Mylan seeks FDA approval for Nuvigil copy; Japan mulls opening up to Indian drugmakers;

> Mylan has filed an application for FDA approval for a copycat version of Cephalon's stay-awake drug Nuvigil. Release

> The Japanese government says it is considering opening its market to generic medications made by Indian drugmakers. Report

> Teva Pharmaceutical Industries saw its stock climb to the highest level in at least 15 years after saying that annual revenue may more than double to $31 billion by 2015. Report

> Cephalon said Robert Roche Jr., who has headed the company's global drug operations since 1995, will resign next month in order to pursue other longstanding interests. Report

> Novartis says it launched Fanapt, its new antipsychotic medication, in the U.S. today. Release

> Sanofi-Aventis formally launched its $1.9 billion bid for the U.S. consumer healthcare company Chattem. Report

Biotech News

> Galapagos and Roche have entered a global alliance to develop new COPD therapies in a deal worth almost $590 million (€406 million). Galapagos will use its discovery platform to identify potential COPD targets and develop small molecule candidates against the targets. Story

> Roche's Genentech unit finally got the FDA nod for Actemra to treat rheumatoid arthritis in patients who have failed other treatments. Story

> GlaxoSmithKline and ChemoCentryx today announced that GSK has exercised its option to obtain an exclusive license for further development and worldwide commercialization of Traficet-EN (CCX282-B), a specific CCR9 antagonist that could offer a new approach for treating inflammatory bowel diseases. Report

> The FDA said today that it will miss the January 16 deadline for MannKind's much-watched inhaled insulin drug Afrezza. The agency says it needs more time to complete its inspection of the insulin manufacturing facilities of N.V. Organon, a third-party supplier to MannKind. The company does not know yet when that inspection will be complete, or when the FDA will announce its ruling on the Afrezza NDA. Story

Biotech IT News

> Use of DNA variations as an indicator of patient response to medicines is one study underway that taps the newly available Vanderbilt University DNA databank, BioVU. The databank--currently available only to Vanderbilt researchers and collaborators--contains de-identified biological samples from 75,000 individuals collected since 2007 and has linked them the matching electronic medical records. Report

> A combination of OntheFly annotation software, the Reflect text-mining web service, and the ProMiner terminology-recognition tool has yielded a 50 percent increase in the productivity of Jackson Laboratory staff indexers for certain curation tasks. Researchers evaluated the automation tools within their Mouse Genome Informatics biocuration workflow and reported results in the journal Database. The mouse genome project is a model organism database for the mouse. Story

> Data processing and bioinformatics may become bottlenecks as the need grows to assemble and compare large numbers of genomes, says Xconomist in a list of five transformational biotechnologies of the future. The 10,000 times cost drop in human genome sequencing is just one indicator of what's to come. Report

> It took the headquarters installation of a server and relational database--plus computers at nine remote sites powered by solar panels to substitute for a power grid--to provide a project database for a struggling malaria tracking project in Uganda. But that only served to highlight a crippling data collection problem, according to Computerworld. The courier method used yielded an eight-month lag between data collection and database entry. Story

> The U.S. Food and Drug Administration continues its build-out of software capabilities for the evaluation of drug candidates. Software maker Pharsight has delivered two data analysis tools to the regulator: Phoenix NLME and Phoenix Connect, deliverables under an ongoing cooperative research and development agreement with CDER. Report

> Finding no commercial solutions matching its biologics R&D needs, Bayer Schering Pharma R&D will spend the next several years collaborating with software maker Genedata to create a biologics data platform. The specialty pharmaceutical company found that existing generic software available for small-molecule discovery and downstream R&D processes was inadequate for its protein-based therapeutics needs, which include library development, screening, engineering, optimization and production processes. Story

And Finally... Sanofi-Aventis' experimental vaccine against dengue protected healthy volunteers against all four strains of the virus in a study. Report

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