> It looks like we won't have an FDA decision on Amgen's Nplate today after all. Amgen says that the agency will miss its deadline and doesn't know exactly when a decision will come. Report
> MethylGene and Celgene have temporarily suspended enrollment of new patients into clinical trials evaluating MGCD0103 after observing pericarditis or pericardial effusion in 19 patients out of approximately 400 patients treated to date. Researchers called it a precautionary move, noting that half of the reported cases "have been deemed by investigators as unlikely to be drug related." Release
> Shares of Silence Therapeutics rose this morning on news that it had been awarded a patent on its lead therapy. Report
> Introgen Therapeutics released additional efficacy data included in regulatory filings for Advexin, an experimental therapy for head and neck cancers. The data demonstrated a statistically significant survival benefit compared to methotrexate. Introgen release
> GBS Venture Partners has invested $6 million in Xenome. The developer is advancing new peptide therapies for pain and inflammation. Report
> Here's some news that Merck can really use: FDA and CDC gave its Gardasil a (re)seal of approval, saying the vaccine is safe and effective for the prevention of some of the strains of genital warts that can lead to cervical cancer. Report
> Well, big pharma doesn't appear to be the safe haven for investors or employees these days. The Industrial Info Resources' Pharmaceutical Tracker has revealed that there are at least 26 plants poised for shutdown. Report
> In a move that is likely to make industry watchdogs wag their tales, Daniel Troy, formerly chief counsel at FDA from 2001 to 2004, has just signed on to be a senior vice president and general counsel at GlaxoSmithKline. GSK report
> The New York Times examines the prospects of two drugs being developed by Sirtris to extend our life span. Report
> The FDA has issued new guidelines that exempt Phase I drugs from certain Good Manufacturing Practice regulations. Report
And Finally... GlobeImmune CEO Timothy Rodell says that the times when private venture capital provided a short bridge to the public markets have been eclipsed by pharma's need for new products, which is driving more partnering and M&A activity. "Because of increased costs and limited public markets, small biotech companies have increasingly relied on private equity and partnering," Rodell said in an interview. GlobeImmune is one of this year's Fierce 15. Report