> Shares of Genmab dived on the news that FDA staffers had some negative views to share on its leukemia drug Arzerra. In a note, staffers remarked that they do "not consider the patient population studied in the BFR group as meeting the regulatory standard for having an unmet medical need." Also, "FDA has determined that GSK will need to conduct a comparative study in order to support approval in a patient population ... who were only required to be refractory to one drug". The remarks were in background notes for an advisory meeting coming up on Friday. Report
> Carl Icahn has picked up some key support for the rebel band of candidates he's nominated to Biogen Idec's board. RiskMetrics Group is supporting two of his four candidates. Report
> The FDA has tacked on another three months to its scheduled review of Johnson & Johnson's new psoriasis drug Stelara. The agency wanted more time to study an amendment to J&J's application and has not asked for any new clinical trials. Story
> The UK's Celleron Therapeutics has licensed a cancer drug from AstraZeneca. Report
> Researchers for Abraxis Bioscience announced that Abraxane nearly doubled progression-free survival time in patients with breast cancer. The Phase II study involved 302 women with metastatic breast cancer. Story
> Spectrum Pharmaceuticals has won a $4.3 million award in its legal spat with Cell Therapeutics over joint venture expenses. Story
> A team of researchers at Oxford University say that they have refined their ability to engineer a virus that targets specific cells, offering a new approach to treating cancer and creating a new generation of vaccines for viral diseases. Report
> Francis Collins, a pioneering geneticist, is the leading candidate for the top job at the NIH, according to a report in Bloomberg. Report
> The Center for Information Technology (CIT) at the National Institutes of Health has expanded its licenses for the text-mining AlmaKnowledgeServer 2 (AKS2) by more than 25%, providing researchers involved in the human salivary proteome project an annotation platform. Report
> Drug makers are turning to Amazon, Google and Microsoft to adopt so-called cloud computing for their R&D efforts, with some noteworthy results, says Chemical & Engineering News. Report
> The Supreme Court agreed to hear Merck's challenge to a circuit court decision to allow the investor suits, which are now consolidated into a class-action proceeding. Report
> Today's the big day for Amylin Pharmaceuticals and its rebel investors. Shareholders will choose between current management and a management overhaul, between company nominees to its board and candidates supported by activist investor Carl Icahn (photo) and Eastbourne Capital Management. Report
> You've seen the drug ad spoofs: Those fake TV commercials that show patients skipping through the tulips, grinning crazily, while a voice-over lists frightening side effects at rapid fire. Well, the FDA apparently watches Saturday Night Live and YouTube, too. And the agency wants those parodies to be instantly outdated. Report
> AstraZeneca has fended off a key Seroquel case. A Delaware judge ruled for the drugmaker, tossing out a lawsuit that claimed the antipsychotic med causes diabetes. Report
> Your new FDA commissioner wants new metrics. Dr. Margaret "Peggy" Hamburg (photo) wrote in a New England Journal of Medicine editorial that the agency's success shouldn't be measured by the number of drugs approved--or even the number of facilities inspected. It should be measured by its ability to promote public health. Report
And Finally... The breakout of swine flu aboard a cruise ship prompted Australian authorities to divert it from metropolitan areas. The ship is being anchored at a remote island while tests are conducted. Report