Roche wins EU backing for better Esbriet label; Pfizer kicks Remoxy back to Pain Therapeutics;

@FiercePharma: EMA favors AstraZeneca's ovarian cancer drug Lynparza that FDA committee dissed. ICYMI Friday | Follow @FiercePharma

@EricPFierce: #Novorossiya gets subpoenaed for information about a manufacturing plant in #DenmarkHill. More | Follow @EricPFierce

@CarlyHFierce: Fed up with Allergan obstinance, Valeant CEO says he'd hike bid past $200 a share. News | Follow @CarlyHFierce

> European drug regulators recommended a labeling update for Roche's ($RHHBY) new idiopathic pulmonary fibrosis drug Esbriet, to emphasize the drug's ability to reduce the risk of death and reinforce its safety profile. Release

> Pfizer ($PFE) kicked the painkiller Remoxy back to Pain Therapeutics after winning approval last week for new tamper-resistant labeling on its pain pill Embeda. Release

> Eli Lilly ($LLY) says it will sell some of Novartis' ($NVS) animal health products to Virbac, after the Indianapolis-based drugmaker closes it buyout of the Novartis unit. Report

> Brazil's pharmaceuticals and consumer health products company Hypermarcas delivered a 48% jump in third-quarter profits thanks to a currency hedge; sales grew by 7%. Report

> Some regulatory lawyers are taking issue with changes the FDA made to new guidance on facility inspections. Report

Medical Device News

@FierceMedDev: ICYMI Friday: New microscope offers 3D cellular images that are fast, detailed and low toxicity. Article | Follow @FierceMedDev

@VarunSaxena2: Edwards profit up 23%, but increased TAVR competition looming. Story | Follow @VarunSaxena2

@EmilyWFierce: ICYMI Friday: $JNJ scores victory in first metal-on-metal hip implant case to go to trial. Article | Follow @EmilyWFierce

> St. Jude Medical snags FDA approval for next-generation ablation catheter. More

> Attorney: FDA final guidance on product recalls not helpful. Story

> Boston Children's Hospital debuts 'Baby MEG' brain imaging system. Article

Biotech News

@FierceBiotech: Sarepta plunges as CEO moves goal line on Duchenne MD drug downfield. Report | Follow @FierceBiotech

@JohnCFierce: Les Echos and Bloomberg both say Viehbacher future in doubt at Sanofi ... among the chief irritants: Viehbacher's move to Boston. | Follow @JohnCFierce

@DamianFierce: Viehbacher's letter to the $SNY board is a wincing read. "Ask Len Schleifer about me!" | Follow @DamianFierce

@EmilyMFierce: Managers of discredited STAP stem cell study refund salary. More from Science | Follow @EmilyMFierce

> Akebia craters as adverse events cloud positive PhIIb anemia data. Article

> INC Research spells out details on $150M IPO. Item

> Pfizer finally abandons all hope in Remoxy, and Durect/Pain Therapeutics feel the sting. Report

CRO News

> SRI's CRO cuts the ribbon on a new early-phase outpost. Item

> MPI buys out a CRO neighbor to bolster early-stage R&D. More

> CROs line up to advise Big Pharma's R&D think tank. Story

> WuXi teams up with Foundation Medicine to bring cancer profiling to China. Article

> Icon posts another revenue jump and dials up its expectations. Report

Biotech IT News

> Billionaire doc teams with Oxford Uni to build 'NASA of biomedicine.' More

> NIH-funded registry of patient-entered genetic data goes live. News

> 23andMe steps up R&D with new hire, poster push. Report

> Human Longevity backer creates $100M fund for 'crazy' ideas. Story

> Microsoft makes cloud-computing available to Ebola researchers. Article

Animal Health News

> USDA awards $4.5M to vets working in underserved areas. Article

> VCA beats Q3 estimates on same-store hospital sales growth. Report

> Are flea-fighting pills gaining ground on OTC topicals? Item

> K-State, Lawrence Livermore team on Dx tools to detect infectious diseases. Story

> Report: Pet owners jump on the probiotics bandwagon. More

And Finally... Ebola-related quarantines are triggering controversy. Report (sub. req.) | Report

Suggested Articles

An online pharmacy has again criticized FDA action after tipping off regulators to the existence of a dangerous impurity in Zantac and other antacids.

A group of senators is asking the FTC to take a careful look at pharma mergers given the cost of drugs in the U.S.

Life’s been tough for J&J's prostate cancer med Erleada in its battle with Pfizer-Astellas’ Xtandi. A new FDA nod could help level the playing field.…