On December 10, Biogen/Eisai’s controversial Alzheimer’s treatment aducanumab was filed for regulatory approval in Japan. It’s unclear whether Japanese regulators…
BUSINESS
Drug Makers Scratching Heads to Meet Daily Rep Report Requirements for New Detailing Guidelines
The health ministry’s new guidelines on ethical drug detailing activities took effect this April, requiring drug makers to properly store the daily work reports of their sales reps, and promptly present documents when required by regulatory authorities. Companies are scurrying…
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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.…