Chugai Pharmaceutical Co., Ltd.’s Evrysdi (risdiplam) is among the latest batch of new drug approvals in Japan, providing another option for spinal muscular atrophy (SMA) patients in the country. The survival motor neuron 2 (SMN2)-directed splicing modifier was granted orphan designation in March 2019 and filed for approval last October.
Latest Japan Approvals Include Evrysdi For SMA
Plus Global First For Imeglimin
Japan's latest batch of product approvals includes the country's second therapy for SMA and the first nod globally for a novel antidiabetic.
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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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Japan recommends eight new drugs for approval, including two for cardiomyopathy, and will also raise prices for multiple products, including Enhertu, on 1 April.
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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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While CMC glitches linger over a US NDA for Elevar/Hengrui’s novel liver cancer combination following a second complete response letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.
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The main 2025 policy priorities for China's government as outlined in an annual report will include the strengthening of commercial insurance for innovative drugs and opening up cell and gene therapy and the hospital sector to foreign investment.