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...
treatment News
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...
QUEENSBURY, N.Y. — Delcath Systems, Inc. (Nasdaq: DCTH), (“Delcath” or the “Company”) an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced the publication of the full results from the investigator-initiated CHOPIN randomized Phase 2 clinical trial, led by Principal Investigator Professor Ellen Kapiteijn,...
QUEENSBURY, N.Y. – Delcath Systems, Inc. (Nasdaq: DCTH), (“Delcath” or the “Company”) an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced the publication of results from a retrospective analysis conducted by researchers at the University of Tubingen, Germany. The study, titled “Characterization of...
TOKUSHIMA, Japan — As presented at 2022 ASCO Annual Meeting on June 6, 2022, DFP-14323 in combination with afatinib (20 mg/day) in stage III/IV non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutation positive in a Phase II clinical trial, has demonstrated fascinating longer median progression-free survival...
SOUTH SAN FRANCISCO, Calif. — Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for the treatment of neurodegenerative diseases and lysosomal storage diseases, today announced new data presentations highlighting the broad potential of its BBB-crossing enzyme replacement...
SOUTH SAN FRANCISCO, Calif. — Denali Therapeutics Inc. (Nasdaq: DNLI) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval for AVLAYAH™ (tividenofusp alfa-eknm), the first FDA-approved biologic specifically designed to cross the blood-brain barrier and reach the whole body, including the brain. AVLAYAH is an enzyme...
PLAINSBORO, N.J. and BAGSVÆRD, Denmark — Today, the New England Journal of Medicine (NEJM) published 26-week results from the phase 3 FRONTIER2 trial evaluating the efficacy and safety of once-monthly and once-weekly denecimig (Mim8) in adults and adolescents 12 years of age and older with hemophilia A (congenital Factor VIII (FVIII) deficiency),...