FORTIFY trial to assess CERAMENT G as part of the surgical repair of severe tibial fractures.
Lund, Sweden, 22 May 2017– BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery, today announced that the first patient has been enrolled by Dr Ravi Karia at the University of Texas Health Science Center at San Antonio into the company's pivotal Investigational Device Exemption (IDE) trial: A Prospective, Randomized, Multicenter Controlled Trial of CERAMENT G as Part of Surgical Repair of Open Diaphyseal Tibial Fractures (the FORTIFY trial: ClinicalTrials.gov Identifier: NCT02820363).
Cambridge, Mass., May 15, 2017 – Imara Inc, a biotechnology company dedicated to developing novel therapeutics for patients with sickle cell disease (SCD) and other hemoglobinopathies, announced today that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation to IMR-687, the company’s lead product candidate. IMR-687 is the first SCD candidate to be designated as a drug for a rare pediatric disease, and this designation builds upon, and is complimentary to, the FDA’s earlier grant of Orphan designation.
DUBLIN, Ireland, May 08, 2017 (GLOBE NEWSWIRE) -- Horizon Pharma plc (NASDAQ:HZNP), a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, today announced that it has agreed to acquire River Vision Development Corp. ("River Vision") and its development-stage medicine teprotumumab (RV001), a fully human monoclonal antibody (mAb) currently in development for Thyroid Eye Disease (TED), a rare, autoimmune inflammatory disorder.
Lund, Sweden, 11th April, 2017 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone scaffolds to treat bone voids caused by trauma, infection, disease or related surgery, announces the appointment of Michael Diefenbeck MD PhD as Chief Medical Officer.
Dr Diefenbeck founded Scientific Consulting in Orthopaedic Surgery in 2014 and has worked for BONESUPPORT on a range of clinical projects related to CERAMENT™ as an independent clinical advisor.
Company anticipates sharing topline data and completing regulatory submissions in 2018
GAITHERSBURG, Md., March 15, 2017 /PRNewswire/ -- Vtesse, Inc. announced today that its registrational study of investigational drug VTS-270 in Niemann-Pick Type C1 disease (NPC) is fully enrolled.
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