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...
HER2
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...
Alphamab Oncology Presents Promising Data for KN046 and KN026 at ESMO 2023
China-based Alphamab Oncology (HKG: 9966) has released data snapshots from clinical studies for two of...
Novartis’ Kisqali Plus Endocrine Therapy Shows Improved Survival in Early Breast Cancer Study
Switzerland-based pharmaceutical company Novartis (NYSE: NVS) has announced additional results from an ongoing Phase III...
Shanghai Henlius Receives GMP Certification from ANVISA for Biosimilar Manufacturing
China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) subsidiary Shanghai Henlius Biotech,...
Jiangsu Hengrui Licenses Pyrotinib to Dr. Reddy’s for Indian Market
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has entered into a licensing agreement with...
Sandoz Receives Positive CHMP Review for Trastuzumab Biosimilar in HER2-Positive Cancers
Sandoz (SWX: SDZ), the generic and biosimilar drug maker set to separate from Novartis (NYSE:...
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)...
Novartis’s Kisqali Reduces Cancer Recurrence Risk in HR+/HER2- Early Breast Cancer: Phase III Results
Swiss pharmaceutical giant Novartis (NYSE: NVS) has published results from a Phase III study of...
AstraZeneca’s Enhertu Shows Promising Results in Phase II HER2-mutant NSCLC Trial
AstraZeneca (AZ; NASDAQ: AZN) has released early data from a Phase II trial investigating the...
Jiangsu Hengrui’s HER2-Targeted ADC SHR-A1811 Aims for CDE’s BTD Status
China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its HER2 targeted antibody-drug...
Zai Lab’s Margenza (Margetuximab) Approved by China’s NMPA for HER2-Positive Breast Cancer
The National Medical Products Administration (NMPA) website has indicated that Zai Lab Ltd’s (NASDAQ: ZLAB,...
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...
MSD’s Keytruda Gains EC Approval for First-Line HER2-Positive Gastric Cancer Treatment
The European Commission (EC) has granted an additional indication to Merck, Sharp & Dohme (MSD;...
Seagen’s Tukysa Meets Primary Endpoint in Phase III Study for HER2+ Breast Cancer
Seagen (NASDAQ: SGEN), currently in the process of being acquired by Pfizer (NYSE: PFE), has...
Amoy Diagnostics and AstraZeneca Expand Collaboration on Companion Diagnostic Development
China-based Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685) has announced a new cooperation agreement with...
Sino Biopharmaceutical Receives NMPA Approval for Biosimilar Herceptin for HER2+ Cancers
Sino Biopharmaceutical Ltd (HKG: 1177) has announced that it has received market approval from the...
Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for SHR-A1811 and Pyrotinib Combo Study
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received approval from...
Transcenta Holding Ltd Secures Global Clinical Trial Approvals for Osemitamab in Gastric Cancer
China-based Transcenta Holding Ltd has reported receiving clinical trial approvals from China’s Center for Drug...
BioNTech’s DB-1303 ADC Shows Promising Results in Solid Tumor Phase I/IIa Trial
Germany’s BioNTech (NASDAQ: BNTX) has released preliminary data from a Phase I/IIa trial for DB-1303,...