press release - Page 20 - Pappas Capital

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.

TYRX - 09/22/2014

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.

Thrasos Therapeutics - 09/16/2014

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.

Rotation Medical - 09/15/2014

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.

Ultragenyx Pharmaceutical - 09/15/2014

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).

TESARO - 09/08/2014

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.

Mirati Therapeutics - 08/11/2014

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.

Ultragenyx Pharmaceutical - 08/05/2014

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).

Chimerix - 07/31/2014

Anthera Pharmaceuticals Announces Acquisition of Sollpura® (liprotamase) for Exocrine Pancreatic Insufficiency From Eli Lilly and Company

Anthera to Form a New Subsidiary, Alkira Therapeutics, to Assume All Development Activities and Registration Activities as a Subsidiary of Anthera
HAYWARD, Calif., July 14, 2014 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH) today announced that it has acquired Sollpura (liprotamase), a novel investigational Pancreatic Enzyme Replacement Therapy ("PERT") from Eli Lilly and Company. Sollpura is a soluble, stable and non-porcine enzyme product intended for the treatment of patients with low digestive enzyme levels, or Exocrine Pancreatic Insufficiency (EPI), due to cystic fibrosis, and potentially other diseases. EPI is characterized by low absorption of fat and other nutrients due to a reduction in digestive enzymes produced by the pancreas.

Anthera Pharmaceuticals - 07/14/2014

CardioDx Announces Aetna and Coventry Health Coverage for Corus® CAD Gene Expression Test

- Blood-Based Test Has Potential to Improve Quality of Care and Lower Costs of Evaluation of Obstructive Coronary Artery Disease -
REDWOOD CITY, Calif. – [July 7, 2014] - CardioDx, Inc., a molecular diagnostics company specializing in cardiovascular genomics, confirmed today that Aetna has established a clinical policy for the company’s Corus® CAD gene expression test. With this decision, the Corus CAD gene expression test is eligible for coverage among Aetna and Coventry Health members. Aetna considers the Corus CAD gene expression test medically necessary for evaluation of non-diabetic adults with chest pain or anginal equivalent symptoms who have no history of obstructive coronary artery disease.

CardioDx - 07/07/2014