REGULATORY

Forxiga’s CKD Indication Up for PAFSC Review on July 28, Possible OK in August

July 15, 2021
AstraZeneca’s SGLT2 inhibitor Forxiga (dapagliflozin) will come up for review by a key health ministry advisory committee on July 28 for an additional indication of chronic kidney disease (CKD). If it clears the panel, a typical schedule points to its…

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REGULATORY

By Eric Persoff

Biopharmaceutical wholesalers in Japan play broader roles than their counterparts overseas. Beyond logistics and distribution, wholesalers perform a variety of tasks related to finance, safety, and commercialization. Such functions are typically cited as justification for various fees, rebates, and allowances…

By Yoshinori Sagehashi

With its first “off-year” drug price revision implemented this April, Japan has now wrapped up all the reform plans agreed upon by four state ministers in 2016 for pharmaceutical pricing. As the government has provided no further mid-term vision for…

The average ratio of female employees at managerial posts stood at just 12.5% at pharmaceutical companies operating in Japan, a Jiho survey revealed. While foreign drug makers had an average 25.0%, the ratio came to as low as 9.8% for…

By Yoshinori Sagehashi

Biogen’s controversial Alzheimer’s drug aducanumab was filed for Japanese regulatory approval in December. If approved, it will be the first…

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

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