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TYRX Receives FDA Clearance for Fully Resorbable AIGISRx® R Antibacterial Envelope

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.

TYRX - 07/09/2013

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.

Ultragenyx Pharmaceutical - 07/03/2013

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”.

Mirati Therapeutics - 06/28/2013

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.

TESARO - 06/28/2013

Zero Infections in High-Risk Cardiac Device Replacements Reported with Use of TYRX Antibacterial Envelope

 
Prospective, Multicenter Study of 532 Case Matched Patients Showed 100% Reduction in Infections

Athens, Greece (June 26, 2013): Use of TYRX, Inc.’s AIGISRx® Antibacterial Envelope reduced major infection rates by 100% in patients undergoing Cardiovascular Implantable Electronic Device (CIED) replacement procedures compared to case-matched retrospective control patients. Investigators presented new interim results from the Citadel / Centurion Clinical Study today at the Late Breaking Clinical Trials session at the European Heart Rhythm Association (EHRA), EUROPACE 2013.

TYRX - 06/26/2013

Anthera Announces Initiation of BRIGHT-SC Phase 2 Clinical Study in IgA Nephropathy with Blisibimod

 
HAYWARD, Calif., June 24, 2013 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with autoimmune disorders, today announced it has initiated the BRIGHT-SC Phase 2 study of blisibimod, a novel inhibitor of B-Cell Activating Factor (BAFF) for the treatment of IgA nephropathy. IgA nephropathy is a chronic autoimmune renal disease characterized by proteinuria and progression to end stage renal disease.

Anthera Pharmaceuticals - 06/24/2013

Liquidia Technologies Announces Extension of Collaboration with PATH to Develop Next Generation Pneumococcal Vaccine

RESEARCH TRIANGLE PARK, NC– May 21, 2013 – Liquidia Technologies today announced that its collaborative agreement with PATH, a global health nonprofit organization, has been extended. The extension of this agreement allows for the continuation of preclinical proof-of-concept studies on a next generation pneumococcal vaccine. If successful, the vaccine could potentially allow for broadened efficacy and manufacturing efficiencies that translate to greater access to the vaccine by the global population. Pneumonia kills approximately 1.3 million children under the age of five years every year—more than any other illness. Nearlyhalf of these deaths are caused by Streptococcus pneumoniae, a bacterium that has many variations globally and is becoming increasingly resistant to antibiotics.

“We are exceptionally proud of the work we have done with PATH and excited about the opportunity to continue this work with them,” said Neal Fowler, Chief Executive Officer at Liquidia Technologies. “Our shared goal to improve vaccine performance and reduce manufacturing costs using our transformative technology remains unchanged as does our confidence that this collaboration has the potential to significantly impact the spread of pneumonia in the developing world.”

Liquidia Technologies - 05/21/2013

Art Pappas Elected to NVCA Board of Directors

RESEARCH TRIANGLE PARK, N.C., May 15, 2013 — The National Venture Capital Association (NVCA) today announced the election of Arthur M. Pappas, managing partner of Pappas Ventures, to its board of directors. He will serve a four-year term. The appointment was made official at the association’s annual meeting – VentureScape 2013 – in San Francisco.

Mr. Pappas has over 30 years of operating experience as a pharmaceutical and biotechnology industry executive and venture capital investor in life science companies. He founded Pappas Ventures in 1994, and works with a team that has invested in numerous life science companies that have created novel innovative products addressing unmet medical needs. Prior to forming Pappas Ventures, he held senior level leadership positions at several multinational pharmaceutical companies, for which he led operations and was responsible for the development, licensing and launch of a number of global products.

The NVCA serves as the venture capital community’s trade association, representing more than 400 members by advocating for policies that encourage innovation and reward long term investment.

Uncategorized - 05/15/2013

Ultragenyx Advances Clinical Development of UX003 for the Treatment of Mucopolysaccharidosis Type 7 (MPS 7)

 
NOVATO, CA – May 15, 2013 - Ultragenyx Pharmaceutical Inc., a biotechnology company focused on developing treatments for rare and ultra-rare genetic disorders, today announced a Phase 1/2 study of UX003 for mucopolysaccharidosis type 7 (MPS 7, or Sly Syndrome). UX003 is a recombinant human β-glucuronidase intended as an enzyme replacement therapy (ERT) for the treatment of MPS 7, an extremely rare autosomal recessive lysosomal storage disorder characterized by a deficiency of the lysosomal enzyme β-glucuronidase and a severe multi-system disease. MPS 7 has no approved therapies.

Ultragenyx Pharmaceutical - 05/15/2013
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