Japan plans to revise its definition of “vaccines of high development priority.” The Ministry of Health, Labor and Welfare’s (MHLW)…
REGULATORY
Japan Approves Precedex for Pediatric Use, Expands Labels for Nubeqa, Rinvoq, and More
The Japanese health ministry on February 24 approved label expansions for a batch of medicines including a pediatric indication for Pfizer’s sedative agent Precedex (dexmedetomidine). An α2 agonist, Precedex is now approved for sedation during non-invasive procedures and tests in…
To read the full story
Related Article
- Label Expansions for Nubeqa, Rinvoq, Imbruvica Now in Line for Approval
February 2, 2023
- Semaglutide in Line for March Approval as Obesity Drug, Precedex Too
January 30, 2023
REGULATORY
- CSL’s HAE Drug, Tecentriq Sarcoma Use Clear Panel Review; February Approval Expected
January 31, 2025
- MHLW to Take Balanced Approach in Dealing with Off-Year Revisions: Minister
January 31, 2025
- MHLW Orders Label Revisions for Lixiana, Keytruda, and More Drugs
January 30, 2025
- Pfizer’s Litfulo Braced for Price Cut after Cost-Effectiveness Assessment
January 30, 2025
- MHLW Panel Finalizes NIP Inclusion of Shingles Jabs, OKs New Basic Immunization Plan
January 30, 2025
As CEO of Morunda, I had the privilege of interviewing Bill Schuster, Country Manager of Viatris in South Korea. Our conversation delved into the multifaceted nature of leadership in the healthcare industry, exploring challenges, successes, and the power of authenticity.A…
A Japanese health ministry panel on December 26 wrapped up its discussions on the next amendment of the Pharmaceuticals and…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s key reimbursement policy panel on December 25 approved an outline of the FY2025 drug price revision, finalizing plans to…
For the first time in many years, Japan appeared to have pivoted to a pro-innovation path with the FY2024 drug pricing reform. All eyes were apparently on this course change as seen in this year’s most-read story list, though the…
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…
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…