Ness Ziona, Israel – Dec 7, 2015 – Atox Bio, developer of immunomodulatory therapeutics for rapidly-progressing infectious diseases in critically ill patients, today announced that it has enrolled the first patient in its Phase 3 study to evaluate AB103 – the first-ever candidate developed for the treatment of Necrotizing Soft Tissue Infections (NSTIs), also known as ‘flesh eating bacteria’. The ACCUTE (AB103 Clinical Composite
endpoint StUdy in necrotizing soft Tissue InfEctions) study is conducted at approximately 40 centers in the U.S. and expects to enroll 290 patients who will receive around the clock coverage by highly experienced surgical teams and critical care support.
Envarsus® XR is Indicated for Patients Converted from Tacrolimus Immediate-release Formulations
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced the U.S. launch of Envarsus® XR (tacrolimus extended-release tablets) for the prophylaxis of rejection in kidney transplant patients who require or desire conversion from immediate release tacrolimus products to once-daily Envarsus® XR.
Helsinki, 3 December 2015 at 9:30 am
Recruitment completed ahead of schedule
Nexstim Plc (NXTMH:HEX, NXTMS:STO), a medical technology company aiming to improve rehabilitation for stroke patients through the use of non-invasive brain stimulation, announces that it has successfully completed enrolment of its Phase III NICHE (Navigated Inhibitory rTMS to Contralesional Hemisphere) clinical trial in stroke therapy, ahead of schedule.
Program aims to develop a new method of delivering trusted antibiotic without risk or costs associated with daily intravenous infusions.
LEXINGTON, Mass., November 10, 2015 /PRNewswire/ -- scPharmaceuticals, Inc., announced today that it has commenced its pivotal trial of subcutaneous administration of the antibiotic ceftriaxone for use with the sc2Wear Patch Pump.
Complete (100%) bioavailability after subcutaneous administration when compared with intravenous administration - Diuresis at 8 and 24 hours was equivalent to diuresis following standard intravenous administration - U.S. and EU regulatory filings anticipated in 2016 –
LEXINGTON, MA. – scPharmaceuticals, Inc. today announced positive results from its pharmacokinetic and pharmacodynamics phase 3 pivotal registration trial. The trial in patients with heart failure compared subcutaneous administration of a novel furosemide formulation with intravenous administration of furosemide USP (the commercial reference product). Furosemide is a diuretic; it induces urine output to reduce fluid overload (edema), a hallmark of heart failure. The trial results indicated that the subcutaneous administration of the novel furosemide formulation was as effective as the traditional intravenous administration in getting furosemide into the blood stream, and in achieving diuresis. The subcutaneous administration used a proprietary biphasic delivery profile. The reference treatment was commercial furosemide injection, USP administered intravenously in accordance with its prescribing information.
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