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Japan Nods Include Global Firsts For Duvroq, Vafseo And First Local Biosimilar Humira

Plus Five-Product Bonanza For Novartis

Executive Summary

Japan’s regulators have approved a large batch of new products, including a novel antibody from Chugai, two world-first nods for the country’s second HIF-PH inhibitors and an asthma therapy, and the first Humira biosimilar in Japan – as well as five drugs from Novartis.

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Sun Loses Shine In Q1, Testing Times In US

Sun’s Q1 earnings were dented by provisions related to the generic pricing investigation settlement with the US Department of Justice of arm Taro, and the impact of pandemic-related lockdowns. Some clinic-administered products bore the brunt of lock-downs in parts of the US, though market share was unaffected.

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The Swiss company's asthma triplet is now approved in Europe and Japan but Enerzair is well behind GSK's rival LABA/LAMA/ICS in the US where Novartis's product has not even been submitted yet.

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