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
- 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
- Japan to Obligate Single IRB in Multi-Center Clinical Trials That Use Competitive Funds
June 24, 2024
- PMDA Reviewing Safety Risks for Duvroq, Opdivo, and More
June 24, 2024
- Japan Panel Raises No Objection to Public Coverage of Shingles Vaccines
June 21, 2024
- SanBio’s Lead Cell Therapy in Line for Conditional Nod but Can’t Be Shipped Until Comparability Is Confirmed
June 20, 2024
- Xevinapant Earns Sakigake Tag, 6 APIs Get Orphan Status
June 20, 2024
- Opposition Party Urges Health Minister to Scrap Off-Year Drug Price Revision
June 19, 2024
- MHLW to Bankroll Up to 50 Billion Yen Each to KM, Daiichi for Vaccine Trials
June 19, 2024
- Nitrosamine Risk Communication Guidance Issued, Effective Immediately
June 19, 2024
- LDP Tweaks Honebuto Text on Off-Year Revision, Waters Down Push for CEA Expansion
June 18, 2024
- ICH Agrees to Draft Nitrosamine Guideline, Aims to Set Acceptable Intakes
June 18, 2024
- PMDA Chief Strenuously Delivering Info on Japan Regulations at Overseas Confabs
June 17, 2024
- First Generics Joining NHI Price List in June Hits Record Low, Bridion is Only Target
June 14, 2024
- MHLW Proposes Supply Info System for All Prescription Drugs, FY2027 Launch Eyed
June 14, 2024
- SanBio’s Lead Cell Therapy Up for Review Again on June 19
June 14, 2024
- Tezspire Braced for CEA Price Cut, AstraZeneca's Appeal Dismissed
June 13, 2024
- LDP Members Urge Modification of Honebuto Draft to Push Rethink of Off-Year Drug Price Cuts
June 13, 2024
- Social Security Budget Ceiling Looks Set to Continue 3 More Years: Honebuto Draft
June 12, 2024
- Honebuto Draft Equivocal on Off-Year Price Cuts, but Focuses on FY2025 Revision
June 12, 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…