized AstraZenecaPlc. to market statin drug Crestor (Rosuvastatin) to prevent first cardiovascular events in patients at high risk.

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COPD
04-26-2010 |  17:32 hs.
Merck & Co. announced agreement with privately-held Nycomed A/S, to market chronic obstructive pulmonary disease drug Daxas(Roflumilast), in Canada and certain European Regions. The drug will be eventually marketed in the United States by Forest Laboratories Inc.

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04-16-2010 |  18:43 hs.
Alexion Pharmaceuticals Inc. announced that the Ministry of Health, Labour and Welfare (MHLW), the Japanese regulators office, approved marketing for Solaris (Eculizumab) drug, indicated for paroxysmal nocturnal hemoglobinuria.

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03-30-2010 |  18:46 hs.
Swiss Roche Holding AG, announce that the European Medicines Agency (EMEA) approved a label expansion use of blockbuster cancer drug Xeloda (Capacitabine) in combination with Sanofi-Aventis SA, Eloxatin (Oxaliplatin) for the initial treatment of post-surgery patients with colon cancer. The combination is also known as XELOX.

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09-30-2008 |  11:09 hs.
The European health authorities have approved Novartis´ osteoporosis drug Aclasta – called Reclasta in the U.S. - for use in men, as well as broadening its use, the Swiss drugmaker announced.

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08-15-2008 |  11:45 hs.

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06-27-2008 |  13:03 hs.

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06-27-2008 |  12:33 hs.

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Market launch in Q3 2008
05-07-2008 |  09:37 hs.
Bayer Schering Pharma announced its new low-dose oral contraceptive YAZ has been approved in the E.U., and the company plans to launch it on the market by autumn 2008.

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Neupro
04-25-2008 |  11:28 hs.
Belgian pharmaceutical group UCB SA announced it had won sooner than expected approval for its Neupro restless legs syndrome (RLS) drug by the Committee for Medicinal Products for Human Use (CHMP).

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02-06-2008 |  12:51 hs.
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