Roche Secures CE Mark for Ventana HER2 Test, Enhancing Access to AstraZeneca’s Enhertu
Roche (SWX: ROG), based in Switzerland, has received CE marking from the European Commission (EC)...
TYO: 4568
AstraZeneca and Daiichi Sankyo’s Enhertu Secures FDA Approval for HER2-Positive Solid Tumors
Partners AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) have been granted an additional...
AstraZeneca and Daiichi Sankyo File for FDA Approval of Datopotamab Deruxtecan in Breast Cancer
AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, and its Japanese partner Daiichi Sankyo (TYO:...
EMA Reviews Datopotamab Deruxtecan Filings from AstraZeneca and Daiichi Sankyo for Oncology Indications
The European Medicines Agency (EMA) has accepted for review two oncology filings for the antibody-drug...
CDE Grants Priority Review to Jiu An’s Adrenaline and AnHeart’s Taletrectinib; Two Others Earn Breakthrough Therapy Designation
The Center for Drug Evaluation (CDE) has announced that Jiu An Pharmaceutical’s adrenaline and AnHeart...
AstraZeneca’s Enhertu Receives Priority Review for Expanded HER2-positive Solid Tumor Indication
UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced that an indication extension filing for...
USPTO Invalidates Key Seagen-Held Patent in ADC Conjugation Dispute with Daiichi Sankyo
In a surprising turn of events in the ongoing intellectual property dispute, the US Patent...
Daiichi Sankyo and Esperion Therapeutics Amend Collaboration on Antilipidemic Drugs
Daiichi Sankyo (TYO: 4568)’s European subsidiary, a Japanese pharmaceutical company, has entered into a collaboration...
FDA Grants Priority Review to MSD and Daiichi Sankyo’s ADC for Lung Cancer
The US Food and Drug Administration (FDA) has accepted under priority review a filing from...
Jiangsu Hengrui Pharmaceuticals Wins NMPA Approvals for SLE and Lymphoma Drug Candidates
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced that...
Enhertu Receives Priority Review Status for HER2-Positive Gastric Cancer Treatment in China
The Center for Drug Evaluation (CDE) website has indicated that Enhertu (trastuzumab deruxtecan), a HER2-targeted...
Daiichi Sankyo Reports 19.5% YOY Revenue Growth in First Half of Fiscal 2023
Japan’s Daiichi Sankyo (TYO: 4568) reported a robust 19.5% year-on-year (YOY) increase in revenue for...
EC Approves AstraZeneca and Daiichi Sankyo’s Enhertu for Advanced HER2+ NSCLC
The European Commission (EC) has granted registration approval for the HER2-directed antibody-drug conjugate (ADC) Enhertu...
MSD Collaborates with Daiichi Sankyo on Development of Innovative ADC Candidates
Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced a strategic collaboration agreement with Japan-based...
EMA’s CHMP Backs Enhertu for Advanced NSCLC with HER2 Mutations
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...
AstraZeneca and Daiichi Sankyo Report Positive Results for Datopotamab Deruxtecan Combo in NSCLC
UK-based pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced positive data from a Phase Ib...
AstraZeneca and Daiichi Sankyo’s Enhertu Earns Two BTDs for HER2+ Malignancies
The US Food and Drug Administration (FDA) has granted AstraZeneca (AZ; NASDAQ: AZN) and Daiichi...
FDA Approves Daiichi Sankyo’s Vanflyta for FLT3-ITD Positive AML Maintenance Treatment
The US Food and Drug Administration (FDA) has granted clearance to Japan-based Daiichi Sankyo (TYO:...
Alibaba Health and Daiichi Sankyo Partner to Innovate in Digital Healthcare Services
China’s Alibaba Health Information Technology Ltd (HKG: 0241) has entered into a strategic partnership with...
AstraZeneca and Daiichi Sankyo’s Enhertu Gains New Indication Approval in China for HER2-Low Breast Cancer
Partners AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) have announced that their co-developed...