Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
US FDA Accepts NDA for Sunovion’s Parkinson’s Disease Treatment
Sunovion Pharmaceuticals, a US subsidiary of Sumitomo Dainippon Pharma, said on June 12 that the US FDA has accepted its new drug application (NDA) for the Parkinson’s disease treatment APL-130277. The agent is a sublingual film formulation of apomorphine designed…
To read the full story
Related Article
- US FDA Approves Sunovion’s Apomorphine Sublingual Film for Parkinson’s
May 25, 2020
- US FDA Accepts Resubmission for Sunovion’s Parkinson’s Med
December 24, 2019
- Sunovion Resubmits Sublingual Parkinson’s Drug in US
November 26, 2019
- FDA Nixes Sunovion’s Parkinson’s Drug, but Requires No New Studies
February 1, 2019
- Apomorphine Sublingual Film Filed in US: Sunovion
April 3, 2018
BUSINESS
- Padcev-Keytruda Gets CHMP Nod for Cisplatin-Ineligible Bladder Cancer
May 25, 2026
- Japan Market Hits Record 11.8 Trillion Yen in FY2025, Keytruda Keeps Title: IQVIA
May 22, 2026
- Kissei Drops Call to Halt New Tavneos Use after Blue Letter Action
May 22, 2026
- Servier’s Voranigo Seen as Potential Standard of Care for Glioma: Expert
May 22, 2026
- Ultragenyx’s LC-FAOD Therapy Dojolvi Now Available in Japan
May 22, 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…