Tags : Breast Cancer

Biosimilars

Samsung Bioepis Launches Ontruzant (trastuzumab, biosimilar) for Early and Metastatic

Shots: The company launches its first oncology treatment Ontruzant (trastuzumab), a biosimilar referencing Herceptin in Brazil. The biosimilar has received ANVISA’s approval for the treatment of metastatic HER2-overexpressing BC, early HER2-overexpressing BC, and advanced gastric cancer Ontruzant is being supplied to SUS through a PDP b/w Samsung Bioepis & Bionovis and Bio-Manguinhos. This the second […]Read More

Biosimilars Regulatory

Henlius and Accord’s Zercepac (trastuzumab, biosimilar) Receive the EMA Approval

Shots: The approval is based on comparative quality studies, clinical studies including preclinical data and resulted in bio-similarity, comparable efficacy and safety of Zercepac (HLX02) vs Herceptin Zercepac is developed under NMPA and EMA biosimilar guidelines and has been evaluated with the reference trastuzumab including comparative quality studies, preclinical studies, a P-I clinical study and […]Read More

MedTech

Zebra Medical Receives the US FDA’s Approval for its HealthMammo

Shots: The US FDA has granted 510 (k) clearance to HealthMammo for boosting early detection of breast cancer in mammograms The tool utilizes the AI to prioritize and identify suspicious mammograms and is automatically sent to Zebra’s platform, where it gets processed and analyzed for suspected breast lesions. The HealthMammo product then returns its result […]Read More

Biotech

Daiichi Sankyo Signs a Research Agreement Gustave Roussy for DS-1062

Shots: Gustave Roussy to receive funding and support from Daiichi Sankyo for integrative research program including clinical, translational, and preclinical studies for DS-1062 and patritumab deruxtecan in lung and breast cancer respectively The research program includes two P-II studies evaluating the efficacy, safety, and markers of response and resistance to DS-1062 & patritumab deruxtecan in […]Read More

Regulatory

Zionexa And Petnet Solutions’ Cerianna (Fluoroestradiol F 18) Receive the

Shots: Cerianna (Fluoroestradiol F 18) is a novel FDA approved molecular imaging agent targeted for PET imaging for detection of estrogen receptor-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer The product will also allow the clinicians better guide treatments for metastatic breast cancer patients and improve patients’ QoL […]Read More