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RSS FeedPosted by Michael Wonder on 13 May 2019
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 ...
Posted by Michael Wonder on 09 Apr 2019
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 ...
Posted by Michael Wonder on 26 Mar 2019
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). ...
Posted by Michael Wonder on 21 Feb 2019
Japan approves two gene treatments in bid to catch up
21 February 2019 - Potential revolutionary treatments have exorbitant price tags. ...
Posted by Michael Wonder on 19 Feb 2019
As medical costs mount, Japan to weigh cost-effectiveness in setting drug prices
18 February 2019 - Japanese doctor Yasushi Goto remembers prescribing the cancer drug Opdivo to an octogenarian and wondering whether ...
Posted by Michael Wonder on 12 Aug 2018
MAESTrO Database on exhibit at ISPOR Asia-Pacific Conference
12 August 2018 - Exciting new features to be launched at the conference. ...
Posted by Michael Wonder on 18 Jul 2018
EU and Japan reinforce their collaboration on inspections of medicine manufacturers
18 July 2018 - Update of 2004 mutual recognition agreement extends scope to sterile products, active pharmaceutical ingredients and biologicals ...
Posted by Michael Wonder on 17 May 2018
FDA faster than global peers at approving new drugs
16 May 2018 - A report from the Centre for Innovation in Regulatory Science released this month finds that the ...
Posted by Michael Wonder on 12 Apr 2018
Ohara cuts price of generic drug for leukaemia
11 April 2018 - Ohara Pharmaceutical Co. has reduced the price of its generic drug for leukaemia to about half ...
Posted by Michael Wonder on 06 Mar 2018
Government to cut price of Opdivo by over 20%
5 March 2018 - Japan’s health ministry said Monday that the government-set price of cancer drug Opdivo will be reduced ...
Posted by Michael Wonder on 17 Dec 2017
Looming tipping point for Japan pharma
15 December 2017 - Changes to Japan’s drug reimbursement system care are inevitable. The only questions are the extent of ...
Posted by Michael Wonder on 14 Dec 2017
Japan to cut price of infamously expensive cancer drug again
14 December 2017 - Government, which already halved Opdivo price, seeks more cost relief. ...
Posted by Michael Wonder on 23 Nov 2017
Japan's MHLW presents drug pricing changes
23 November 2017 - Japan's Ministry of Health, Labour and Welfare has proposed changes to its reimbursement policy that would ...
Posted by Michael Wonder on 18 Nov 2017
Japan to step up price cuts for off-patent drugs
18 November 2017 - New pricing scheme aimed at curbing soaring medical expenses. ...
Posted by Michael Wonder on 17 Nov 2017
Towards a single development programme for new antibiotics in EU, Japan and US
17 November 2017 - EMA, PMDA and FDA to further align data requirements and explore options to streamline paediatric development. ...