Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
BUSINESS
Daiichi/Merck Pull HER3-DXd Filing for NSCLC in US
Daiichi Sankyo and US Merck said on May 29 that they have voluntarily withdrawn their FDA application for the HER3-targeting antibody-drug conjugate (ADC) patritumab deruxtecan (HER3-DXd) after it missed the overall survival (OS) goal in a confirmatory study. The filing…
To read the full story
Related Article
- Daiichi Sankyo’s HER3 ADC Hits PFS Goal in EGFR-Mutant Lung Cancer
September 18, 2024
- FDA Snubs Daiichi Sankyo’s HER3 ADC over Third-Party Manufacturing Issue
June 28, 2024
- Daiichi’s HER3 ADC Gets Priority Review in US for 3rd Line EGFR-Mutated NSCLC
December 26, 2023
- Daiichi Sankyo’s HER3 ADC Posts Positive PII Data in 3rd Line NSCLC, US Filing Eyed by March
September 12, 2023
- Daiichi Sankyo Rolls Out Lung, Breast Cancer Data for HER3-Directed ADC
March 22, 2023
- Daiichi Sankyo’s HER3 ADC Enters PIII for EGFR-Mutated NSCLC
August 10, 2022
- Daiichi Sankyo’s HER3-Directed ADC Shows Promise in Breast Cancer
June 7, 2022
- Daiichi Sankyo’s HER3 ADC Gets Breakthrough Therapy Tag in US
December 27, 2021
- Daiichi Sankyo’s ADC U3-1402 Scores 39% ORR for EGFR-Mutated NSCLC in PI
June 8, 2021
BUSINESS
- AG Price Parity Plan Stokes Industry Fears of Patient, Pharmacy Defections
December 12, 2025
- Kyowa Kirin Names Abdul Mullick as Next CEO from March 2026
December 12, 2025
- Regeneron Files Libtayo for Squamous Cell Carcinoma in Japan
December 12, 2025
- Chugai to Donate 100 Million Yen to Support Nobel Laureate Sakaguchi’s Research
December 12, 2025
- Regeneron Lines Up 5 Late-Stage Assets for Japan: Commercial Head
December 11, 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…