The latest batch of product approvals in Japan includes the first to be granted anywhere globally for AbbVie Inc.'s anti-interleukin-23 antibody Skyrizi (risankizumab), as well as nods for Japan’s first gene-based therapy and a pioneering marketing clearance in Asia for a CAR-T drug, Novartis AG's Kymriah.
Japan Approvals Include World-First For Skyrizi, Kymriah As Asia's First CAR-T
Japan approves a large batch of new products including significant first nods globally for AbbVie's antibody for psoriasis and Japan's first gene-based therapy, as well as a pioneering first approval in Asia for a CAR-T drug.
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Amid ongoing generic drug supply problems, Japan's government is to set up a new fund to support corporate investments geared towards manufacturing and consolidation.
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Japan adds four new pediatric vaccines, including for MMRV and norovirus, to a list of priority vaccines eligible for assistance in regulatory processing.
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A plan to reduce benefits under Japan's financial safety net for patients contributing to the costs of their long-term medical care is being reconsidered by the government following protests from patient and doctor groups.
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Japan adds four new pediatric vaccines, including for MMRV and norovirus, to a list of priority vaccines eligible for assistance in regulatory processing.
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