DURHAM, N.C., Nov. 13, 2014 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that its investigational broad-spectrum antiviral brincidofovir has been selected as one of two investigational agents to be evaluated in a clinical study in patients with confirmed Ebola Virus Disease in west Africa. Chimerix and the University of Oxford are in the process of finalizing a definitive agreement for supplying brincidofovir for the planned clinical trial.
Chimerix's Brincidofovir Selected for Use in Ebola Clinical Trial in West Africa by International Consortium
Ultragenyx Granted EU Orphan Drug Designation for KRN23 for the Treatment of X-Linked Hypophosphatemia
Novato, CA, Oct. 30, 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 that the European Commission has granted orphan medicinal product designation for recombinant human monoclonal IgG1 antibody for fibroblast growth factor 23 (KRN23 or UX023) for the treatment of X-linked hypophosphatemia (XLH). XLH is an inherited metabolic bone disease characterized by short stature, skeletal deformities, bone pain, fractures, and muscle weakness.
Chimerix hammers out an emergency PhII Ebola study for antiviral
October 28, 2014 -- Chimerix has outlined plans for a small Phase II study of its powerful antiviral brincidofovir as a counterpunch to Ebola.
In recent weeks the biotech ($CMRX) has added details on its study design listed on clinicaltrials.gov. The trial calls for 50 patients aged 2 months to 75 years old who test positive for the lethal Ebola virus. While the online site notes that no recruiting is being done yet, Chimerix lists a company contact for the study along with plans to start off Ebola patients with a 200-mg dose of brincidofovir (CMX001), to be followed up with four 100-mg doses over the next two weeks. The study is slated to wrap up a little more than a year from now.
Ultragenyx Granted Orphan Drug Designation for Triheptanoin for the Treatment of Glucose Transporter Type-1 Deficiency Syndrome
NOVATO, CA – October 27, 2014 – Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced that the FDA Office of Orphan Products Development has granted orphan drug designation for triheptanoin (UX007) for the treatment of glucose transporter type-1 deficiency syndrome (Glut1 DS). Glut1 DS, also known as De Vivo disease, is a rare and potentially severely debilitating disease characterized by seizures, developmental delay, and movement disorder. Ultragenyx is conducting a Phase 2 study of triheptanoin in patients with Glut1 DS.
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.
