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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Japan's national insurance to cover Novartis' gene therapy Zolgensma

26 February 2020 - Japan’s national insurance plans to cover Novartis’ gene therapy drug Zolgensma. ...

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Japan Ministry of Health, Labor and Welfare approves Opdivo (nivolumab) for the treatment of patients with unresectable advanced or recurrent oesophageal cancer

21 February 2020 - First approval of Opdivo for treatment of advanced oesophageal cancer. ...

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Exploring the application of cost-effectiveness evaluation in the Japanese National Health Insurance System

3 February 2020 - Advances in health care due to the development and introduction of new drugs and medical devices have ...

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Japan drug price reforms risk hurting investment: Bristol-Myers CEO

3 October 2019 - Japan’s “overly restrictive” drug pricing policies risk diverting foreign direct investment to China and other markets, ...

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Roche wins Japan approval for personalised cancer drug Rozlytrek

18 June 2019 - Swiss drugmaker Roche’s push into personalised cancer medicines hit a milestone on Tuesday with Japanese approval ...

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Extremely high drug prices should be reviewed for appropriateness

21 May 2019 - As medicine advances, a succession of highly efficacious but extremely costly therapeutic drugs have arrived on ...

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Novartis gets approval to sell Kymriah in Japan for $306,000

15 May 2019 - A Japanese government panel approved on Wednesday a price of 33.5 million yen ($305,800) for Novartis’ cancer ...

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Japan health ministry orders Ono Pharmaceutical to add warning to Opdivo cancer drug after death

10 May 2019 - The health ministry said Thursday that a patient taking the cancer drug Opdivo has died and ...

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Daiichi Sankyo’s EZH1/2 dual inhibitor valemetostat (DS-3201) receives SAKIGAKE designation for treatment of patients with relapsed/refractory peripheral T-cell lymphoma from Japan MHLW

9 April 2019 - SAKIGAKE designation will provide development support and accelerated review of valemetostat, an investigational and potential first-in-class EZH1/2 ...

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AbbVie announces first regulatory approval of Skyrizi (risankizumab) for the treatment of plaque psoriasis, generalised pustular psoriasis and erythrodermic psoriasis and psoriatic arthritis in Japan

26 March 2019 - This marks the first regulatory approval globally for SKYRIZI™ (risankizumab). ...

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Japan approves two gene treatments in bid to catch up

21 February 2019 - Potential revolutionary treatments have exorbitant price tags. ...

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