Bio-Thera Solutions Receives NMPA Approval for Three Cancer Treatments Including a Novel ADC
Bio-Thera Solutions Ltd (SHA: 688177), a China-based biopharmaceutical company, has received separate clinical trial approvals...
HER2
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...
Bayer’s BAY 2927088 Receives FDA Breakthrough Therapy Designation for HER2-Mutated NSCLC
The US Food and Drug Administration (FDA) has granted Germany-based Bayer AG (ETR: BAYN) breakthrough...
Johnson & Johnson’s Talquetamab and Daiichi Sankyo’s Enhertu Eye Priority Review in China
The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson (J&J, NYSE:...
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...
Johnson & Johnson to Acquire Ambrx Biopharma in a Deal Valued at USD 2 Billion
Johnson & Johnson (J&J; NYSE: JNJ), a global healthcare conglomerate, has announced its intention to...
Astellas’ Zolbetuximab Faces FDA Rejection Due to Manufacturing Facility Deficiencies
The US Food and Drug Administration (FDA) has issued a rejection for a filing submitted...
Biocytogen Strikes Exclusive Licensing Deal with US-Based Radiance Biopharma for Innovative BsADC
Biocytogen Pharmaceuticals (Beijing) Co., Ltd (HKG: 2315), a leading biopharmaceutical company based in China ,...
European Commission Expands Keytruda Indications for Advanced Cancer Treatments
The European Commission (EC) has granted Merck, Sharp & Dohme (MSD; NYSE: MRK) additional indications...
HighField Biopharmaceutical Doses First Patient in HFK1 Clinical Trial Targeting Solid Tumors
Hangzhou-based HighField Biopharmaceutical, a leader in immuno-oncology focused on innovative lipid-based therapies, has announced the...
Jiangsu Hengrui Receives NMPA Approval for Esophageal Cancer and Breast Cancer Clinical Trials
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has received approval from the National Medical Products...
AstraZeneca Receives FDA Approval for Truqap in HR-Positive, HER2-Negative Breast Cancer
UK-based pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced last week that it has received regulatory...
Zymeworks and BeiGene Terminate Licensing Agreement for ZW49 ADC
Zymeworks Inc. (NASDAQ: ZYME), a Canada-based biotech company, has announced in its Q3 financial report...
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...
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:...