(IN BRIEF) BioNTech and Duality Biologics have received Breakthrough Therapy designation from the FDA for their antibody-drug conjugate (ADC) candidate, BNT323/DB-1303. The designation is for the treatment of advanced endometrial cancer in patients who have progressed following immune checkpoint inhibitor … Read the full press release
Posted in Germany, Healthcare, Pharma & Biotech, Technology
Tagged advanced endometrial cancer, antibody-drug conjugate, BioNTech SE, BNT323, Breakthrough Therapy, DB-1303, Duality Biologics, DualityBio, endometrial cancer, FDA, HER2, Human Epidermal Growth Factor Receptor 2, Prof. Özlem Türeci M.D., uterine cancer, Vivian Gu M.D.
Designation based on phase III HAVEN 3 study demonstrating Hemlibra prophylaxis significantly reduced bleeds compared to no prophylaxis First medicine to show superior efficacy compared to prior factor VIII prophylaxis in an intra-patient comparison BASEL, 19-Apr-2018 — /EuropaWire/ — Roche … Read the full press release
Posted in Healthcare, Netherlands, Pharma & Biotech, Switzerland
Tagged Breakthrough Therapy, haemophilia, Hemlibra, inhibitors, medicines, Roche, Sandra Horning MD
Investigational Enzyme Replacement Therapy to Treat Non-Neurological Manifestations which characterize Niemann-Pick Type B PARIS, 5-6-2015 — /EuropaWire/ — Sanofi and its subsidiary Genzyme announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olipudase alfa. … Read the full press release
Posted in France, Pharma & Biotech, Science
Tagged Breakthrough Therapy, Genzyme, Niemann-Pick Type B, olipudase alfa, Richard Peters, Sanofi, sphingomyelin, US FDA
EuropaWire (EW) is the first truly pan-European and leading press release distribution and newswire service for Europe and the European Union working towards consolidating Europe’s voice on the global newswire and media scene. The newswire service comes with advanced submission forms, flexible pricing and PR budgeting, granular targeting, nearly uncapped reach across countries, markets, verticals, industries, audiences, languages, etc., translation and localisation for greater local PR impact, in-depth distribution reporting, metrics and insights including measured PR reach, reads, engagements, impact, etc., no cap on words, images and multimedia to go along with your release, among others. Your press releases will be seen among the releases of Europe’s biggest and most prominent companies, brands and institutions.
HOW TO GET STARTED?
PHARMA & BIOTECH: The largest repository of EU/European pharma & biotech press releases spanning 12 years (2012-2024)
