EndoStim withdraws IPO plans; NEJM positive data on Pulmonx emphysema device;

@FierceMedDev: ICYMI yesterday: Chemotherapy cooling cap to reduce hair loss for breast cancer patients gets FDA nod. Article | Follow @FierceMedDev

@VarunSaxena2: ICYMI yesterday: Edwards grabs option to acquire transcather mitral valve replacement startup. Article | Follow @VarunSaxena2

@EmilyWFierce: Cornell scientists create first litter of puppies through in vitro fertilization. FierceAnimalHealth story | Follow @EmilyWFierce

> GERD device maker EndoStim has withdrawn its plans for a $35 million IPO. More

> Data were published in the New England Journal of Medicine on a Pulmonx device to treat emphysema. The prospective, randomized study found that the Zephyr Endobronchial Valve offered statistically significant improvement in lung function, exercise capacity and quality of life in severe emphysema patients. More

> The Centers for Medicare & Medicaid Services (CMS) has approved a transitional pass-through payment for high frequency stimulation under the Medicare hospital outpatient payment system, Nevro ($NVRO) announced. It takes effect on Jan. 1. More

Biotech News

@FierceBiotech: With Roche in the rearview mirror, Constellation Pharma grabs $55M round. Article | Follow @FierceBiotech

@JohnCFierce: Now we get to see if Merck KGaA can swing big and actually hit the ball. Article | Follow @JohnCFierce

> After failing a PhII/III, Raptor steers Huntington's drug into a pivotal trial. Article

> Puma's once-vaunted cancer drug dogged by side effects in Phase II results. Item

> In a win for NYC, gut-brain biotech Kallyope launches with $44M. News

> FierceBiotech Radio on the burning hole in Gilead's $25B pocket and AbbVie's future in hematology. More | Subscribe

Pharma News

@FiercePharma: India's Dr. Reddy's responds to U.S. FDA warning letter. FiercePharmaAsia article | Follow @FiercePharma

@CarlyHFierce: I'm sorry, but you had 20 years to brainstorm on this, and you came up with "Dengvaxia?" | Follow @CarlyHFierce

> FDA Commissioner to talk drug safety with top Chinese officials. More

> Sanofi gets first approval for long-anticipated vaccine against dengue fever. Story

> McCaskill raps 'Mr. Wu-Tang' Shkreli in Senate hearing over drug price hikes. Article

CRO News

> Icon buys a trial site network with an eye on patient data. News

> WuXi and PRA break up their Chinese joint venture. More

> Charles River digs into Parkinson's R&D with Fox Foundation in tow. Story

> Quintiles extends its R&D hand-holding service to biopharmas large and small. Report

> Restructured AMRI cuts the ribbon on a drug discovery hub. Article

Pharma Manufacturing News

> Sucampo finalizes $278M deal of R-Tech Ueno's manufacturing plant in Japan. News

> Axxess Pharma has tapped SDC Nutrition for product manufacturing. Report

> FDA issues import alert on Pan Pharma, ramping up its pressure on the India drugmaker. Story

> Eli Lilly to manufacture human and animal drugs in separate facilities. Article

> Study: Shortfall of skilled inspectors in India hinders pharma industry. Item

Pharma Asia News

> WuXi and PRA Health amend ties in China. Item

> U.S. FDA files import alert on India's Pan Drugs. More

> China aims precision medicine plans at chronic diseases. Report

> Bangladesh again noted for dominant domestic drug manufacture. Story

> Takeda inks pact with Cour for celiac disease therapy via nanoparticles. Article