• Abbott Laboratories, of Abbott Park, Ill., said it submitted a supplemental biologics license application with the FDA and a Type II Variation to the European Medicines Agency seeking approval to market Humira as a treatment for juvenile rheumatoid arthritis in the U.S. and juvenile idiopathic arthritis in the European Union. The filings mark the first pediatric indications sought for Humira and are based on the results of a Phase III, 48-week study that included 171 children (ages 4 to 17) with polyarticular JRA. Humira is being studied in pediatric Crohn's disease, and Abbott plans to initiate trials for pediatric and adolescent psoriasis later this year.

• Advanced Cell Technology Inc., of Worcester, Mass., reported for the first time that hemangioblast precursor cells derived from human embryonic stem cells can be used to achieve vascular repair. The research from ACT and collaborators appears online (ahead of print) in the journal Nature Methods. It describes an efficient method for generating large numbers of bipotential progenitors, or hemangioblasts, from hES cells that are capable of differentiating into blood vessels, as well as into all blood and immune cell lineages.

• Affitech A/S, of Oslo, Norway, agreed to produce fully human monoclonal antibodies against an undisclosed oncology target for F. Hoffmann-La Roche Ltd., of Basel, Switzerland. In exchange for screening and antibody engineering work, Affitech will receive an unspecified amount of research fees, milestone payments and royalties.

• AVI BioPharma Inc., of Portland, Ore., received three contracts worth a combined $7.1 million from the Department of Defense to use Neugene antisense technology to develop therapeutics against Ebola virus, Marburg virus, Bacillus anthracis (anthrax) and ricin toxin. A program for dengue virus is in the final stages of discussion. AVI shares (NASDAQ:AVII) rose 27 cents Monday, or 9.8 percent, to close at $3.04.

• Axela Biosensors Inc., of Toronto, and BioCheck Inc., of Foster City, Calif., entered a licensing and supply agreement for clinical reagents that will be commercialized into biomarker assays on Axela's dotLab System. An initial set of research assays will be focused on protein biomarker analysis. Axela intends to further develop those into individual and multiplexed clinical diagnostic panels. The majority of reagents that will be transferred to Axela's platform currently are offered as in vitro diagnostic products by BioCheck.

• Biolex Therapeutics, of Pittsboro, N.C., entered an agreement with Genmab A/S, of Copenhagen, Denmark, under which Genmab will evaluate Biolex's LEX System as a manufacturing platform for antibodies. The deal relates to Genmab's new UniBody antibody technology. Terms were not disclosed.

• BioLife Solutions Inc., of Bothell, Wash., entered a supply and licensing agreement with Intercytex Group plc, of Cambridge, UK. Terms of the 10-year deal include an intellectual property escrow provision that guarantees Intercytex access under certain conditions to BioLife's HypoThermosol storage and preservation media, when used in the production of Intercytex' Vavelta, a facial rejuvenation product and ICX-TRC, a hair regeneration product, as well as annual license fees payable to BioLife.

• Cell Therapeutics Inc., of Seattle, said it gained fast-track designation from the FDA for pixantrone, an anthracenedione being investigated for the treatment of relapsed or refractory indolent non-Hodgkin's lymphoma. In granting fast-track designation, the FDA noted that results from previous studies demonstrated activity. Prior results demonstrated that the addition of pixantrone to a fludarabine/rituximab-based regimen in relapsed or refractory indolent NHL yielded a 70 percent response rate.

• Cryo-Cell International Inc., of Oldsmar, Fla., said it isolated a new type of adult stem cell with potential for treating a range of diseases. The stem cell, called a maternal placental stem cell (MSPC), is taken from the discarded placental tissue immediately after childbirth. Like stem cells recovered from umbilical cord blood, these cells may be collected without any risk to the mother or child. Maternal stem cells have not to date been used in human therapies, though researchers believe they may serve as an alternative to embryonic stem cells in some applications. Cryo-Cell is proceeding with steps to commercialize the service and expects to announce a targeted launch date in the coming months.

• Emergent Technologies Inc., of Austin, Texas, announced the final closing of its $27 million Fund IV, which will be used to commercialize technology from University of Texas System institutions. ETI has launched two biotechnology companies in the last six months: Mimetic Solutions LLC and Beacon Sciences LLC.

• 454 Life Sciences Corp., of Branford, Conn., entered a collaboration with the Malaysian Genomics Resource Centre to apply high-speed DNA sequencing and bioinformatics technologies for the characterization of tropical organisms and diseases. 454 and MGRC will apply the high-throughput Genome Sequencer FLX System to bioinformatics projects in Malaysia. 454, a majority-owned subsidiary of CuraGen Corp., is being acquired by Roche Holdings Inc., of Basel, Switzerland.

