New facility will add 30% capacity to Shire’s internal plasma manufacturing network once fully operational Expanded capacity supports continued strong growth of Shire’s leading immunoglobulin portfolio and further strengthens ability to deliver complex therapies for rare immune-mediated conditions DUBLIN, 25-Jun-2018 … Read the full press release
With first U.S. commercial installation at Hennepin Healthcare, the Philips Ingenia Elition performs MRI exam times up to 50% [1] faster with no compromise in image quality AMSTERDAM, 11-Jun-2018 — /EuropaWire/ — Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in … Read the full press release
Posted in Healthcare, Netherlands, Science, Technology
Tagged Clinicians, diagnostic, healthtech, MRI, MRI_exam, Philips Ingenia Elition, U.S. FDA
New System Expands Neurovascular Product Portfolio for the Treatment of Acute Ischemic Stroke DUBLIN, 17-Jan-2018 — /EuropaWire/ — Medtronic plc (NYSE:MDT) today announced that the company’s Neurovascular business unit received U.S. Food and Drug Administration (FDA) clearance of the Riptide(TM) Aspiration System, … Read the full press release
Posted in Healthcare, Ireland, Pharma & Biotech
Tagged artery, blood clot, Dr. Daniel Sahlein, Medtronic, Neurovascular, Riptide(TM) Aspiration System, Stacey Pugh, stroke, thrombus, U.S. FDA
High-throughput application of artus CMV QS-RGQ MDx Kit on QIAsymphony streamlines critical and frequently performed viral infection test for transplant patients Germantown, Maryland, and Hilden, Germany, 07-Jun-2017 — /EuropaWire/ — QIAGEN (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced it has … Read the full press release
Posted in Germany, Healthcare, Pharma & Biotech
Tagged anti-CMV therapy, artus®, automated, CMV kit, CMV QS-RGQ MDx kit, QIAGEN, QIAsymphony platform, Thierry Bernard, U.S. FDA
Lexington, Mass., USA, 20-Jan-2017 — /EuropaWire/ — Shire plc (LSE: SHP, NASDAQ: SHPG) announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the Class 2 resubmission of a New Drug Application (NDA) for SHP465, a long-acting, triple-bead, … Read the full press release
Posted in Healthcare, Ireland, Pharma & Biotech
Tagged ADHD, Andrew J. Cutler MD, New Drug Application, PDUFA, Philip Vickers PhD, Prescription Drug User Fee Act, Shire plc, SHP465, U.S. FDA
New system reduces number of steps in the treatment process for hemophilia A patients on ADYNOVATE [Antihemophilic Factor, (Recombinant), PEGylated] LEXINGTON, Mass., 04-Aug-2016 — /EuropaWire/ — Shire plc (LSE: SHP, NASDAQ: SHPG) announced that the U.S. Food and Drug Administration (FDA) … Read the full press release
Posted in Healthcare, Ireland, Pharma & Biotech
Tagged ADYNOVATE, BAXJECT III reconstitution system, Perry Sternberg, Shire plc, U.S. FDA
Basel, Switzerland, 24-11-2014 — /EuropaWire/ — Basilea Pharmaceutica Ltd. (SIX: BSLN) reports today that the U.S. Food and Drug Administration (FDA) announced a public meeting of the Anti-Infective Drugs Advisory Committee to discuss the New Drug Application (NDA) for the investigational … Read the full press release
Basel, Switzerland, 11-12-2013 — /EuropaWire/ — Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that the U.S. Food and Drug Administration (FDA) designated isavuconazole as a Qualified Infectious Disease Product (QIDP) for the treatment of invasive aspergillosis. QIDP status provides priority review and … Read the full press release
Posted in Government, Healthcare, Pharma & Biotech, Switzerland
Tagged Barbara Zink, Basilea Pharmaceutica, fungal infections, invasive aspergillosis, Isavuconazole, isavuconazonium sulfate, Peer Nils Schröder, QIDP, Qualified Infectious Disease Product, Ronald Scott, treatment, U.S. FDA, zygomycosis
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