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

Suggested Articles

Millions of tests are urgently needed as the virus keeps communities across the country in lockdown and hospitals are overwhelmed with patients.

The FDA granted its first emergency authorization for a rapid antibody blood test for COVID-19 developed by Cellex.

The ultimate goal is to move as many patients as possible out of the clinic that don’t need immediate, critical care.