HORSHAM, Pa. — Johnson & Johnson (NYSE:JNJ) announced today the U.S. Food and Drug Administration (FDA) approved DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT). D-VRd is the only anti-CD38 antibody-based regimen with approved indications across newly diagnosed patients, regardless of transplant eligibility. The pivotal Phase...
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BEERSE, Belgium – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the European Commission (EC) has granted marketing authorisation for the expanded use of DARZALEX®▼ (daratumumab) subcutaneous (SC) formulation in two new indications. The first authorisation of these new indications is for the use of daratumumab SC in...
TAIPEI, Taiwan — Dasher Neuroscience Holdings Inc. (TPEx: 7829) (“Dasher Neuroscience”), an AI-driven biopharmaceutical company focused on central nervous system (CNS) drug discovery and development, today announced that it has successfully completed patient enrollment in its global, multi-center Phase 2 clinical trial evaluating YA-101, its flagship candidate for the treatment of...
Codiak BioSciences, Inc. (NASDAQ: CDAK), a clinical-stage biopharmaceutical company pioneering the development of exosome-based therapeutics as a new class of medicines, today announced the online publication of a new manuscript, Exosome mediated genetic reprogramming of tumor associated macrophages by exoASO-STAT6 leads to potent monotherapy anti-tumor efficacy, in the American Association...
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...
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...
Cambridge, UK – AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the 1st-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. The Committee for Medicinal Products for Human...
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...