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...
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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...
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...
CARLSBAD, Calif. — Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion of DAWNZERA™ (donidalorsen) for the routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12...
Dawson James – Can-Fite (CANF): Two Patients Alive at Four years – Let’s Go Pivotal Can-Fite announced new data from the Phase 2 advanced liver cancer study, including overall survival of nearly four years in two patients who are under namodenoson treatment. We are looking for a stream of regulatory...
BOSTON, Mass. — Day One Biopharmaceuticals, Inc., now part of Servier Group, today announced that it has completed enrollment in the FIREFLY-2 clinical trial, which is evaluating the efficacy, safety and tolerability of tovorafenib vs standard of care chemotherapy in the front-line setting of therapy for patients aged 6 months to 25 years with...
BRISBANE, Calif. – Day One Biopharmaceuticals Inc. (Nasdaq: DAWN), a commercial-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved OJEMDA (tovorafenib), a type II RAF inhibitor, for the treatment...
London, England – There are ~7,000 rare diseases that together affect 300 million people. For the vast majority of these patients there are no approved treatments, representing a huge unmet medical need. Advances in the understanding of the molecular basis of rare diseases, the continued development of therapeutic platforms such...