Procedure Performed at Vanderbilt Heart and Vascular Institute
Monmouth Junction, NJ. (August 7, 2013): TYRX, Inc. announced today that the first implantation of its new AIGISRx R Fully Resorbable Antibacterial Envelope has taken place at the Vanderbilt Heart and Vascular Institute in Nashville, TN by Dr. Christopher R. Ellis. The AIGISRx R Antibacterial Envelope received U.S Food and Drug Administration (FDA) clearance on May 20, 2013.
TYRX Announces First U.S. Implantation of AIGISRx® R Fully Bioresorbable Antibacterial Envelope
Ultragenyx Initiates New Development Program Studying Triheptanoin (UX007) for the Treatment of Glucose Transporter Type-1 Deficiency Syndrome (Glut1 DS)
Phase 2 Trial Initiation Planned for Year End
NOVATO, Calif., Aug 05, 2013 (GLOBE NEWSWIRE via COMTEX) -- Ultragenyx Pharmaceutical Inc., a biotechnology company focused on developing treatments for rare and ultra-rare genetic disorders, today announced its plan to develop triheptanoin (UX007) for the treatment of seizures in glucose transporter type-1 deficiency syndrome (Glut1 DS). Glut1 DS is a rare and severely debilitating disease caused by mutations in the SLC2A1 gene, which encodes for a protein called glucose transporter type-1 (Glut1). The disease is characterized by seizures, developmental delay and movement disorders. The Glut1 protein transports glucose from blood into the brain. Because glucose is the primary source of energy for the brain, this defect in the Glut1 transporter results in a chronic state of brain energy deficiency. The company is planning to initiate a Phase 2 trial studying triheptanoin in Glut1 DS by the end of 2013.
LipoScience Research Sheds Light On Novel Markers Via Nuclear Magnetic Resonance (NMR) Spectroscopy
Posters Presented at American Association of Clinical Chemistry (AACC) Meeting Highlight Utility of NMR Technology in Inflammatory Disease Risk Assessment and Diagnosis of Diabetes
RALEIGH, N.C., JULY 31, 2013 — /PRNewswire/ -- Researchers from LipoScience, Inc. (NASDAQ: LPDX), a diagnostic company pioneering a new field of personalized NMR diagnostics to advance the quality of patient care in cardiovascular, metabolic and other diseases, are presenting two posters today that highlight the utility of the company's proprietary nuclear magnetic resonance (NMR) technology in measuring novel markers of systemic inflammation, as well as in diagnosing diabetes through measurement of blood glucose. The posters, which will be presented during the Technology/Design Development session at the American Association of Clinical Chemistry (AACC) annual meeting in Houston, Tex., will be on display today from 9:30 a.m. to 5:00 p.m.
TESARO Initiates Phase 3 Trial of Niraparib for Treatment of Patients with Ovarian Cancer
First Patients Enrolled in the NOVA Study
WALTHAM, Mass., July 23, 2013 (GLOBE NEWSWIRE) -- TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today announced that it has initiated patient enrollment in a Phase 3 trial of niraparib, an inhibitor of poly ADP-ribose polymerase (PARP), for the treatment of ovarian cancer. This trial, referred to as NOVA, will evaluate a single daily 300 milligram dose of niraparib in 360 patients with high grade serous, platinum sensitive, relapsed ovarian cancer compared to placebo.
TYRX Receives FDA Clearance for AIGISRx® Neuro Antibacterial Envelope
Expands Access to Proven Antibacterial Technology to Neurosurgery
Monmouth Junction, NJ. (July 23, 2013): TYRX, Inc. announced today that it has received U.S. Food and Drug Administration (FDA) clearance to market the AIGISRx Antibacterial Envelope for use with vagus nerve stimulators, which are currently used to treat seizure disorders and depression. This approval extends TYRX’s leadership in the
commercialization of implantable medical devices designed to help reduce surgical-site infections (SSIs) associated with implantable devices into the field of neurosurgery.
Stem cell therapy for transplants developed by Athersys Inc. may end need for long-term immunosuppressive drugs
CLEVELAND, Ohio (July 23, 2013) -- One of the biggest problems facing anyone who receives an organ transplant is rejection. When the immune system, which is designed to keep us healthy, reacts to a donated organ as if it were a foreign invader and attacks, doctors have to prescribe powerful drugs to keep it in check.
Those drugs, called immunosuppressants, are a necessary evil for most transplant recipients for as long as they live. They prevent rejection, but can lead to infection, gastrointestinal disease, pancreatitis, cancer and kidney failure.
Chimerix CEO: Public market is critical to financing biotech R&D
July 15, 2013
Chimerix (Nasdaq: CMRX) CEO Ken Moch is speaking out about the role of the public market in financing research and development.
Moch, whose company hit the public market earlier this year, recently spoke at a hearing held by the House Financial Services’ Subcommittee on Capital Markets and Government Sponsored Enterprises.
Ultragenyx Gains Worldwide Rights for Triheptanoin (UX007)
Option Exercised for Ex-North American Territories
Novato, CA –July 11, 2013--Ultragenyx announced that it has expanded its exclusive license from Baylor Research Institute (BRI)in Dallas, Texas,to develop and commercialize triheptanoin outside of North America. The global license includes rights to patents, patent applications and other intellectual property related to the composition and formulation of UX007 as well as its use in treating a number of diseases including fatty acid oxidation disorders (FAOD), the lead indication being developed by the company.
TYRX Receives FDA Clearance for Fully Resorbable AIGISRx® R Antibacterial Envelope
AIGISRx Antibacterial Envelope Uniquely Designed to Combat Surgical Site Infections Associated with Cardiac Implantable Electronic Devices (CIEDs)
Monmouth Junction, NJ. (July 9, 2013): TYRX, Inc. announced today that it has received U.S. Food and Drug Administration (FDA) clearance to market the Fully Resorbable AIGISRx R Antibacterial Envelope for use with pacemakers and implantable cardioverter defibrillators (ICDs). The AIGISRx Antibacterial Envelope received approval from Health Canada in January 2013.
AIGISRx is a fully bioresorbable, antibacterial mesh envelope, intended to hold CIEDs securely in place in order to provide a stable environment when implanted in the body. Key to its design, AIGISRx R contains the antimicrobial agents rifampin and minocycline, which are released locally into the tissue, to help reduce surgical site infections (SSIs) associated with CIED implantation. Multiple studies have shown that in patients at high-risk for device infection, CIED implantation with the AIGISRx Antibacterial Envelope significantly reduced device infections by 70% - 100%, compared to patients who did not receive the AIGISRx.
Ultragenyx Announces a Positive Signal in Interim Data from Phase 2 Study of UX001 in Hereditary Inclusion Body Myopathy
Study to continue to 48 weeks, followed by extension study testing higher dosage
Novato, CA—July 3, 2013—Ultragenyx Pharmaceutical Inc., a biotechnology company focused on developing treatments for rare and ultra-rare genetic disorders, announced interim 24-week data from a 48-week Phase 2 clinical study of UX001 in 47 patients with hereditary inclusion body myopathy (HIBM), a progressive muscle-wasting disease. The study compared treatment with a total daily dose of 6 grams or 3 grams of UX001 with placebo. UX001, an oral sialic acid extended-release (SA-ER) tablet, is designed to replace the deficient sialic acid substrate in patients with HIBM.
