FDA delays BG-12 decision by three months; Biotech vet Itin takes helm at Cytos;

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> The FDA has delayed the PDUFA date on Biogen Idec's ($BIIB) closely-watched MS drug BG-12 by three months, citing the need for more time to review the application. As is the case with all simple delays, the regulators did not ask for more trials, just more time. BG-12 is widely viewed as a key new MS drug which is likely to dominate the market for new entries. Report

> The Belgian biotech ThromboGenics says the FDA has approved its eye drug Jetrea (ocriplasmin), clearing the path to a drug launch at the beginning of 2013. Report

> Christian Itin, the former CEO at Micromet--recently bought out by Amgen ($AMGN)--has landed at the helm of Cytos Biotechnology in Switzerland. Story

> Completing a full slate of late-stage flops, Nabi says that its smoking cessation drug NicVAX combined with Chantix was no better than Chantix alone at getting people to quit smoking. Story

Pharma News

@FiercePharma: NYT explores the sorry state of some pharma manufacturing plants--and their contributions to drug shortages. More | Follow @FiercePharma

> Abbott adds 550 to layoffs toll as split-up nears. Story

> Facing Monday trial, Pfizer settles bellwether Chantix case. Article

> Teva, HGS beef up layoff plans in U.S. News

Medical Device News

 @FierceMedDev: Boston Scientific's Q3 2012 earnings report has very few bright spots, as restructuring continues. More | Follow @FierceMedDev

 @MarkHFierce: Computer viruses are running wild in hospital medical devices, MIT Technology Review reports. More | Follow @MarkHFierce

 @DamianFierce: Stryker is scaling back its profit projections after a disappointing third quarter. More | Follow @DamianFierce

> Trauson Holdings: China's next med device M&A target. Item

> Baxter posts Q3 growth, but device sales slide. Article

> Medtronic launches MRI-safe pacemaker in Japan. News

Vaccines News

> J. Craig Venter explores printable vaccines. Article

> GSK recalls infant vaccine in Australia. Story

> University of Minnesota researchers call for better flu vaccine. More

> Study: HPV vaccine does not increase signs of sexual activity. More

> Special Report: 10 promising therapeutic vaccines 2012. Report

Pharma Manufacturing News

> Ben Venue begins limited manufacturing at Ohio drug plant. News

> Criminal investigators search site linked to meningitis outbreak. Report

> Watson to sell manufacturing tech to seal $5.9B Actavis deal. Story

> FDA warns stem cell outfit Celltex about GMP no-nos. Article

And Finally… New animal research indicates that nanoparticles could be promising in restoring the flow of blood to the brain following a traumatic brain injury. Release

 

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