MECHELEN, Belgium, — Interim results from an ongoing phase 2, randomized, placebo-controlled trial of the investigational drug TMC207 for the treatment of multidrug-resistant tuberculosis (MDR-TB) were published in the New England Journal of Medicine today. TMC207 is being developed by Tibotec BVBA. The data show that the addition of TMC207...
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PLYMOUTH MEETING, Pa.– INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that peer-reviewed data from a retrospective study investigating the long-term clinical and safety response of patients treated with INO-3107...
Data Analysis Supports Use of Predictive Enrichment Markers in Phase 2b OraGrowtH210 Trial AUSTIN, Texas – Lumos Pharma, Inc., a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, announced that results of peer-reviewed analyses of data from two prior pediatric growth hormone deficiency (PGHD) studies have been published in...
TOKYO & MUNICH & BASKING RIDGE, N.J. – New data for datopotamab deruxtecan (Dato-DXd), a TROP2 directed DXd antibody drug conjugate (ADC) being developed by Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca, show an encouraging tumor response rate in patients with advanced non-small cell lung cancer (NSCLC) with...
Tokyo, Japan and Basking Ridge, NJ – Positive high-level results from the TROPION-Breast02 Phase III trial showed Datroway (datopotamab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to investigator’s choice of chemotherapy as 1st-line treatment for...
Based on TROPION-Lung05 phase 2 trial results and supported by data from the TROPION-Lung01 phase 3 trial Second U.S. approval for Daiichi Sankyo and AstraZeneca’s DATROWAY in less than six months TOKYO & BASKING RIDGE, N.J. – Datroway (datopotamab deruxtecan or Dato-DXd) has been approved in the US for the...
TROPION-Lung02 and TROPION-Lung04 phase 1b results support combination of Daiichi Sankyo and AstraZeneca’s DATROWAY with immunotherapy as first-line treatment for advanced or metastatic NSCLC TROPION-Lung02 results include first exploratory QCS analysis of DATROWAY in first-line setting NeoCOAST-2 phase 2 results continue to show potential for DATROWAY plus durvalumab and single-agent...
TOKYO, Japan and MUNICH, Germany — The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for DATROWAY® (datopotamab deruxtecan) as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. DATROWAY...
PHOENIX, Ariz. — It seems everyone is soliciting donations for Nov. 30’s Giving Tuesday, the global generosity movement that falls each year on the Tuesday after Thanksgiving. Created in 2012 as a philanthropic response to consumerism and the buying frenzy of Black Friday and Cyber Monday, Giving Tuesday unleashes the...
CARLSBAD, Calif. — Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA) has approved DAWNZERA™ (donidalorsen) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. DAWNZERA is the first and only RNA-targeted medicine approved for HAE, designed...