Japan’s ruling coalition sustained a crushing blow in the Lower House election last month, only managing to win 215 seats,…
REGULATORY
Aricept’s Lewy Body Dementia Indication to Be Modified after Post-Launch Trial Miss
For the first time in more than 14 years, the Japanese health ministry is requiring a partial change of approval under its pharmaceutical reexamination system. Eisai’s Aricept (donepezil) now braces for such modification process, which also entails a label revision,…
To read the full story
Related Article
- Lewy Body Dementia Specialist Sees Aricept Approval Modification as Positive Move
December 6, 2022
- Aricept Label Now Modified for Lewy Body Dementia Indication: Eisai
November 30, 2022
- Aricept Generics Earn Lewy Body Dementia Indications
March 14, 2019
- MHLW Approves Additional Indications for Aricept, 2 Other Drugs
September 22, 2014
REGULATORY
- MHLW Proposes Upping Copay Limits in High-Cost Medical Expense Scheme
November 25, 2024
- Japan’s New Economic Package Covers Pharma-Related Steps, but Not Repeal of Off-Year Revisions
November 25, 2024
- AstraZeneca’s COVID Antibody, Daiichi’s TROP2 ADC, and More Up for Review on Dec. 6
November 25, 2024
- Pharma Renews Call for Abolishing Off-Year Revisions, but MHLW Stays Put with Honebuto
November 22, 2024
- Pharma Pushes to Scrap Off-Year Revisions; LDP Members Urge Fresh Talks by 4 Ministers
November 22, 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…