Cardiovascular Systems receives a CE mark; Cook Medical hit with warning letter;

@FierceMedDev: ICYMI yesterday: Spinoff Halyard Health gets boost from Ebola fears, stock up modestly in market debut. Article | Follow @FierceMedDev

@VarunSaxena2: ICYMI yesterday: Maryland provides seed financing to 15 med tech startups. Item | Follow @VarunSaxena2

@EmilyWFierce: This just in from the $ACT earnings call: "Actergan." | Follow @EmilyWFierce

> Cardiovascular Systems received a CE Mark for its Stealth 360 orbital atherectomy catheter treatment system for severe peripheral artery disease. News

> The FDA flagged device manufacturer Cook Medical with a warning letter about its Bloomington, IN, plant after below-par performance in a regulatory inspection last summer. More

> Developer of 3D scanning solutions, Fuel3D, closed a $6.4 million funding round that will be used to imove the company into the biometrics and eyewear markets, increase production, customer support and international retail distribution. Release

Biotech News

@FierceBiotech: Novartis gears up for FDA scrutiny with a new blood cancer drug. Report | Follow @FierceBiotech

@JohnCFierce: Should Chris Viehbacher replace John Lechleiter at $LLY? Now that would be interesting. | Follow @JohnCFierce

@DamianFierce: The most metal researcher in all of science. More | Follow @DamianFierce

@EmilyMFierce: Science Cafés are growing in popularity. More | Follow @EmilyMFierce

> GlaxoSmithKline heads to the FDA with its next big respiratory bet. Report

> AstraZeneca's $2B oncology contender shows promise in prostate cancer. Article

> Can Rockwell Medical win FDA approval for its dialysis drug? More

Pharma News

@FiercePharma: ICYMI: PATH Malaria Vaccines Initiative nets $156 million from Gates Foundation. FierceVaccines story | Follow @FiercePharma

@EricPFierce: Boehringer Ingelheim unloads US API plant to Chinese company even as it expands in China. FiercePharmaManufacturing article | Follow @EricPFierce

@CarlyHFierce: ICYMI yesterday: Here's a first: Regeneron cuts forecast after hard-charging Eylea sales miss. Article | Follow @CarlyHFierce

> Actavis rides success of branded drugs and M&A to positive Q3. More

> Allergan loses fight to block Ackman from voting for a Valeant takeover. Article

Drug Delivery News

> Distinct, compartmental reactions in an 'artificial cell' offer controlled delivery action. More

> OptiNose submits NDA to FDA. Item

> MIT spinoff SQZ Biotech nabs startup prizes for cell-squeezing delivery enhancer. Story

> AstraZeneca, University of Manchester create new center for advanced drug delivery. Article

> Study: Timing of administration an oft-overlooked factor in drug delivery. More

Diagnostics News

> Diagnostics companies homing in on rapid mobile tests to quell Ebola outbreak. Report

> Myriad signs expanded deal with AbbVie for cancer Dx. More

> AstraZeneca shells out $150M for cancer Dx outfit Definiens. Item

> LabCorp bets $6B in diversification deal with Covance. Story

> Qiagen beats the Street's Q3 numbers with success of companion Dx and next-gen TB test. Article

Pharma Marketing News

> Who's king of the orphan drug hill? BMS, Merck, Celgene and Roche, to name a few. Article

> A tale of two studies: Prescribe Pradaxa 'with caution'? Or rely on FDA's safety backing? More

> Sovaldi's not the only superhero launch: Meet the rest of the pharma Avengers. Story

> Sales speedster Eylea faces a tougher track in new DME market, Regeneron SVP says. Article

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