Spectranetics raises $110M in debt for Stellarex; Postmarket device surveillance board adds 4 members;

@FierceMedDev: ICYMI yesterday: AstraZeneca, NCI tap French company to develop companion mobile app for cancer drugs. Article | Follow @FierceMedDev

@EmilyWFierce: Google Life Sciences will now be known as "Verily." More | Follow @EmilyWFierce

> Upstart wins CE mark for first swallowable weight-loss gastric balloon. Article

> Minimally invasive cardiovascular company Spectranetics ($SPNC) has raised $110 million in a credit facility led by Midcap Financial and Silicon Valley Bank. It's intend to back the company through the U.S. launch of drug-coated balloon Stellarex, which it acquired from Covidien in January for an undisclosed sum. Spectranetics intends to submit a PMA to FDA for Stellarex. More

> Four new board members have been chosen for the National Medical Device Evaluation System Planning Board, which is slated to create a national system for medical device postmarket surveillance and evaluation. These are Mark Deem, a managing partner at The Foundry; Barbara Evans, George Butler Research Professor and Director of the Center for Biotechnology and Law at University of Houston Law Center; Bill Murray, President and CEO of the Medical Device Innovation Consortium; and Kenneth Reali, president and CEO of Clinical Innovations. More

> Aesthetics players Galderma and Zeltiq ($ZLTQ) have partnered to market each other's offerings for facial rejuvenation and non-invasive fat reduction, respectively. More

Biotech News

@FierceBiotech: Busy Roche inks another immuno-oncology discovery pact, this time with Pieris. News | Follow @FierceBiotech

@JohnCFierce: In the category of 'can't make this stuff up,' $NWBO issued a followup statement saying why Leary wouldn't work. More | Follow @JohnCFierce

> Pfizer bets up to $1B on BioAtla's approach to immuno-oncology. More

> Alexion grabs an FDA OK--the 41st of '15--for rare-disease drug Kanuma. News

> Sitting on $25B, Gilead goes shopping for high-dollar buyouts. Article

Pharma News

@FiercePharma: Japan's Kaketsuken at center of major vaccine, blood product records fraud. FiercePharmaAsia story | Follow @FiercePharma

@CarlyHFierce: J&J, AbbVie's Imbruvica builds on case for first-line CLL use at ASH. More | Follow @CarlyHFierce

> Beleaguered Daiichi Sankyo shuttering German antibody business. News

> Valeant weighs Paragon sale to get out of FTC spotlight. Story

Drug Delivery News

> 'Smart' hydrogel wound dressing delivers drugs from reservoirs. News

> FDA funds computer simulations in bid to speed up development of long-acting generics. Story

> Clearside closes $20M round for candidates that are injected into the eye's suprachoroidal space. More

> University of Warwick spinout develops first transdermal ibuprofen pain patch. Report

> Metal 'nano-terminator' liquefies on demand to bring cancer down. Article

Pharma Manufacturing News

> FDA gives Sun Pharma go-ahead to manufacture generic version of cancer drug Gleevec. Item

> Associated Press: Taxpayers' tally to entice Novo Nordisk to NC may top $130M. More

> South African health activists protest Sanofi over lack of BCG vaccine. Article

> Catalent production issues at French plant cause delay in GSK launch. Story

> AstraZeneca shuttering Bengaluru, India API plant, citing low demand. Report

Pharma Asia News

> China economy not the main culprit in pharma slowdown, FT says. Article

> Outlook for early 2016 in Asia sees headwinds for Japan, India and Thailand. Report

> Japan's Kaketsuken at center of major vaccine, blood product records fraud. More

> China superbug has already gone global, Danish researcher says. Story

> India a potential center for orphan drug development and demand. Article

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