Cyberonics rebuffed on CMS determination again; Lexmark buys Claron for $37M;

@FierceMedDev: ICYMI yesterday: FDA approves Medtronic's drug-coated balloon, setting up clash with Bard in new U.S. market. Article | Follow @FierceMedDev

@EmilyWFierce: Covidien shareholders approve proposed $43B merger with Medtronic; Medtronic shareholder vote TK. Article | Follow @EmilyWFierce

> The appeals board of the Department of Health and Human Services has supported an existing 2007 National Coverage Determination from The Centers for Medicare & Medicaid Services (CMS) that does not cover the VNS Therapy System from Cyberonics ($CYBX) for treatment-resistant depression. The company said it is evaluating its options for challenging the decision. Release

> Lexmark International ($LXK) acquired medical image viewing company Claron Technology for about $37 million and will add the company's technology to its Perceptive Software division. Release

> The FDA has approved Bellafill from Suneva Medical for the correction of acne scars, making it the only filler approved for this indication in the U.S. Release

> Off-label usage of hyperbaric oxygen therapy for everything from autism to aging prevention is becoming more common, The Wall Street Journal reports. It's approved as a treatment for indications including long-term cancer radiation treatment side effects and non-healing wounds that are a common diabetic complication. Story

Biotech News

@FierceBiotech: A record year for biotech inspires some great expectations for 2015. Editor's Corner | Follow @FierceBiotech

@JohnCFierce: Third Rock-backed GBT bags $48M round, plots upcoming IPO. Report | Follow @JohnCFierce

@DamianFierce: $GUD's CEO says he got so many calls about FDA priority review voucher that Knight may make a business out of it. More from Bloomberg | Follow @DamianFierce

> Tracon eyes a $57.5M IPO to get its cancer drug into Phase III. Report

> Gilead buys its way into the blockbuster NASH race with $470M deal. Article

> The biotech blitz: Seres Health lands $65M for PhIII C. diff push. News

> CytomX bags $20M for its novel antibodies with Pfizer leading the charge. Article

> Moderna hauls in $450M to push its pioneering approach to mRNA. News

Pharma News

@FiercePharma: Hello, hep C pricing war: Gilead hits back at AbbVie with exclusive CVS deal. More | Follow @FiercePharma

@CarlyHFierce: NPS is officially up for sale. Will deal-minded Shire bid? Story | Follow @CarlyHFierce

> Pharmacyclics chief puts his staff in training to be geniuses. Item

> Salix CEO takes a hike in latest fallout from inventory snafu. Report

> Gilead hits back at AbbVie with exclusive CVS hep C deal. More

Biotech Research News

> Mouse study points to a particular T cell target for diabetes, insulin resistance. Report

> Cold Spring Harbor scientists find a biomarker for p53 cancer mutations. Item

> Positive primate study for Parkinson's inspires a rally for Minerva. Story

> Johns Hopkins stem cell team tests out CRISPR tech, with encouraging results. More

> CHOP scientists herald new approach to neurodegenerative diseases. Article

Pharma Manufacturing News

> Hospira recalls cancer med that was focus of warning letter. More

> FDA delays enforcing track-and-trace rules by four months. Report

> FDA sends warning letter to China's Novacyl Wuxi. News

> Patients had problems after being given IVs intended for training, FDA reports. Story

> Valeant says inhaled drug used on infants may be contaminated. Article

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