• Amgen Inc., of Thousand Oaks, Calif., and Johnson & Johnson, of New Brunswick, N.J., could be asked to conduct clinical safety studies of their erythropoiesis-stimulating agents (ESAs) Aranesp, Epogen and Procrit, according to an FDA briefing document. On Thursday, the Oncologic Drugs Advisory Committee will meet on risks associated with the red blood cell boosters, such as possible tumor promotion or cardiovascular problems. In the briefing document released ahead of the meeting, agency reviewers said there is no evidence that ESAs improve quality of life or cancer outcomes, and therefore many more patients are exposed to ESA risks than receive benefits from fewer transfusions. In addition, they said there are insufficient data from adequate and well-controlled studies to assess effects on survival or tumor promotion employing recommended ESA doses, so the agency is asking its advisers whether any additional safety information should be obtained. Some analysts believe this continuing hubbub could further hurt sales of the billion-dollar products, while others view recent label changes that added black box warnings to the ESAs as the FDA's final line in the sand.

• CellCyte Genetics Corp., of Kirkland, Wash., selected an unnamed supplier to produce its lead compound, CCG-TH30, for initial clinical trials. CCG-TH30 is designed to deliver and retain stem cells in the heart, and CellCyte is collecting toxicology and preclinical data to support a Phase Ia trial.

• Chembio Diagnostics Inc., of Medford, N.Y., and Avago Technologies Inc., of San Jose, Calif., signed a letter of intent to enter into a collaboration that would integrate Chembio's DPP technology and assay development expertise with Avago's opto-electronic measurement technology. The parties intend to develop rapid point-of-care diagnostic systems, with the first focus on various HIV test prototypes, which would employ Chembio's DPP technology that would be developed with third parties pursuant to their specifications. Financial terms were not disclosed.

• Entelos Inc., of Foster City, Calif., entered a strategic alliance with Jubilant Biosys Ltd., a subsidiary of Jubilant Organosys, of Bangalore, India. The companies will jointly develop and provide drug discovery and development services, including predictive biosimulation, preclinical and clinical testing, drug formulation, manufacturing and supply. The companies also plan to build a portfolio of drug candidates together.

• 4SC AG, of Martinsried, Germany, said it and the Institute for Molecular Virology at the University of Munster were able to show that mice infected with highly pathogenic bird flu viruses can be healed effectively using 4SC's SC75741 drug candidate. SC75741 was as part of 4SC's NFkB project. It is designed to prevent multiplication of influenza viruses. 4SC said it is holding initial talks with possible development partners from the pharmaceutical industry.

• Invitrogen Corp., of San Diego, and Cytori Therapeutics Inc., of Carlsbad, Calif., entered into a global strategic supply and commercialization agreement to offer adipose-derived stem cell-based research products to life science researchers. Invitrogen will offer Cytori's stem cell products to broaden the understanding of adult stem cells and to discover and accelerate development of preclinical applications for adipose-derived stem cells. Financial terms were not disclosed.

• Syngenta Seeds Inc., of Golden Valley, Minn., entered an agreement under which BioTrove Inc., of Woburn, Mass., will supply genomics technology to accelerate Syngenta's research and development and breeding programs across all its seeds businesses. Syngenta gains access to the OpenArray system, which is used for conducting genotyping analyses in a microarray format. Terms of the agreement were not disclosed.

• VASTox plc, of Oxford, UK, selected VOX C1100 as the lead candidate within its Duchenne muscular dystrophy drug discovery program. The small molecule is designed to compensate for low levels of dystrophin by increasing levels of a similar protein called utrophin. VASTox expects to submit an investigational new drug application for VOX C1100 by mid-2008 and begin clinical trials in the second half of 2008.

• Viragen Inc., of Plantation, Fla., said results from a sponsored in vitro study conducted at Umea University in Sweden showed that Multiferon (multisubtype, human alpha interferon) suppressed development of resistant human melanoma clones to a far greater degree than recombinant alpha interferon (Intron, Schering-Plough Corp.). Results suggested that the mixture of six human alpha subtypes present in Multiferon (a1, a2, a8, a10, a14, a21) provides distinct benefits vs. other alpha interferon products in vitro with respect to reducing the number of resistant clones. The study has been accepted for publication in AntiCancer Research, International Journal of Cancer Research and Treatment. In February 2006, Multiferon was approved in Sweden for the first-line adjuvant treatment of high-risk malignant melanoma. Viragen is preparing to proceed with a European Union regulatory filing.