• Genentech Inc., of South San Francisco; Abbott, of Abbott Park, Ill.; and The Walter and Eliza Hall Institute of Medical Research in Melbourne, Australia, said they are working together in a tripartite research collaboration to discover new cancer drugs. Under the terms, Genentech and Abbott will be responsible for the development, manufacturing and commercialization of potential new drugs, while the discovery stage of the collaboration will involve an integrated approach engaging research sites in South San Francisco, the Chicago area and in Melbourne. Specific financial terms were not disclosed.

• Genmab A/S, of Copenhagen, Denmark, received antitrust clearance under the Hart-Scott-Rodino Act for its agreement to purchase Fremont, Calif.-based PDL BioPharma Inc.'s antibody manufacturing facility in Brooklyn, Minn., for $240 million. That transaction, reported earlier this month, is expected to close at the end of this quarter. (See BioWorld Today, Feb. 22, 2008.)

• Living Cell Technologies Ltd., of Melbourne, Australia, signed a term sheet with the Barbara David Center for Childhood Diabetes to establish a diabetes clinical trial program in Denver. Under the agreement, LCT and BDC collaboratively pursue regulatory approval and then conduct a U.S. trial in Type I diabetes patients with DiabeCell, LCT's encapsulated porcine insulin-producing cells. The study is planned to start in 2009.

• NanoBio Corp., of Ann Arbor, Mich., and the University of Michigan reported results demonstrating that their nasally delivered vaccinia vaccine can protect animals against 77 times the potentially lethal dose of smallpox without the safety risks associated with existing smallpox vaccines. The study in mice shows that NanoBio's killed-virus vaccine elicits an immune response by delivering immune-alerting antigens directly to the lining of the nasal mucosa, where the virus first enters the body. The results were published in the February 2008 issue of Clinical and Vaccine.

• Ortho Biotech Products LP, of Bridgewater, N.J., said it believes that conclusions of a study published in the Journal of the American Medical Association do not provide an accurate reflection of the safety profile of erythropoiesis-stimulating agents (ESAs) when used to treat chemotherapy-induced anemia in cancer patients. The JAMA study, made public Wednesday, asserts that ESA use in cancer patients is associated with an increased risk of venous thromboembolism and death. Researchers identified 51 trials with 13,611 patients to examine survival, and analysis of those data indicated that the risk of death was significantly higher for patients given ESAs vs. placebo. Examining the rate of incidents of venous thromboembolism in 38 trials (8,172 patients), researchers found that was a significantly increased risk (57 percent) of VTE among those treated with ESA (334 events among 4,610 patients) vs. the control group (173 events among 3,562 patients). ESAs have been under fire over the past year on safety concerns, which led to revised labeling and reimbursement issues. Ortho Biotech sells Procrit (epoetin alfa), while Thousand Oaks, Calif.-based Amgen Inc. markets Aranesp (darbepoetin alfa) and Epogen (epoetin alfa).

• Ovation Pharmaceuticals Inc., of Deerfield, Ill., said the FDA accepted for filing its new drug applications for Sabril (vigabatrin) in two types of epilepsies. The agency assigned a priority review for the drug in infantile spasms and will review the submission for refractory complex partial seizures in that same time frame.

• Serenex Inc., of Durham, N.C., signed a clinical trial agreement with the Center for Cancer Research at the National Cancer Institute for conducting a Phase I trial of the company's oral, small-molecule Hsp90 inhibitor, SNX-5422. The study, which will be funded by the NCI, is designed to evaluate the safety, tolerability and pharmacokinetics of the drug, as well as identify efficacy biomarkers.

• Sirion Therapeutics Inc., of Tampa, Fla., said its new drug application for Durezol (difluprednate ophthalmic emulsion) was accepted for filing by the FDA and granted priority review for use as a twice-daily steroid in postoperative ocular inflammation. The FDA issued a PDUFA date of June 26.

• Stem Cell Therapy International Inc., of Tampa, Fla., signed a memorandum of understanding to merge with Histostem Co. Ltd., of Seoul, Korea, subject to further discussions with respect to operational details and the signing of a definitive agreement. The deal is intended to provide Histostem with a U.S. facility and access to U.S. markets, and the Korean company plans to submit its research data, already approved by Korean regulators, to the FDA for umbilical stem cell treatments. To date, Histostem has treated more than 500 patients with stem cells. Financial terms of the agreement were not disclosed.

• Sucampo Pharma Europe Ltd., of Oxford, UK, said it filed a marketing authorization application for lubiprostone in the UK for chronic idiopathic constipation in adults. That product previously gained approval in the U.S. by parent firm Sucampo Pharmaceuticals Inc. and is sold under the brand Amitiza. Lubiprostone is designed to work by selectively activating Type-2 chloride channels in the intestinal lumen, which facilitates intestinal fluid secretion and enhances intestinal motility.

• Veridex LLC, of Raritan, N.J., said the FDA granted an expanded clearance for the CellSearch System as an aid in monitoring metastatic prostate cancer patients. The CellSearch System, already approved for metastatic breast and metastatic colorectal cancer patients, identified as counts circulating tumor cells in a blood sample to predict progression-free survival and overall patient survival.

• ViroPharma Inc., of Exton, Pa., said Vincent J. Milano will succeed Michel de Rosen as president and CEO, effective March 31. Milano, who has served as the firm's chief financial officer and chief operating officer, also was elected to ViroPharma's board. De Rosen will continue as nonexecutive chairman. The company also appointed Daniel B. Soland chief operation officer, also effective March 31.