Tariffs have been a defining feature of US trade policy under President Donald Trump’s second administration. Since Trump unveiled his “reciprocal” tariff policy in April 2025, the landscape has shifted repeatedly.In February 2026, the US Supreme Court invalidated tariffs imposed…
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
- Sanofi Japan Bets on Beyfortus Track Record with NIP Inclusion in Sight
November 11, 2026
- Vital KSK’s Medleap Pivots to In-House Drug Filings, Eyes 2029 Launch
November 10, 2026
- Alfresa, Partners Seal Share Deal to Formalize Biosimilar JV
November 10, 2026
- Japan Ethical Drug Sales Rise 3.5% in September: Crecon
November 10, 2026
- Shionogi Grabs Japan Nod for Updated COVID Vaccine
November 10, 2026
As Japan’s budget season draws near, the Ministry of Finance (MOF) has renewed its push for a full-scale “off-year” drug…
Japan is pressing ahead with broader drug price cuts under its cost-effectiveness assessment (CEA) system, despite lingering questions over the…
Members of a key reimbursement policy panel on October 28 raised no objections to expanding drug makers’ access to deliberations…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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…