Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…
BUSINESS
Japanese PI Waiver Good News to Mega Pharma and Emerging Players Alike: Pfizer Execs
The Japanese government’s policy change in late 2023 to no longer require Japanese PI studies before multiregional clinical trials, except when deemed necessary, will benefit not only mega pharma companies but also emerging biopharmas, says senior officials of Pfizer Japan.…
To read the full story
Related Article
- MHLW to Clarify Criteria for Japanese PI Waivers through Q&A, Calls for Data-Based Justifications
October 14, 2025
- PMDA Stresses Science-Based Decisions on Japanese PI Waivers: Symposium
August 5, 2025
- PMDA to Clarify Position on Japanese PI Trials at August Symposium amid Industry Confusion
July 10, 2025
- JPMA to Investigate the Status of Application of Japanese PI Waiver
April 22, 2025
- Japan Officially Drops Japanese PI Requirement before Global Trial Entry
December 26, 2023
- Japan to Basically Drop Japanese PI Requirement before Global Clinical Trials
September 14, 2023
- Approve 16 Pediatric Cancer Meds as Exceptional Step Beyond Law, Oncologist Urges
August 8, 2023
BUSINESS
- Eylea Bio-AG to Carry DME Indication Missing from Fuji’s Biosimilar Label
December 5, 2025
- Forxiga Generics Launch in Japan at 33.6% of Originator Price: Sawai, T’s Pharma
December 5, 2025
- Vimpat Copies Hit Shelves at 35% of Originator Price as 10 Firms Flock to Market
December 5, 2025
- Keytruda Extends Japan Sales Lead to 26 Straight Months in November: Encise
December 5, 2025
- Meiji Pharma Takes Stake in Lyric Bio to Back Next-Gen IVIg Manufacturing
December 5, 2025





