• Acusphere Inc., of Watertown, Mass., said its new drug application for Imagify (perflubutaine polymer microspheres for injectable suspension) was accepted for review by the FDA. Imagify is an ultrasound imaging agent for the detection of coronary artery disease. With a standard review, the agency's target action date is Feb. 28, 2009.

• Adventrx Pharmaceuticals Inc., of San Diego, received $600,000 from Research Triangle Park, N.C.-based Theragenex LLC resulting from a dispute regarding Theragenex's alleged breach of contract concerning the license of Adventrx's antiviral, ANX-211. The two companies jointly dismissed all claims.

• Agilent Technologies Inc., of Santa Clara, Calif., said it acquired the Nano instruments business unit of MTS Systems Corp., of Oak Ridge, Tenn. That deal was intended to strengthen Agilent's portfolio of instrumentation for imaging, characterizing and quantifying nanomechanical material properties. Financial terms were not disclosed.

• Anesiva Inc., of South San Francisco, said it launched Zingo (lidocaine hydrochloride monohydrate) powder intradermal injection system approved to treat pain associated with peripheral intravenous line placements and blood draws in children 3 to 18 years of age. The product was approved in August 2007. (See BioWorld Today, Aug. 20, 2007.)

• AtheroGenics Inc., of Atlanta, received notice from Nasdaq that its stock price is below the $1 minimum required for continued listing. The company plans to request a hearing to present its compliance plan.

• Basilea Pharmaceutica Ltd., of Basel, Switzerland, said it has obtained regulatory approval from Health Canada for Zeftera (ceftobiprole), a first-in-class anti-MRSA broad-spectrum cephalosporin, to treat complicated skin and soft tissue infections, including diabetic foot infections. Basilea plans to co-promote the drug in Canada with its partner Janssen-Ortho Inc., of Toronto. Ceftobiprole currently is under review by regulatory authorities in the U.S., the EU, Australia, Russia, South Africa and Switzerland.

• Bavarian Nordic A/S, of Kvistgard, Denmark, filed a patent infringement suit against Oxford, UK-based Oxford Biomedica plc in the U.S. District Court of the Southern District of California. Bavarian Nordic claims that Oxford Biomedica infringed patents relating to its MVA-BN technology by commercializing the technology in ways that have yielded large payments from Paris-based Sanofi-Aventis Group under the TroVax agreement. Oxford Biomedica is developing TroVax immunotherapy in prostate cancer.

• Case Western Reserve University School of Medicine, in Cleveland, in collaboration with Copernicus Therapeutics Inc. and Polygenix Inc., both also of Cleveland, was selected to receive $3.9 million in funding from the Ohio Biomedical Research Commercialization Program. The grant is expected to support preclinical effectiveness and safety studies in support of regulatory filings with the FDA to initiate clinical testing. Research will focus on the areas of cystic fibrosis, retinitis pigmentosa and breast cancer.

• Cellumen Inc., of Pittsburgh, said it has initiated research in collaboration with the FDA's National Center for Toxicology Research that will use Cellumen's CellCiphr toxicity risk-assessment technology to profile blinded samples of known liver toxicity compounds, including both failed and marketed drugs. The NCTR will incorporate the knowledge generated by Cellumen to develop a liver toxicity knowledge base, the firm said. Cellumen will use the profiling data and compound safety data from the collaboration to further develop the diversity in the CellCiphr database and the types of cell panels and to advance the classifier informatics tools.

• DOR BioPharma Inc., of Ewing, N.J., said it has entered into a collaboration with Philadelphia-based Numoda Corp. for its confirmatory Phase III trial of orBec for the treatment of gastrointestinal graft-vs.-host disease. Numoda is guaranteeing the agreed trial budget against cost overruns and will take an equity position in DOR common stock in exchange for a portion of its services

• Durect Corp., of Cupertino, Calif., said the FDA has granted orphan drug designation to Eladur (bupivacaine), a transdermal patch being investigated as a therapy for the relief of persistent pain associated with post-herpetic neuralgia. Results of a 60-patient Phase IIa clinical trial showed that Eladur improved pain control vs. placebo during the three-day continuous treatment period.

• Genmab A/S, of Copenhagen, Denmark, said it reached a development milestone for ofatumumab (HuMax-CD20) under its 2006 collaboration with London-based GlaxoSmithKline plc, triggering a payment of about DKK 29 million (US$6.1 million). That milestone involved treating the first patient in a Phase II study in relapsing-remitting multiple sclerosis. Ofatumumab is a fully human monoclonal antibody designed to target a distinct small loop epitope on the CD20 receptor on the surface on B cells. (See BioWorld Today, Dec. 20, 2006.)

