erbB-2 Receptor – Talk Bio

Zymeworks Pivots to Royalty-Driven Model After Strong Ziihera Data in Gastric Cancer

3 weeks ago talkbio0Tagged Biological Factors, buyback, erbB-2 Receptor, Jazz, Malignant neoplasm of stomach, milestone payments, Regulatory Filing, Royalty-Driven Model, Strategy, Ziihera, Zymeworks

Zymeworks; royalty-driven model; Ziihera; gastric cancer; HER2; biologics; milestone payments; stock buyback; biotech strategy; Jazz Pharmaceuticals; regulatory filing

Jazz and Zymeworks Bispecific Antibody Zanidatamab Delivers Practice-Changing Results in Stomach Cancer Study

3 weeks ago talkbio0Tagged Antibodies, Bispecific, erbB-2 Receptor, gastroesophageal adenocarcinoma, Jazz, Malignant neoplasm of stomach, orphan drug designation, Overall Survival, Pharmacotherapy, Phase 2 trial, Phase 3, practice-changing, Progression-Free Survival, Zanidatamab, Zymeworks

Jazz Pharmaceuticals; Zymeworks; zanidatamab; bispecific antibody; HER2; gastroesophageal adenocarcinoma; stomach cancer; phase 2 trial; phase 3 HERIZON-GEA-01; overall survival; progression-free survival; chemotherapy; practice-changing; Orphan Drug designation

Pressure On, Purpose Questioned as Second Round of FDA Priority Review Vouchers Revealed

3 weeks ago talkbio0Tagged Anemia, Sickle Cell, Biosimilars, Commissioner 's National Priority Voucher, Drug Approval, drug price, eli lilly, erbB-2 Receptor, Malignant neoplasm of lung, Obesity, Priority Review, public health medicine (field), Tuberculosis, Drug-Resistant, United States Food and Drug Administration, voucher program

FDA; Commissioner’s National Priority Voucher; priority review; drug approval; voucher program; Eli Lilly; Novo Nordisk; her2 lung cancer; obesity drugs; drug-resistant tuberculosis; sickle cell disease; biosimilars; public health; drug pricing; regulatory controversy

Boehringer Ingelheim breaks into oncology as FDA grants accelerated approval to Hernexeos (zongertinib) for HER2 TKD–mutated NSCLC

4 months ago talkbio0Tagged Accelerated, Approved, Beamion, Boehringer Ingelheim, competition, Confirmatory Trial, Enhertu, erbB-2 Receptor, Frequency of Responses, HER2-mutant, Hernexeos, Identifier, LUNG-1, Mutation, Non-Small Cell Lung Carcinoma, non-squamous NSCLC, Oncomine Dx Target Test, oral targeted therapy, Priority Review, Requirement, TKD, United States Food and Drug Administration, Zongertinib

Boehringer Ingelheim; Hernexeos; zongertinib; FDA approval; accelerated approval; non-squamous NSCLC; HER2 TKD mutations; Oncomine Dx Target Test; Beamion LUNG-1; objective response rate; first oral targeted therapy for HER2-mutant NSCLC; priority review; breakthrough therapy designation; confirmatory trial requirement; competition with Enhertu

Inside ASCO 2025: Big Data Drops and a Towering Campaign – Key News Highlights

6 months ago talkbio0Tagged 2025, Artificial Intelligence, ASCO, Big Data, campaigns, Cancer Research, Clinical Oncology, erbB-2 Receptor, Malignant neoplasm of breast, Malignant neoplasm of lung

ASCO 2025; cancer research; big data; campaigns; clinical oncology; artificial intelligence; HER2; lung cancer; breast cancer; therapeutic vaccines

FDA Approves Roche’s PATHWAY HER2 Test for HER2-Ultralow Metastatic Breast Cancer

10 months ago talkbio0Tagged Approved, Biochemical Pathway, Carcinoma breast stage IV, Diagnosis, Enhertu, erbB-2 Receptor, HER2-ultralow, Pet Animal, Precision Medicine, Roche (company), United States Food and Drug Administration

Roche, PATHWAY HER2 (4B5) test, FDA approval, HER2-ultralow, metastatic breast cancer, companion diagnostic, Enhertu, personalized medicine

Pfizer’s IBRANCE Demonstrates Significant Efficacy in HR+, HER2+ Metastatic Breast Cancer

12 months ago talkbio0Tagged Anti-HER2 therapy, Carcinoma breast stage IV, erbB-2 Receptor, Hormone Therapy, Ibrance, palbociclib, Phase 3, Progression-Free Survival, standard-of-care

IBRANCE (palbociclib), HR+/ HER2+ metastatic breast cancer, Phase 3 PATINA trial, Progression-free survival (PFS), Standard-of-care therapies, Anti-HER2 therapy, Endocrine therapy

Jazz Pharmaceuticals Presents Groundbreaking HER2 Biliary Tract Cancer Data Ahead of FDA Decision

2 years ago talkbio0Tagged Biliary Tract Cancer, Decision, erbB-2 Receptor, Jazz, Priority Review, United States Food and Drug Administration, Zanidatamab

Jazz Pharmaceuticals, HER2, Biliary Tract Cancer, FDA Decision, Zanidatamab, Priority Review