Blog
RSS FeedPosted by Michael Wonder on 20 Oct 2020
Fujifilm seeks approval for Avigan as COVID-19 treatment in Japan
19 October 2020 - Fujifilm said it was seeking approval for its flu drug Avigan as a treatment for COVID-19 in ...
Posted by Michael Wonder on 28 Sep 2020
Ultomiris (ravulizumab) receives approval in Japan for atypical haemolytic uraemic syndrome in adults and children
25 September 2020 - Ultomiris is the first and only long-acting C5 inhibitor for atypical haemolytic uraemic syndrome, reducing the treatment ...
Posted by Michael Wonder on 28 Sep 2020
Enhertu approved in Japan for the treatment of patients with HER2 positive metastatic gastric cancer
25 September 2020 - Approval of SAKIGAKE designated medicine is based on pivotal phase 2 DESTINY-Gastric01 trial and represents second approval ...
Posted by Michael Wonder on 28 Sep 2020
Opdivo and Yervoy combination therapy approved in Japan to expand use for the treatment of microsatellite instability high colorectal cancer, and Opdivo for additional dosage and administration in monotherapy dosing regimen
25 September 2020 - Ono Pharmaceutical and Bristol-Myers Squibb announced today that the companies have received approval for combination therapy ...
Posted by Michael Wonder on 25 Aug 2020
Imfinzi approved in Japan for the treatment of extensive-stage small cell lung cancer
21 August 2020 - Only PD-1/PD-L1 immunotherapy to demonstrate both a significant survival benefit and improved response rate in combination with ...
Posted by Michael Wonder on 03 Aug 2020
Japan and Pfizer reach COVID-19 vaccine deal to treat 60 million people
1 August 2020 - The government has reached a deal to have Pfizer and BioNTech supply 120 million doses of ...
Posted by Michael Wonder on 29 Jul 2020
Teva announces new drug application filing in Japan for Ajovy (fremanezumab) injection
29 July 2020 - Teva Pharmaceutical Industries today announced Otsuka has submitted an application to the Pharmaceuticals and Medical Devices Agency ...
Posted by Michael Wonder on 22 Jul 2020
Japan approves dexamethasone as second drug for coronavirus treatment
22 July 2020 - The health ministry has approved the use of the steroid drug dexamethasone for the treatment of ...
Posted 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 ...