• Abraxis BioScience Inc., of Los Angeles, said its hospital-based products business, Abraxis Pharmaceutical Products, received FDA approval of its supplemental new drug application on a new dose of Oxytocin injection. The product is indicated to initiate or improve uterine contractions in labor-related uses.

• Dynavax Technologies Corp., of Berkeley, Calif., said the National Institute of Allergy and Infectious Diseases awarded the firm a two-year $3.25 million grant to continue development of a universal influenza vaccine for controlling seasonal and emerging pandemic flu strains. Research at Dynavax, funded by the National Institutes of Health starting in 2003, focuses on a vaccine that incorporates a second-generation Toll-like receptor 9 agonist and the conserved influenza antigen nucleoprotein. The new grant is directed toward advancing preclinical research into investigational new drug application-enabling studies and product development. With that funding, the company expects to move the program into clinical development next year.

• Encysive Pharmaceuticals Inc., of Houston, filed with the FDA a request for formal dispute resolution to contest the third approvable letter for Thelin. The company originally submitted a new drug application for Thelin in pulmonary arterial hypertension in 2005, and received the third letter from the agency in June stating that the clinical development program did not demonstrate the evidence of efficacy needed for approval. Formal dispute resolution is an FDA process where sponsors can challenge regulatory decisions by bringing the dispute to the attention of agency supervisors. In preparation for the submission, Encysive assembled a team to review the FDA's rationale for withholding approval and to review the statistical analysis plan for the pivotal STRIDE-2 data. If that formal dispute resolution is unsuccessful, the company will be required to conduct an additional pivotal study, which could take two years to complete. (See BioWorld Today, June 19, 2007.)

• GammaCan International Inc., of Kiryat Ono, Israel, said its lead cancer immunotherapy, VitiGam, received orphan drug designation from the FDA for Stage IIb to Stage IV metastatic melanoma. That would give the drug seven years of marketing exclusivity upon approval. The company anticipates filing an investigational new drug application for a Phase I/II trial by the end of the year, with testing to start in early 2008.

• GW Pharmaceuticals plc, of Porton Down, UK, and Bayer Inc., a Toronto-based subsidiary of Bayer AG, said Health Canada approved a new indication for Sativex, a cannabis-derived product delivered through an oral spray. The product was approved in Canada as adjunctive analgesic treatment for persistent background pain in adult patients with advanced cancer who experience moderate to severe pain during the highest tolerated dose of opioid therapy. Sativex was approved in 2005 for treating neuropathic pain in adults with multiple sclerosis. Both approvals carry conditions.

• Lux Biosciences Inc., of Jersey City, N.J., said the FDA granted fast-track designation to LX211, a next-generation calcineurin inhibitor intended to treat non-infectious posterior, intermediate and panuveitis. Fast-track status provides ways to expedite drug development and review and would allow Lux to submit a new drug application for LX211 as a rolling submission. The company began enrolling patients in its pivotal program earlier this year, and pending successful results, could seek regulatory approval for the drug in late 2008. Rights to LX211 in ophthalmic indications were licensed from Isotechnika Inc., of Edmonton, Alberta, which is investing the compound in Phase III trials in psoriasis.

• Meridian Bioscience Inc., of Cincinnati, said wholly owned subsidiary Meridian Life Science Inc. was awarded a five-year contract (base year plus four option years) worth up to $12.2 million by the National Institutes of Allergy and Infectious Diseases. Meridian will manufacture up to 10 clinical experimental vaccines per year at its biopharmaceutical facility in Memphis, Tenn. The contract requires production and safety testing of experimental non-influenza and influenza virus vaccines and other vaccine-related products for use in humans. Meridian will be manufacturing suspensions of viruses that have been shown in vitro and in vivo to be promising candidates for use in vaccination of humans.

• Nanotherapeutics Inc., of Alachua, Fla., entered a two-year Cooperative Research and Development Agreement with the Vaccine Branch of the National Cancer Institute to use its technology to produce HIV peptide oral vaccine nanoparticles. They will use the company's nanoparticle delivery system, which is designed to enable oral targeted delivery of large molecules to the gastrointestinal tract to improve immune response. Terms of the deal were not disclosed.

• OxiGene Inc., of Waltham, Mass., announced the publication of data from a preclinical study of two triple-drug combinations that included its combretastatin A4 phosphate (Zybrestat) product: CA4P, paclitaxel and manumycin A, and CA4P, paclitaxel and carboplatin. Both combinations produced positive antineoplastic activity in mouse xenograft models of anaplastic thyroid cancer using two human ATC cell lines. Results were published in the Journal of Clinical Endocrinology and Metabolism. The vascular disrupting agent is in a 180-patient pivotal trial in that indication.

• PharmAthene Inc., of Annapolis, Md., said its stock resumed trading Tuesday under the original "HAQ" symbol. As of today, the shares will trade on AMEX under the new symbol, "PIP." PharmAthene, which is developing medical countermeasures against biological and chemical threats, earlier this month closed its reverse merger with publicly traded Healthcare Acquisition Corp., of Des Moines, Iowa. (See BioWorld Today, Jan. 23, 2007.)

• Response Genetics Inc., of Los Angeles, plans to work with the University of California in San Francisco to conduct a two-year study of patient outcomes and genetic information with the goal of developing a diagnostic test for pancreatic cancer. UCSF will provide tissue samples while Response Genetics will assume the administrative costs of the study, which will use its technology to extract and analyze genetic information from the samples.

• The Medicines Co., of Parsippany, N.J., submitted a supplemental new drug application to the FDA for thrombin inhibitor Angiomax (bivalirudin) in the immediate treatment of acute coronary syndromes (ACS). The submission is based on data from the ACUITY clinical trial of nearly 14,000 ACS patients, in which the Angiomax group had 50 percent fewer episodes of major bleeding and a mortality rate of 3.8 percent compared to the control group, which had a mortality rate of 4.4 percent. The data also prompted the American College of Cardiology and the American Heart Association to grant Angiomax a Class I recommendation as part of the treatment to be considered for unstable angina and non-ST-elevated myocardial infarction, two common forms of ACS. Angiomax is approved for percutaneous coronary intervention.

• Tripos Discovery Research Ltd., of Richmond, Va., a wholly owned subsidiary within the Commonwealth Biotechnologies Inc. group of companies, secured a milestone payment from Montreal-based Gemin X Biotechnologies Inc., stemming from the companies' January 2006 agreement. It results from the identification of a lead preclinical candidate for a Gemin X program in the study of ligands to prevent a telomeric DNA/protein interaction implicated in cancer.

• VaxGen Inc., of South San Francisco, finalized a material transfer agreement with ImmuneRegen BioSciences Inc., of Scottsdale, Ariz. VaxGen will provide recombinant protective antigen, the active ingredient in its anthrax vaccine, for testing with ImmuneRegen's adjuvant Viprovex. In previous preclinical studies, Viprovex positively impacted survival before and after exposure to anthrax.