> With Novartis close at its heels, Merck KGaA has filed for FDA approval of its new oral therapy for multiple sclerosis. The pharma company had applied to the EMEA back in July as it seeks to bring the first new oral drug for MS to the market. Novartis has laid plans to file for an approval of its oral MS drug in Europe and the U.S. later this year. Report
> FDA staffers have raised questions about the risk of liver problems linked to GlaxoSmithKline's pazopanib. The findings "strongly suggest that pazopanib may be associated with a significant risk of severe idiosyncratic hepatic injury if used in a larger patient population," according to the agency's review. An expert panel is scheduled to review the drug on Monday. Story
> Chelsea Therapeutics jumped 16 percent on the news that a further analysis of its trial for Droxidopa confirmed benefits for five symptoms. The developer also confirmed that the drug had failed to meet its primary endpoint, which had once been considered by some analysts as a near certainty. Report
> As expected, the board at Facet Biotech has unanimously voted to recommend that stockholders reject Biogen Idec's hostile bid of $14.50 a share. Report
> Molecular Detection , a company developing Detect-Ready assays designed to increase the speed and accuracy of infectious disease diagnosis, today announced completion of a $3.3 million Series C financing. Release
> DiscoveRx has inked a global agreement with GSK to provide access to its PathHunter ß-Arrestin parental cell lines, clones and associated reagents for use in GSK's internal GPCR screening and profiling efforts. Release
Pharma News
> It's been a long time coming, but FDA is finally working to overhaul its safety communications. The agency posted a new plan for announcing safety problems to healthcare providers and the public, patterned on a 2006 report by the Institute of Medicine. Report
> You all know Dierdre Connelly (photo). Late of Eli Lilly, she's now GlaxoSmithKline's chief of North American pharmaceuticals. She's one of the most powerful women in the drug industry. But do you really know Dierdre Connelly? Article
> Takeda Pharmaceutical (TKPH) is taking on the world. It's launching four new overseas subsidiaries to market its products, aiming to expand its territory substantially. The four units will be based in Mexico, Sweden, Belgium and Turkey, taking on those countries plus Norway, Denmark and Luxembourg. Report
> It's a tale of two companies, Swiss style. The Financial Times compares pharma rivals Roche and Novartis, whose headquarters are both in Basel, Switzerland. Just about a mile apart, in fact. But as the FT outlines, their strategies are almost polar opposites. Report
> Over the past month, the Pittsburgh Post-Gazette newspaper has offered little comment on Mylan's (MYL) decision to sue the paper over articles that led to an FDA investigation of the drugmaker's manufacturing facility, but now the paper is firing back. In its answer to the lawsuit, the Post-Gazette asks the U.S. District Court to dismiss the drugmaker's lawsuit and order Mylan to cover its court costs. Report
>Vaccine News
> Over the past few years the vaccines industry has grown from a therapeutic sideshow to one of the main attractions of biopharma. As the Wall Street Journal pointed out, three big deals early this week underscore just how much things have changed. Report
> Shares of BioCryst were buoyed by the news that the Birmingham, AL-based developer had responded to a request from the Department of Health and Human Services seeking information on how it could go about setting up an emergency stockpile of its experimental flu drug peramivir. Report
> Shares of Vical shot up after the company announced a $1.3 million contract with the U.S. Navy to support testing of its new DNA vaccine. Report
> The European Commission has approved two new swine flu vaccines from Novartis and GlaxoSmithKline, wrapping a record-setting program for the testing and approval of a new jab. Story
And Finally... A study of female monkeys' grooming habits provides new clues about the way humans socialize. Release