• Hunt Biosciences Ltd., of Trondheim, Norway, was launched as the commercial arm of the HUNT Study, a population-based biobank operated as a satellite facility to the Norwegian University of Science and Technology. The Hunt Study offers close to 100,000 genetic samples gathered over 20 years.

• IGI Inc., of Buena, N.J. said it received a Small Business Technology Transfer grant from the National Cancer Institute to evaluate a parathyroid hormone PTH (7-34) analogue to treat alopecia induced by chemotherapy in breast cancer patients. In the initial phase of animal testing, IGI successfully formulated PTH 7-34 into its Novasome encapsulation technology, which stimulated and maintained hair growth in mice. Under the grant, it will formulate a PTH 7-34 Novasome cream and provide clinical samples to Boston University, which will study them in chemotherapy patients.

• Metabolic Research Inc., of Montgomery, Texas, said it secured an exclusive license to technologies relating to the use of fungi, plants and/or animals for the production of anti-inflammatory and analgesic products for treating inflammatory diseases. Worldwide licenses were gained from technology developers David Summers and T.W. Owen in exchange for 2.5 million shares. The company then was restructured, and Summers installed as the new CEO and president and Owen as chief financial officer. They are now the sole members of the board.

• MGI Pharma Inc., of Bloomington, Minn., and Helsinn SA, of Lugano, Switzerland, filed a supplemental new drug application with the FDA for Aloxi (palonosetron hydrochloride) injection for postoperative nausea and vomiting. Aloxi already is approved by the FDA for nausea and vomiting associated with emetogenic cancer chemotherapy.

• Millipore Corp., of Billerica, Mass., and Gen-Probe Inc., of San Diego, said Millipore will market Gen-Probe's Mycoplasma Tissue Culture Non-Isotopic test. The new agreement expands on the companies' existing collaboration, begun in 2005, to create a new generation of nucleic acid tests.

• Omrix Biopharmaceuticals Inc., of New York, filed for approval if its hepatitis B immunoglobulin, HBIG, product in Sweden. It said it anticipates approval of HBIG by the second quarter 2008. HBIG is used to prevent HBV reinfection following liver transplants. The product currently is marketed in Israel.

• Oragenics Inc., of Alachua, Fla., received a warning letter from the American Stock Exchange saying it does not meet certain continued listing standards related to the makeup of its board. Oragenics has until Aug. 2 to regain compliance.

• Proteome Systems Ltd., of Sydney, Australia, entered a licensing and commercialization deal for its Eukarion topical compounds with Minerva Healthcare Inc., a new venture launched by the founders of Impax Laboratories Inc., of Hayward, Calif.; Athena Diagnostics Inc., of Worcester, Mass.; and IVAX Corp., of Miami. PSL has granted an option to license its topical Eukarion compounds to Minerva for development and commercialization subject to Minerva completing an initial fund raising. Under the terms, PSL will receive an up-front license fee of $4 million, along with an undisclosed milestone payment for clinical development, 12 percent royalties on sales and a 10 percent equity stake in Minerva, which plans to focus on drugs and devices for skin conditions.

• Stem Cell Innovations Inc., of Houston, entered an agreement to examine the hepatic metabolism of a set of compounds from Copenhagen, Denmark-based Lundbeck A/S. SCI will use its C3A human liver cell line, originally developed for use in an artificial liver used to support patients waiting for transplantation. Terms were not disclosed.

• Viragen Inc., of Plantation, Fla., said it and the Memorial Sloan-Kettering Cancer Center are ending their collaboration on VG101, a jointly owned humanized antibody being developed for the treatment of Stage IV malignant melanoma. Viragen intends to refocus resources on preclinical studies planned of VG102, a monoclonal antibody for solid tumors, and VG106, an anticancer cytokine. Separately, Viragen and partners from the Roslin Institute and Oxford Biomedica plc, of Oxford, UK, used the OVA avian transgenic manufacturing platform to increase expression levels of interferon alpha-2a by at least 10-fold over previously reported results.

• Vivo Ventures LLC, of Palo Alto, Calif., closed Vivo Ventures Fund VI LP, at $275 million, which brings the firm's funds under management to more than $650 million. The new fund will follow the same general approach as Vivo's prior funds and invest in companies developing and commercializing therapeutic products - drugs and devices for human disease. Since Vivo's inception in 1997, the funds have invested in 50 such companies.

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