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Sep 09, 2019, 08:00 ET Daiichi Sankyo Advances [Fam-] Trastuzumab Deruxtecan (DS-8201) in Japan with Regulatory Submission in HER2 Positive Metastatic Breast Cancer

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced the submission of a New Drug Application (NDA) to Japan's Ministry of...


Sep 04, 2019, 02:00 ET Daiichi Sankyo Presents Positive Results of the ENTRUST-AF PCI Study of LIXIANA®▼ (edoxaban) in Patients with Atrial Fibrillation

- ENTRUST-AF PCI study achieved the primary safety endpoint of non-inferiority in bleeding for edoxaban-based dual therapy compared with VKA-based...


Sep 02, 2019, 08:00 ET ETNA-AF Registry Data Provide Real-world Evidence of the Efficacy and Safety Profile of LIXIANA®▼ (edoxaban) in Elderly NVAF Patients

- Global and European real-world outcome analyses in non-selected atrial fibrillation (AF) patients on edoxaban, including those who are elderly with ...


Aug 21, 2019, 17:00 ET Updated Clinical Results and New Translational Research Data for Daiichi Sankyo's ADCs U3-1402 and DS-1062 to be Presented at the 2019 World Conference on Lung Cancer

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that updated results and new translational research data from two phase 1 ...


Aug 02, 2019, 19:40 ET FDA Approves Daiichi Sankyo's TURALIO™ (pexidartinib) for the Treatment of Select Patients with TGCT, a Rare and Debilitating Tumor

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the U.S. Food and Drug Administration (FDA) approved TURALIO™...


Jun 21, 2019, 08:00 ET Daiichi Sankyo Provides Update on FDA Review of Quizartinib for the Treatment of Patients with Relapsed/Refractory FLT3-ITD AML

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the company received a Complete Response Letter (CRL) from the U.S....


Jun 18, 2019, 08:00 ET Daiichi Sankyo's VANFLYTA® Receives Approval in Japan for the Treatment of Relapsed/Refractory FLT3-ITD AML

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced today that the Ministry of Health, Labor and Welfare (MHLW) of Japan has...


Jun 02, 2019, 08:00 ET Daiichi Sankyo Presents Preliminary Phase 1 Data for TROP2 Targeting ADC DS-1062 in Patients with Non-Small Cell Lung Cancer at 2019 ASCO Annual Meeting

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that preliminary results from the dose escalation part of a phase 1 study with...


Jun 01, 2019, 08:00 ET Daiichi Sankyo's Pexidartinib Demonstrated Further Improvement with Continued Treatment of Tenosynovial Giant Cell Tumor Patients in New Long-Term Analysis Presented at 2019 ASCO Annual Meeting

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo), today announced that new data from a pooled analysis of the phase 3 ENLIVEN study and...


May 31, 2019, 08:00 ET Daiichi Sankyo Presents Preliminary Phase 1 Data for HER3 Targeting ADC U3-1402 in Patients with EGFR Mutated Non-Small Cell Lung Cancer at 2019 ASCO Annual Meeting

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that preliminary results from the dose escalation part of the phase 1 study...


May 15, 2019, 17:00 ET Daiichi Sankyo Data Presentations at 2019 ASCO Annual Meeting Highlight Depth of ADC Pipeline and Promises of Oncology Portfolio

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it will present new data for several investigational compounds in...


May 14, 2019, 12:57 ET FDA Oncologic Drugs Advisory Committee Votes in Favor of Daiichi Sankyo's Pexidartinib for the Treatment of Select Patients with TGCT, a Rare, Debilitating Tumor

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory ...


May 08, 2019, 02:00 ET Daiichi Sankyo Announces [Fam-] Trastuzumab Deruxtecan Demonstrated Clinically Meaningful Response in Patients with Refractory HER2 Positive Metastatic Breast Cancer, a Population with High Unmet Need

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca today announced positive topline results for the pivotal phase 2...


