• Basilea Pharmaceutica Ltd., of Basel, Switzerland, said it has submitted a marketing authorization application for ceftobiprole for the treatment of complicated skin and soft tissue infections to Swissmedic by its license partner Janssen-Cilag AG, a Johnson & Johnson company. The product previously had achieved accelerated assessment for its marketing authorization. Ceftobiprole currently is under review by regulatory authorities in the U.S., Canada and in the European Union. Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica Ltd. and Cilag GmbH International.

• Bioniche Life Sciences Inc., of Belleville, Ontario, said the first permit has been issued for its E. coli O157:H7 cattle vaccine, and that the first order of vaccine has been shipped to that customer. The vaccine will be used to reduce shedding of bacteria, which can contaminate food, water and the environment. The vaccine remains under review by the Canadian Food Inspection Agency and the U.S. Department of Agriculture. The CFIA in December said it was agreeable to issuing permits that allow cattle owners, through their veterinarians, to request the vaccine be supplied to them by Bioniche. Since then, Bioniche began production of the vaccine.

• Bolder BioTechnology Inc., of Boulder, Colo., was awarded a $685,984 Phase II Small Business Innovation Research grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases, which provides funds to continue research to optimize a human protein to enhance its ability to inhibit formation of new blood vessels as a possible approach for treating rheumatoid arthritis. Bolder previously received a $100,000 Phase I grant, which it used to demonstrate the feasibility of producing long-acting VEGF inhibitor proteins using the company's targeted PEGylation technology.

• Eusa Pharma Inc., of Doylestown Pa., said it has acquired from Innocoll, of Ashburn, Va., rights to the antibiotic surgical implant Collatamp G for all markets outside the U.S. Eusa also acquired similar rights to the late-stage development products Collatamp G topical and implantable CollaRx bupivacaine for postsurgery pain control. The acquisition also grants Eusa an option to the U.S. rights for CollaRx bupivacaine. In addition, Innocoll will transfer to Eusa its pan-European sales and marketing infrastructure, which has a presence in more than 20 European territories, as well as its distribution network covering more than 25 other countries around the world.

• Genentech Inc., of South San Francisco, resubmitted a supplemental biologics license application to the FDA, seeking approval of Avastin (bevacizumab), in combination with paclitaxel chemotherapy, for patients who have not received chemotherapy for their locally recurrent or metastatic breast cancer. The resubmission, based on the pivotal Phase III trial E2100, marks the beginning of a six-month review period by the FDA. The filing had been set back by the FDA's request for an independent review of patient scans from a pivotal trial. Separately, Genentech partner F. Hoffmann-La Roche Ltd., of Basel, Switzerland, gained approval of Avastin in Europe for the first-line treatment of patients with advanced non-small-cell lung cancer, in combination with platinum-based chemotherapy. Avastin, an antibody designed to specifically inhibit vascular endothelial growth factor, was first approved in 2004 for metastatic colorectal cancer and went on to gain approvals in other indications. (See BioWorld Today, Sept. 12, 2006.)

• Neuralstem Inc., of Rockville, Md., said its shares have been accepted for listing on the American Stock Exchange under the symbol "CUR." They are expected to begin trading there shortly. Shares of the company, which is developing stem cell products, have been trading on the OTC Bulletin Board.

• Northfield Laboratories Inc., of Evanston, Ill., said the SEC has completed its investigation of the firm's practices surrounding its PolyHeme blood substitute product. The company said that the SEC does not intend to recommend any enforcement action.

• ProNAi Therapeutics Inc., of Kalamazoo, Mich., said results from its first mechanism-of-action studies for its PNT2258 oncology drug candidate were positive. The compound centers on the BCL2 gene's role in triggering cell death in cancer cells. BCL2 plays a central role in dysregulation of apoptosis in malignant cells, which presents an opportunity for molecular-targeted drug discovery. PNT2258 targets a DNA sequence upstream of BCL2 promoters within a region of genomic instability. ProNAi's preclinical research currently is examining methods for safe and effective delivery of oligonucleotides to regulate BCL2 in difficult-to-treat cancers.

• Virax Holdings Ltd., of Australia, said it has received $1 million from Transgene SA, of Strasbourg, France, under a Transgene-Roche licence agreement for immunotherapeutic product TG4001. Payment was under the terms of the Virax-Transgene agreement announced by Virax in March.

• ZymoGenetics Inc., of Seattle, said the FDA has extended its approval decision date for the firm's recombinant thrombin rThrombin until January. Regulators said they need more time to review new data from ZymoGenetics about how the product is manufactured. The extension will delay a $40 million milestone payment from Bayer HealthCare AG, which hinges on approval of rThrombin.