St. Jude wins heart valve approval; EU battle rages over device approval system changes;

 @FierceMedDev: Post-PMA, Cardiovascular Systems pursues public offering. More | Follow @FierceMedDev

 @MarkHFierce: Spurned by Illumina, Roche may have found a new gene sequencer/Dx company to love. But at what price? Story | Follow @MarkHFierce

 @DamianFierce: With election long passed, device tax lobbyists ply Dems. Article | Follow @DamianFierce

> Smith & Nephew ($SNN) is rolling out a new modular rail system treatment designed for external bone fixation and deformity correction. Item

> Johnson & Johnson/Ethicon ($JNJ) won FDA 510(k) clearance for its new Enseal G2 cordless tissue sealer device. Release

> St. Jude Medical ($STJ) won FDA approval for its new Trifecta valve, which is designed to replace diseased, damaged or malfunctioning aortic heart valves. Release

> nContact, a maker of catheter and surgical ablation devices has raised $6.7 million out of a $13 million fundraising goal. Story

> Hatch Medical secured two U.S. patents regarding its percutaneous spinal stabilization system. Release

> Conflict continues between the European Parliament and European Commission over plans to develop a centralized medical device approval system more like the U.S. model. Story

Biotech News

 @FierceBiotech: Amgen scores PhIII success with BioVex virus against melanoma. More | Follow @FierceBiotech

 @JohnCFierce: AstraZeneca feels sting of union backlash against R&D upheaval. Story | Follow @JohnCFierce

 @RyanMFierce: Merck slashes data-management costs with China site. Article | Follow @RyanMFierce

> Volatile BioLineRx shares decimated by PhII/III schizophrenia drug failure. Story

> Lone Star biotech banks $11.4M for PhII orphan drug odyssey. Article

> Amgen scores PhIII success with BioVex virus against melanoma. News

Pharma News

 @FiercePharma: FDA Commish Hamburg taps acting chief of generics office. Kathleen Uhl was former head's senior adviser. Report | Follow @FiercePharma

 @EricPFierce: Italy's the 2nd largest API maker behind China, says Italian expert. Who would have guessed it? India is 3rd. More | Follow @EricPFierce

> Valeant nabs skin-care specialist Obagi for $344M. News

> Merck KGaA, Bristol-Myers plan joint assault on China's diabetes market. More

> Reuters: Roche jumps into bidding for lab equipment maker Life Tech. Story

Biomarkers News

> Luminex to collaborate with Merck on Alzheimer's biomarker diagnostic. Report

> Mount Sinai wins $5M to study vocal disorder biomarkers. Item

> Pee in a cup to diagnose gastroesophageal cancer. More

> GenoMine test spots three new kidney cancer biomarkers. Article

> Texas research team spots Barrett's esophagus biomarkers. Story

Drug Delivery News

 @MichaelGFierce: Spectrum picks up orphan cancer drug with stabilized delivery. More | Follow @MichaelGFierce

> New nanomed reduces inflammation in injured tissue by natural means. Story

> Delivery gel releases drugs in response to pressure. More

> Shire bets on PhII protein-delivery therapy to fight infant blindness. Article

> Needle-free ear infection patch delivers bacteria-killing vaccine. Item

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