Court deadline looms in Edwards Lifesciences class action suit; Gout test launches in Europe;

@FierceMedDev: Cheney worried defibrillator was vulnerable to hacking from terrorists. Item | Follow @FierceMedDev

@MarkHFierce: Kona Medical, a 2013 Fierce 15 winner, drew in $10M in new funding to hit China with its renal denervation device. Release | Story | Follow @MarkHFierce

@MichaelGFierce: ICYMI: AstraZeneca teams with Taris to research bladder cancer delivery device. Story from FierceDrugDelivery | Follow @MichaelGFierce

> Those wishing to sue Edwards Lifesciences ($EW) for allegedly inflating sales projections of its Sapien heart valve have a major court deadline coming up on Nov. 18. Item

> Sapiens Steering Brain Stimulation, a German/Dutch company focused on developing next-generation brain stimulation devices, has brought on a new CEO. Item

> U.K. regulators have raised standards for hip implants. Story (sub. req.)

> Since 2005, nearly 800 patients have had surgical instruments left inside them after a procedure. Story

> A researcher at Harvard Medical School and colleagues have come up with an implantable gel designed to treat diabetes that produces a compound to stimulate insulin secretion. It contains genetically modified light-sensitive cells. Item

> Boulder Diagnostics is rolling out its new in vitro diagnostic blood for gout in Europe. Item

Biotech News

@FierceBiotech: ICYMI last week: FierceMedicalDevices' 2013 Fierce 15. Feature | Follow @FierceBiotech

@JohnCFierce: Latest biotech IPO tally: 39 done, 15 in the queue--report updated with stock performance as of last Thursday. Feature | Follow @JohnCFierce

@DamianFierce: Quintiles is shuttering an early-phase Indian facility as regulatory hurdles make times tough. FierceCRO article | Follow @DamianFierce

@EmilyMFierce: FierceBiotech is looking for an associate editor. Details here | Follow @EmilyMFierce

> Iroko gets a thumbs-up from FDA on lower-dose NSAID. Item

> Novartis advances rival CDK 4/6 cancer drug to Pfizer's palbociclib. Article

> TetraLogic joins IPO rush with $103.5M offering to fuel cancer drug R&D. News

> Lilly's Lechleiter isn't budging from stand-alone $5B R&D strategy--yet. Story

> Actelion wins crucial FDA approval for next-gen lung disease drug Opsumit. News

Pharma News

@FiercePharma:  ICYMI, most popular special report this weekend: Top 15 Drug Launch Superstars | Follow @FiercePharma

@EricPFierce: Novartis' Sandoz is the 2nd largest generics maker in the world. It targets biosimilars to stay there. More | Follow @EricPFierce

@CarlyHFierce: We now present: Top 10 generics makers by 2012 revenue. Special report | Follow @CarlyHFierce

> Regeneron and Bayer's Eylea turns out positive BRVO trial data. Story

> India's bargain-priced cancer drugs lure Chinese smugglers. Article

> Japan's Eisai says U.K. cost watchdogs must open up--or else. Report

CRO News

> WuXi is first in China with CLIA-OK genomics lab. Item

> Novella teams with Scioderm for 'breakthrough' drug. More

> DrugDev picks up CFS Clinical for trial software. Story

> Aenova snags Haupt to boost CMO presence. News

> Clinlogix buys German CRO with eye on Euro demand. Article

Biotech IT News

> Pfizer and Roche back protein shape change monitoring startup. Story

> Deloitte unveils another EHR-driven software tool. News

> Statisticians fret over misuse of data-crunching software. More

> Veeva stock soars following successful IPO. Article

> Roche to shutter 454, 6 years after buying NGS business. Story

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