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...
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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...
LAUSANNE, Switzerland — Debiopharm, a privately-owned, Swiss-based biopharmaceutical company aiming to develop innovative therapies and to improve patient quality of life, today announced the successful completion of patient enrollment in its open-label, single-arm, multi-center Phase III study (NCT06129539) ‘A Study to Assess the Efficacy, Safety and Pharmacokinetics of Debio 4326...
LAUSANNE, Switzerland – Debiopharm (www.debiopharm.com), a Swiss-based global biopharmaceutical company, today announced the signature of an exclusive license agreement with Merck KGaA, Darmstadt, Germany, a leading science and technology company, for the development and commercialization of xevinapant (Debio 1143). Xevinapant, a potent, oral of Inhibitor of Apoptosis Proteins (IAP) antagonist,...
LAUSANNE, Switzerland — Debiopharm, a privately-owned, Swiss-based biopharmaceutical company committed to establishing tomorrow’s standards of care in oncology and rare diseases, today announced that the first patient has been randomized in the OXTEND-03™ clinical trial. This pivotal Phase III trial is designed to evaluate the efficacy and safety of Debio 4126, a...
First patient dosed with Debiopharm’s first-in-class CD37 targeted antibody drug conjugate (ADC) in a Phase 1/2, multicenter, open-label trial, for patients with acute myeloid leukemia (AML) LAUSANNE, Switzerland — Debiopharm, a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standards of care to cure cancer and infectious diseases, today announced...