• GlaxoSmithKline plc, of London, said it has responded to the FDA's questions regarding its application for approval of its Cervarix vaccine to prevent cervical cancer. Given that final data from GSK's Phase III pivotal efficacy study, HPV-008, are expected later this year, GSK said it has decided to augment its application for approval with these data. GSK said it anticipates submitting the data in the first half of 2009. FDA action is expected to take up to six months following submission.

• Goodwin Biotechnology Inc., of Plantation, Fla., said it has begun working with Paris-based Areva Inc.'s lead-212 initiative to treat cancer. GBI will manufacture a new conjugated drug that will be radiolabeled by the NCI with lead-212.

• Hana Biosciences, of South San Francisco, said the FDA has granted orphan drug designation to Marqibo (vincristine sulfate injection, Optisome) for the treatment of adult patients with metastatic uveal melanoma. The product currently is in Phase II testing at the University of Texas M.D. Anderson Cancer Center in Houston.

• Ipsogen SA, of Marseille, France, said its JAK2 tests for myeloproliferative disorders received CE marking in Europe, allowing their use beyond research-only purposes. The tests are designed to enable the identification and quantification of JAK2 mutations. Ipsogen licensed the product from INSERM, the French National Health and Medical Research Institute.

• Lung Rx Inc., a wholly owned subsidiary of United Therapeutics Corp., of Silver Spring, Md., said it has submitted a new drug application to the FDA for inhaled formulation of treprostinil for the treatment of pulmonary arterial hypertension. The firm said its NDA is supported by data from TRIUMPH-1, a randomized, double-blind, placebo-controlled 235-patient Phase III study. The company said the pivotal trial was one of the first to assess the incremental benefit of an add-on therapy in PAH patients who already are receiving an approved background therapy.

• MAP Pharmaceuticals Inc., of Mountain View, Calif., presented data from an in vitro study evaluating receptor pharmacology of MAP0004, orally inhaled dihydroergotamine (DHE) for the potential treatment of migraine, compared to intravenous DHE. In the receptor pharmacology study, MAP0004 stimulated receptors that relieve migraine at levels comparable to I.V. DHE, but did not activate receptors associated with side effects frequently seen with I.V. DHE. In addition, MAP0004 did not affect receptors that have a role in regulating pulmonary function. The study results were presented at the American Headache Society Annual Scientific Meeting in Boston.

• NanoViricides Inc., of West Haven, Conn., said Japanese ophthalmologist and corneal researcher Kazuo Tsubota has agreed to perform confirmatory animal efficacy studies of the nanoviricide anti-EKC drug candidate, EKC-Cide, against EKC (epidemic kerato-conjunctivitis) in Japan.

• Oncolin Therapeutics Inc., of Houston, said a team of scientists supported by an Oncolin Sponsored Research Agreement has discovered a new inhibitor of glycolysis, which is superior to the other known inhibitors. Those results were confirmed in both in vitro as well as in vivo brain tumor models. Those new results have demonstrated that the compound that Oncolin in collaboration with the M.D. Anderson Cancer Center are currently developing clearly displays significantly better pharmacokinetics, increased potency and efficacy, the company said.

• Sangamo BioSciences Inc., of Richmond, Calif., published preclinical data in Nature Biotechnology showing that the company's zinc finger DNA-binding protein nucleases permanently modified the CCR5 gene to make human CD4 T-cells resistant to HIV infection. In a second experiment, treatment of HIV-infected mice led to increased numbers of CD4 cells and a statistically significant reduction in viral load (P < 0.001) compared to controls. Sangamo's most advanced zinc finger program is in Phase II for diabetic neuropathy.

• Senetek plc, of Napa, Calif., terminated its marketing agreement for Pyratine-6 with Cranford, N.J.-based Triax Aesthetics LLC. The companies had teamed up in August 2007 to market the second-generation cytokinin dermatology product. Triax returned $1.1 million to Senetek as well as all product inventory and intellectual property.

• Stanford University School of Medicine researchers received approximately $5.6 million from the California Institute for Regenerative Medicine to support creation of new pluripotent human stem cell lines. The awards support two types of research; creation of new human embryonic stem cell lines from excess or discarded early stage human embryos created by in vitro fertilization; and the derivation of new pluripotent human stem cell lines either through a technique called somatic cell nuclear transfer or by modifying neonatal or adult cells to render them pluripotent.