First adalimumab biosimilar gains approval in Japan

30 June 2020 - Fujifilm Kyowa Kirin Biologics said it has received Japanese regulatory approval to manufacture and market the ...

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Novartis receives simultaneous approval for five new products from Japanese Ministry of Health, Labour and Welfare, offering Japanese patients a broad range of novel treatment options

29 June 2020 - Novartis Pharma today announced that the Japanese Ministry of Health, Labour and Welfare simultaneously approved five ...

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Bayer submits vericiguat for marketing authorization in the EU and Japan for the treatment of chronic heart failure

5 June 2020 - Regulatory submissions based on positive data from Phase III VICTORIA study recently published in the New England ...

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Cost-effectiveness evaluation for pricing medicines and devices: a new value-based price adjustment system in Japan

18 May 2020 - In Japan, a new cost-effectiveness evaluation system for medicine and medical device pricing was employed in April ...

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Japan OKs public insurance coverage for SMA drug Zolgensma

13 May 2020 - A panel that advises the health minister approved on Wednesday coverage for Novartis' spinal muscular atrophy ...

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Japan to set price of SMA drug Zolgensma at 167 million Yen

12 May 2020 - Japan's health ministry is planning to set the price of Novartis AG's spinal muscular atrophy drug ...

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Japan approves Gilead Sciences' remdesivir as COVID-19 drug

7 May 2020 - Japan on Thursday approved Gilead Sciences Inc’s remdesivir as a treatment for COVID-19, making it the country’s ...

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Japan to offer anti-flu drug Avigan to 38 countries as early as this week

29 April 2020 - Japan will begin providing the anti-flu drug Avigan for free to 38 countries as early as ...

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Remdesivir drug to be approved for coronavirus patients in May

28 April 2020 - The government will soon approve the anti-viral drug remdesivir for treatment of coronavirus patients, Japan’s first ...

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Avigan ingredient shortage hits Japan stockpile plan

17 April 2020 - Lack of element from China spurs to push to find domestic suppliers. ...

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Fujifilm accelerates production of its influenza anti-viral drug Avigan for COVID-19

15 April 2020 - Fujifilm has announced that it has expanded its manufacturing capacity to significantly increase production of its ...

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Daiichi Sankyo submits application for CAR T therapy axicabtagene ciloleucel for treatment of patients with certain relapsed/refractory B-cell lymphomas in Japan

30 March 2020 - Submission based on previous pivotal trial data and a phase 2 study in Japan in patients ...

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Tepmetko (tepotinib) approved in Japan for advanced NSCLC with METex14 skipping alterations

25 March 2020 - TEPMETKO (Tepotinib) Approved in Japan for Advanced NSCLC with METex14 Skipping Alterations. ...

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Enhertu approved in Japan for treatment of patients with HER2 positive unresectable or metastatic breast cancer

25 March 2020 - Approval based on the pivotal DESTINY-Breast01 trial represents third approval ever under the conditional early approval system ...

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Novartis receives approval from Japanese Ministry of Health, Labour and Welfare for Zolgensma the only gene therapy for patients with spinal muscular atrophy

19 March 2020 - Reimbursement with MHLW is expected by the end of 1H20, pending agreement, Zolgensma will be available at ...

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