Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced positive Phase 3 results for a Libtayo® (cemiplimab) combination treatment were presented today during a late-breaking session at the European Society for Medical Oncology Virtual Congress 2021. The trial, which met its primary overall survival (OS) endpoint and all key secondary endpoints, assessed the investigational use of...
treatment News
SOUTH SAN FRANCISCO, Calif. and VANCOUVER, Canada – ESSA Pharma Inc. (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, today announced the presentation of updated dose escalation data from its Phase 1/2 study evaluating masofaniten (formerly EPI-7386) in combination with enzalutamide. ...
EMERYVILLE, Calif. — Estrella Immunopharma, Inc. (NASDAQ: ESLA), a clinical stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS® T-cell therapies to treat cancer and autoimmune diseases, today announced that the first patient has been dosed in the second cohort of its dose escalation study of Phase I/II STARLIGHT-1 trial for EB103,...
DEER PARK, Ill. — Eton Pharmaceuticals (Nasdaq: ETON), an innovative pharmaceutical company focused on developing, acquiring, and commercializing products to address unmet needs in patients suffering from rare diseases, today announced the commercial availability of Nitisinone Capsules for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary...
A group of more than 40 EU lawmakers backed the idea of an EU action plan for rare diseases, in a letter addressed to European Commission President Ursula von der Leyen.
VICTORIA, British Columbia — Eupraxia Pharmaceuticals Inc. (“Eupraxia” or the “Company”) (NASDAQ:EPRX) (TSX:EPRX), a clinical-stage biotechnology company leveraging its proprietary DiffuSphere™ technology designed to optimize local, controlled drug delivery for applications with significant unmet need, today announced the first patient dosed in the Phase 2b randomized, placebo-controlled portion of the...
EMERYVILLE, Calif. – Eureka Therapeutics, Inc., a clinical-stage biotechnology company developing novel T-cell therapies to treat solid tumors, today announced the initiation of ARYA-2, a Phase I/II open-label, dose escalation clinical trial of ET140203 ARTEMIS® T-cell therapy in pediatric patients with relapsed or refractory hepatoblastoma (HB), hepatocellular neoplasm not otherwise specified (HCN-NOS),...
BRIDGEWATER, N.J. — Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that the European Commission has approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in...
Beerse, Belgium — Janssen-Cilag International NV, a Johnson & Johnson company, today announced that the European Commission (EC) has approved a new indication for DARZALEX® (daratumumab) subcutaneous (SC) formulation as monotherapy for the treatment of adult patients with smouldering multiple myeloma (SMM) at high-risk of developing multiple myeloma.3 SMM is an...
PRINCETON, N.J. — Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has granted approval to Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy...