CardioDx Announces Results of Study Demonstrating the Benefits of the Corus CAD Gene Expression Test Use in an African American Patient Population

CardioDx Announces Results of Study Demonstrating the Benefits of the Corus CAD Gene Expression Test Use in an African American Patient Population

- Patients with Low Corus CAD Scores Had a 95% Decreased Rate of Referral for Advanced Cardiac Testing Versus Patients with Elevated Corus CAD Scores -

REDWOOD CITY, Calif. – [October 20, 2014] - CardioDx, Inc., a molecular diagnostics company specializing in cardiovascular genomics, today announced the presentation of the study, “The Use of a Gene Expression Score Showed Clinical Utility in Evaluating African Americans Presenting with Symptoms Suggestive of Obstructive Coronary Artery Disease in a Primary Care Practice,” at the 36th Annual North American Meeting of the Society for Medical Decision Making, taking place from Oct. 18-22 in Miami.

LabCorp Announces Agreement to Acquire LipoScience

NMR LipoProfile test expands LabCorp’s offering of personalized diagnostic tests
BURLINGTON, N.C.--(BUSINESS WIRE)--Sep. 25, 2014-- Laboratory Corporation of America® Holdings (LabCorp®) (NYSE:LH) and LipoScience, Inc. (NASDAQ:LPDX), a provider of specialized cardiovascular diagnostic laboratory tests based on nuclear magnetic resonance (NMR) technology, today announced that they entered into a definitive merger agreement under which LabCorp would acquire LipoScience for a purchase price of $5.25 per share in cash, or a transaction value of $85.3 million which represents a total enterprise value of approximately $63 million. The Board of Directors of LipoScience has unanimously approved the agreement and recommended approval of the transaction by LipoScience’s stockholders.

“We are very pleased that LipoScience, a premier laboratory focused on personalized diagnostics for cardiovascular and metabolic disorders, is joining the LabCorp family,” said David P. King, Chairman and Chief Executive Officer of LabCorp. “LipoScience’s NMR LipoProfile test will enhance our innovative clinical decision support programs, advancing the Fifth Pillar of our strategy as we provide ever-broader, differentiated knowledge services to physicians and patients. Furthermore, LipoScience’s novel application of NMR technology furthers the Fourth Pillar of our strategy by continuing our leadership in scientific innovation. In addition to LipoScience’s strategic fit, the transaction is expected to be accretive to LabCorp’s earnings in year one, and to earn its cost of capital by year three.”

Medtronic Announces CE Mark and European Launch of TYRX(TM) Absorbable Antibacterial Envelope

MINNEAPOLIS - Sept. 22, 2014 - Medtronic, Inc. (NYSE: MDT) has received CE (Conformité Européenne) Mark for the TYRX(TM) Absorbable Antibacterial Envelope. This innovative mesh envelope covers an implantable cardiac device to help stabilize the device after implantation and reduce surgical-site infections.

The efficacy of the previous generation, non-absorbable TYRX(TM) Antibacterial Envelope* has been shown in three published studies, with new six-month follow-up data from the CITADEL/CENTURION Study presented at Cardiostim 2014. Six months following implantation, patients who received a single- or dual- chamber implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy (CRT) replacement device with a TYRX Antibacterial Envelope experienced lower infection rates than a historical cohort of patients who were implanted without the envelope.

Thrasos Announces Successful Formal Interim Analysis and Clinical Update

Clinical trial continues following dose selection; enrollment has reached 200
MONTREAL, September 16, 2014 – Thrasos Therapeutics, a biotherapeutics company focused on delivering new solutions for kidney disease, today announced that a pre-planned formal interim analysis of 140 subjects enrolled in its Phase 2 clinical study of THR-184 for Acute Kidney Injury (AKI) has been completed. The study will now continue and the dosing strategy will be adjusted based on recommendations of the Independent Data Monitoring Committee (IDMC). At this time 200 subjects have been enrolled in the ongoing clinical trial.

