Japan approved its 39-trillion-yen economic stimulus package on November 22. It does not explicitly state that the drug price revision…
REGULATORY
PMDA Updates Veklury Label to Allow Its Use in Moderate COVID-19
The Pharmaceuticals and Medical Devices Agency (PMDA) has revised the label of Gilead Sciences’ antiviral agent Veklury (remdesivir) to allow its use not only in severe COVID-19 cases but also in moderately ill patients. With the drug’s supplies to Japan…
To read the full story
Related Article
- Veklury Expands Label for Mild COVID-19
March 22, 2022
- Japan Prepping to Expand Veklury Label beyond Severe COVID-19: PMDA
December 25, 2020
- Check Latest Info and Make Careful Decision on Veklury Use: PMDA Review Report
May 19, 2020
- Chuikyo OKs Special Mixed Care Scheme for Veklury
May 11, 2020
- Japan Approves Remdesivir as First Drug for COVID-19
May 8, 2020
- Gilead Japan Expected to Offer Remdesivir for Free for Now
May 7, 2020
- Gilead Files Remdesivir for COVID-19 in Japan
May 4, 2020
- Japan Likely to Take FDA’s Anticipated EUA as Cue for “Special” Remdesivir OK
May 1, 2020
- Japan to Quickly Utilize “Special Approval” Scheme for Remdesivir after It’s OK’ed Overseas: Minister
April 30, 2020
- Japan Might Approve Gilead’s Remdesivir for COVID-19 in May
April 28, 2020
- Gilead Japan to Seek Early Remdesivir Filing If Initial Data Prove Positive: Development Chief
April 16, 2020
- Gilead Launches PIII Remdesivir Trials for COVID-19 in Japan
April 15, 2020
- Gilead-Sponsored Remdesivir Trial Expected to Start This Month: Minister
April 3, 2020
- Japan to Join NIH-Sponsored COVID-19 Trial for Gilead’s Remdesivir
March 24, 2020
- Gilead Launches PIII Studies for Remdesivir for COVID-19, Japan Included
February 28, 2020
REGULATORY
- Ex-Minister Takemi to Set Up Nonprofit to Bolster Pharma Innovation
December 11, 2024
- LDP Study Group Urges Health, Finance Ministers to Drop Off-Year Revisions
December 11, 2024
- PM Ishiba Elusive on Course of Off-Year Revisions: Diet Session
December 10, 2024
- Gene Therapies from Ferring, Ultragenyx in Line for Orphan Status, Moderna mRNA Drug Too
December 10, 2024
- PM Ishiba Takes Note of Opposition Party’s Plea for Scrapping Off-Year Revisions
December 9, 2024
For 25 years, Morunda has been interviewing leaders in Japan’s pharmaceutical and medical device industry. Most country managers typically come from a commercial background, rooted in sales and marketing. It’s rare to find country managers who come from finance or…
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…