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

 OncoMed (OMED) presented updated results from two phase 1b trials of
demcizumab (anti-DLL4) at the ESMO 2014 Congress over the weekend. Both
studies demonstrated encouraging tumor response rates. In the pancreatic cancer
study, demcizumab + gemcitabine + ABRAXANE demonstrated a 41% partial 
response (PR) rate and a 45% stable disease (SD) rate, resulting in an overall
clinical benefit rate of 86%. In the non-squamous NSCLC study, demcizumab +
ALIMTA + carboplatin demonstrated 3% CR, 45% PR, and 39% SD, resulting
in an overall clinical benefit rate of 88%. Demcizumab was described as
generally well tolerated in both studies. The truncated dosing schedule for
demcizumab appeared to prevent the onset of late cardiopulmonary toxicity, as
none of the 64 patients in the two studies who received the truncated dosing 
experienced any moderate-to-severe cardiopulmonary toxicities. Phase 2 studies
in these two cancer indications are expected to commence by the end of 2014. 

Read More: http://research-ca.bmocapitalmarkets.com/documents/c70fa216-f89c-471b-b35e-2b0b16304167.pdf

Data Supports Phase 2 ALPINE Study of Tarextumab in Pancreatic Cancer and Phase 2 PINNACLE Trial in Small Cell Lung Cancer

MADRID and REDWOOD CITY, Calif., Sept. 29, 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, presented promising data on safety and anti-tumor activity from the ALPINE and PINNACLE Phase 1b clinical studies of tarextumab (anti-Notch2/3, OMP-59R5) at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid, Spain.

"The Phase 1b tarextumab data presented at ESMO 2014 support our randomized Phase 2 clinical programs with this novel antibody targeting the Notch pathway," said Jakob Dupont, M.D., OncoMed's Chief Medical Officer. "In the ALPINE study of patients with pancreatic cancer, we are seeing promising anti-tumor activity and tolerability in combination with standard of care. Notably, we now have pharmacodynamic evidence of Notch pathway inhibition, which provides clinical validation that tarextumab is hitting its desired target. In our PINNACLE trial of small cell lung cancer patients, we have seen a number of partial responses and tarextumab has been well tolerated in combination with standard platinum and etoposide chemotherapy."

Read More: http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=873389

MADRID and REDWOOD CITY, Calif, Sept. 28, 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, presented safety and efficacy data from two Phase 1b clinical trials of demcizumab (anti-DLL4, OMP-21M18) in pancreatic cancer and non-small cell lung cancer (NSCLC) at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid, Spain.

Results from the Phase 1b studies demonstrate that demcizumab, in combination with standard-of-care chemotherapy, is well tolerated, especially in patients where the company's risk mitigation, monitoring and truncated dosing strategies have been employed. Encouraging tumor response rates were presented at ESMO from a study of demcizumab with gemcitabine or gemcitabine plus Abraxane® (paclitaxel protein-bound particles for injectible suspension) (albumin bound) in patients with first-line pancreatic cancer, and from the study of demcizumab plus pemetrexed and carboplatin for the first-line treatment of Stage III/IV NSCLC. OncoMed's Phase 1b studies identified the demcizumab dosing schedules for the company's planned randomized Phase 2 proof-of-concept trials.

"As we advance to Phase 2 clinical trials of demcizumab, we have successfully identified strategies that result in both favorable tolerability and compelling response rates," said Jakob Dupont, M.D., OncoMed's Chief Medical Officer. "To date, sixty-four patients have been enrolled and treated on the demcizumab truncated dosing schedule that will be used in our randomized Phase 2 studies. The majority of these patients have now been followed for greater than 100 days without any moderate-to-severe cardiopulmonary toxicities and a number of patients remain on treatment."  

"Based on the data generated from our Phase 1b studies in pancreatic and non-small cell lung cancer we have identified a dosing regimen with impressive anti-tumor activity and an acceptable safety profile. We have confidence that these data enable the advancement of both programs into planned randomized Phase 2 studies in pancreatic cancer and NSCLC.  Results from our Phase 1b demcizumab program not only signal the potential safety and anti-tumor activity for this drug, but also provide encouragement for the potential of an anti-cancer stem cell hypothesis," said Paul J. Hastings, Chairman and Chief Executive Officer. 


Read More: http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=873324

REDWOOD CITY, Calif., Aug. 28, 2014 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), announced today that the U.S. Food and Drug Administration (FDA) has removed the partial clinical hold on enrollment in the company's vantictumab (anti-Fzd7, OMP-18R5) Phase 1 clinical trials. Vantictumab is being studied in combination with standard-of-care chemotherapy in three Phase 1b clinical trials in patients with advanced non-small cell lung cancer (NSCLC), advanced HER2-negative breast cancer and advanced pancreatic cancer. Enrollment and dosing of new patients is expected to resume within the next few weeks as the study sites' institutional review boards (IRBs) receive and approve the revised trial protocols.

