Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Kyowa Kirin, MEI Drop PI3Kδ Inhibitor Outside Japan after US FDA Guidance
Kyowa Kirin and MEI Pharma said on December 6 that they will cease the development of their phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor zandelisib (ME-401) for B-cell malignancies outside of Japan in accordance with the latest guidance from the US FDA.…
To read the full story
Related Article
- Kyowa Kirin Axes Flagship Kidney Disease Drug Candidate
May 11, 2023
- Kyowa Kirin/MEI Deliver in Japan PII Trial for B-Cell Non-Hodgkin’s Lymphoma
November 21, 2022
- MEI, Kyowa Begin PIII Study on Lymphoma Drug Zandelisib
August 19, 2021
- Kyowa Kirin Commences Japan PII of Zandelisib for Indolent B-Cell Non-Hodgkin’s Lymphoma
October 5, 2020
- Kyowa Kirin Snags Global Rights to MEI’s Blood Cancer Drug in Expanded Deal
April 15, 2020
- Kyowa Kirin License Novel Blood Cancer Treatment from US Company
November 7, 2018
BUSINESS
- Espha to Reinvest AG Profits into New Biz after Reform; Xarelto AG Logs 19 Billion Yen
May 15, 2026
- Meiji Opposes French Fund’s Push to Review Pharma Spin-Off
May 15, 2026
- FRONTEO Opens AI Drug Discovery Lab, Pivots to Out-Licensing Model
May 15, 2026
- Inqovi-Venetoclax Combo Wins FDA Approval in AML: Taiho
May 15, 2026
- Chugai Files Gazyva for Idiopathic Nephrotic Syndrome in Japan
May 15, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
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…
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…