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Boston Scientific's Advanix Biliary Plastic Stents receive FDA 510(k) clearance and CE Mark approval

Boston Scientific Corporation today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration and CE Mark approval to market its Advanix™ Biliary Plastic Stents for the treatment of biliary strictures, including biliary stone disease, benign biliary strictures, and suspected and confirmed malignancies in the biliary system. The product is now available in Europe and other international markets; the Company plans to launch it in the U.S. this quarter.

21 Oct 2010

Lodestone Clinical Trials Supply Management solution achieves 'Powered By SAP Netweaver' certification

Lodestone Management Consultants today announced the new software release 1.0 of its Clinical Trials Supply Management (CTSM) Add-On Suite®. The solution has achieved SAP certification as powered by the SAP NetWeaver® technology platform, providing more transparency and a reduction of overages in the complex and time-consuming clinical development process of which the clinical supply chain is a key component.

21 Oct 2010

Zyvox achieves higher clinical success rate than vancomycin in MRSA nosocomial pneumonia study

Results of a new international phase 4 study of patients with nosocomial pneumonia due to proven methicillin-resistant Staphylococcus aureus (MRSA) demonstrated that the antibiotic Zyvox® (linezolid) achieved a statistically significantly higher clinical success rate compared with vancomycin for the primary endpoint. The ZEPHyR (Linezolid in the treatment of subjects with nosocomial pneumonia proven to be due to methicillin-resistant Staphylococcus aureus) study was the largest ever conducted in this population.

21 Oct 2010

Bruker installs BioSpec 170/25 system at CEA NeuroSpin research center

Bruker announced today that it has successfully installed its BioSpec® 170/25 system at the CEA NeuroSpin research center near Paris, France. The world's first horizontal ultra-high magnetic field 17.2 Tesla MRI system features a magnet bore diameter of 25 cm. It is equipped with a novel Bruker BGA-S™ gradient system with unsurpassed amplitude and slew rate specifications for cutting-edge preclinical in vivo imaging on small animals.

21 Oct 2010

Health Canada approves ULORIC to lower serum uric acid levels in patients with gout

Takeda Canada, Inc. is pleased to announce that ULORIC® (febuxostat), an innovative oral urate-lowering therapy to lower serum uric acid levels in patients with gout is now available in Canada. This medication is the first new treatment option in more than 40 years for the approximately three per cent of Canadians who have hyperuricemia associated with gout.1 ULORIC was discovered by Teijin Pharma Limited of Tokyo and licensed to Takeda for the Canada market.

21 Oct 2010

PolyMedix plans PMX-60056 Phase 2 clinical trial in interventional cardiology

PolyMedix, Inc., a biotechnology company focused on developing new therapeutic drugs to treat infectious diseases and acute cardiovascular disorders, has announced plans for a Phase 2 clinical trial of PMX-60056 in interventional cardiology, and the establishment of a focused Heptagonist Clinical Advisory Board (CAB). PMX-60056 is a synthetic small-molecule designed to reverse the anticoagulant activity of heparin and low molecular weight heparins (LMWH).

21 Oct 2010

LabCorp third quarter revenues increase 7.7% to $1,276.5 million

Laboratory Corporation of America® Holdings today announced results for the quarter ended September 30, 2010.

21 Oct 2010

DynaVox releases new additions to Vmax line of communication devices

DynaVox, the leading provider of speech generating devices and symbol-adapted special education software used to assist individuals in overcoming speech, language and learning challenges, today announced the release of two new additions to the Vmax™ line of communication devices, the Vmax+ High Performance and the Vmax+ Battery Efficiency.

21 Oct 2010

Kensey Nash 2011 first quarter decreases 14% to $17.0 million

Kensey Nash Corporation , a medical device company primarily focused on regenerative medicine for a wide range of medical procedures, today reported the results for its first quarter ended September 30, 2010.

21 Oct 2010

Baxter third quarter net income increases 12% to $595 million

Baxter International Inc. today announced its financial results for the third quarter of 2010, and provided its fourth quarter and updated full-year 2010 financial outlook.

From Baxter International Inc. 21 Oct 2010

Mylan receives final FDA approval for Pramipexole Dihydrochloride Tablets

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Pramipexole Dihydrochloride Tablets, 0.125 mg, 0.25 mg, 0.5 mg, 1 mg and 1.5 mg, the generic version of Boehringer Ingelheim's Mirapex Tablets, a Parkinson's disease treatment.

21 Oct 2010

Orthovita 2010 third quarter increases 5% to $23.3 million

Orthovita, Inc., an orthobiologics and biosurgery company, today announced that product sales for the third quarter of 2010 were $23.3 million, a 5% increase over product sales of $22.3 million in the third quarter of 2009.

21 Oct 2010

Genmab A/S reports DKK 78 million in net sales for Arzerra

Genmab A/S announced today that the net sales for Arzerra(R) (ofatumumab) during the third quarter of 2010 were approximately DKK 78 million (approximately USD 14 million).

21 Oct 2010

First Edition: October 21, 2010

Today's headlines include news about how opponents of the health law are steering the educational efforts that surround it, as well as poll results that suggest continued Republican inroads at the polls.

21 Oct 2010

UHCMC improves workflow using Toshiba's suite of systems

One of the top priorities for healthcare facilities today is improving operational efficiency. To help address this issue, University Hospitals Case Medical Center (UHCMC) in Cleveland, Ohio, rated among the best hospitals in the nation, recently purchased a suite of systems from Toshiba America Medical Systems, Inc., including an Aplio MX, two Xario XGs and two Aplio XG systems.

21 Oct 2010

North Carolina Academic Center to conduct youth violence prevention research

North Carolina will be home to the nation's first rurally focused youth violence prevention center, with a federal grant worth nearly $6.5 million to support a new project based in Robeson County and led by University of North Carolina at Chapel Hill researchers.

21 Oct 2010

Cord Blood to explain queries on VoiceAmerica Radio Network

Cord Blood America, Inc. the umbilical cord blood stem cell preservation company focused on bringing the life-saving potential of stem cells to families nationwide and internationally, is pleased to announce that Chairman, CEO and co-founder Matthew Schissler and Dr. Geoffrey O'Neill, Vice President, Operations, will appear for one hour live on "Go Rogue & Get Rich" on The VoiceAmerica Radio Network.

21 Oct 2010

IDEV includes two stents to SUPERA product line for treating patients with peripheral vascular disease

IDEV Technologies, Incorporated (IDEV), an innovative leader in the development and commercialization of minimally invasive medical technologies, today announced another step in the implementation of its strategy to expand its product line for treating patients with peripheral vascular disease with the addition of two longer stents to its SUPERA product line.

21 Oct 2010

Danaher 2010 third quarter Sales increases 16% to $3.2 billion

Danaher Corporation announced today that GAAP net earnings for the quarter ended October 1, 2010 were $646.4 million, or $0.95 per diluted share, which includes a $0.34 gain related to the formation of the Apex Tool Group joint venture, and represents a 79% increase as compared to GAAP net earnings per diluted share of $0.53 for the third quarter 2009.

From Danaher 21 Oct 2010

ICON 2010 third quarter Net revenue increases 2% to $225 million

ICON a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today reported its financial results for the third quarter ended September 30, 2010.

21 Oct 2010