SARASOTA (Jan. 25, 2017) – Sarasota Memorial Hospital is among the first in Florida to offer high-risk patients a less invasive treatment for carotid stenosis – the buildup of plaque inside the carotid arteries that can lead to potentially disabling strokes and death.

Recently cleared by the FDA for the treatment of high-risk patients who have suffered symptoms of a warning stroke (TIA), TransCarotid Artery Revascularization (TCAR) is a new endovascular procedure that potentially avoids some of the complications that may occur with current treatment options. ​
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At this time, Silk Road Medical’s ENROUTE Transcarotid Neuroprotection and Stent System is the only device currently approved for TCAR procedures by the FDA. 

Read More: http://www.smh.com/Home/News-Events/Release/sarasota-memorial-hospital-among-first-to-offer-innovative-treatment-for-carotid-artery-disease

SAN DIEGO, Jan. 20, 2017 /PRNewswire/ — Accriva Diagnostics, a Warburg Pincus portfolio company, announced today the definitive agreement with Werfen, a privately held medical diagnostics firm headquartered in Barcelona, Spain, and its subsidiary Instrumentation Laboratory (IL) headquartered in Bedford, MA, whereby Werfen and IL have acquired all shares of Accriva. The transaction was successfully closed on January 19, 2017.

The Accriva portfolio, including globally recognized point-of-care (POC) diagnostic products for coagulation and anti-platelet therapy response, will allow IL to establish a market-leading position in hospital-based POC Hemostasis testing, expand its position in POC Critical Care testing and complement its leadership in the Hemostasis Laboratory segment.

Read More: https://www.pehub.com/2017/01/werfen-and-instrumentation-lab-to-buy-pe-backed-accriva-diagnostics/

REDWOOD CITY, Calif., Jan. 20, 2017 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (NASDAQ:OMED), a clinical-stage company focused on discovering and developing novel anti-cancer stem cell and immuno-oncology therapeutics, today announced dosing of the first patient in a Phase 1b clinical trial of brontictuzumab (anti-Notch1, OMP-52M51) plus chemotherapy in patients with metastatic colorectal cancer.

The Phase 1b trial is intended to determine the maximum-tolerated dose of brontictuzumab in combination with trifluridine/tipiracil (Lonsurf®).  The Phase 1b trial is designed to assess safety, preliminary efficacy and immunogenicity, as well as predictive and pharmacodynamics biomarkers.  Metastatic colorectal cancer patients who have received at least two prior lines of therapy will be enrolled in the dose-escalation portion of the trial, and once a maximum tolerated dose is identified, additional patients whose tumors test high for the activated form of Notch1 will be enrolled in an expansion cohort. 

Read More: ​​​​http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=1008598

NEW YORK--(BUSINESS WIRE)--

Remedy Pharmaceuticals, a privately-held pharmaceutical company focused on bringing life-saving hospital-based treatments to people affected by central nervous system related edema, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its investigational drug, CIRARA, for treatment of severe cerebral edema in patients with acute ischemic stroke.

“The Orphan Drug Designation, in addition to our FDA Fast Track status, is an important achievement as we advance our development plans for CIRARA to combat severe cerebral edema in large hemispheric infarction,” notes Sven Jacobson, CEO of Remedy Pharmaceuticals. “CIRARA could significantly enhance currently available treatment options for this desperately at-need patient population.”

Read More: ​http://finance.yahoo.com/news/remedy-pharmaceuticals-cirara-granted-orphan-150000319.html

Omada Health has announced five new senior hires, most notably a new chief medical officer, Dr. Paul Chew, who previously served as senior VP and global chief medical officer at Sanofi. The company also announced the hire of Tom Schoenherr as chief commercial officer, a position he previously held at Counsyl.

“For the last five years, we’ve worked to establish Omada Health as a leader in digital health, publishing clinically-validated results and operating on an outcomes-based revenue structure since Day One,” Omada Cofounder and CEO Sean Duffy said in a statement. “Bringing on Paul and Tom, experts in their fields with proven track records for clinical development and scaling healthcare businesses, is the next step in Omada’s evolution. Employers, payers, and health systems know digital health is here to stay, and the companies that will succeed are those that deliver outcomes and scale effectively. We’ve built a team to do exactly that.”

Read More: http://www.mobihealthnews.com/content/omada-health-adherium-recruit-pharma-vets-and-more-digital-health-hires

Omada Health has accomplished a rare feat in the crowded world of digital health hopefuls: it's backed up lofty claims with actual results, helping the company score federal government reimbursements for its high-tech diabetes prevention program. Now, Omada is taking on some major biopharma talent as it heads into 2017 with the goal of becoming a go-to "digital therapeutics" option.

Omada has hired former Sanofi chief medical officer (CMO) Dr. Paul Chew to serve as the company's new CMO and Tom Schoenherr, who helped lead genomic sequencing upstart Counsyl to the $100 million threshold, as its new chief commercial officer (CCO). The firm's also snapped up Dr. Carolyn Jasik of the University of California at San Francisco to serve as medical director and industry vet Rob Guigley (formerly of Counsyl and AstraZeneca) as the VP of health plan sales.
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Read More: ​http://fortune.com/2017/01/06/exclusive-omada-health-hires-sanofi-counsyl/

Vascular surgeons at Thomas Jefferson University Hospital will become the first in Philadelphia to perform a recently post-clinical trial approved procedure to treat carotid artery disease, a condition that annually affects more than 300,000 people in the United States.

