Japan plans to revise its guidelines on the drone delivery of medicines later this month, which would mark the first revision since they were established two years ago. Service providers are closely watching how they will be revised, with calls…
Will Zolgensma Delay Spur Revision of Sakigake Designation System?
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- 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
- Revision of Guidelines on Drone Drug Deliveries Expected by March-End: Will Powerful Meds Be OK'ed?
March 17, 2023
- FY2024 Pricing Reform Likely to Focus on “Balance” between Rewarding Innovation and Optimizing LLP Prices
February 6, 2023
- LDP Expects to Finalize Tax Reform Plan This Week; Will It Expand R&D Credit System?
December 13, 2022
- Japan Should Hone Emergency Approval Scheme Based on Xocova Example
November 28, 2022
- Pharma Industry Stays Pat on “No” to Off-Year Plan, Why Not Going for Trade-Off?
November 22, 2022
The healthcare supply chain in Japan, as in all major markets, consists of biopharmaceutical manufacturers selling to wholesalers who in turn sell to hospitals, clinics, and pharmacies, where the drugs are finally dispensed to patients. Each party ideally contributes value…
Authorized generic (AG) strategies taken by innovative drug makers might help soften the impact of generic competition in their businesses but such tactics might also accelerate the application of “G1”/“G2” price cuts for their off-patent brand-name medicines, a Jiho tally…
Japan’s health ministry announced new NHI prices to be applied in April under the FY2022 drug price revision in the official gazette on March 4, with the earlier application of so-called “G1” price cuts to be implemented for the first…