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AstraZeneca/BMS's Dapagliflozin Needs European Epidemiological Study, But Headed For Strong Label

 
• By John Davis

Europe's CHMP takes divergent stance to FDA on dapagliflozin, clearing it for treating diabetes if AstraZeneca and Bristol-Myers Squibb conduct a post-marketing study. The committee also cleared ruxolitinib and ferumoxytol, but rejected Folotyn, for EU marketing.

The EU’s Committee for Medicinal Products for Human Use (CHMP) is recommending approval for AstraZeneca PLC's and Bristol-Myers Squibb Co.'s new antidiabetic, dapagliflozin, if the partners conduct an epidemiological study to further assess a potential cancer risk.

The CHMP decision, announced April 19 as part of its monthly release of opinions on drug applications, shows yet again that regulatory authorities in the

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