The number of new graduates hired for sales rep roles increased in FY2025 after declining for five consecutive years, a…
BUSINESS
FDA Snubs Daiichi Sankyo’s HER3 ADC over Third-Party Manufacturing Issue
Daiichi Sankyo and Merck said on June 26 that the US FDA has rejected an application for their antibody-drug conjugate (ADC) patritumab deruxtecan (HER3-DXd) due to inspection findings at a third-party manufacturer. The partners said that the agency issued a…
To read the full story
Related Article
- Daiichi Sankyo’s HER3 ADC Hits PFS Goal in EGFR-Mutant Lung Cancer
September 18, 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
- Fujifilm Seeks Japan Nod for Stem Cell Therapy for Meniscus Injuries
May 15, 2025
- Tecentriq Filed for Thymic Carcinoma in Japan: Chugai
May 15, 2025
- Chugai’s DMD Gene Therapy Snags Conditional Approval in Japan
May 14, 2025
- Sumitomo Charts Revival Plan, Eyes 250 Billion Yen with 3 Key Meds by FY2027
May 14, 2025
- Suzuken Forms Tie-Up with Dongwon Group in South Korea
May 14, 2025
The traditional HR Business Partner (HRBP) model, once the gold standard for HR delivery, is undergoing a significant transformation. Many organizations, particularly in industries like pharmaceuticals, are moving towards a more agile resource model, aiming to streamline HR operations and…
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 key reimbursement policy panel on December 25 approved an outline of the FY2025 drug price revision, finalizing plans to…
For the first time in many years, Japan appeared to have pivoted to a pro-innovation path with the FY2024 drug pricing reform. All eyes were apparently on this course change as seen in this year’s most-read story list, though the…
A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…
The Ministry of Health, Labor and Welfare (MHLW) posted the final report compiled by its pharmaceutical regulation panel on its website on April 24, providing cases of drugs that could be exempted from all-case post marketing surveillance (PMS).The MHLW plans…
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…