REGULATORY

Japan Approves Forxiga for CKD, Rinvoq’s Atopic Dermatitis Use and More

August 26, 2021
Japan on August 25 approved a list of drugs for new indications and dosages including AstraZeneca’s SGLT2 inhibitor Forxiga (dapagliflozin) for the treatment of chronic kidney disease (CKD), making it the first drug indicated for CKD in the country. The…

To read the full story

Related Article

REGULATORY

By Tatsuya Otsuka

A bill to amend the Pharmaceutical and Medical Devices (PMD) Law is expected to be submitted to the ordinary session of the Diet this year, which was convened on January 17 for a 150-day run. The proposed amendment is for…

A total of 15 new drugs (APIs) joined the NHI price list in 2021 with peak sales forecasts topping at 10 billion yen, many of them in the area of orphan diseases and with few mega launches, according to a…

Japan’s all-important reimbursement policy panel on December 22 approved an outline of the next drug pricing reform scheduled for April 2022, which embraces plans to reward innovative new indications and introduce a grace period for so-called “spillover” re-pricing.The reform outline…

By Philip Carrigan

Remember what it was like back in March, when we all started working from home? There was a distinct change in the air - a sense of freedom and excitement about the novelty of being able to work from home.…

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