Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Astellas/Pfizer’s Xtandi Given FDA’s Priority Review for Hormone-Sensitive Prostate Cancer
Astellas Pharma and its partner Pfizer said on August 21 that the US FDA has granted a priority review status for Xtandi (enzalutamide) for the treatment of men with metastatic hormone-sensitive prostate cancer (mHSPC), with the agency’s decision expected by…
To read the full story
Related Article
- Xtandi Filed for Hormone-Sensitive Prostate Cancer in Japan
July 31, 2019
- EMA Accepts Xtandi for Review in Hormone-Sensitive Prostate Cancer
July 25, 2019
- Astellas/Pfizer Unveil Positive Xtandi Data for Hormone-Sensitive Prostate Cancer
February 13, 2019
- Xtandi Smashes Primary Goal in Patients with mHSPC in PIII Trial
December 25, 2018
BUSINESS
- Leqembi FY2025 Global Sales Reach 88 Billion Yen: Eisai
May 1, 2026
- Rohto Files CMV Corneal Endotheliitis Drug in Japan
May 1, 2026
- Mochida Files in Japan for PAH Drug Tyvaso DPI
May 1, 2026
- Tanabe Clinches EU Approval for Parkinson’s Drug Onerji
May 1, 2026
- 3D “Deeply Disappointed” by Toho Plan to Seek Defense Trigger Approval
May 1, 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…