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Tag: approval

  • Clovis’s ovarian cancer drug wins accelerated FDA approval

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    (Reuters) – The U.S. Food and Drug Administration said on Monday it granted accelerated approval to Clovis Oncology Inc's ovarian cancer drug in patients whose disease advanced despite chemotherapy. The drug, Rubraca, secured approval for patients whose tumors have a specific gene mutation called BRCA – identified by an FDA-approved companion diagnostic test, the FDA…

  • Ducks culled in Bulgaria after bird flu found on three farms

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    More than 4,000 ducks were culled in Bulgaria over the past few days after bird flu was found on three farms, the Bulgarian food safety agency said on Monday. “They were killed after a virulent bird flu was discovered,” Martin Radev, the agency spokesman said. “Most probably, it is H5N8 but I am still not…

  • Fewer deaths and complications with female physicians?

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    Elderly hospital patients may be less likely to die prematurely or be readmitted for serious complications when they’re treated by female physicians, a U.S. study suggests. With female doctors, patients had 4 percent lower odds of dying within a month after being admitted to the hospital and a 5 percent smaller chance of repeat hospitalizations…

  • Top Spanish drugmaker fears disruption if EMA moves from Britain

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    By Emma Pinedo MADRID (Reuters) – The likely relocation of the European Medicines Agency (EMA) from London threatens to disrupt the approval of new drugs and is a medium and long-term worry for top Spanish drugmaker Almirall, its chief executive said on Monday. The EMA, Europe's equivalent the U.S. Food and Drug Administration, approves medicines…

  • Spain’s Almirall eyes Valeant skin drugs to boost dermatology

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    By Emma Pinedo MADRID (Reuters) – Spanish drugmaker Almirall, which is building up its business in skin treatments, could be interested in acquiring dermatology assets from Canada's Valeant Pharmaceuticals, the head of the Barcelona-based company said on Monday. Valeant is looking at divesting various products as it tries to reduce its massive debt load, with…