• Accelr8 Technology Corp., of Denver, said it has started joint research programs with Washington University in St. Louis School of Medicine and with the Denver Health and Hospital Authority to identify antibiotic resistance mechanisms using Accelr8's patented analytical methods. The firm said its BACcel system will use the methods to speed the diagnosis of life-threatening infections in critically ill patients, particularly for health care-associated infections.

• Akela Pharma Inc., of Montreal, has extended the territory coverage of a license and development agreement with Janssen Pharmaceutica NV, a division of New Brunswick, N.J.-based Johnson & Johnson, for Fentanyl Taifun, to include Canada. The existing agreement already covers the European Union, Eastern Europe, Russia, the Middle East and Africa. All other conditions of that deal remain in effect. The product will be distributed in Canada by Janssen-Ortho Inc. Akela will receive an unspecified signing fee, development and regulatory milestones as well as commercial sales milestones in line with current commercial expectations regarding the Canadian market as compared with the European Union market.

• AtheroGenics Inc., of Atlanta, received notification from Nasdaq that the company has not regained compliance with the listing requirements because the market value of the company's listed securities has fallen below $50 million for 10 consecutive business days, making it subject to delisting. AtheroGenics said it will request a hearing to seek continued listing. The company said it expects to meet the listing standard when it issues its 2007 financial statements, which are expected to have total assets and total revenue in excess of $50 million for the 2007 fiscal year.

• Celgene Corp., of Summit, N.J., and Pharmion Corp., of Boulder, Colo., said that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 has expired without the U.S. Federal Trade Commission requesting additional information about Celgene's pending $2.9 billion acquisition of Pharmion, which is expected to close in April. The cash and stock deal, announced in November, brings four commercials products to Celgene. (See BioWorld Today, Nov. 20, 2007.)

• DOR BioPharma Inc., of Ewing, N.J., said the FDA has granted orphan drug designation to oral BDP (beclomethasone dipropionate), a highly potent, topically active corticosteroid that has a local effect on inflamed tissue, for the treatment of pediatric Crohn's disease. BDP has been marketed worldwide since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma. It also is the active ingredient in orBec, DOR's investigational compound for the treatment and prevention of graft-vs.-host disease.

• Galapagos NV, of Mechelen, Belgium, said its BioFocus DPI service division has entered a two-year target discovery collaboration with Janssen Pharmaceutica, a division of New Brunswick, N.J.-based Johnson & Johnson, in the field of oncology. BioFocus DPI will apply Galapagos' adenoviral platform to identify novel drug targets for development. BioFocusDPI will receive an up-front payment of €2.9 million (US$4.3 million). In total, BioFocus DPI may receive additional research, acceptance, license and development fees of up to €7.6 million if predetermined criteria are achieved.

• Luminex Corp., of Austin, Texas, said the FDA granted 510(k) clearance for xTAG respiratory viral panel (RVP), the first FDA-cleared assay to simultaneously detect and identify 12 viruses and viral subtypes, with qualitative results in a few hours. Traditional testing for that many viruses requires multiple individual diagnostic tests to be performed on a patient sample and can take several days to provide a thorough diagnosis. The test is the first to detect and differentiate influenza A subtypes H1 and H3. It also tests for adenovirus, which the Centers for Disease Control and Prevention recently identified as causing multiple deaths, and respiratory syncytial virus A and B, the most common cause of bronchiolitis and pneumonia in infants and children.

• MGI Pharma Inc., of Minneapolis, and its partner Helsinn Healthcare SA, of Lugano, Switzerland, said the FDA has accepted the firms' supplemental new drug application for Aloxi (palonosetron hydrochloride) oral capsules. Aloxi injection is approved in the U.S. for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy and for the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. The supplemental application for the oral capsule formulation was submitted Oct. 24, 2007, the companies said. The Prescription Drug User Fee Act action date for the supplemental application is Aug. 22.

• Montreux Equity Partners LLC, of Menlo Park, Calif., closed a $250 million MEP IV venture capital fund focused on therapeutic-oriented life sciences companies, exceeding its $200 million target. Lazard Freres & Co. LLC acted as placement agent.

• Novacea Inc., of South San Francisco, said it has decided to scale back its clinical development activities for AQ4N (banoxantrone), an investigational anticancer prodrug, including discontinuing the recently initiated clinical trial in acute lymphoblastic leukemia and delaying its planned clinical trial in B-cell lymphoma. The firm said the move is part of an effort to preserve its capital resources and to fully evaluate strategic alternatives. The company said it will continue enrollment in an ongoing Phase Ib/IIa clinical trial of AQ4N in patients with glioblastoma multiforme. Novacea said its capital resources totaled about $110 million in cash and receivables at the end of the third quarter of 2007, and projected that its cash burn rate will be about $17 million to $19 million in 2008. The company in November ended its ASCENT-2 Phase III clinical trial of Asentar (DN-101) for the treatment of patients with androgen-independent prostate cancer, due to an imbalance of deaths between the two treatment arms observed by the data safety monitoring board. (See BioWorld Today, Nov. 6, 2007.) Novacea said it will continue with its partner Schering-Plough Corp., of Kenilworth, N.J., to analyze the ASCENT-2 data and will provide an update on the analyses later this year.

• PhytoMedical Technologies Inc., of Princeton, N.J., said research outcomes from ongoing in vitro studies of its cancer compounds demonstrated the ability to kill a strain of human brain cancer cells that is otherwise highly resistant to available drugs. Researchers determined that one of several "bis-intercalator" cancer drugs in development at PhytoMedical achieved a 50 percent or greater cancer cell kill rate a minimum concentration in studies of the SF-295 strain of human glioblastoma cancer cells. The bi-intercalator compounds are designed to intercalate, or insert their anticancer molecules inside DNA sites of specific cancer cells, thereby preventing the ability of the cancer cells to replicate and leading to cell death.

• Shire plc, of Philadelphia, has received FDA approval for three additional dosage strengths for attention deficit hyperactivity disorder treatment Vyanse (lisdexamfetamine dimesylate). The new dosages are for 20 mg, 40 mg and 60 mg, supplementing the existing 30-mg, 50-mg and 70-mg dosage strengths currently available.

• SkyePharma plc, of London, and Sciele Pharma Inc., of Atlanta, said the FDA has approved all four new dosage strengths of Sular, a calcium channel blocking agent for the treatment of high blood pressure. The new Sular formulation uses SkyePharma's patented Geomatrix technology, which provides a lower dose of the drug for each of its current doses, the companies said. The firms expect to launch the new formulation during the first quarter. SkyePharma said it will receive $2 million on the approval and also mid-single-digit royalties on net sales of new Sular.

• Upstream Biosciences Inc., of Vancouver, British Columbia, said it is partnering with the Provincial Laboratory for Public Health in Alberta to begin in vitro testing of the firm's novel compounds for the potential treatment of malaria, which affects 500 million people worldwide each year, resulting in more than 1 million annual deaths.

• Xanthus Pharmaceuticals Inc., of Cambridge, Mass., said the FDA granted orphan drug designation to fludarabine phosphate oral tablets in B-cell chronic lymphocytic leukemia. That designation provides regulatory assistance and would guarantee the product seven years of marketing exclusivity upon approval. Xanthus licensed U.S. rights to fludarabine from Berlin-based Schering AG in 2006.