Will Zolgensma Delay Spur Revision of Sakigake Designation System?
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
- 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
- Novartis Japan Chided over Flawed Zolgensma Data, Delayed Responses
April 8, 2020
COMMENTARY
- How Will Japan Deal with Expected Cost Spike with Japan-Made Antibiotic APIs?
April 1, 2025
- Fair or Unfair? PMP Return Applied for First Time in Off-Year Revision
March 24, 2025
- Evolving GLP-1 Drugs: Could Double and Triple Agonists Achieve Blockbuster Status?
March 4, 2025
- New Govt Fund for Innovative Drugs: Twists, Turns, and Hope
February 10, 2025
- Companies Welcome Generic Drug Fund, but Fret Pricing and Regulations
February 5, 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…