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Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19
worldpharmanews
July 26, 2021
Roche announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Ronapreve™ (casirivimab and imdevimab), for the treatment of patients with mild to moderate COVID-19 via intravenous infusion.
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Takeda expands Covid-19 vaccine supply deal with Moderna
pharmaceutical-technology
July 22, 2021
Takeda Pharmaceutical has entered a new agreement with Moderna and the Government of Japan’s Ministry of Health, Labour and Welfare (MHLW) to import and supply 50 million doses of Moderna’s mRNA Covid-19 vaccine in the country.
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Japan First to Approve Roche’s Ronapreve to Treat COVID-19
contractpharma
July 22, 2021
Roche received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Ronapreve (casirivimab and imdevimab), for the treatment of mild to moderate COVID-19 via intravenous infusion.
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Japan's Ministry of Health, Labour and Welfare Grants Priority Review for Enfortumab Vedotin NDA
americanpharmaceuticalreview
May 17, 2021
Astellas Pharma Inc. announced Japan's Ministry of Health, Labour and Welfare (MHLW) has granted priority review for the company's New Drug Application (NDA), which was submitted in March.
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Japan approves Bristol Myers Squibb’s B-cell lymphoma therapy
pharmaceutical-business-review
March 31, 2021
Bristol Myers Squibb has received Japan’s Ministry of Health, Labour and Welfare (MHLW) approval for its Breyanzi (lisocabtagene maraleucel; liso-cel) to treat patients suffering from relapsed or refractory (R/R) large B-cell lymphoma (LBCL) and R/R ...
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Takeda submits New Drug Application for lanadelumab in Japan
pharmaceutical-business-review
March 18, 2021
Japan-based, R&D-driven Takeda Pharmaceutical Company Limited has submitted a New Drug Application (NDA) for lanadelumab to the Ministry of Health, Labour and Welfare (MHLW) in Japan.
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AstraZeneca’s heart failure treatment Forxiga gets approval in Japan
pharmaceutical-technology
December 02, 2020
The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved AstraZeneca’s Forxiga (dapagliflozin) for treating patients with chronic heart failure (HF) who are receiving standard of care in the country.
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Novartis Expands with Kymriah Manufacturing Site in Asia
americanpharmaceuticalreview
November 11, 2020
Novartis announced the receipt of marketing authorization from Japan’s Ministry of Health, Labor and Welfare (MHLW) for Foundation for Biomedical Research and Innovation at Kobe (FBRI) to manufacture and supply commercial Kymriah® (tisagenlecleucel) for..
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Novartis Expands Kymriah Manufacturing Footprint
contractpharma
November 05, 2020
Novartis has received marketing authorization from Japan’s Ministry of Health, Labor and Welfare (MHLW) for Foundation for Biomedical Research and Innovation at Kobe (FBRI) to manufacture and supply commercial Kymriah (tisagenlecleucel) for patients ...
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Novartis Receives Approval for Five Products from Japanese Ministry of Health
americanpharmaceuticalreview
July 10, 2020
Novartis Pharma announced the Japanese Ministry of Health, Labour and Welfare (MHLW) approved five new treatment options for Japanese patients.