Insightec submits PMA for focused ultrasound device; CE mark for Coldplay Cryoballoon;

@FierceMedDev: Check out this year's Fierce 15: The new strategic med tech mania sets the stage for 2015's Fierce 15. Feature | Follow @FierceMedDev

@VarunSaxena2: ICYMI: Silk Road reels in $57M to commercialize its system for stroke prevention. Article | Follow @VarunSaxena2

@EmilyWFierce: Subway ups the ante on antibiotic-free meat pledge. FierceAnimalHealth story | Follow @EmilyWFierce

> C2 Therapeutics has gained a CE mark for its Coldplay CryoBalloon Focal Ablation System to treat the precursor to esophageal cancer. More

> Insightec has submitted a PMA with the FDA for approval of its MR-guided, focused ultrasound device Exablate Neuro to treat essential tumor. More

> Reuters ran an article on how the unhealthy but routine habits at hospitals, like interrupted sleep and poor nutrition, could be making patients sicker. Story

Biotech News

@FierceBiotech: Gene therapy for brain protein boosts memory in aged mice. FierceBiotechResearch article | Follow @FierceBiotech

@JohnCFierce: Moderna launches the 3rd or 4th personalized cancer vaccine co. in a month. Release | Follow @JohnCFierce

@DamianFierce: Casting the Coen Bros. $VRX movie: Clooney obviously plays Ackman, and then maybe John Goodman for Pearson. William H. Macy as Pyott? | Follow @DamianFierce

> AIT pushes ahead with plans for $40M Nasdaq IPO. Report

> Relypsa wins patiromer OK but gets hammered on black box restrictions. Story

> Moderna joins the personalized cancer vaccine rush with third new venture. Article

> FierceBiotech Radio on doomsdays for Valeant, Biogen and biotech VC. More

Pharma News

@FiercePharma: Parnell shares advance on strong Q3 revenue growth. FierceAnimalHealth story | Follow @FiercePharma

@EricPFierce: ICYMI: After shutting plant over mold issues, France's decides using CMOs makes more sense. FiercePharmaManufacturing story | Follow @EricPFierce

@CarlyHFierce: Good news for Allergan: Men want to treat wrinkles. Bad? They're clueless about products. FiercePharmaMarketing article | Follow @CarlyHFierce

> Perrigo to slash 800 jobs, buy back $2B of its stock in move to fend off Mylan. Story

> Compounder targets Turing's now-pricey Daraprim with $1-per-pill alternative. Article

> Valeant shares nosedive on short seller's 'phantom sales' allegations. Report

CRO News

> Quintiles pairs up with IMS to use real-world data in Phase III trials. Report

> BioClinica revamps its CRO partner program. Item

> SRI inks a $100M contract with NIH to study treatments for radiation exposure. More

> Quintiles shuffles its C-suite with new CFO, COO. News

> Evotec partners up for rare disease R&D in a discovery deal. Article

Pharma Manufacturing News

> Roche partner Chugai significantly expanding antibody capacity at Japan plant. Story

> Biogen's manufacturing feels the pain of its cost-cutting. Report

> Perrigo to consolidate supply chain operations as part of downsizing. Item

> Feds get guilty pleas from suppliers in massive drug diversion operation. More

> AstraZeneca opens plant in Russia. News

Pharma Asia News

> Abbott still eager for emerging markets, but currency headwinds an issue. Article

> Asia's dengue epidemic highlights race for treatment, vaccine options. More

> Chinese hackers said to target U.S. tech and pharma companies. Report

> BeiGene heads to Nasdaq with $100M IPO in China oncology boom. Story

> Yabao expands ties in diabetes pact with a busy Eli Lilly in China. Article