Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
Zolgensma’s Japan Launch Delayed into 2020 as Sakigake Review Drags On, MHLW Still Eager to Make Decision by Year-End
The Japan debut of Novartis’ spinal muscular atrophy (SMA) gene therapy Zolgensma is expected to be delayed into next year as regulators have yet to wrap up its review nearly a year after its filing despite its sakigake tag. Although…
To read the full story
Related Article
- Novartis’ Flawed and Delayed Inquiry Responses in Zolgensma Review “Extremely Unusual”: PMDA Report
April 16, 2020
- Zolgensma Up for Japan Advisory Panel Meeting on Feb. 26, Listing Expected as Early as May
February 17, 2020
- Zolgensma Not on Roster for Nov. 13 MHLW Panel Review
November 7, 2019
- Novartis’ SMA Gene Therapy Filed in Japan on Nov. 1 after US, EU; What Will Happen to Sakigake Status?
November 13, 2018
- AVXS-101 Is Game Changer for SMA Treatment: Novartis Neuroscience Chief
October 24, 2018
BUSINESS
- CSL Behring Japan Names Edward Wright as New Chief
October 2, 2026
- Takeda Welcomes 39 Prospective 2027 Hires in Japan
October 2, 2026
- Nippon Shinyaku Reports 5-Year Efficacy Data for DMD Hopeful
October 2, 2026
- Taiho’s ASTX030 Hits PIII Goal, US Filing Planned
October 2, 2026
- Ono Moves US Venture Capital Arm to Cambridge
October 2, 2026
The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…
The development of Boehringer Ingelheim’s survodutide is gathering pace, putting the GLP-1/glucagon receptor agonist in contention to become the next…
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…