FDA clears Bayer next-gen glucose monitoring system; Congressional committee to take up user fee bill;

@FierceMedDev: Interesting: Researchers Discover Non-Surgical Test for Brain Cancer - Release | Follow @FierceMedDev

> The FDA has cleared Bayer HealthCare's CONTOUR Next EZ, a new blood glucose monitoring system. The system is being introduced on a market-by-market basis and is currently available elsewhere as CONTOUR XT. Bayer release

> Congressional committees will consider legislation next week that will renew and expand fees paid by device companies to help fund the FDA. News

> U.S. Rep. Edward Markey, (D-MA), failed to add legislation to a bill to renew the FDA's device user fee program that would have tightened regulation of the 510(k) approval process. Story

> Zeltiq Aesthetics ($ZLTQ) scored a win in a South Korean court, which ordered that criminal judgments and monetary fines be imposed against two individuals for false and exaggerated advertising of a cooling device not approved for fat reduction. Release

> NLT Spine's eSpin discectomy device has received CE mark approval, enabling the company to market it in Europe. NLT release

> St. Jude Medical ($STJ) will make its latest technologies available to patients in India. "India is a very important market for St. Jude Medical and we are dedicated to improving the care of patients throughout the country," Kaustav Banerjee, country manager, said. Report

> An optical imaging system could make diagnosing malaria easier, faster and more accurate, researchers say. It uses "speckle imaging," which measures the differences in how laser light bounces off the membranes of healthy and infected red blood cells. Article

> Mediware Information systems has closed its $2.2 million acquisition of Cyto Management System, which makes technology to track chemotherapy patients and medication. Story

> Nurse Alarm Systems, which makes fall-monitoring products, among other devices, has moved its headquarters and manufacturing to Connecticut from Massachusetts. Article

Pharma News

 @FiercePharma: Baxter beats Wall Street projections but gets FDA questions on new treatment. Article | Follow @FiercePharma

Biotech News

 @FierceBiotech: Gilead wows analysts as 7977 combos quell hepatitis C in most patients. Article | Follow @FierceBiotech

 @JohnCFierce: I've begun to put more thought into this year's Fierce 15. Not a bad time to start emailing me with suggestions. | Follow @JohnCFierce

 @RyanMFierce: Medivir's stock trading down after new TMC435 data in hepatitis C. In study, up to 80% cured. Disappointing? Article | Follow @RyanMFierce

> Alder broadens antibody work with $38M D round. Story

> GSK puts Human Genome Sciences in play with $2.59B buyout offer. News

CRO News

> INC Research and Astellas expand alliance. Article

> Unsecured creditors get more time to bid on Cetero. News

> Moody's eyes investor backlash for InVentiv after CRO acquisitions. More

> Australia's vivoPharm grabs RMIT University drug discovery tech. Story

> Children's tastes overlooked in clinical trials. Item

Vaccine News

> Scancell's DNA melanoma vaccine poised for Phase II. Article

> Passive vaccine could treat cocaine overdose. News

> Personalized brain cancer vaccine improves survival. Story

> Study: Dengue virus research needs to focus on people, not mice. More

> DNA vaccine for prostate cancer moves into Phase III. Item

Pharma Manufacturing

> Baxter to erect $1B plasma plant. Story

> CSL recalling product tainted with ethylene glycol. Article

> U.S. Marshals seize ultrasound gel containing dangerous levels of bacteria. News

> J&J plant overhaul turning into 4-year project. More

And Finally... A team of scientists at the University of Dundee has made a "sonic screwdriver" that could be used in complex surgeries. Article

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