Japan’s ruling coalition sustained a crushing blow in the Lower House election last month, only managing to win 215 seats,…
REGULATORY
HeartSheet’s Conditional Approval to Be Withdrawn as Early as August
The Ministry of Health, Labor and Welfare (MHLW) is expected to withdraw the current conditional, time-limited approval of Terumo’s regenerative medicine product HeartSheet as early as next month, with the final decision now made not to grant it the full…
To read the full story
Related Article
- Chuikyo Urges Rethink of Health Coverage for Conditionally Approved Regenerative Medicines
August 9, 2024
- Terumo to End Sale of HeartSheet after Panel’s Thumbs-Down
July 22, 2024
- Japan Panel Says No to Full Approval of HeartSheet, Clears Breyanzi’s Broader Label
July 22, 2024
- AnGes Alters Strategy for Collategene, Halts Japan Sales for Fresh Submission
June 25, 2024
REGULATORY
- Opposition CDP Eyes Nonpartisan Bill to Scrap Off-Year Drug Price Revisions
November 14, 2024
- MOF Stands Firm on Push for Full-Scale Off-Year Revision in FY2025
November 14, 2024
- Kisunla Gets Reimbursement Listing with Daily NHI Price of 8,560 Yen
November 14, 2024
- Japan to Apply Leqembi’s General Pricing Rules for Similar AD Therapies
November 14, 2024
- Japan Panel OKs Listing of Kisunla, Tepezza, Quviviq, and Many More
November 14, 2024
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…