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MHLW Sets Volume Thresholds for Drug Orders to Resolve Generic Shortages
January 28, 2022
Late last year, Japan’s health ministry urged drug makers to lift their shipment restrictions for medicines deemed to be in sufficient supply at least by a certain parameter to iron out generic supply issues. Now,…

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January 28, 2022
Fujifilm said on January 27 that it will acquire a cell therapy manufacturing facility in California from US biotech startup Atara Biotherapeutics for some US$100 million, a move that marks its full-scale entry into the cell therapy CDMO business.Atara, which…
January 28, 2022
Otsuka Pharmaceutical said on January 27 that it has signed a deal with Tokyo-based virtual reality (VR) solution developer Jolly Good for codevelopment and exclusive sales in Japan of a social skills training (SST) platform utilizing VR.The joint business aims…
January 28, 2022
A health ministry panel agreed on January 26 that applications based on information in the public domain would be acceptable for seven APIs including metformin for eight infertility treatment indications. With this decision, public knowledge-based…
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…

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