• Abbott, of Abbott Park, Ill., said the European Committee for Medicinal Products for Human Use has issued a positive opinion recommending approval of Humira (adalimumab) for the treatment of moderate to severe plaque psoriasis. Psoriasis will be the fifth disease indication for HUMIRA. Humira was developed by the former Cambridge Antibody Technology, of Cambridge, UK, now part of MedImmune Inc.

• Alios BioPharma Inc., of South San Francisco, and the Cleveland Clinic today announced that they have entered into an exclusive worldwide license agreement focused on development of small-molecule RNase L activators for the treatment of a broad range of viral diseases such as chronic hepatitis B and hepatitis C, HIV, influenza and others. The technology also is applicable to the treatment of cancer for both solid tumors and hematological malignancies such as leukemia. The agreement grants Alios exclusive worldwide rights to Cleveland Clinic patents, technology and preclinical small molecules relating to RNase L activation. Under the terms of the agreement, Alios will provide the Cleveland Clinic an up-front license fee, various development, regulatory and commercial milestones, and royalties on net sales. In addition, Alios will sponsor ongoing research at the Cleveland Clinic for a period of two years. Alios will continue the research and development of those compounds with the goal of advancing molecules toward clinical development for both chronic and acute viral diseases and for cancer. The agreement covers the use of RNase L activators for all human, veterinary and agricultural applications. Financial terms were not disclosed.

• Argos Therapeutics Inc., of Durham, N.C., said it has granted exclusive research and development rights based on its regulatory T-cell technology to Johnson & Johnson subsidiary Therakos Inc., of Exton, Pa. Terms of the agreement were not disclosed.

• DeCODE genetics, of Reykjavik, Iceland, launched deCODEme, a service that enables individuals to get a detailed look at their own genome. Subscribers who send a cheek swab can learn what their DNA reveals about ancestry, body traits and genetic variants associated with higher or lower average risk of disease. The information will be continually updated as new discoveries are made.

• Discovery Laboratories Inc., of Warrington, Pa., said the FDA has accepted the firm's Nov. 1 submission as a complete response to the April 2006 approvable letter for Surfaxin (lucinactant), natural human lung surfactant with KL-4 peptide, for the prevention of respiratory distress syndrome in premature infants. The FDA set May 1, 2008 as its target date to complete its review of the new drug application for the product.

• DSM Pharmaceutical Products, of Parsippany, N.J., and Crucell NV, of Leiden, the Netherlands, have granted licensing rights for their PER.C6 cell line to Daiichi Sankyo, of Tokyo. Financial terms of the agreement were not disclosed.

• Endo Pharmaceuticals Inc., of Chadds Ford, Pa., and Penwest Pharmaceuticals Co., of Danbury, Conn., said they have filed a lawsuit against Impax Laboratories Inc., of Hayward, Calif., in the U.S. District Court for the District of Delaware related to Impax's abbreviated new drug application for Opana ER (oxymorphone HCl) extended-release tablets CII. The lawsuit alleges infringement of certain Orange Book-listed U.S. patents that cover the Opana ER formulation. It also seeks a declaratory judgment stating that Impax has no legitimate basis to trigger the Hatch-Waxman ANDA patent litigation process because the FDA has rescinded its acceptance of the application.

• GeoPharma Inc., of Largo, Fla., disclosed second-quarter results for its reporting period ending September 30, listing total revenues of $6 million compared to $6.8 million in the first quarter. The firm, which has won approval of its first generic drug, the veterinary product carprofen, said it is making progress on 12 ANDAs and other drugs in the pipeline.

• Helix BioPharma Corp., of Aurora, Ontario, said that the firm's CEO position will no longer be jointly held by Donald Segal and John Docherty. Segal will assume the role of CEO, and Docherty will take the position of president. Segal is a founding partner, and Docherty joined the company in 1999.

• Humanetics Corp., of Minneapolis, said Congress has awarded the company an additional $3.8 million from the fiscal year 2008 Defense Appropriations Act, signed by President Bush. This award to Humanetics brings the total funding received by the company from the Department of Defense to slightly less than $7 million. The 2008 funding will be used by Humanetics to continue development, clinical testing, regulatory approval, manufacturing and commercialization of a number of medical radiation countermeasures. The firm's lead candidate, BIO 300, is undergoing large animal efficacy and human safety trials. The company also is working with several preclinical lead candidates which are showing promising early results.

