• AcelRx Pharmaceuticals Inc. of Redwood City, Calif. completed an end-of-Phase II meeting with the FDA regarding its breakthrough pain management therapy for opioid-tolerant cancer patients, ARX-02. The FDA provided guidance on Phase III program design and NDA requirements.

• Benitec Ltd., of Melbourne, Australia, commenced a research and development program for an expressed RNAi product for chronic intractable pain associated with diseases such as cancer and HIV, or neuropathic pain. There currently is no treatment to prevent the development of neuropathic pain, nor to adequately, predictably and specifically control established neuropathic pain.

• The Biomedical Advanced Research and Development Authority (BARDA) is providing three sets of grants totaling $10.4 million to help the World Health Organization (WHO) to assist developing countries with pandemic influenza vaccine manufacturing infrastructure, training on influenza vaccine manufacturing, and development and distribution of certain technologies for pandemic influenza vaccines. As part of an ongoing international cooperative agreement in the Initiative for Vaccine Research, BARDA awarded a $6.4 million grant to the WHO. The funds will support requests from developing countries to expand regulatory systems, construct and validate vaccine manufacturing facilities, and transfer new technology for recombinant or cell-based influenza vaccines.

• Irvine, Calif.-based Cortex Pharmaceuticals Inc. regained worldwide rights to develop and commercialize its ampakine compounds for schizophrenia and depression. The compounds resulted from a 1999 research collaboration with NV Organon, which gave Organon exclusive, worldwide rights to the drug. Pursuant to acquisition by Merck & Co. Inc., of Whitehouse Station, N.J., and a subsequent reorganization process, Merck has discontinued development of Ampakine, allowing Cortex to regain the rights.

• Embera NeuroTherapeutics Inc., of Shreveport, La., said that the Louisiana State University Health Sciences Center has received a $3.9 million grant from the National Institute on Drug Abuse to fund the next stages of development of EMB-001 for cocaine dependence. In addition, the money will be used to support the clinical development of EMB-001 for smoking cessation.

• Emergent BioSolutions Inc., of Rockville, Md., said that its anthrax monoclonal antibody development program investigating AVP-21D9 for inhalational anthrax has been granted fast-track status by the FDA. Emergent recently commenced a Phase I trial for AVP-21D9, a fully human monoclonal antibody product candidate for treating symptoms of inhaled anthrax. Emergent's Phase I trial, which involves 50 healthy volunteers, is a dose-escalation study designed to evaluate the safety and pharmacokinetics of the monoclonal antibody candidate.

• Intra-Cellular Therapies Inc., of New York, reported results from studies demonstrating the anti-Parkinson and other beneficial effects of ITI-002 (IC200214), a phosphodiesterase type I inhibitor. The preclinical data, presented at the World Parkinson Congress in Glasgow, Scotland, showed that ITI-002 was effective in improving motor and nonmotor behaviors relevant to the treatment of Parkinson's disease. In preclinical models of PD, ITI-002 was shown to restore normal motor function when given in combination with L-DOPA (Levodopa). In other preclinical models, ITI-002 was shown to improve cognitive performance and to increase daytime wakefulness without causing psychomotor stimulation.

• Juvaris BioTherapeutics Inc., of Burlingame, Calif., published preclinical data showing that JVRS-100 increased survival in acute myelogenous leukemia, with benefits retained after the end of treatment. The data were published in Cancer Biology & Therapy. JVRS-100 is a cationic lipid-DNA complex immunotherapy currently in Phase I trials for leukemia.

• Medicago USA Inc., a wholly owned subsidiary of Medicago Inc., of Quebec City, broke ground last week on its virus-like particle plant-based commercial grade vaccine facility in Research Triangle Park, N.C., which is targeted to produce 10 million doses of pandemic influenza vaccine per month, and on an annual basis, produce 40 million doses of seasonal Influenza vaccine or 120 million doses of pandemic influenza vaccine.

• Noven Pharmaceuticals Inc., of Miami, completed its acquisition of global rights to Daytrana (methylphenidate transdermal system) from affiliates of Basingstoke, UK-based Shire plc. Terms were not disclosed. Daytrana originally was licensed to Shire in 2003 and was launched in the U.S. in 2006 for attention deficit hyperactivity disorder. Shire's net sales for the first half of the year totaled $34.7 million.

• PharmaMar SA, a subsidiary of Grupo Zeltia SA, of Madrid, Spain, and its partner, Centocor Ortho Biotech Products LP, of Horsham, Pa., a Johnson & Johnson company, said Yondelis (trabectedin), a tris tetrahydroisoquinoline alkaloid, was approved in combination with pegylated liposomal doxorubicin hydrochloride for the treatment of patients with platinum-sensitive ovarian cancer in Brazil, India and Argentina.

• SemBioSys Genetics Inc., of Calgary, Alberta, said that it has retained Deloitte & Touche Corporate Finance Canada Inc. to advise the company on potential strategic alternatives. Last year, SemBioSys worked successfully with Deloitte in the sale of other strategic assets as a source of funding. SemBioSys has re-engaged Deloitte on a broader strategic mandate, including a sale or merger, a partnering transaction for either its biosimilar insulin or Apo cardiovascular program, an asset sale, a refinancing in connection with a significant restructuring or a winddown of the company's business. The company also is working with a Canadian investment bank on a regional partnering and financing strategy.