FDA delays decision on Auxilium's Xiaflex; Pfizer pays $1M milestone to Oxford BioMedica; new target for brain tumors;

@FierceBiotech: ICYMI from FierceCRO: PPD snags Acurian for recruitment software. News | Follow @FierceBiotech

@JohnCFierce: No Teva deal for Rexahn. Press release | Follow @JohnCFierce

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> The FDA is delaying their decision on Auxilium's bid to expand the use of Xiaflex to include Peyronie's disease. The new PDUFA deadline is Dec. 6. Report

> Pfizer ($PFE) is handing over a $1 million milestone payment to Oxford BioMedica as the antibody PF-06263507 enters the clinic. Report

> A group of scientists at Mount Sinai are setting up a biotech incubator in East Harlem. Report

Medical Device News

@FierceMedDev: Sign up to receive our new publication FierceDiagnostics in your inbox each Wednesday. Sign up here | Follow @FierceMedDev

@DamianFierce: J&J is switching up its Chinese leadership as local authorities eye drug and device firms. News | Follow @DamianFierce

@MarkHFierce: The sleep apnea device industry is poised to get an infusion of a number of new treatments. ICYMI yesterday | Follow @MarkHFierce

> GlySure glucose monitor tests well in hospital trial. Item

> Study: Insulin pump beats injection in kids with Type 1 diabetes. Article

> InVivo tanks after pushing back spinal study. More

Pharma News

@FiercePharma: China arrests British consultant and wife for trafficking in private information. Pharma probe churns on… Yesterday's story | Follow @FiercePharma

@EricPFierce: Swiss CMO Siegfried building a manufacturing plant in China. ICYMI from FiercePharmaManufacturing | Follow @EricPFierce

@CarlyHFierce: ICYMI yesterday: Eye-drug specialist Akorn buys rival Hi-Tech for $640M. Article | Follow @CarlyHFierce

> Onyx staffers to get word on layoffs 30 days after Amgen deal wraps. Story

> Simcere going private thanks to $495M buyout by chairman. Report

> Endo's Qualitest unit snags niche generics player for $225M. News

> J&J rejigs Chinese ops to centralize under local chairman. Article

Drug Delivery News

@MichaelGFierce: Ceptaris nets first-ever FDA approval for topical lymphoma chemo gel. Article | Follow @MichaelGFierce

> Chip lined with human cells tests cancer drug delivery with minimal cost. Story

> Singapore team makes 'nanocages' for protein drug delivery. Article

> Lipidor, Karolinska post sound PhI/IIa results for novel spray-on psoriasis drug. News

> Nano-gold's penetrating methods revealed in MIT, Swedish study. More

> FDA clears Novo Nordisk's insulin injection pen for children. Item

Diagnostics News

> U Texas group finds ovarian cancer Dx works better over time. More

> Harvard, Danish team develop new brain cancer MRI approach. Story

> Applied Proteomics mulls Alzheimer's companion Dx. Article

> Life Technologies loses exec to Dx startup. Item

> Exosome, Mount Sinai forge Dx development partnership. Report

And Finally… A team at Johns Hopkins says that a specific protein, NY-ESO-1, is found in virtually all cases of high-grade meningiomas, a common brain tumor. And they say that this new target already figures in to a clinical study under way at the National Cancer Institute. Release

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