• The Chinese State Food and Drug Administration approved a new dosage formulation of EPIAO for anemia associated with chemotherapy by 3SBio Inc., of Shenyang, China. The drug is designed to rapidly restore hemoglobin to normal levels. The approval was based on a clinical trial showing a weekly subcutaneous injection of 36,000 IU EPIAO was similar to administration of 10,000 IU three times a week.

• 4SC AG, Planegg-Martinsried, Germany, received orphan drug designation from the FDA for resminostat in hepatocellular cancer. Resminostat is a pan-histone-deacetylase inhibitor in Phase II trials for advanced HCC, with results expected toward the end of 2011.

• Bluebird Bio, of Cambridge, Mass., exclusively licensed its RMCE technology for making knock-in rodents for laboratory use to GenOway SA, of Lyon, France. Terms were not disclosed. GenOway specializes in genetically modified rodents, while Bluebird is developing gene therapies.

• Amarantus BioSciences Inc., of Sunnyvale, Calif., and Generex Biotechnology Inc., of Toronto, said they selected the development of a MANF-based therapeutic for the treatment of the beta cell destruction at the root of diabetes as the second program in their joint research collaboration disclosed in late May. The first collaboration program involves a MANF-based diagnostic to identify a subpopulation at risk for developing Type I or Type II diabetes.

• AnaptysBio Inc., of San Diego, selected an anti-IL17 monoclonal antibody candidate, ANB004, generated using its SHM-XEL platform. The company's most advanced compound, ANB004 is in development for autoimmune and inflammatory conditions.

• Gilead Sciences Inc., of Foster City, Calif., granted new licensing terms to India-based Hetero Drugs Ltd., Matrix Laboratories Ltd., Ranbaxy Laboratories Ltd. and Strides Arcolab Ltd. for three HIV/AIDS drugs currently in late-stage clinical development. Gilead also entered a licensing agreement with the Medicines Patent Pool Foundation, the first biopharmaceutical company to do so. The licensing terms grant the pool and Gilead's Indian partners future rights to elvitegravir, an integrase inhibitor; cobicistat, an antiretroviral boosting agent; and the "Quad," which combines four Gilead HIV medicines in a once-daily, single-tablet regimen. Gilead licensed rights to commercialize elvitegravir from Japan Tobacco Inc., of Tokyo, which is working with Gilead to ensure future access to elvitegravir in the developing world.

• Hybrigenics SA, of Paris, said preclinical results demonstrated that its inecalcitol was 11 times more potent than calcitriol in inhibiting the growth in vitro of the LNCaP human hormone-dependent prostate cancer cell line. In vivo mice results also showed that inecalcitol, a vitamin D receptor agonist, was 480 times less toxic than calcitriol, the naturally active metabolite of vitamin D. Hybrigenics is developing inecalcitol for the first-line treatment of metastatic hormone-refractory prostate cancer in combination with Taxotere and for treatment of severe psoriasis. The results were published online in the International Journal of Cancer.

• PharmAthene Inc., of Annapolis, Md., demonstrated 36-month stability of its recombinant protective antigen anthrax vaccine, a technical milestone under its Biomedical Advanced Research and Development Authority contract. Stability has historically been a stumbling block for recombinant anthrax vaccine programs, the company said. (See BioWorld Today, Feb. 24, 2010.)

• PharmaVentures Ltd., of Oxford, UK, has been engaged by Avexa Ltd., of Melbourne, Australia, to find a licensing partner for apricitabine, a product in development for HIV.

• Stem Cell Therapeutics Corp., of Calgary, Alberta, presented preclinical data showing that its NTx-428 regimen, comprising treatment with human chorionic gonadotropin followed by erythropoietin, significantly decreased brain matter loss and improved functional recovery of symptoms in a rodent model of fluid percussion injury. Researchers also observed a significant increase in cell count number in the dentate gyrus region and specifically CA3 neuron population. Data were presented at the National Neurotrauma Symposium in Hollywood, Fla.

• Under a new licensing agreement between the two companies, Zogenix Inc., of San Diego, will undertake clinical development and commercialization of a long-acting, injectable formulation of risperidone using technology developed by Durect Corp., of Cupertino, Calif. Zogenix expects to begin clinical studies of the resulting product candidate, Relday, in patients with schizophrenia in early 2012.