The Ministry of Health, Labor and Welfare (MHLW) on November 29 proposed a more stringent application of the current 40% entry price rule for first oral generics towards the FY2024 drug pricing reform.Under the current rule, first oral generics are…
After Death in First-in-Human Study, MHLW Needs to Release Info. to Alleviate Concerns about Participation in Studies
To read the full story
Related Article
- MHLW Revises Safety Guidance on FIH Studies Following Death of Subject
January 6, 2020
- Eisai Discontinues Development of Epilepsy Drug after Death in PI; “Will Never Be Administered to Humans in the Future”
January 6, 2020
- MHLW Panel Concerned about Further Clinical Trial for Eisai’s Investigational Epilepsy Drug Following Death
December 23, 2019
- Causal Link between Eisai’s Epilepsy Drug and Trial Death Can’t Be Ruled Out: MHLW
December 2, 2019
- Eisai Halts Epilepsy Drug Studies after Death in Japan PI
July 31, 2019
COMMENTARY
- Key Figures in Next Drug Pricing Reform Now All in Place, In What Direction Will They Go for Pro-Innovation Drive?
November 15, 2023
- Predicting Clinical, Financial Impact of Hemophilia Gene Therapy in Japan
November 7, 2023
- Reform Proposal Signals Perception Gap between Industry, Govt on Purpose of Market Expansion Re-Pricing
October 31, 2023
- With 2nd Strategy Penned, Can Japan Play Catch-Up with US & Europe in SaMD Push?
October 3, 2023
- Hopes to Nix Budget Ceiling Dashed, How Will Industry Get Its Message Across to Govt?
September 4, 2023
Referrals can be an absolute game-changer in recruitment.When someone in your network recommends a candidate, they often have firsthand insight into the person’s skills, work ethic, values and ambitions. This insider knowledge results in higher quality candidates who are a…
Chugai Pharmaceutical’s Phesgo (pertuzumab + trastuzumab + vorhyaluronidase alfa) and Novartis’ Leqvio (inclisiran) will be newly added to the Japanese reimbursement list along with a batch of other medicines on November 22. Three drugs carry peak sales outlooks of over…
The main players in the FY2024 reimbursement policy reform are now all in place, with the roster rounded out by the appointment of former health minister Katsunobu Kato for the Liberal Democratic Party’s (LDP) prominent social security post at the…
Authorized generic (AG) strategies taken by innovative drug makers might help soften the impact of generic competition in their businesses but such tactics might also accelerate the application of “G1”/“G2” price cuts for their off-patent brand-name medicines, a Jiho tally…
Japan’s health ministry announced new NHI prices to be applied in April under the FY2022 drug price revision in the official gazette on March 4, with the earlier application of so-called “G1” price cuts to be implemented for the first…