EpiCept wins orphan drug designation; Gilead's profits soar; Jubilant, Endo expand discovery pact;

> EpiCept has won the FDA's orphan drug designation for its pain med NP-1. The therapy is designed to treat the pain from damage to the peripheral nervous system. EpiCept release

> Gilead's fourth quarter profit shot up 43 percent and the company says its sales prospects for 2010 are bright. Story

> India's Jubilant Biosys and Endo Pharmaceuticals (ENDP) have expanded their drug discovery partnership in oncology, following the successful delivery of an early stage milestone. Release

> Movetis has launched its lead product for chronic constipation in Germany and hopes to begin selling it in the UK in the second quarter. Story

Pharma News

> There's nothing like a surprise CEO announcement to get the media excited. For your reading pleasure, we rounded up some of the more interesting takes on a) Vasella's tenure, b) Jimenez' personality and background, and c) Novartis present and future. Article

> The good news: Drugmakers appear to be getting the FDA's tread-carefully message when it comes to DTC advertising. The bad: We're probably less likely to hear catchy jingles, see edgy campaigns, or meet endearing product mascots. DTC report

> Though Sanofi's anti-clotting med Lovenox is falling off the patent cliff soon, CEO Chris Viehbacher (photo) says that the company has already been planning for an alternate route downstream. Article

> Teva scores again. The Israeli generics maker won a favorable ruling in the U.S. District Court for the District of Delaware yesterday after a judge determined that a Merck patent on the cancer treatment Temodar is unenforceable. Teva report

> India's Claris Life Sciences is looking for more deals. According to the Business Standard, the injectable-drug maker that inked a supply arrangement with Pfizer recently is on the prowl for more multinationals to buy its off-patent wares. Claris report

Manufacturing News

> Manufacturing missteps are behind the near quadrupling of drug and medical device recalls in the UK between 2004 and 2008. Report

> Inadequate process control, lack of master production and control records, and inadequate details on training intended to prevent future GMP violations have combined to earn Sunrise Pharmaceutical an FDA warning letter. Report

> The Millipore/Roka Bioscience collaboration reported earlier is bearing additional fruit: A tool for early detection of mycoplasma contamination in bioprocessing. The partners have an assay for Pseudomonas aeruginosa on the market already. Article

> Batch processes are easy, so you can't necessarily blame API makers for using them. But a little quality-by-design creativity, coupled with an understanding of API physical properties and reaction kinetics, can lead to continuous manufacturing processes that improve the bottom line and establish leadership. Report

> Keeping an eye on your contractors? An employee of the waste-disposal company used by Sanofi-Aventis at a plant in Kansas City, MO, pleaded guilty last week to the theft of 1,000 pounds of pseudoephedrine byproduct over the course of a decade. Item

Slideshow: The FDA approvals of 2009. Launch ⇒

And Finally... Researchers at MIT and Rockefeller University have successfully grown hepatitis C virus in otherwise healthy liver cells in the laboratory, an advance that could allow scientists to develop and test new treatments for the disease. Release

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