LipoScience Research Sheds Light On Novel Markers Via Nuclear Magnetic Resonance (NMR) Spectroscopy

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.

Mirati Therapeutics and MethylGene Announce Completion of Plan of Arrangement

 
Mirati Therapeutics Begins Operations

San Diego, California and Montreal, Canada, June 28, 2013 – MethylGene Inc. (“MethylGene”) (TSX:MYG) and Mirati Therapeutics Inc. (“Mirati Therapeutics”) today announced the successful completion, effective June 28, 2013, of the previously announced plan of arrangement (the “Arrangement”), whereby, among other things, MethylGene would migrate to the State of Delaware in the United States of America. Under the Arrangement, Mirati Therapeutics, a holding company, has become the ultimate parent corporation of MethylGene and its subsidiaries. Each MethylGene shareholder received one share of Mirati Therapeutics common stock (“Mirati Share”) for every 50 common shares of MethylGene held, having the effect of a 1 for 50 reverse split. In addition, all outstanding warrants and options have become exerciseable for Mirati Shares and the exercise price and the number of common shares issuable thereunder have been proportionately adjusted to reflect the 1 for 50 effective reverse split. The Mirati Shares are expected to commence trading on the TSX on July 3, 2013, under the symbol “MYG”.

TESARO Announces Presentation of Rolapitant Pharmacokinetic (PK) Data at the MASCC/ISOO International Symposium

 
PK Data from Drug-Drug Interaction Study Describes Lack of CYP3A4 Interactions

BERLIN, June 28, 2013 (GLOBE NEWSWIRE) -- TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today announced that results from a pharmacokinetic study of rolapitant, an NK-1 receptor antagonist, were presented this morning at the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) International Symposium in Berlin. These data support that rolapitant may be administered concomitantly with other pharmaceutical products that are metabolized by the liver microsomal enzyme CYP3A4, without a requirement for dose adjustment of the co-administered product. Pharmacokinetic data for other NK-1 receptor antagonists indicate that doses of concomitantly administered products metabolized by CYP3A4 must often be adjusted.