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
US FDA Requests Additional Data for Tolvaptan for Treatment of ADPKD: Otsuka
Otsuka Pharmaceutical announced on August 30 that it has received a Complete Response Letter (CRL) from the US FDA, stating that the agency cannot approve the company’s vasopressin V2 receptor antagonist tolvaptan for the treatment of adult patients with rapidly…
To read the full story
Related Article
- Otsuka’s Jynarque Earns FDA Nod for ADPKD at Second Attempt
April 26, 2018
- Tolvaptan Re-Submitted to US FDA for ADPKD: Otsuka
November 8, 2017
BUSINESS
- Novo Nordisk Launches Higher-Capacity Awiqli Pen in Japan
December 4, 2025
- Daiichi Sankyo Wins US Appeal in Seagen ADC Patent Dispute
December 4, 2025
- Vimpat Generics Win Added Use, Clearing Path for Full-Label Launch
December 4, 2025
- Alfresa, CMIC Ink Pact to Build Vaccination Support Platform
December 3, 2025
- Lundbeck Japan Plans to Double Workforce by 2028 as It Eyes 3 Drug Approvals
December 2, 2025
As Japan approaches the Fiscal System Council’s “autumn recommendation,” a notable shift is taking shape. The Ministry of Finance (MOF),…
Japan’s drug pricing panel on November 19 discussed a wide range of potential pricing changes related to patent-protected medicines, including…
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…