(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
(IN BRIEF) Sanofi has announced the discontinuation of the global clinical development program for tusamitamab ravtansine, following an interim analysis of the Phase 3 CARMEN-LC03 trial. The trial assessed tusamitamab ravtansine as a monotherapy in previously treated metastatic non-squamous non-small … Read the full press release
Posted in Business, France, Healthcare, Industrial, Management, News, Pharma & Biotech, Science
Tagged Dietmar Berger, NSCLC, Sanofi, Tusamitamab Ravtansine
(IN BRIEF) AstraZeneca and Daiichi Sankyo have received European Union (EU) approval for their drug Enhertu as a monotherapy for the treatment of advanced non-small cell lung cancer (NSCLC) in adult patients with activating HER2 mutations who require systemic therapy … Read the full press release
Posted in Business, Environment, European Union, Healthcare, Industrial, Management, News, Pharma & Biotech, Science, Technology, United Kingdom
Tagged AstraZeneca, Daiichi Sankyo, Dave Fredrickson, Enhertu, EU approval, HER2-Mutant, Ken Keller, lung cancer, Martin Reck, monotherapy, NSCLC, partnership, sustainability
Application is being reviewed under the US FDA’s Real-Time Oncology Review pilot programme Based on results of the Phase III IMpower010 study, presented at ASCO, that showed adjuvant Tecentriq improved disease-free survival by more than one-third in PD-L1-positive early-stage lung cancer, compared with … Read the full press release
Posted in Healthcare, Marketing, News, Pharma & Biotech, Switzerland
Tagged atezolizumab, Cancer Immunotherapy, chemotherapy, FDA, Levi Garraway, lung cancer, non-small cell lung cancer, NSCLC, Real-Time Oncology Review, Roche, sBLA, supplemental Biologics License Application, Tecentriq®, treatment, tumours
(PRESS RELEASE) CAMBRIDGE, 20-Nov-2020 — /EuropaWire/ — AstraZeneca (LON: AZN), a global, science-led biopharmaceutical company, has announced the US Food and Drug Administration (FDA) approval of its Imfinzi (durvalumab) for an additional dosing option, a 1,500mg fixed dose every four … Read the full press release
Posted in Healthcare, News, Pharma & Biotech, Science, Technology, United Kingdom
Tagged bladder cancer, Dave Fredrickson, Imfinzi, Io, lung cancer, NSCLC, oncology, SCLC, Small cell lung cancer, Victoria M. Villaflor MD
Imfinzi improves progression-free survival (PFS) by more than 11 months compared to standard of care and is the first medicine to show superior PFS in this setting Data presented at the ESMO 2017 Congress follows FDA’s recent Breakthrough Therapy Designation … Read the full press release
Posted in Healthcare, Pharma & Biotech, United Kingdom
Tagged AstraZeneca, Dr. Luis Paz-Ares, Imfinzi, MedImmune, NSCLC, PACIFIC trial, Sean Bohen
Marks GSK’s fourth Breakthrough Therapy designation London, UK, 17-1-2014 — /EuropaWire/ — GlaxoSmithKline plc (LSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Tafinlar®(dabrafenib) for treatment of patients with metastatic BRAF V600E … Read the full press release
New test expands cancer diagnostics portfolio and strengthens Roche Diagnostics’ comprehensive tumour marker menu 19-7-2013 — /europawire.eu/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the global launch (except US) of Elecsys ProGRP, a test that distinguishes between the two … Read the full press release
Posted in Business, Healthcare, Pharma & Biotech, Science, Switzerland
Tagged Cancer, cancer diagnosis, lung cancer, non-small cell, NSCLC, ProGRP test, Roche, SCLC, small cell
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