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...
treatment News
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...
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...
Boston — Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, announced that the European Medicines Agency (EMA) Committee on Orphan Medicinal Products (COMP) has issued a positive opinion on orphan drug designation for DB-OTO, Decibel’s lead...
OSAKA, Japan & WALTHAM, Mass. — Deciphera Pharmaceuticals, LLC, a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines, and Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “Ono”), today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP)...
NEW YORK — Delcath Systems, Inc. (NASDAQ: DCTH) , a medical technology company testing its proprietary treatment method for primary and metastatic cancers to the liver, announced today that the United States Food and Drug Administration (“FDA”) granted Delcath’s application for orphan-drug designation for the drug melphalan for the treatment...