Shots: The P-I dose-escalation study will assess the safety, tolerability, and preliminary efficacy of DS-1055 in adult patients with r/r advanced or metastatic head and neck, gastric and esophageal cancers, […]readmore
Tags : Daiichi
1. LEO Reports the US FDA’s Acceptance of BLA for Tralokinumab to Treat Adults with Moderate to Severe Atopic Dermatitis Published Date: Jul 10, 2020 | Tags: LEO, Reports, US, […]readmore
The American Society of Clinical Oncology (ASCO) is a platform for cancer experts to share views on the latest advancements and new approaches in cancer research and was held virtually […]readmore
Biotech
Regulatory
Daiichi Sankyo and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) Receive the US
Shots: The US FDA’s BT designation is based on an ongoing P-II DESTINY-Lung01 study assessing Enhertu in 170 patients with HER2 mutant or HER2 overexpressing unresectable and m-nsq. NSCLC, progressed […]readmore
Shots: Immunic has exercised its exclusive option to license a group of compounds for Daiichi’s IMU-856. Daiichi to receive up front, certain future development, approval & sales milestone payments plus […]readmore
1. Johnson & Johnson Initiates Voluntarily Recall of a Single Lot of its Baby Powder in the US Published: Oct 18, 2019 | Tags: JnJ, Initiates, Voluntarily, Recall, Baby Powder, US […]readmore
Shots: The BLA submission is based on P-I study and the pivotal P-II DESTINY-Breast01 study. The P-II DESTINY-Breast01 study assessing Trastuzumab deruxtecan in 253 patients with HER2+ unresectable/metastatic breast cancer […]readmore
Shots: The approval of Minnebro (Esaxerenone) tablets (1.25/2.5/5 mg) is based on P-III ESAX-HTN study in patients with hypertension, with its regulatory approval submitted to MHLW in Feb’18 In Q2’19, […]readmore
Shots: The P-II DESTINY-Breast01 study involves assessing of Trastuzumab Deruxtecan (DS-8201) in 253 patients with HER2+ unresectable and/or m-breast cancer prior treated with trastuzumab emtansine The P-II DESTINY-Breast01 study result: […]readmore
Shots: Esperion to receive $150M upfront, $150M sales milestones and up to $900M regulatory milestones including royalties. Daiichi to get exclusive commercialization rights for Esperion’s bempedoic acid and bempedoic acid […]readmore