To read the full story
Related Article
- Yescarta Sails through PAFSC Review; Panel Roughly OKs Novartis’ Corrective Measures after Zolgensma Delay
December 4, 2020
- Sakigake Status Should Not Be Granted to Novartis Products until It Takes Prevention Measures for Approval Delay: Pharma Bureau Chief
September 8, 2020
- Will Zolgensma Delay Spur Revision of Sakigake Designation System?
June 11, 2020
- Zolgensma Hits Japan Market with Stringent Conditions Attached
May 21, 2020
- Chuikyo Members Frown on Zolgensma’s Sakigake Premium; Topic Up for 2022 Pricing Debate
May 14, 2020
- Japan Regulators Upped Zolgensma Price after Novartis Complaints: Chuikyo Paper
May 13, 2020
- Zolgensma to Get Japan’s Highest List Price 167 Million Yen, but Peak Sales Put at Just 4 Billion Yen
May 12, 2020
- Novartis’ Flawed and Delayed Inquiry Responses in Zolgensma Review “Extremely Unusual”: PMDA Report
April 16, 2020
- (Update) Japan Approves Novartis’ SMA Gene Therapy Zolgensma; 15-20 Patients Expected Annually
March 19, 2020
- Zolgensma Now in Line for Japan Approval in March, All Eyes Now Riveted on Price
February 27, 2020
REGULATORY
- LDP Tariff Task Force Broadly OKs First Proposal
April 22, 2025
- GSK’s Blenrep, Moderna RSV Jab Edge Closer to Japan Approval with Panel OK
April 22, 2025
- Ruling Coalition Wary of Scrapping Coverage for OTC-Like Drugs
April 21, 2025
- Diuretic, Hypertension Drugs, Zolgensma under PMDA Risk Review
April 21, 2025
- Chugai’s DMD Gene Therapy Now in Line for Conditional Approval
April 21, 2025
Your company’s employer brand is your reputation as an employer and is crucial in attracting top talent. Some reputations are just not good; they may or not be deserved. That is just the perception in the market. Years ago there…
For the first time in many years, Japan appeared to have pivoted to a pro-innovation path with the FY2024 drug pricing reform. All eyes were apparently on this course change as seen in this year’s most-read story list, though the…
The Ministry of Health, Labor and Welfare (MHLW) posted the final report compiled by its pharmaceutical regulation panel on its website on April 24, providing cases of drugs that could be exempted from all-case post marketing surveillance (PMS).The MHLW plans…