Sientra brings on new CEO to remedy ills; Philips opens image-guided simulation facility;

@FierceMedDev: Resurgent 23andMe CEO says the genetic testing company is not up for sale. Article | Follow @FierceMedDev

@VarunSaxena2: ICYMI: Boston Sci's Watchman hit by restrictive CMS coverage decision, recall over blood leakage. Story | Follow @VarunSaxena2

@EmilyWFierce: Women are suing Endo Health Solutions and Patheon for child support after contraceptive packaging mishap. FiercePharmaManufacturing story | Follow @EmilyWFierce

> After losing almost 85% of its value in the past three months on a manufacturing site shutdown, recently public breast implant company Sientra ($SIEN) has brought in a new chairman and CEO, Jeffrey Nugent, to remedy its ills. He was previously the interim president and CEO at Biolase. More

> Royal Philips ($PHG) opened a new image-guided therapy innovation facility in Best, the Netherlands. It's in an existing facility and is intended to offer an in-house simulation facility for early and continuous product design validation and end-user testing. More

> The FDA has notified AirXpanders ($AXP) that its AeroForm tissue expander for use ahead of breast implants can be reviewed via a de novo pathway. That offers a less daunting regulatory hurdle than PMA approval. The device does not have a predicate, so it can't be considered a 510(k) submission, but is also considered relatively low risk. More

> Partners Samsung and EarlySense won an International Consumer Electronics Show 2016 Innovation Award in the smart home category for their contact-free vitals and sleep monitor. More

Biotech News

@FierceBiotech: Soon-Shiong's NantKwest is spending more on stock buybacks than R&D. Report | Follow @FierceBiotech

@JohnCFierce: Anacetrapib will be either the best come-from-behind PhIII victory or an awfully expensive new cautionary tale about R&D hubris. Hmmmm. | Follow @JohnCFierce

@DamianFierce: Tough day at the Robert J. Coury Global Center, on 1000 Mylan Blvd. More from the WSJ | Follow @DamianFierce

> Regeneron plots a $150M R&D expansion, adding 300 jobs at its New York hub. Article

> Mesoblast disappoints in another below-the-range biotech IPO. Item

> AstraZeneca wins big with fast FDA OK of AZD9291 for lung cancer. News

Pharma News

@FiercePharma: Aratana unveils branding and partnering plans at investor day. FierceAnimalHealth story | Follow @FiercePharma

@EricPFierce: ICYMI: whacking 1,200 jobs, closing plants in US, Ireland, Italy and Spain, but building one in Switzerland. Article | Follow @EricPFierce

@CarlyHFierce: Boehringer ups the ante in IPF drug race with awareness funding. FiercePharmaMarketing report | Follow @CarlyHFierce

> Regeneron expanding New York campus again, adding 300 jobs. More

> Gilead scores additional indications for Harvoni in hep C, HIV patients. Story

> Analysts improve outlook for Teva's Copaxone as it shakes off Novartis competition. Article