Apr 29, 2019, 18:30 ET Daiichi Sankyo Announces Two Lancet Oncology Publications of Phase 1 Dose Expansion Results of [Fam-] Trastuzumab Deruxtecan in HER2 Positive Metastatic Breast and Gastric Cancer

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca today announced the publication of two manuscripts in The Lancet Oncology ...


Apr 09, 2019, 08:00 ET Daiichi Sankyo's EZH1/2 Dual Inhibitor Valemetostat (DS-3201) Receives SAKIGAKE Designation for Treatment of Patients with Relapsed/Refractory Peripheral T-Cell Lymphoma from Japan MHLW

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that valemetostat (DS-3201), an investigational and potential...


Apr 04, 2019, 08:30 ET Daiichi Sankyo Provides Update on Ongoing FDA Review for Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the U.S. Food and Drug Administration (FDA) has extended the review...


Apr 03, 2019, 08:00 ET EMA Validates Daiichi Sankyo's Marketing Authorization Application for Pexidartinib for Treatment of Patients with TGCT, a Rare, Debilitating, Non-Malignant Tumor

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the European Medicines Agency (EMA) validated the Marketing Authorization...


Mar 28, 2019, 19:30 ET Daiichi Sankyo and AstraZeneca Announce Global Development and Commercialization Collaboration for Daiichi Sankyo's HER2 Targeting Antibody Drug Conjugate [Fam-] Trastuzumab Deruxtecan (DS-8201)

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced today that it has entered into a global development and commercialization...


Mar 28, 2019, 19:29 ET Daiichi Sankyo Confirms Plans to Accelerate BLA Submission to U.S. FDA for [Fam-] Trastuzumab Deruxtecan (DS-8201) in HER2 Positive Metastatic Breast Cancer Post T-DM1

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced plans to accelerate filing of the Biologics License Application (BLA)...


Mar 19, 2019, 05:30 ET Data from the Non-interventional EMIT-AF/VTE Study Shows Low Thromboembolic and Bleeding Event Rates in Unselected Elderly AF/VTE Patients on Oral, Once-daily LIXIANA®▼ Undergoing Diagnostic or Therapeutic Procedures

In 2019, the Edoxaban Clinical Research Programme will deliver new evidence on LIXIANA®▼ (edoxaban) use in clinical practice. EMIT-AF/VTE is one of...


Mar 19, 2019, 05:04 ET CLEAR Wisdom Demonstrated First-in-class, Oral, Once-daily, ACL Inhibitor Bempedoic Acid Significantly Lowered LDL-Cholesterol and Reduced hsCRP

Daiichi Sankyo Europe GMbH (hereafter, 'Daiichi Sankyo') and Esperion (NASDAQ: ESPR) today announced that the Phase 3 results from CLEAR Wisdom of...


Mar 18, 2019, 10:00 ET Daiichi Sankyo Presents Positive Results of the First Randomised, Controlled Trial of Uninterrupted Oral, Once-daily LIXIANA®▼ (edoxaban) in Atrial Fibrillation Patients Undergoing Catheter Ablation

ELIMINATE-AF is the first set of data presented in 2019 from the Edoxaban Clinical Research Programme, which will deliver new evidence to support the ...


Feb 28, 2019, 07:00 ET Daiichi Sankyo Europe and Esperion Announce Validation of the Marketing Authorisation Application (MAA) for Bempedoic Acid and the Bempedoic Acid / Ezetimibe Fixed Dose Combination Tablet

Application is based on results of a robust development programme, which demonstrated that bempedoic acid was well tolerated and efficacious for...


Feb 22, 2019, 08:00 ET Daiichi Sankyo Shifts Several Top Leaders to New Roles for Company's Launch into its Next Growth Phase

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced senior-level organizational changes to oversee the realization of the...


Feb 05, 2019, 08:00 ET FDA Grants Priority Review for Daiichi Sankyo's New Drug Application for CSF1R Inhibitor Pexidartinib for Treatment of Patients with TGCT, a Rare, Debilitating Tumor

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug...