Japan’s ruling coalition sustained a crushing blow in the Lower House election last month, only managing to win 215 seats,…
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REGULATORY
- Payer Chides AnGes’s Course Change on Collategene, Urges Re-Think of System’s Set-Up
July 4, 2024
- Over 60% of Generic Firms Carry Jointly Developed Products, 98% of Espha Drugs Fall into This Category
July 3, 2024
- LDP Group Calls for MCI Screening for Early Detection of Alzheimer’s
July 3, 2024
- New ICH Topic on RWD to Be Proposed towards Its Use in Regulatory Review
July 2, 2024
- Sato Named MHLW’s Top Pharmacy Officer; Kiyohara to Steer Drug Pricing Reform
July 2, 2024
- MHLW Shuffles Senior Bureaucrats, Ihara Tapped as Vice Health Minister
July 2, 2024
- PMDA Kicks Off Consultations for Pediatric and Rare Disease Drugs
July 2, 2024
- PMDA Opens 1st Overseas Office in Bangkok
July 2, 2024
- Minister Wants Consensus on Future Generic Industry at Upcoming Confab
July 1, 2024
- MHLW to Revise Process to Share Info on Nitrosamine Impurities after Guidance Issued
June 28, 2024
- MHLW Project Team Proposes New Subsidies for Early R&D of Intractable Disease Drugs
June 28, 2024
- MHLW Sets Up Global Strategy HQ to Bolster Innovation Ecosystem
June 28, 2024
- MHLW Panel OKs Different Safety Scheme for Fujimoto’s Revlimid Generic despite Concerns
June 27, 2024
- Constitutional Democratic Party Calls for Scrapping Off-Year Price Revisions
June 27, 2024
- Sakigake Tag to Be Withdrawn for Lisata’s Cell Therapy CLBS12
June 27, 2024
- Health Minister Set to Meet Generic Execs to Hear Views on Industry Revamp
June 26, 2024
- Japan's First Eylea Biosimilar Wins Nod, Potential Listing in November
June 25, 2024
- Health Ministry Changes Avigan Approval Conditions
June 25, 2024
- Japan Approves Novartis’ Fabhalta, Lilly’s Jaypirca, and Lots More
June 25, 2024
- Japan OKs Honebuto Paper, Modest Wording on Off-Year Revisions Finalized
June 24, 2024
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For over two decades, Morunda has been at the forefront of interviewing and understanding leaders within Japan’s dynamic healthcare industry, particularly in pharmaceuticals and medical devices. What sets apart successful country managers in this competitive arena isn’t just their professional…
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…