In a recent conversation with James Feliciano, former president of AbbVie Japan, we delved into the intricacies of leadership in the Japanese pharmaceutical industry. Feliciano, a seasoned industry veteran, shared valuable insights into his experiences, challenges, and successes.Navigating the Abbott…
REGULATORY
Will Japan Reinstate Sakigake Status for Aducanumab? Many See It Unlikely
Speculation is growing that Japanese regulators will not reinstate its sakigake fast-track designation for Biogen’s Alzheimer’s drug aducanumab, which made a surprising comeback last month with the company announcing a plan to seek approval. The word is that the medicine…
To read the full story
Related Article
- In Shocking U-Turn, Biogen/Eisai Say to File Aducanumab in Early Next Year
October 23, 2019
- Sakigake Status Withdrawn for Aducanumab: MHLW
September 20, 2019
REGULATORY
- MHLW Panel Sorts Out Challenges for Stable Supply of Plasma-Derived Products
December 24, 2024
- Deferred PMP Cuts Likely to Batter Stelara; 7 Drugs Subject to Rule after LOE
December 24, 2024
- CEA Expansion, Higher Copay Likely to Be Included in Minister Budget Deal
December 24, 2024
- Off-Year Price Revision to Hit 53% of Listed Drugs in 2025, Down from 69%
December 23, 2024
- Opposition Parties Submit Bill to Scrap Off-Year Drug Price Revisions
December 23, 2024
The Ministry of Health, Labor and Welfare (MHLW) on December 18 presented a proposal to define the scope of products…
Eli Lilly’s Kisunla (donanemab) will join the Japanese reimbursement list on November 20, with a health ministry panel giving the…
Will an “off-year” drug price revision happen in April 2025 or not? Over the last week, expectations have been up…
A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…
A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…
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…