REGULATORY

Lilly’s Retevmo Clears PAFSC for Thyroid Cancer; Lenvima/Keytruda to Get RCC Indication

February 7, 2022

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Eli Lilly’s RET kinase inhibitor Retevmo (selpercatinib) sailed through reviews by a key health ministry advisory panel on February 4 for two additional indications for use in certain patients with thyroid cancer and medullary thyroid cancer. The Pharmaceutical Affairs and…

To read the full story

MHLW Approves Label Expansions for Retevmo, Keytruda, Lenvima and More
February 28, 2022

REGULATORY

LDP Lawmakers’ League Urges Economic Efficiency in Drug Use
May 27, 2026
LDP Panel OKs Immunization Act Bill Aimed at Beyfortus NIP Use
May 27, 2026
US Calls Out Japan’s Market Expansion Re-Pricing Rules as “Unfair”: IP Report
May 26, 2026
CEA Review Group Holds First Meeting, Technical Debate Yet to Begin
May 26, 2026
AstraZeneca’s Oral SERD, MSD RSV Antibody Clear Japan Panel Review
May 26, 2026

Chuikyo Debate on FY2026 Drug Pricing Reform

Chuikyo OKs New CEA Handling, with Third-Party Verification Ahead

Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…

COMMENTARY

Are Technical Discussions Enough for Japan’s CEA System?

By Ken Yoshino

Japan is finally launching technical discussions on its cost-effectiveness assessment (CEA) system. A health ministry-funded research group is set to…

COLUMN

The Patient North Star: How Gilead Japan Redefined Innovation

By Philip Carrigan

In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…