• AVI BioPharma Inc., of Portland, Ore., said preclinical results showed that the company’s Neugene therapeutics demonstrated efficacy against all strains of influenza A, including H5N1, the avian influenza strain. The company plans to file an investigational new drug application with the FDA later this year for the treatment of influenza A virus. The data are being presented at the Keystone Symposia conference "Advances in Influenza Research: From Birds to Bench to Bedside," in Steamboat Springs, Colo. AVI’s stock (NASDAQ:AVII) rose 15.8 percent Thursday, or $1.04, to close at $7.63.

• Bayer Pharmaceuticals Corp., of West Haven, Conn., and Onyx Pharmaceuticals Inc., of Emeryville, Calif., said Swiss regulatory authorities approved Nexavar (sorafenib) for advanced renal-cell carcinoma after nephrectomy and prior palliative or adjuvant therapy with cytokines. Nexavar, which has been shown to double progression-free survival in patients with advanced kidney cancer, will be marketed by Bayer in Switzerland. The drug is under review for full European approval. In addition, Bayer has completed filings in several other countries, including Mexico, Australia, Brazil, Canada and Turkey.

• ChemDiv Inc., of San Diego, and Carna Biosciences Inc., of Kobe, Japan, entered a collaboration to develop and market annotated kinase-focused libraries targeting kinases for various pathways and disease. ChemDiv’s chemistry permits small-molecule drug development for such kinases, while Carna’s background in kinase assay development and profiling provides rapid screening results for an added annotated component to ChemDiv’s kinase libraries. The agreement’s financial terms were not disclosed.

• CuraGen Corp., of Branford, Conn., named Frank Armstrong president and CEO. Most recently, he has served as the CEO of Bioaccelerate, a development company built to acquire and advance potential drug candidates. Armstrong was appointed to CuraGen’s board last year, and will continue to serve as a member; in addition, he will join the board of CuraGen’s majority owned subsidiary, 454 Life Sciences Inc., also of Branford. CuraGen, a cancer-focused firm, also said Robert Patricelli was elected its non-executive chairman.

• CytImmune Sciences Inc., of Rockville, Md., received a Phase I Small Business Innovation Research grant to advance its tumor-targeted nanotherapies based on the company’s pegylated colloidal gold nanoparticle platform. CytImmune will receive $500,000 over a two-year period from the National Cancer Institute to support preclinical evaluations and manufacturing of CTY-21001, an investigational product that will consist of TNF and a thiolated paclitaxel analogue bound to the surface of 27 nm pegylated colloidal gold nanoparticles.

• Galapagos NV, of Mechelen, Belgium, said its service division, BioFocus, has entered a three-year target discovery alliance with Arthrogen BV, a joint venture of the Dubai Bone & Joint Center and the Academic Medical Center in Amsterdam, the Netherlands. The alliance focuses on identifying novel targets for gene therapy applications in rheumatoid arthritis. BioFocus will extend its SilenceSelect collection with new gene sets, set up cellular assays and screen the expanded collection in the assays. The human protein targets identified will be characterized and validated. Galapagos will receive an up-front payment and research and development funding, and it will be eligible for development milestones, all of which could total more than €7.5 million (US$9.1 million) for each target.

• Genentech Inc., of South San Francisco, and Biogen Idec Inc., of Cambridge, Mass., submitted a supplemental biologics license application to the FDA for the use of Rituxan (rituximab) as first-line treatment of previously untreated patients with low-grade or follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma in combination with cyclophosphamide, vincristine and prednisone (CVP) or CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy or following CVP chemotherapy in those patients who achieved a response of stable disease or better. The submission is based on efficacy and safety data from two studies of Rituxan in 644 patients. Rituxan was first approved in November 1997 to treat relapsed or refractory low-grade or follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma.

• ImmunoGen Inc., of Cambridge, Mass., said Millennium Pharmaceuticals Inc., also of Cambridge, extended an agreement that gives it certain rights to test ImmunoGen’s Tumor-Activated Prodrug technology with antibodies to specific targets and to license the right to use the technology to develop products. The agreement is now scheduled to expire one year later on March 30, 2007. It was signed in March 2001. (See BioWorld Today, March 7, 2001.)

• Pharmion Corp., of Boulder, Colo., submitted to the FDA a new drug application supplement for Vidaza (azacitidine) to add intravenous administration to instructions in the demethylating agent’s prescribing information. The filing, based on existing clinical data and recently completed studies, would maintain Vidaza’s dosing at 75 mg/m2 daily, for seven days, every four weeks. The company expects a response within the standard review time of six to 10 months from the date of submission. Nearly two years ago, May 19, 2004, the drug became the first FDA-approved product for myelodysplastic syndromes (MDS).