The hospital announced this week that it will begin enrolling patients for a procedure known as Transcarotid Artery Revascularization, an operation designed to clear plaque and reduce the stroke risk associated with the disease.

“Our goal is to treat the blockage with as little procedural risk as possible so that our patients can return to full and productive lives,” said Dr. Paul DiMuzio, Division Director of Vascular and Endovascular Surgery at Thomas Jefferson University Hospital. “It’s imperative for surgeons and physicians to keep a close eye on emerging research and new options which might change the way we treat this disease.”

Read More: http://www.phillyvoice.com/jefferson-becomes-first-philly-hospital-enroll-patients-new-heart-procedure/

Enters 2017 with $184.6 Million in Cash
Potential for Five Program Opt-ins Totaling Over $170M
Anti-TIGIT (I/O#2) IND Filed

REDWOOD CITY, Calif., Jan. 05, 2017 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage company focused on discovering and developing novel anti-cancer stem cell and immuno-oncology therapeutics, today pre-announced its 2016 year-end cash balance and reviewed key anticipated events for 2017.

OncoMed ended 2016 with approximately $184.6 million in cash.  OncoMed's current cash is estimated to be sufficient to fund operations through at least the third quarter of 2018, without taking into account future potential milestone payments from partners.  Full-year cash expenses for 2016 were approximately $115 million, in accordance with the company's 2016 guidance.  OncoMed expects 2017 operating cash burn to be less than $100 million, before considering potential milestones/opt-ins.

"2017 represents a potentially transformational year for our company," said Paul J. Hastings, OncoMed's Chairman and Chief Executive Officer.  "Phase 2 clinical trial results for demcizumab and tarextumab are anticipated in the first half of the year, and together those investigational drugs will be eligible for potential partner opt-ins totaling close to $100 million.  Three additional programs, vantictumab, ipafricept and anti-RSPO3, are also eligible for potential partner opt-ins this year, and OncoMed could receive more than $170 million in total 2017 partner opt-in payments.  At the same time, our earlier-stage programs are making progress in the clinic, we will be reporting on that progress, our two novel immuno-oncology candidates, anti-TIGIT and GITRL-Fc trimer are advancing into the clinic, and we continue to discover and develop additional novel agents directed at new immuno-oncology targets."

Read More: http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=1006643

REDWOOD CITY, Calif., Jan. 04, 2017 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (NASDAQ:OMED), a clinical-stage company focused on discovering and developing novel anti-cancer stem cell and immuno-oncology therapeutics, today announced dosing of the first patient in a Phase 1b clinical trial of anti-DLL4/VEGF bispecific antibody (OMP-305B83) plus chemotherapy in patients with second-line metastatic colorectal cancer.

The anti-DLL4/VEGF is the first antibody developed utilizing OncoMed's BiMAb™ bispecific platform technology and is designed to have anti-cancer stem cell, immunomodulatory and anti-angiogenic activity.  Thirty patients with metastatic colorectal cancer who have failed first-line treatment, typically bevicizumab plus FOLFOX (folinic acid, fluorouracil, oxaliplatin) chemotherapy, will receive second-line treatment in the Phase 1b multicenter, open-label dose escalation and expansion study of the anti-DLL4/VEGF bispecific antibody in combination with FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy.  This trial is designed to determine the safety, preliminary efficacy, immunogenicity, pharmacokinetics and biomarker effects of the anti-DLL4/VEGF bispecific antibody plus FOLFIRI.  A second Phase 1b study in patients with platinum resistant ovarian cancer is expected to begin enrolling patients soon.

Read More: http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=1006300

Abstract

Objective: To examine the outcomes of a Medicare population who participated in a program (provided by Omaha Health) combining digital health with human coaching for diabetes risk reduction. 

Method: People at risk for diabetes enrolled in a program combining digital health with human coaching. Participation and health outcomes were examined at 16 weeks and 6 and 12 months. 

Results: A total of 501 participants enrolled; 92% completed at least nine of 16 core lessons. Participants averaged 19 of 31 possible opportunities for weekly program engagement. At 12 months, participants lost 7.5% (SD = 7.8%) of initial body weight; among participants with clinical data, glucose control improved (glycosylated hemoglobin [HbA1c] change = −0.14%, p = .001) and total cholesterol decreased (−7.08 mg/dL, p = .008). Self-reported well-being, depression, and self-care improved (p < .0001).

Discussion: This Medicare population demonstrated sustained program engagement and improved weight, health, and well-being. The findings support digital programs with human coaching for reducing chronic disease risk among older adults.

Read More: http://journals.sagepub.com/doi/full/10.1177/0898264316688791?utm_source=Rock+Weekly&utm_campaign=a1b05706ab-Rock_Weekly_2-13&utm_medium=email&utm_term=0_e44ef774d4-a1b05706ab-90918221&mc_cid=a1b05706ab&mc_eid=79bb3b005e&