Phase I Data on Anti-Notch1 Selected for Oral Plenary Presentation

REDWOOD CITY, Calif., Oct. 30, 2014 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, will present clinical data from three anti-cancer stem cell clinical programs at the 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics Meeting to be held November 18-21, 2014 in Barcelona, Spain.

Among the presentations will be clinical data from OncoMed's anti-Notch1 (OMP-52M51) solid tumor clinical trial. Interim results from the Phase 1a study have been selected for an oral plenary session presentation. Additional data will be presented from the demcizumab (anti-DLL4, OMP-21M18) and tarextumab (anti-Notch2/3, OMP-59R5) programs.


Read More: http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=879319

Wright Medical Group Inc. (WMGI:US), a U.S. maker of bone implants, will merge with Tornier NV, creating a new company valued at $3.3 billion in the latest proposed tax inversion since tighter rules were announced last month.

The legal address for the new company, to be called Wright Medical Group NV, will be in the Netherlands, where Tornier has been based for about eight years, the companies said yesterday in a statement. Wright has been based in Memphis, Tennessee, where the new combined company’s U.S. headquarters will remain, according to the statement.

“This combination will create the premier extremities-biologics company with a broad global reach,” Robert Palmisano, Wright’s president and chief executive officer, said in the statement. “Together, we will have one of the most comprehensive upper and lower extremity product portfolios in the market.”

Read More: http://www.businessweek.com/news/2014-10-27/wright-medical-will-merge-with-tornier-in-all-stock-deal

MURRAY HILL, N.J.--(BUSINESS WIRE)--C. R. Bard, Inc. (NYSE: BCR) today announced the U.S. Food and Drug Administration (FDA) approval of the Lutonix® 035 Drug Coated Balloon (DCB) Catheter for percutaneous transluminal angioplasty (PTA), after pre-dilatation, for the treatment of de novo or restenotic lesions up to 150mm in length in native vascular disease of the superficial femoral or popliteal arteries with reference vessel diameters of 4-6mm. This approval follows a unanimous favorable recommendation from the FDA’s Circulatory Systems Devices Advisory Panel in June 2014. The Lutonix® 035 DCB—the first and only FDA-approved DCB in the U.S.— is an angioplasty balloon coated with a therapeutic dose of the drug paclitaxel, and also utilizes standard mechanical dilatation of the vessel to restore blood flow for patients with peripheral arterial disease (PAD) in the femoropopliteal arteries.

“The Lutonix® 035 DCB gives clinicians another option as they seek to provide prolonged patency to patients confronted with femoropopliteal occlusive disease.”

FDA approval of the Lutonix® 035 DCB was supported by results of the LEVANT 2 pivotal study, a global, prospective, single-blind, randomized, 54-site study (42 sites in the U.S. and 12 in Europe) that enrolled all patients under one protocol. At one year, the LEVANT 2 study demonstrated improved patency of the Lutonix® 035 DCB compared to standard PTA: 73.5 percent vs. 56.8 percent, p<0.001 by Kaplan-Meier time-to-event analysis. It also demonstrated clinical benefits of sustained improvement in Rutherford Class and improved walking distance scores. The LEVANT 2 study followed a rigorous blinding protocol designed to reduce bias in the results to accurately and scientifically assess and compare the long-term performance of key clinical measures. The LEVANT clinical program, which includes registry data, enrolled more than 1,000 patients and demonstrated robust safety of the device comparable to PTA, including the same low rate of distal embolic events and rate of reintervention for thrombotic events.

Read More: http://www.businesswire.com/news/home/20141010005327/en/Lutonix%C2%AE-035-Drug-Coated-Balloon-FDA-Approved-DCB#.VD7G0vnF_d0