• Immunicon Corp., of Huntingdon Valley, Pa., said that it has received a notice from the Nasdaq stock market informing the firm that it does not comply with the continued listing requirements. That rule requires that Immunicon have a minimum of $10 million in stockholders' equity to continue listing its securities on the Nasdaq global market. The firm has until Nov. 27 to submit a plan for regaining and sustaining compliance with the listing requirements.

• Inflazyme Pharmaceuticals Ltd., of Vancouver, British Columbia, said its shareholders approved the sale of the majority of its research and development assets to Biolipox AB, of Stockholm, Sweden. Of the votes cast, 98 percent voted for the sale. In return for the sale, which includes the PDE inhibitors, the LSAIDs and the Protein Therapeutics technology, Inflazyme receives $4 million in cash and up to $7 million in potential milestones plus royalty payments, which include $1.5 million upon a decision to enter a Phase IIb clinical study with a PDE inhibitor; $2.5 million upon a decision to initiate a Phase III study with a PDE inhibitor; $3 million upon a decision to begin a Phase III clinical study with an LSAID; and a royalty of 1.25 percent on net sales of the first PDE inhibitor commercialized. Inflazyme also may receive up to 35 percent of the proceeds from the subsequent sale or licensing of the Protein Therapeutics technology if that happens within 12 months of the asset sale.

• Schering-Plough Corp., of Kenilworth, N.J, said it has received antitrust clearance from the U.S. Federal Trade Commission for its planned acquisition of Organon BioSciences NV, of Oss, the Netherlands, from Akzo Nobel NV, of Amsterdam, the Netherlands. The $14.4 billion acquisition was announced in March. Schering-Plough still needs to secure certain regulatory approvals, including clearance from the U.S. Federal Trade Commission but expects the transaction to be completed by year-end. Separately, Schering-Plough said that the European Commission approved the 48-week standard dose of Pegintron (peginterferon alfa - 2b, 1.5 mcg/kg once weekly) and Rebetol (ribavirin, 800 - 1,400 mg daily) combination therapy for retreating adult patients with chronic hepatitis C whose prior treatment with interferon alpha (pegylated or nonpegylated) and ribavirin combination therapy or interferon alpha monotherapy did not result in a sustained response.

• Singulex Inc., of Hayward, Calif., signed a collaboration with researchers at Washington University School of Medicine in St. Louis to increase the clinical utility of validated and recently discovered biomarkers in human disease. Singulex also said the firm will get a $900,000 Phase I/II Fast Track Small Business Innovation Research contract from the National Cancer Institute to create biomarker assays to help predict patient response and therapeutic efficacy of cancer therapies in development. Scientists at Washington University will be part of Singulex's Erenna Technology Access Program (ETAP) to develop biomarker assays for both validated and putative biomarkers in important disease areas, including breast cancer, Alzheimer's disease, diabetes and stroke. ETAP allows early access for institutions and companies to Erenna, the company's biomarker detection platform system, which incorporates biomarker detection and optimized immunoassays.

• ThromboGenics NV, of Leuven, Belgium, said it has begun preclinical development of an anti-VPAC antibody for thrombocytopenia. Thrombocytopenia, which is the reduced number of platelets in blood, is a common severe side effect of chemotherapy and increases the risk of bleeding and severity of hemorrhage. Researchers at the University of Leuven and ThromboGenics have developed a novel therapeutic approach, showing that the inhibition of VPAC could stimulate the production of platelets. VPAC is a receptor present at the surface of bone marrow cells called megakaryocytes, which, when mature, produce platelets.

• UCB SA, of Brussels, Belgium, said it has been informed by the European Medicines Agency that the Committee for Medicinal Products for Human Use adopted a negative opinion on the market authorization application in the European Union for Cimzia (certolizumab pegol) in the treatment of patients with Crohn's disease. UCB plans to appeal, and a decision is expected during the first half of 2008. Cimzia is a pegylated anti-TNF, for which UCB filed a biologics license application in early 2006. The drug was approved in Switzerland for Crohn's disease in September of this year, and UCB said preparation for a U.S. regulatory submission for Cimzia in treating rheumatoid arthritis is ongoing.