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 Finally Bags US OK for Parkinson’s Disease Istradefylline
Over a decade after its first filing, Kyowa Kirin’s Parkinson’s disease (PD) drug istradefylline was approved by the US FDA under the brand name of Nourianz, with the company now gearing up for its launch between September and December. The…
To read the full story
Related Article
- Kyowa Kirin’s Parkinson’s Med Rejected Again in Europe
November 16, 2021
- European Panel Rejects Kyowa Kirin’s Parkinson’s Med
July 29, 2021
- Kyowa Kirin’s Parkinson’s Med Accepted for Review in Europe
January 7, 2020
- FDA Accepts NDA Resubmission for Parkinson’s Drug Istradefylline: Kyowa Kirin
April 8, 2019
- Kyowa Kirin Resubmits Istradefylline for US Approval for 1st time in 12 Years, Based on Japanese Data
March 4, 2019
- Parkinson’s Med Nouriast Fails in PIII Study in US, Europe: Kyowa Kirin
December 14, 2016
- Kyowa Hakko Receives Not-Approvable Letter from FDA for Istradefylline
March 10, 2008
- Kyowa Hakko Submits NDA for KW-6002 Combination Therapy for Parkinson's Disease in US
May 14, 2007
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…