Rotation Medical Initiates Post-Market Clinical Study Of Rotator Cuff Repair System With Bioinductive Implant

- First patient enrolled and treated by Ted Schlegel, MD, at Steadman Hawkins Clinic in Denver -
Plymouth, MN – September 15, 2014 – Rotation Medical, a medical device company focused on developing new technologies to treat rotator cuff disease, today announced that it has initiated a multi-center post-market clinical study evaluating the use of the Rotation Medical rotator cuff system in treating supraspinatus rotator cuff tendon tears. The study will be conducted with leading orthopaedic and sports medicine surgeons across the U.S., including Ted Schlegel, MD, from Steadman Hawkins Clinic, Jeffrey Abrams, MD, from Princeton Orthopaedic Associates and Timothy Codd, MD, from Towson Orthopaedic Associates/University of Maryland Medical System, among others.

Ultragenyx Announces Positive Results From a Long-Term Phase 1/2 Study of KRN23 in Adult Patients With X-Linked Hypophosphatemia

All Patients Continued to Demonstrate Increases in Serum Phosphorus and the Majority Maintained Levels in the Normal Range

NOVATO, Calif., Sept. 15, 2014 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced the presentation of results from a long-term Phase 1/2 extension study, conducted by Kyowa Hakko Kirin Pharma, Inc., of the investigational fully human anti-FGF23 monoclonal antibody KRN23 (UX023) in adult patients with X-linked hypophosphatemia (XLH). The cumulative 16-month data, combining the four-month dose escalation period data from INT-001 and the 12-month extension data from INT-002, were presented at the American Society of Bone and Mineral Research (ASBMR) Annual Meeting in Houston.

TESARO Announces Submission of Rolapitant New Drug Application (NDA) to U.S. Food and Drug Administration

WALTHAM, Mass., Sept. 8, 2014 (GLOBE NEWSWIRE) -- TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today announced that it has submitted the New Drug Application (NDA) for oral rolapitant to the U.S. Food and Drug Administration (FDA). Rolapitant is an investigational neurokinin-1 (NK-1) receptor antagonist developed for the prevention of chemotherapy-induced nausea and vomiting (CINV).

 

Mirati Therapeutics Receives Orphan Designation from U.S. Food & Drug Administration for Mocetinostat in Diffuse Large B-Cell Lymphoma

SAN DIEGO, Aug. 11, 2014 /PRNewswire/ -- Mirati Therapeutics, Inc. (NASDAQ: MRTX) today announced that the U.S. FDA has granted Orphan Drug Designation to mocetinostat, a spectrum selective HDAC inhibitor, for diffuse large B-cell lymphoma (DLBCL). In June, mocetinostat was granted Orphan Drug Designation as a treatment for myelodysplastic syndrome (MDS). Orphan drug designation is also being sought for bladder cancer patients with specific genetic alterations.

Ultragenyx Announces License of Intellectual Property for the Treatment of Epilepsy and Other Seizure-Related Disorders With Triheptanoin

New Patent Also Issued With Composition Claims for Triheptanoin

NOVATO, Calif., Aug. 5, 2014 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced a license agreement with UniQuest Pty Limited for intellectual property related to the treatment of refractory epilepsy and other seizure-related and neurologic disorders with triheptanoin (UX007). The intellectual property originated from research on epilepsy and other neurologic models conducted at The University of Queensland.

New Data on Chimerix's Brincidofovir Supports Safety and Antiviral Activity Against Multiple Life-Threatening DNA Viruses in Organ Transplant Recipients

Three Abstracts Presented at 2014 World Transplant Congress

DURHAM, N.C., July 31, 2014 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, presented new data on its investigational antiviral, brincidofovir (BCV, CMX001), at the 2014 World Transplant Congress (WTC) in San Francisco.

Data presented at WTC support brincidofovir's antiviral activity and safety profile in hematopoietic cell transplant (HCT) and solid organ transplant recipients who were treated for viral infections including adenovirus (AdV), cytomegalovirus (CMV), BK virus, Epstein-Barr virus (EBV) and varicella zoster virus (VZV).