For 25 years, Morunda has been interviewing leaders in Japan’s pharmaceutical and medical device industry. Most country managers typically come from a commercial background, rooted in sales and marketing. It’s rare to find country managers who come from finance or…
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REGULATORY
- MHLW Seeks 2-Year Extension of Raise on R&D Tax Credit Ceiling: FY2023 Reform Request
August 26, 2022
- MHLW’s Health Policy Bureau Eyes COI Management System, Upgraded Clinical Research Database: FY2023 Budget Request
August 26, 2022
- MHLW to Request a 33.26 Trillion Yen General Account Budget for FY2023
August 26, 2022
- Lilly’s Tirzepatide in Line for Approval as Early as September as Japan’s 1st GIP/GLP-1 Agent
August 26, 2022
- Japan Approves Label Expansions for Lynparza, Ultomiris, Keytruda, Tagrisso, and More
August 25, 2022
- 1st Meeting of New Drug Distribution and Pricing Panel Set for Aug. 31
August 25, 2022
- AstraZeneca’s COVID Cocktail Up for Aug. 29 PAFSC Session; Comirnaty Pediatric Booster Too
August 23, 2022
- MHLW to Seek Budget for Integrated Drug Supply Info System for FY2023
August 23, 2022
- MHLW to Boost Orphan Program to Fuel New Drug Development: FY2023 Budget Request
August 23, 2022
- After Repeated Scandals, PMDA Sets Up New Division to Provide GMP Inspection Know-How to Prefectures
August 22, 2022
- Study Group Agrees on Need to Craft Transparent Rules for Use of Pseudonymized Info
August 22, 2022
- Operational Issues of Emergency Approval Scheme Will Be Addressed If Needed: Pharma Bureau Chief
August 19, 2022
- New Panel on Drug Distribution and Pricing Likely to Launch on Aug. 31
August 18, 2022
- AZ’s Asthma Drug Tezepelumab Up for MHLW Panel Review on August 29
August 17, 2022
- Generic Makers Flock to Samsca’s Heart Failure Market after Patent Invalidated; Gx Listing Expected in December
August 16, 2022
- Authorized Generics Approved for Nexium, Samsca, Lipitor, Careram
August 16, 2022
- First Generics for 5 APIs Approved towards December Listing, with 8 Firms for Nexium
August 16, 2022
- MHLW Leaks Personal Info on Intractable Disease Patients
August 16, 2022
- Lilly’s GIP/GLP-1 Receptor Agonist Up for PAFSC Review on August 25
August 15, 2022
- Takashi Hanyuda Tapped as Senior Vice Health Minister
August 15, 2022
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Earlier this month, the Ministry of Finance (MOF) unveiled a long list of social security proposals towards the FY2025 budgeting,…
A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…
A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…
The Japanese health ministry on December 22 approved a batch of medicines for additional indications, including Otsuka Pharmaceutical’s atypical antipsychotic Rexulti (brexpiprazole) and Zenyaku Kogyo’s anti-CD20 antibody Rituxan (rituximab).Rexulti is now newly indicated for the treatment of depression and depressive…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…
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…