New York, NY – Health Canada on Wednesday approved Pfizer’s gene therapy fidanacogene elaparvovec, now to carry the brand name Beqvez, for the treatment of adults with hemophilia B. Beqvez is an adeno-associated virus-based gene therapy that delivers a functioning and high-activity copy of the human coagulation FIX gene, which...
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DAEJEON, South Korea — PharmAbcine Inc., a clinical-stage biotech company focusing on next-generation antibody therapeutics, announced today the initiation of patient dosing in the Phase 1a/b clinical trial of PMC-309 in patients with advanced or metastatic solid tumors. PMC-309 is an IgG1 monoclonal antibody with specific binding to VISTA in...
DAEJEON, South Korea — PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of next-generation antibody therapeutics, announces the publication of preclinical research in Science Advances, highlighting the potential of its Tie2-activating antibody program, PMC-403, in treating Idiopathic Systemic Capillary Leak Syndrome (ISCLS). The results underscore the...
BURLINGTON, Mass.- PharmaEssentia Corporation (TPEx: 6446), a global biopharmaceutical innovator leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the company’s Biologics License Application (BLA) for...
BURLINGTON, Mass. – PharmaEssentia USA Corporation, a subsidiary of Taiwan-based PharmaEssentia Corp. (TPEx: 6446), a global biopharmaceutical innovator leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced the resubmission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration...
BURLINGTON, Mass. — PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced that the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®)...
Madrid – PharmaMar (MSE: PHM) has announced today a new license and commercialization agreement with the Eczacıbaşı Pharmaceuticals Marketing Co. to commercialize the anticancer drug lurbinectedin in Turkey. Under the terms of the agreement, PharmaMar will receive a non-disclosed upfront payment and will be eligible for additional remunerations, including regulatory...
PERTH, Australia — PharmAust Limited (ASX: PAA & PAAOA), a clinical-stage biotechnology company, is pleased to announce that it has met its primary safety and tolerability endpoints with monepantel (MPL) and, importantly, demonstrated a positive signal of potential efficacy. Rates of disease progression in patients with Motor Neurone Disease (MND)...
Leiden, The Netherlands – Pharming Group N.V. (“Pharming” or “the Company”) (Euronext Amsterdam: PHARM/Nasdaq: PHAR) announces the successful completion of patient enrolment in the pivotal Phase II/III triple-blind, randomized, placebo-controlled study of leniolisib for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS). Leniolisib is a small molecule PI3Kδ inhibitor...
Leiden, The Netherlands – Pharming Group N.V. (EURONEXT Amsterdam: PHARM)/(Nasdaq: PHAR) announces that the first patient has been dosed in its Phase III pediatric clinical trial evaluating a new pediatric formulation of the investigational drug leniolisib, an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, in children ages one to six...