Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
COMMENTARY
Will It Be Possible to Eliminate Unnecessary Equivalence Studies for Generics?
Some generic manufacturers supply healthcare providers with bioequivalence data, which compare drug concentrations in the blood, on generics administered through the intravenous route such as anticancer drugs although such data are not required by the national guidelines. They do so…
To read the full story
COMMENTARY
- Rare Cancer Case Raises New Questions about AAV Gene Therapy Safety
July 27, 2026
- A Turning Point for Pharma? Chuikyo Reform Could Open Door to Greater Industry Role
July 13, 2026
- DORA Use Could Expand as Japan Opens Door to “Sleep Disorders” Specialty
July 6, 2026
- New Generic Listings Plunge, Industry Heads for a Shakeout
July 1, 2026
- Adaptation, Diversification Key as Drug Wholesalers Face Profit Squeeze
June 16, 2026
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
Adeno-associated virus (AAV) gene therapies have long been viewed as carrying only a minimal risk of insertional mutagenesis — a…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…