FDA staffers confirm efficacy of Shire drug; Hawaii Biotech emerges from bankruptcy; Vertex to break ground on new HQ;

@FierceBiotech: Is Pfizer's new R&D plan doomed to failure? Item | Follow @FierceBiotech

@JohnCFierce: Investigators at Mayo/collaborators say they cured prostate tumors in mice using human vax. Story | Follow @JohnCFierce

> An FDA staff review of Shire's Firazyr, an injectable designed to stop serious swelling among patients suffering from a rare genetic illness, concludes that the treatment demonstrated efficacy in a pivotal trial. An FDA advisory committee meeting on Firazyr is slated for Thursday and analysts say an approval could pave the way to $100 million in sales by 2015. Report

> The vaccine developer Hawaii Biotech has emerged from bankruptcy. Report

> Shares of Senesco Technologies jumped after the FDA removed a clinical hold on a lead drug. Story

> Australia's bioMD has won shareholder approval to take over unlisted Allied Medical. Story

> In yet another sign of just how hard it is for a biotech company to go public these days, the Dutch company Agendia says it will pull its IPO due to market conditions. Story

Pharma News

@FiercePharma: Report: Lilly must buy company or be acquired. News | Follow @FiercePharma

> Reports: AZ close to selling dental unit to Dentsply. Article

> Forest fights back against Icahn in filing. Item

> Schering Plough $473M IRS ruling holds. Report

> Watson seeks to market generic Avodart. Item

Biotech Research News

> Musicians rock on with energy drinks, pharma misuse. Item

> Brain-in-a-beaker gives scientists a peek into Parkinson's. Article 

> iPS stem cell scientists fight back against bad press. News 

> Scientists take another look at the genetics of crime. Story 

> Vaccine turns body's defenses against prostate cancer tumor. Report

Manufacturing News

> Plant radiation leak sends four for decontamination. Item 

> Pharmacies bolster supply chain role by giving flu shots. News 

> FDA outlines next steps to ensure safe products. Story 

> J&J revs recall machine for Risperdal. Article 

> Novartis, AZ, Sanofi advance in Russia. Report

> Pfizer shows sustainability/cost balance at packaging plant. Story

And Finally... With an FDA approval of the blockbuster Incivek in the bag, Vertex will break ground tomorrow on its sprawling new biotech headquarters facility in Boston's Innovation District. And developers hope that many more biotechs will follow in its footsteps. Report

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