(IN BRIEF) AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application for Enhertu plus pertuzumab has been accepted for Priority Review by the FDA for the first-line treatment of HER2-positive metastatic breast cancer. The application is supported by data from the … Read the full press release
Posted in Business, Healthcare, News, Pharma & Biotech, Science, Technology, United Kingdom
Tagged ADC, antibody-drug conjugate, AstraZeneca, breakthrough therapy designation, cancer treatment innovation, Daiichi Sankyo, DESTINY-Breast09, Enhertu, Enhertu plus pertuzumab moves closer to first-line approval in HER2-positive metastatic breast cancer after FDA Priority Review acceptance, FDA, FDA grants Priority Review to Enhertu plus pertuzumab for 1st-line HER2-positive metastatic breast cancer following DESTINY-Breast09 success, HER2-positive breast cancer, Ken Takeshita, metastatic breast cancer, oncology, pertuzumab, Priority Review, progression-free survival, Real-Time Oncology Review, Susan Galbraith, THP regimen, trastuzumab deruxtecan
(IN BRIEF) Boehringer Ingelheim’s HERNEXEOS® (zongertinib tablets) has received accelerated approval in China for patients with advanced NSCLC carrying HER2 mutations who have progressed after prior therapy. The approval is supported by Beamion-LUNG 1 data, which showed a 71% objective … Read the full press release
Posted in Business, Financial, Germany, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology
Tagged AACR 2025, Beamion-LUNG 1, Beamion-LUNG 2, Boehringer Ingelheim, breakthrough therapy designation, CHINA, HER2 mutations, HERNEXEOS, New England Journal of Medicine, NMPA approval, non-small cell lung cancer, NSCLC, oncology, partnership, Shashank Deshpande, targeted therapy, tyrosine kinase inhibitor, Wu Yilong, zongertinib
(IN BRIEF) The FDA has accepted AstraZeneca’s sBLA for Imfinzi as a perioperative immunotherapy regimen in resectable early‑stage and locally advanced gastric and GEJ cancers, granting Priority Review with a decision expected in Q4 2025. The application leverages MATTERHORN Phase III data … Read the full press release
Posted in Business, Financial, Government, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged 2025 decision, adjuvant, AstraZeneca, breakthrough therapy designation, clinical paradigm shift, durvalumab, early-stage, EFS hazard ratio, event-free survival, FDA priority review, FLOT chemotherapy, gastric cancer, gastroesophageal junction cancer, high unmet need, Imfinzi, Levi Garraway, locally advanced, MATTERHORN Phase III, neoadjuvant, overall survival, Perioperative Immunotherapy, resectable, sBLA, Susan Galbraith
(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan has been accepted by the U.S. FDA for treating advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) in patients who have previously received systemic therapies. The … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged advanced NSCLC, antibody-drug conjugate, AstraZeneca, Biologics License Application, BLA, breakthrough therapy designation, Daiichi Sankyo, datopotamab deruxtecan, drug approval, EGFR-mutated, EGFR-tyrosine kinase inhibitors, FDA, metastatic NSCLC, non-small cell lung cancer, NSCLC, objective response rate, oncology, partnership, Phase III Trials, Priority Review, safety profile, systemic therapies, TROP2-directed, TROPION-Lung01, TROPION-Lung05, TROPION-Lung14, TROPION-Lung15
AstraZeneca’s first Breakthrough Therapy Designation for a respiratory medicine Designation based on Phase IIb PATHWAY data that demonstrated tezepelumab significantly reduced asthma exacerbations compared to placebo in severe asthma CAMBRIDGE, 12-Sep-2018 — /EuropaWire/ — AstraZeneca and its partner Amgen Inc. (Amgen) … Read the full press release
Posted in Healthcare, Pharma & Biotech
Tagged Amgen, asthma, AstraZeneca, breakthrough therapy designation, eosinophilic_phenotype, medicine, respiratory, Sean Bohen, tezepelumab
Second FDA Breakthrough Therapy Designation for MPDL3280A following bladder cancer in 2014 BASEL, 3-2-2015 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received a second Breakthrough Therapy Designation from the United States Food and … Read the full press release
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