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RSS FeedPosted by Michael Wonder on 30 Jun 2020
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 ...
Posted by Michael Wonder on 29 Jun 2020
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 ...
Posted by Michael Wonder on 07 Jun 2020
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 ...
Posted by Michael Wonder on 20 May 2020
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 ...
Posted by Michael Wonder on 14 May 2020
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 ...
Posted by Michael Wonder on 12 May 2020
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 ...
Posted by Michael Wonder on 07 May 2020
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 ...
Posted by Michael Wonder on 29 Apr 2020
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 ...
Posted by Michael Wonder on 28 Apr 2020
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 ...
Posted by Michael Wonder on 20 Apr 2020
Avigan ingredient shortage hits Japan stockpile plan
17 April 2020 - Lack of element from China spurs to push to find domestic suppliers. ...
Posted by Michael Wonder on 15 Apr 2020
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 ...
Posted by Michael Wonder on 30 Mar 2020
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 ...
Posted by Michael Wonder on 25 Mar 2020
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. ...
Posted by Michael Wonder on 25 Mar 2020
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 ...
Posted by Michael Wonder on 19 Mar 2020
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 ...