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…
REGULATORY
Conditional OK Might Be an Option for KM Biologics Jab: Komeito Lawmaker
Japan could look at the use of its conditional early approval system for an inactivated COVID-19 vaccine being developed by KM Biologics without waiting for the proposed introduction of an emergency clearance scheme, Komeito lawmaker Kozo Akino said on February…
To read the full story
Related Article
- KM Biologics to File COVID Jab in Japan Spring 2023: Official
November 29, 2022
- KM Biologics’ COVID-19 Vaccine Approval Likely to Delay into FY2023
November 11, 2022
- KD-414 Presumed to Have Superior Efficacy over Vaxzevria: KM Bio President
July 7, 2022
- 1st Dose of COVID-19 Jab Given in Adult and Pediatric Trials: KM Biologics/Meiji
May 10, 2022
- KM Biologics to Soon Begin Pediatric PII/III for COVID Jab, 1st Japan Trial to Include Kids below Age 5
April 21, 2022
- KM Biologics to File COVID-19 Vaccine as Early as September, Chancing Emergency Approval
April 21, 2022
- KM Biologics Eyes COVID-19 Booster Filing as Early as Spring, Trial Start Slated by Year-End
October 26, 2021
- KM Biologics’ COVID-19 Jab Enters Japan PII/III Study
October 25, 2021
- KM Biologics Moves Up COVID-19 Vaccine Target, Aims for Rollout in FY2022
September 22, 2021
- KM Biologics Kicks Off Japan PI/II for COVID-19 Vaccine
March 23, 2021
REGULATORY
- FY2023 Extra Budget Clears Diet, 1.4 Billion Yen to Boost Drug Production
December 1, 2023
- Council OKs Public-Knowledge Application for Truvada Use as PrEP for HIV
December 1, 2023
- Average NHI-Market Price Gap for 2024 Revision at 6.0%, Smallest in 30 Years
December 1, 2023
- MHLW Proposes Tightening 40% Entry Pricing for New Oral Generics
November 30, 2023
- Lawmakers Request 4-Valent HPV Vaccination Program for Males to Minister
November 30, 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…
A member of the Ministry of Health, Labor and Welfare’s (MHLW) study group on the generic industry on November 13…
A health ministry study group on pharmaceutical regulations on October 13 roughly agreed on a reform plan for Japanese regulatory…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…
A key Japanese reimbursement policy panel on December 16 approved the government-backed plan for the FY2023 “off-year” drug price revision.…
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…