NICE and AstraZeneca Fail to Reach Agreement on Enhertu Reimbursement for NHS
The UK’s National Institute for Health and Care Excellence (NICE) has announced that negotiations with...
HER2
AstraZeneca’s AKT Inhibitor Truqap Misses Primary Endpoints in Phase III TNBC Trial
AstraZeneca (NASDAQ: AZN), a leading UK-based pharmaceutical company, has encountered a setback in the Phase...
BioNTech and MediLink’s HER3 ADC BNT326 Faces Partial Clinical Hold in the US
BioNTech SE (NASDAQ: BNTX), a German biotechnology company, and its Chinese co-development partner MediLink Therapeutics...
RemeGen’s Disitamab Vedotin Shows Positive Results in Phase III Trial for HER2 Positive Breast Cancer
RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced positive results from...
Astellas Resubmits FDA Application for Vyloy as Treatment for CLDN18.2-Positive Cancer
Astellas Pharma Inc. (TYO: 4503), a Japanese pharmaceutical company, has resubmitted its first-in-class anti-CLDN18.2 biologic...
Huadong Medicine’s EGFR Inhibitor Mefatinib for NSCLC Accepted by NMPA for Review
Huadong Medicine Co., Ltd (SHE: 000963), a leading pharmaceutical company based in China, has announced...
Betta Pharmaceuticals Files for Market Approval of CDK4/6 Inhibitor BPI-16350 in China
Betta Pharmaceuticals Co., Ltd (SHE: 300558), a Chinese pharmaceutical company, has announced that it has...
Henlius’ HER2 Dual-Targeted Therapy Gets Green Light for Global Phase III Trial by FDA
Shanghai Henlius Biotech Co., Ltd (HKG: 2696) has announced that it has received approval from...
US FDA Greenlights Henlius Biotech’s Hanquyou as Biosimilar to Roche’s Herceptin
Shanghai Henlius Biotech Inc. (HKG: 2696) has achieved a significant milestone with the US Food...
Guangzhou LBP Earns NMPA Nod for HER2 Detection Reagent to Guide Breast Cancer Treatment
Guangzhou LBP Medicine Science & Technology Co., Ltd (SHA: 688393), a biopharmaceutical company based in...
Boehringer Ingelheim Surpasses Bayer in Pharma Sales with EUR 20.8 Billion in 2023
Boehringer Ingelheim, a major German pharmaceutical company, has released its financial report for 2023, announcing...
Sanofi Explores Sale of Amunix Pharmaceuticals as It Shifts Focus to Immunology
Sanofi (NASDAQ: SNY), the France-based pharmaceutical giant, is reportedly in talks with potential buyers for...
Enhertu Shows 58.3% Response Rate in Phase II Lung Cancer Study, AstraZeneca and Daiichi Sankyo Report
The Phase II DESTINY-Lung05 study results for Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate co-developed by...
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)...
Alphamab Oncology’s JSKN003 Demonstrates Promising Results in Phase I HER2-Targeted Solid Tumor Study
Alphamab Oncology (HKG: 9966) presented compelling data from a Phase I clinical trial of its...
Jiangsu Hengrui Pharmaceuticals Secures IND Approvals for Two Drug Candidates from China’s NMPA
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has received Investigational New Drug (IND) approvals from...
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:...
AstraZeneca’s AKT Inhibitor Truqap Approved in Japan for HR+, HER2- Breast Cancer
AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, has registered with Japan’s Ministry of Health,...
MSD Partners with IDEAYA Biosciences to Develop Combination Therapy for Endometrial Cancer
Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced a partnership with IDEAYA Biosciences (NASDAQ:...