• Anesiva Inc., of South San Francisco, granted Particle Therapeutics Ltd., of Oxford, UK, a specific-use license. Anesiva's drug-delivery technology will be incorporated into Particle's needle-free, intradermal delivery system for glucagon, a hormone commonly used for the treatment of hypoglycemia associated with Type I and Type II diabetes. Anesiva will receive an undisclosed up-front payment, along with potential milestone payments. It also would receive royalties on resulting sales, as well as royalties on revenues from any sublicensing of the technology by Particle.

• Avant Immunotherapeutics Inc., of Needham, Mass., said it was informed by Nasdaq that it was approved to list its common stock on the Nasdaq Capital Market. The stock will be transferred there from the Nasdaq Global Market at the opening of business today.

• Bar Harbor BioTechnology Inc., of Trenton, Maine, was granted a development award of $334,632 from the Maine Technology Institute to develop human genetic profiling products. The company, founded in September 2006 by scientists from Jackson Laboratories in Bar Harbor, Maine, is working to develop easy-to-use gene detection arrays, computational tools and bioinformatics resources for molecular profiling. Its technology is intended to allow analysis of hundreds of genes simultaneously for their expression and/or gene copy number profile. It plans to launch its first suite of products Oct. 1.

• Cardiome Pharma Corp., of Vancouver, British Columbia, and co-development partner Astellas Pharma US Inc., of Deerfield, Ill., said the FDA requested they participate in a panel review to be conducted by the Cardiovascular and Renal Drugs Advisory Committee, Dec. 11-12. The new drug application for the intravenous formulation of vernakalant hydrochloride, for the acute conversion of atrial fibrillation, will be reviewed as part of a two-day meeting regarding therapies for acute conversion of heart arrhythmias. The FDA also requested Astellas file additional information including final safety and efficacy data from the ACT 2 clinical trial, which was ongoing at the time of original NDA submission. As a result of that amendment to the NDA, the FDA has indicated that the action date under the Prescription Drug User Fee Act will be extended by three months to Jan. 19. The NDA for vernakalant was submitted in December and accepted for review in February.

• Cephalon Inc., of Frazer, Pa., said the FDA granted orphan drug designation to Treanda (bendamustine HCl) for the treatment of chronic lymphocytic leukemia. Cephalon plans to submit a new drug application this quarter to the FDA for Treanda for the treatment of patients with CLL. It also plans later this year to file for approval of the drug, a purine analogue/alkylator hybrid, for treating indolent non-Hodgkin's lymphoma in patients refractory to rituximab.

• CytoGenix Inc., of Houston, said it is breaking ground on a new 20,000-square-foot facility in Houston that will house the company offices, laboratory and DNA production plant. CytoGenix said the facility will provide the space needed to expand both research and development and DNA production. The company is developing products and services based on its synDNA production and single-stranded DNA expression technology.

• Merck Serono, of Geneva, a division of Merck KGaA, said the European Commission granted marketing authorization for a new formulation of Rebif (interferon beta-1a) for treating relapsing multiple sclerosis. The new formulation was developed to improve injection tolerability while targeting an improved immunogenicity profile. The approval applies to all 27 countries in the European Union, as well as Iceland, Liechtenstein and Norway. Launches will start in September. Rebif originally was approved in Europe in 1998, and in the U.S. in 2002.

• Neuralstem Inc., of Rockville, Md., entered a collaborative agreement with the ALS Clinic at University of Michigan Health System. The goal is to provide further proof-of-principle data to move Neuralstem's spinal cord stem cells into patients with amyotrophic lateral sclerosis. The company expects its first investigational new drug application will be filed this year, for the treatment of ischemic paraplegia.

• Novocell Inc., of San Diego, said researchers identified two prominent cancer cell-signaling pathways as essential for the efficient proliferation and self-renewal of human embryonic stem cells. Researchers studying the self-renewal of hESCs discovered a link with insulin-like growth factor-1 and ERBB2/3, both pathways implicated in cancer. The findings were pre-published online in Blood. Researchers from Novocell; Invitrogen Corp., of Carlsbad, Calif.; and the University of Washington collaborated on the published study.

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