Keyword: Drug Safety

News

EU Set to Simplify Clinical Trial Rules

11.07.2012 - The European Union's executive is due to propose new rules next week to make it easier for drug companies and researchers to carry out cross-border clinical trials, in a bid to cut...

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K-V Sues FDA over Makena in Fight for Survival

06.07.2012 - K-V Pharmaceutical is suing the U.S. Food and Drug Administration for not cracking down on compounded versions of its premature birth drug Makena, in a last-ditch fight for the...

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GlaxoSmithKline Settles Healthcare Fraud Case for $3 Billion

03.07.2012 - GlaxoSmithKline agreed to plead guilty to misdemeanor criminal charges and pay $3 billion to settle what government officials on Monday described as the largest case of healthcare...

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FDA OKs First Obesity Drug in 13 years

28.06.2012 - U.S. health regulators approved the first new weight-loss drug in 13 years, allowing Arena Pharmaceuticals to bring its Belviq pill to market as public health advocates push for...

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Toxic Capsules Help the Medicine Go down in China

18.06.2012 - Hou Zhihui breaks open a cold-medicine capsule, pours the powder on to a piece of steamed dough and folds it together. He passes the miniature bun to a colleague who pops it in her...

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Fresenius on US Regulator's Radar over Dialysis

16.06.2012 - U.S. health regulators are looking at whether Fresenius Medical Care violated any rules by failing to alert dialysis clinics about risks linked to one of its products. Last...

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Novo Nordisk Hit by U.S. Delay to New Insulin Drug

08.06.2012 - Danish drugmaker Novo Nordisk , the world's biggest insulin maker, said on Friday that U.S. health regulators had extended their review of its new ultra-long-acting insulin Tresiba...

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EMA Boosts EU Transparency with Online Publication of Suspected Side Effect Reports

31.05.2012 - The European Medicines Agency has today begun publishing suspected side effect reports for medicines authorised in the European Economic Area (EEA) on a new public website: www...