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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- Label Revisions Ordered for Brimonidine, Finerenone, and More
June 12, 2024
- MHLW to Issue Nitrosamine Risk Communication Guidance by June-End; Draft Now Ready
June 11, 2024
- Govt’s New Capitalism Council Proposes Extending Scope of Mixed-Billing Scheme
June 11, 2024
- Japan Enacts Bill to Amend Regenerative Medicine Safety Act, Clinical Trial Act
June 11, 2024
- Make Onsite GMP Inspections Mandatory for Patented Meds and New Generics: MHLW Proposal
June 10, 2024
- MHLW Proposes Creating Legal Provision on RWD-Only Drug Submissions
June 10, 2024
- Japan Eyes Withdrawal Rule for Conditional Approval, More Flexible Nods
June 10, 2024
- LDP Policy Board Endorses Fiscal Consolidation HQ’s Proposal to Extend CEAs
June 10, 2024
- Japan Grants Orphan Tag to Cannabidiol, 6 More APIs
June 10, 2024
- Health-Savvy Lawmakers Urge Revamp of Off-Year Revisions: LDP Policy Panel
June 7, 2024
- Abolish Off-Year Revisions, No to Broader CEA Use: Eto Group to Ministers
June 7, 2024
- LDP League on Medical Patches Urges Clarification of “Medical Necessity” as New Coverage Rule Looms
June 7, 2024
- Japan Eases Rule on Regulatory Submissions for Combination Therapies
June 6, 2024
- Japan Health Ministry Panel Gives Blessing to Novartis’ PNH Drug Iptacopan and More
June 4, 2024
- Make Single IRB Mandatory in Multi-Center Trials That Use Competitive Funds: Deregulation Panel
June 4, 2024
- Finance Minister Acknowledges Wholesalers’ Plight with Frequent Drug Price Revisions
May 31, 2024
- Nitrosamine Guideline to Be Proposed as New Topic for ICH at Fukuoka Confab
May 31, 2024
- Expand Mixed-Billing Scheme to Cover Gene Panel Test: LDP Committee Proposal
May 31, 2024
- Japan Selects JN.1 for COVID-19 Vaccine Formula in 2024-2025 Season
May 30, 2024
- PMDA Cuts Fees for Pediatric, Orphan Drug Consultations
May 30, 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…