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) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced that the European Commission (EC) has approved DAWNZERA™ (donidalorsen) in the European Union (EU) for the routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older. The approval follows the positive opinion of the Committee for...