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Dato
11.12.2015
Veloxis announces change in management
Veloxis Pharmaceuticals A/S (NASDAQ: VELO) announced today that Dr. William J. Polvino steps down as President and CEO after more than six years in the role.
Dato
08.12.2015
Atox Bio Enrolls First Patient in Phase 3 Study of Potential Treatment for Necrotizing Soft Tissue Infection (Flesh Eating Bacteria)

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.

Dato
07.12.2015
Veloxis Launches Envarsus® XR for Treatment of Kidney Transplant Patients in U.S.

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. 

Dato
03.12.2015
ACACIA PHARMA: DR PATRICK VINK TO SUCCEED IAN KENT AS NON-EXECUTIVE CHAIRMAN
Cambridge, UK – 3rd December 2015: Acacia Pharma Group plc (“Acacia Pharma”), the supportive care company developing products for US and international markets, today announces that Ian Kent will retire as non-executive Chairman on 31st December 2015 and will be succeeded by Dr Patrick Vink.
Dato
03.12.2015
Nexstim Plc Announces Completion of Enrolment of Phase III Clinical Trial in Stroke Therapy

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.

Dato
13.11.2015
Enterome and Gustave Roussy enter into a microbiome-based collaboration to develop novel immunotherapy solutions to treat cancer
Paris, France – November 12, 2015 - Enterome Bioscience SA, a pioneer in the development of therapeutic solutions (drugs and diagnostics) based on the gut microbiome, announces that it has entered into a collaborative development agreement with Gustave Roussy, Europe’s first comprehensive cancer centre.
Dato
10.11.2015
scPharmaceuticals Announces Start of Pivotal Trial for Subcutaneous Delivery of Leading Antibiotic

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.  

Dato
05.11.2015
scPharmaceuticals Announces Positive Results from Pivotal Trial of its Novel Subcutaneous Furosemide Formulation in Patients with Heart Failure

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. 

Dato
23.10.2015
Vtesse, Inc. Expands Scientific Advisory Board and Appoints New VP of Clinical Operations to Support Late-Stage Clinical Study of Lead Drug Candidate VTS-270
GAITHERSBURG, Md., Oct. 22, 2015 /PRNewswire/ -- Vtesse, Inc. announced today the addition of Elizabeth Berry-Kravis, M.D., Ph.D., Professor of Pediatrics, Neurological Sciences and Biochemistry at Rush University Medical Center to its Scientific Advisory Board (SAB) and that Michael Massaro has joined the company as Vice President, Clinical Operations. Today's news comes on the heels of Vtesse's recent announcement that Rush University Medical Center has enrolled three patients in its pivotal Phase 2b/3 clinical trial with VTS-270 for treatment of Niemann-Pick Type C1 Disease (NPC). Vtesse expects up to 20 sites (across the United States and the European Union) to participate in this clinical trial.
Dato
21.10.2015
FIRST U.S. STUDY OF CERAMENT™ ANTIBIOTIC ELUTING BONE SUBSTITUTE IN THE MANAGEMENT OF CHRONIC OSTEOMYELITIS PRESENTED AT EBJIS
CERAMENT™|G Shown to Decrease Infection and Increase New Bone Growth in a Pivotal Animal Model
 Lund, Sweden, (PRNEWSWIRE) October 20, 2015 – BONESUPPORT™, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, today announced data from the first U.S. study of CERAMENT™ with Gentamicin in an infected rat model as presented by the Hospital for Special Surgery (HSS) at the recent European Bone & Joint Infection Society (EBJIS)
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