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After FDA snub, EMA backs FibroGen, Astellas’ roxadustat

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The EU regulator has approved  FibroGen and Astellas Evrenzo for adults with anaemia caused by chronic kidney disease (CKD), just days after the FDA turned down the drug in the US.

Source
Pharmaforum

Aducanumab tops 2021’s biggest potential launches

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The US FDA’s verdict on Biogen’s aducanumab is one of the biggest events on biopharma’s 2021 calendar. And the Alzheimer’s antibody owns another accolade: of the novel projects slated to reach the market this year, aducanumab attracts the sellside's highest revenue forecasts.

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EP Vantage

Astellas, FibroGen get approval in Japan for Evrenzo to treat anaemia of CKD in adult patients not on dialysis

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Astellas Pharma and FibroGen have announced the receipt of approval from the Japan’s Ministry of Health, Labour and Welfare (MHLW) for Evrenzo (roxadustat) to treat anaemia in adult patients suffering from chronic kidney disease (CKD) but not on dialysis.

Source
Pharmaceutical Business Review