"We are pleased by the FDA's action to allow the resumption of enrollment in the vantictumab clinical trials," said Jakob Dupont, MD, OncoMed's Chief Medical Officer. "Patient safety is our top priority. The revised protocols were developed with input from the vantictumab clinical investigators and academic bone experts and are intended to mitigate the risks of future adverse events as we seek an optimal efficacious dose to take forward in the development of this first-in-class WNT pathway inhibitor."

The partial clinical hold occurred on July 1, 2014 following the company's voluntary halt to its Wnt pathway programs due to observed on-target mild-to-moderate bone-related adverse events. The FDA removed the partial clinical hold to permit the enrollment of vantictumab clinical trials following its review of a substantial clinical safety and efficacy data package and revised study protocols submitted by the company. The amendments for the Phase 1b combination trials include modified dosing regimens, risk mitigation measures, such as increased monitoring and bone protection strategies, and modified enrollment criteria.

"The diligence and dedication of OncoMed's clinical development team to temporarily halt the vantictumab studies and submit a comprehensive response to the FDA has led to a prompt action by the agency," said Paul J. Hastings, Chairman and Chief Executive Officer of OncoMed. "We look forward to proceeding with the vantictumab Phase 1b clinical studies, and to the potential opt in by our partner Bayer based on data from these trials, to realize the future potential of this novel first-in-class WNT pathway inhibitor."


Read More: http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=868147

About half of all strokes could be caused by a narrowing of the carotid artery – the pipeline that ushers blood flow through the neck and to the brain. The Bay Area’s Silk Road Medical may have found a less-invasive way to increase the blood flow to the brain, using traditional stenting concepts but kicking ‘em up a notch.

To do so, Silk Road has just raised $15 million from four investors as part of a $22.5 million round, according to regulatory filings. This brings total investment in the company, founded in 2007, to more than $50 million. The company has listed Warburg Pincus and The Vertical Group as its main investors, though more are clearly involved.

The company has got a “transcarotid stent” that’s equipped with what’s called dynamic flow reversal, a mechanism that protects the brain by temporarily redirecting blood flow away from the brain while the stent is being inserted. It also carries away debris that’s inadvertently created during the procedure, Silk Road said, trapping it in a filter outside the body.

Read more: http://medcitynews.com/2014/08/silk-road-medical-raising-22-5-million-less-invasive-stroke-preventing-stent/#ixzz3B4aylzLz

REDWOOD CITY, Calif., Aug. 7, 2014 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today reported financial results and reviewed corporate events for the quarter ended June 30, 2014.

"We continue to execute on our research and development objectives, advancing our product candidates and building our portfolio of proprietary and innovative discovery programs," said OncoMed's Chairman and Chief Executive Officer, Paul J. Hastings. "The recent start of the Phase 2 ALPINE trial of tarextumab in pancreatic cancer represents an important milestone for the company, and we expect further pipeline progress and presentations of clinical and preclinical data in the second half of 2014."

Read More: http://finance.yahoo.com/news/oncomed-pharmaceuticals-announces-second-quarter-123000459.html

SUNNYVALE, Calif., July 23, 2014 /PRNewswire/ -- Silk Road Medical, Inc., a developer of advanced devices for the transcarotid treatment of intra- and extra-cranial cerebrovascular disease, announced today the appointment of Michael P. Wallace to the position of Chief Technology Officer.  In this new role, Michael will lead the company's Research and Development efforts across its family of transcarotid access and treatment devices.

Prior to joining Silk Road Medical, Michael was the Vice President of Research and Development at Boston Scientific's Electrophysiology Division and previously held senior technical leadership roles at Baxano Surgical, Inc., BARRx Medical, and Boston Scientific Neurovascular / Target Therapeutics. He has over 20 years of experience in the medical device field and holds over 120 issued or pending US patents.

Read More: http://www.prnewswire.com/news-releases/silk-road-medical-appoints-ground-breaking-innovator-as-chief-technology-officer-268257952.html

REDWOOD CITY, Calif., July 16, 2014 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced that patient dosing has begun in the randomized, placebo-controlled Phase 2 portion of the company's "ALPINE" (Antibody therapy in first-LinePancreatic cancer Investigating anti-Notch Efficacy and safety) clinical trial of its anti-Notch 2/3 cancer stem cell antibody, tarextumab (OMP-59R5), being studied for the treatment of pancreatic cancer.

Tarextumab is being tested in combination with Abraxane(R) (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine in patients with previously untreated stage IV pancreatic cancer. The ALPINE trial is being conducted at up to 30 sites in the U.S. and is expected to enroll approximately 124 patients. The Phase 2 clinical trial will compare the progression-free survival (PFS) of 15 mg/kg tarextumab administered every two weeks versus placebo in combination with Abraxane plus gemcitabine in all patients. Additionally, PFS will be assessed using a predictive biomarker for high tumor Notch3 expression. Secondary and exploratory endpoints, including overall survival and overall response rate, pharmacokinetics, safety and other biomarkers, will also be evaluated.

Read More: http://finance.yahoo.com/news/oncomed-pharmaceuticals-initiates-randomized-phase-123000405.html