Amicus halts trial enrollment; FDA wants more Televancin data;

> Amicus Therapeutics halted enrollment in a Phase II trial of AT2220 for Pompe disease and announced that the FDA had put a clinical hold on the study. Amicus launched the mid-stage trial in June, 2008. In a statement, the company noted that "two patients enrolled in the trial experienced self-reported adverse events and subsequently withdrew from the trial. The events were categorized by the site investigator as serious and probably related to treatment with AT2220." Release [1]

> The FDA wants more data on Theravance's infection treatment telavancin but won't require the developer to launch a new trial. Regulators want more input on evaluating risk, says Theravance, including more data on risks related to specific kidney-related conditions. An FDA panel has recommended the drug, which guards against hospital-acquired pneumonia and other infections. Release [2]

> Xconomy reports that the University of Washington spin-off Arzeda has hired Michael Martino as CEO and gained commitments from two VC groups to anchor a $12 million Series A. Report [3]

> Cell Therapeutics has begun a "collective dismissal procedure" concerning its employees in Bresso, Italy. The collective dismissal will involve a total of 62 employees. Cell Therapeutics release [4]

> Argolyn Bioscience CEO Nick Ellis says the developer is seeking $10 million in investment funds to launch human trials of its lead program. Report [5]

> Endo Pharmaceuticals has notified DURECT that it is returning Endo's rights in the U.S. and Canada to develop and commercialize TRANSDUR-Sufentanil, a transdermal patch in development intended to treat chronic pain. Release [6]

> A reduction in expenses helped cut Human Genome Science's losses in the fourth quarter. Report [7]

> Senators Tom Harkin and Arlen Specter have reintroduced legislation that would loosen restrictions on federal support for stem cell research. Report [8]

> FDA is slapping a black-box warning on Reglan (metoclopramide) drugs, widely used by patients with chronic heartburn and other gastrointestinal disorders. Originated by Wyeth, the tablet form was sold to Schwarz Pharma and the injectable to Baxter Healthcare several years ago, and it's marketed as a generic by several other companies, the Associated Press reports. Report [9]

> Merck CEO Richard Clark (photo [10]) got a $200,000 pay raise in 2008, barely a bump compared with the big hike in compensation he enjoyed in 2007. But that growth still beats the raise he'll get for 2009: Nada. Report [11]

And Finally... GTC Biotherapeutics plans to put its expertise in transgenics to use in developing follow-on biologics. The developer has struck a collaboration agreement with AgResearch Limited of New Zealand to develop transgenic founder animals to produce two follow-on biologic monoclonal antibodies. GTC release [12]