Japan’s drug pricing panel held its final round of industry hearings on December 10 as it heads toward the FY2026…
BUSINESS
FDA Accepts Sawai’s ANDA for Tecfidera Generic
Japanese generic major Sawai Pharmaceutical said on June 7 that the US FDA has accepted its abbreviated new drug application (ANDA) for its generic version of Biogen’s multiple sclerosis drug Tecfidera (dimethyl fumarate) - its third US ANDA filing after…
To read the full story
BUSINESS
- Mochida to Bring in Morning Sickness Drug from Canada’s Duchesnay
December 16, 2025
- Global PIII Trial Halted for Arcus-Partnered TIGIT Drug: Taiho
December 16, 2025
- Vyvdura Now Available in Prefilled Syringe: Argenx Japan
December 16, 2025
- AbbVie Japan Seeks Rinvoq’s Broader Label for Alopecia Areata
December 16, 2025
- AbbVie Files Atogepant for Acute Migraine Attacks in Japan
December 16, 2025
Japan has presented its latest draft policy direction for its FY2026 drug pricing reform. While the package includes a string…
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…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…