BUSINESS

Decision on Pfizer Vaccine Unlikely to Come before Japan Data Submission Slated by February

December 21, 2020
Japan will grant exceptional approval to Pfizer/BioNTech’s COVID-19 vaccine “if safety and efficacy are confirmed,” Chief Cabinet Secretary Katsunobu Kato said on December 18 following its regulatory filing on the day. The submission was based on global PIII data, but…

To read the full story

Related Article

BUSINESS

By Takashi Ohama

The Ministry of Health, Labor and Welfare (MHLW) appears to be ready to begin post-launch drug price adjustments based on cost-effectiveness assessments (CEAs) for the first time since the system was introduced in April 2019. As price tweaks will be…

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…

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

After decades in recruitment, I say from experience that there’s a particular way to attract candidates to a given role. Do it right, and you’ll have talent chasing you. Get it wrong, and you’ll be left listening to the crickets…