Japan’s ruling coalition sustained a crushing blow in the Lower House election last month, only managing to win 215 seats,…
REGULATORY
MSD’s 9-Valent HPV Vaccine Nearing Finish Line in Japan 5 Years after Filing, but Vaccination Policy Remains Iffy
Nearly five years after its submission in Japan, MSD’s nine-valent HPV vaccine has finally passed through review by the Pharmaceuticals and Medical Devices Agency (PMDA), and could come up for final panel discussions any time soon. However, with what is…
To read the full story
Related Article
- MSD’s 9-Valent HPV Vaccine Now Available in Japan
February 25, 2021
- MSD to Launch Silgard 9 on Feb. 24, but Mass Supply in Japan Unlikely Until 2023
February 5, 2021
- HPV Vaccines Clinically Significant in Japan, PMDA Says in Silgard 9 Review Report
July 28, 2020
- Japan Ob-Gyn Society Lauds Approval of 9-Valent HPV Vaccine, Plaintiffs Renew Protest
July 27, 2020
- 9-Valent HPV Vaccine Hits Finish Line, but Japan Launch Schedule Uncertain with High Global Demand
July 22, 2020
- Reinstate “Active Recommendation” for HPV Vaccines: LDP Lawmakers’ League
July 22, 2020
- Japan Approves MSD’s 9-Valent HPV Vaccine 5 Years after Filing
July 21, 2020
- Japan Approval for MSD’s 9-Valent HPV Vaccine Delayed into July
June 30, 2020
- Japan OK for MSD’s 9-Valent HPV Vaccine Could Be Delayed after Deluge of Comments Hit Proposed Rule Changes
June 26, 2020
- MSD’s 9-Valent HPV Vaccine Now in Line for June Approval; Eyes on Its Possible Inclusion in National Immunization Program
May 25, 2020
- Add MSD’s 9-Valent HPV Vaccine to National Immunization Program If Approved: Lawmakers
May 21, 2020
- MSD’s 9-Valent HPV Vaccine Up for Review in 1st Online PAFSC Meeting
April 16, 2020
- MSD Applies for 9-Valent HPV Vaccine
July 29, 2015
REGULATORY
- Scrap Off-Year Price Revisions, Smaller Japan Firms Face Uphill Battle: DPP Exec
November 28, 2024
- DPP Confirms Plan to Urge 4 Ministers to Scrap Off-Year Price Revisions
November 28, 2024
- Panel OKs 1-Year Extension of HPV Catch-Up Vaccinations, with Strings Attached
November 28, 2024
- Sakigake Tag Granted for Iclepertin, Brogidirsen
November 28, 2024
- MHLW Seeks Comments on Rx-to-OTC Switch of Tadalafil, 2 Other APIs
November 27, 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…