Improving U.S. regulation of drug-device combos; Eye tracking to diagnose concussion;

@FierceMedDev: Updated w/ info from $MDT: Medtronic recalls CoreValve TAVR component due to presence of particulate matter. Story | Follow @FierceMedDev

@VarunSaxena2: FDA issues warning on heart pump safety issues: strokes, blood clots and bleeding. Article | Follow @VarunSaxena2

@EmilyWFierce: ICYMI from FiercePharma: British watchdog cracks down on Pfizer for huge price hikes on epilepsy drug. Story | Follow @EmilyWFierce

> The FDA Law Blog has published its take on how to improve pending U.S. legislation on combination drug-device products. More

> Researchers reported a successful trial using eye movement tracking during video watching as a biomarker to diagnose concussions. More

> The FDA has approved its small, hand-held Patient Therapy Controller from Flowonix Medical; it works with the company's intrathecal infusion devices to deliver a bolus of medication from an implanted pump. More

> Glaukos ($GKOS) has completed enrollment in a U.S. pivotal, 500-patient randomized trial for its iStent inject to treat glaucoma for which it expects to submit a PMA. More

Biotech News

@FierceBiotech: Pfizer takes the lead in another hot immuno-oncology contest. Report | Follow @FierceBiotech

@JohnCFierce: Tick tock--Fierce 15 noms deadline is approaching. More | Follow @JohnCFierce

@DamianFierce: Probably the best thing about having lots of money is how it turns itself into even more money. Story | Follow @DamianFierce

> Decimated by clinical failure, Xoma turns to plan B. More

> NantKwest's record-setting IPO heaps another billion on Soon-Shiong's fortune. Story

> Sanofi deepens its Evotec ties with a $330M diabetes deal. Article

Pharma News

@FiercePharma: $GSK rehires former China government affairs director Shi. FiercePharmaAsia story | Follow @FiercePharma

@EricPFierce: ICYMI: #FDA may add Baxter #saline Mexico plant to US supply. Now if Baxter can just quit having to recall saline. More | Follow @EricPFierce

@CarlyHFierce: What was summer before I covered takeover battles? | Follow @CarlyHFierce

> Actavis gets subpoena as DOJ probe of generic pricing moves up food chain. More

> Horizon has said it's ready to up its bid, Depomed CEO says. So where's the new offer? Article

> Biogen's Tecfidera faces new challenge as scientists call for monitoring for brain infections. News

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