REGULATORY

Kadcyla, Keytruda, Imfinzi in Line for Label Expansion in August

July 20, 2020
The Ministry of Health, Labor and Welfare (MHLW) is expected to add new indications for several major drugs as early as August, including MSD’s I/O star Keytruda (pembrolizumab) for use in advanced esophageal cancer, with their approval plans reported to…

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REGULATORY

By Yoshinori Sagehashi

On December 10, Biogen/Eisai’s controversial Alzheimer’s treatment aducanumab was filed for regulatory approval in Japan. It’s unclear whether Japanese regulators…

With a tumultuous year heading towards a close, let us share the 10 most-read stories on PHARMA JAPAN in 2020. With 2020 being a biennial drug price revision year, our global readers apparently had their eyes riveted on which products…

Japan’s key reimbursement policy panel on December 20 approved an outline of its FY2020 drug pricing reform next April, with…

The Ministry of Health, Labor and Welfare (MHLW) on November 27 added to the NHI price list Japan’s first biosimilars of Avastin (bevacizumab), Nesp (darbepoetin alfa), and Forteo (teriparatide). The NHI prices of first biosimilars are set at 70% of…

Japan will go ahead with the introduction of a cost-effectiveness assessment (CEA) scheme for drugs and medical devices in April…

By Philip Carrigan

As we navigate the lingering effects of the global pandemic, one thing is unmistakably clear - change is here. We’ve changed, and so have our companies. The entire workplace has transformed, but it’s not always a change for the better.…