On December 10, Biogen/Eisai’s controversial Alzheimer’s treatment aducanumab was filed for regulatory approval in Japan. It’s unclear whether Japanese regulators…
REGULATORY
PMDA Updates Veklury Label to Allow Its Use in Moderate COVID-19
The Pharmaceuticals and Medical Devices Agency (PMDA) has revised the label of Gilead Sciences’ antiviral agent Veklury (remdesivir) to allow its use not only in severe COVID-19 cases but also in moderately ill patients. With the drug’s supplies to Japan…
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REGULATORY
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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…
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.…