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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)
Dato
12.10.2015
River Vision Announces Completion of Enrollment in Graves' Orbitopathy Study
NEW YORK, Oct. 9, 2015 /PRNewswire-iReach/ -- River Vision Development Corp. (RVDC) today announced the completion of enrollment of a Phase 2 clinical study of RV001 (teprotumumab) for the treatment of Graves' Orbitopathy (GO). RV001 is a fully human IGF-1 receptor antagonist antibody with a safety database comprised of more than 700 cancer patients. The study is being conducted at 15 sites in the US and Europe and has enrolled 88 patients with moderate to severe disease.
Dato
07.10.2015
NEW DATA FROM OXFORD UNIVERSITY HOSPITALS DEMONSTRATE SUPERIOR OUTCOME WITH CERAMENT™ ANTIBIOTIC ELUTING BONE SUBSTITUTE COMPARED TO COLLAGEN AND CALCIUM SULFATE IN THE MANAGEMENT OF CHRONIC OSTEOMYELITIS

·         50% Less Fracture Rates with CERAMENT™ with Gentamicin

·         50% Less Infection Recurrence with CERAMENT™ with Gentamicin

·         313 Patients Total in All Groups with a Minimum of 1 Year Follow-Up

Lund, Sweden, (PRNEWSWIRE) October 6, 2015 – BONESUPPORT™, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, today announced new data from the Bone Infection Unit at the Nuffield Orthopaedic Centre (part of Oxford University Hospitals) as presented at the recent European Bone & Joint Infection Society (EBJIS) meeting.  The study, a comparative evaluation of three local antibiotic delivery materials used as bone defect fillers after excision of chronic osteomyelitis, found CERAMENT™ with Gentamicin performed better in all primary outcomes; recurrence rate, fracture rate and wound leakage rate, despite a higher percentage of compromised Class B hosts.  The three study groups encompassed a total of 313 patients each with a minimum 1- year follow-up.  The group including CERAMENT™ with Gentamicin resulted in fifty percent less fractures, fifty percent less infection recurrences and fewer prolonged wound leaks as compared with the collagen or calcium sulfate products.  

Dato
29.09.2015
Vtesse, Inc. Initiates Phase 2b/3 Clinical Trial of VTS-270 for Treatment of Niemann-Pick Type C1 (NPC) Disease

During its first year of operations, Vtesse advances lead program into late-stage, pivotal trial and launches www.theNPCstudy.com

- Goal is to establish a clear foundational data set on the safety and efficacy of VTS-270 for treatment of NPC

GAITHERSBURG, Md., Sept. 28, 2015 /PRNewswire/ -- Vtesse, Inc. today announced that the first three patients have been screened for inclusion in its pivotal Phase 2b/3 clinical trial with VTS-270 for treatment of Niemann-Pick Type C1 Disease (NPC). This clinical trial follows a Phase 1 study conducted by researchers at the National Institutes of Health (NIH) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). 

Dato
29.09.2015
CERAMENT™ ANTIBIOTIC ELUTING BONE SUBSTITUTES FOR THE MANAGEMENT OF OSTEOMYELITIS PROMINENT AT THE 34TH ANNUAL MEETING OF THE EUROPEAN BONE & JOINT INFECTION SOCIETY (EBJIS)

CERAMENT™ with Gentamicin Shown to Decrease Recurrence of Infection and Increase Bone Formation

Lund, Sweden, (PRNEWSWIRE) September 24, 2015 – BONESUPPORT™, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, today announced the presentation of new clinical data with the Company’s platform bone void filler, CERAMENT™ with antibiotics which was presented at the 34th Annual Meeting of the European Bone & Joint Infection Society (EBJIS) on September 10-12 in Lisboa, Portugal.  CERAMENT™|G is the first CE-marked antibiotic eluting bone substitute indicated to promote and protect bone healing in the management of osteomyelitis and was prominently featured at EBJIS, a European association of orthopedic surgeons, trauma surgeons, infection specialists and microbiologists.  

Dato
09.09.2015
Biom’Up secures EUR 31,3 million in Series C financing from Bpifrance Large Venture, Gimv and Lundbeckfond Ventures
St-Priest, 9 September 2015, 7:30 AM CET – Biom’Up today announced that the company has secured EUR 31,3 million in a Series C financing round from an investment syndicate consisting of Gimv, Bpifrance Large Venture and Lundbeckfond Ventures, alongside its existing shareholders (InnoBio, Sham Innovation Santé, ACG Management, Sofimac, Mérieux Développement, OTC AM, Euroainvest and l’Améliane) and the company’s management team. This third institutional financing round represents a milestone for the international growth and scaling of the business. 
Dato
08.09.2015
Sanifit raises €36.6M ($41.3M) in Series C financing round
Financing will advance Sanifit’s lead drug candidate through phase IIb as a treatment for cardiovascular diseases linked to calcification and through
phase II/III for calciphylaxis.


Palma de Mallorca, Spain, September 8, 2015 - Laboratoris Sanifit S.L., a clinical-stage
biopharmaceutical company, today announces that it has raised €36.6M ($41.3M) in a Series
C financing round. The company is focused on the development of SNF472, an experimental
drug for the treatment of cardiovascular diseases linked to calcification in patients with End
Stage Renal Disease (ESRD) undergoing haemodialysis.
Dato
25.08.2015
CERAMENT™ WITH ANTIBIOTICS TO BE FEATURED EXTENSIVELY AT THE 34TH ANNUAL MEETING OF THE EUROPEAN BONE & JOINT INFECTION SOCIETY (EBJIS)
Lund, Sweden, (PRNEWSWIRE) August 25, 2015 – BONESUPPORT™, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, today announced that its platform bone void filler, CERAMENT™ with antibiotics, will have a significant presence at the upcoming 34th Annual Meeting of the European Bone & Joint Infection Society (EBJIS) taking place September 10-12 in Lisboa, Portugal. The annual meeting will feature twelve presentations and posters highlighting the outstanding long-term clinical benefits of CERAMENT™|G, the first antibiotic eluting bone substitute indicated to promote and protect bone healing in the management of osteomyelitis.
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