Japan plans to revise its definition of “vaccines of high development priority.” The Ministry of Health, Labor and Welfare’s (MHLW)…
REGULATORY
Japan Panel OKs Novartis’ siRNA Dyslipidemia Therapy and More
A Japanese health ministry panel on August 21 backed regulatory approval for a throng of new medicines, including Novartis Pharma’s inclisiran, which would become the first siRNA therapy for dyslipidemia in the country, if approved. Inclisiran, marketed as Leqvio in…
To read the full story
Related Article
- Eisai CEO Anticipates Leqembi Approval in Europe and China by March
December 18, 2023
- Leqembi to Cost 2.98 Million Yen per Year, Re-Pricing Might Be Triggered on Patient Upswing
December 14, 2023
- Leqembi to Debut on Dec. 20; Eisai Sees SC Version and Blood Biomarker as Drivers for Wider Use
December 14, 2023
- Leqembi OK’ed for Listing on Dec. 20; Peak Sales Put at 98.6 Billion Yen
December 13, 2023
- Phesgo, Epkinly, Leqvio Hit Japan Market, Wegovy Launch Set for Feb. 22
November 24, 2023
- Chuikyo Agrees to Adopt Normal Rules to Price, Re-Price Leqembi
November 16, 2023
- Listing OK’ed for Phesgo, Leqvio, Epkinly, and More; 30 Billion-Plus Yen Peak Sales for 3 Meds
November 16, 2023
- Industry Prods Careful Debate on Creating Separate Rules for Leqembi Re-Pricing
November 9, 2023
- Medical, Long-Term Care Data Linkage Holds Key to CEA: Leqembi Debate
October 30, 2023
- Leqembi’s Initial Pricing Won’t Factor in Benefits in Long-Term Care
October 19, 2023
- Post-Launch Re-Pricing Likely the Focus of Chuikyo Leqembi Discussions
October 5, 2023
- As Chuikyo Begins Pricing Debate of Leqembi, Panelists Urge Safety, Fair Access
September 28, 2023
- Japan Approves Multiple Firsts, Leqembi, Arexvy, Leqvio, and More
September 26, 2023
- Leqembi Subject to Cost Control Rule for Potential Big Sellers, MHLW Still Set to Meet Listing Deadline
September 26, 2023
- Japan Approves Eisai/Biogen’s Alzheimer’s Drug Leqembi
September 25, 2023
- Eisai’s Alzheimer’s Drug Clears Advisory Panel, Now in Line for Japan Approval
August 22, 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…