• Abbott, of Abbott Park, Ill., said its scientists discovered dual-variable domain Ig, a technology that combines the function and specificity of two or more monoclonal antibodies into one molecular entity that demonstrated drug-like properties and manufacturing feasibility. Those molecules allow for the development of individual drug candidates that target multiple disease-causing molecules in various therapeutic categories. Data were published online in Nature Biotechnology.

• Abraxis BioScience Inc., of Los Angeles, and Biocon Ltd., of Bangalore, India, received approval to market Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in India to treat breast cancer. A commercial launch on the Indian market is expected in 2008 following the completion of the appropriate importation certifications. Abraxis and Biocon signed a collaboration deal in August, giving Biocon rights to Abraxane in India, Pakistan, Bangladesh, Sri Lanka, the United Arab Emirates, Saudi Arabia, Kuwait and certain other South Asian and Persian Gulf countries. Meanwhile, Abraxis intends to initiate a worldwide, head-to-head Phase III registration trial comparing weekly Abraxane to Taxotere, administered every three weeks, in first-line metastatic breast cancer, and plans for additional Phase III trials of Abraxane in non-small-cell lung cancer and melanoma. Abraxane is approved for breast cancer in the U.S. and is under review in Europe, Australia, Russia and China. In a separate release Thursday, Abraxis reported that the European Committee for Human Medicinal Products issued a positive opinion recommending approval of Abraxane in Europe for metastatic breast cancer in women who have failed therapy in the first-line setting. A formal decision by European regulators on the drug's marketing application is expected within the next three to four months.

• Acceleron Pharma Inc., of Cambridge, Mass., said preclinical results of ACE-031, its lead product for muscle dystrophy, amyotrophic lateral sclerosis and cancer-related muscle loss, demonstrated its ability to increase muscle mass despite concurrent treatment with glucocorticoids. In the mouse model, treatment with dexamethasone resulted in weight loss and a 5 percent reduction in lean body mass, and treatment with ACE-031 resulted in a 19 percent increase in lean body mass. Combination treatment resulted in an 11 percent increase in lean body mass, showing that ACE-031 was able to offset the muscle loss caused by dexamethasone. Those data were presented at the muscle society meeting in Sicily, Italy.

• BioMerieux, of Marcy l'Etoile, France, received FDA clearance to market Vidas BRAHMS PCT, an in vitro diagnostic test to be used with critically ill patients on their first day of admission to the intensive care unit. The test will aid physicians in assessing a patient's risk for progression to severe sepsis and septic shock.

• Cleveland BioLabs Inc., of Cleveland, completed good manufacturing practices compliant (cGMP) manufacturing of Protectan CBLB502, and the firm is anticipating a contract decision from the Department of Defense later this year. The company submitted CBLB502 to the DoD in response to a request for proposal for medical radiation countermeasures to treat gastrointestinal effects of acute radiation syndrome. The RPF award could provide funding for development through FDA approval, as well as a commitment to purchase up to 500,000 doses, thereafter. The program is undergoing accelerated development under the FDA's two-animal rule, and the company plans to submit an investigational new drug application for human testing this year.

• Critical Outcome Technologies Inc., of London, signed a pilot project agreement with Merck Serono, a division of Darmstadt, Germany-based Merck KGaA, to identify drug development candidates for an undisclosed oncology cellular target. The scope of the project consists of COTI using its technology Chemsas to discover four to six drug candidates built on two to three scaffolds against a specific cellular target chosen by Merck, and Merck will then evaluate the compounds and decide whether to synthesize and test the suitability of the molecules as leads for the target. Financial terms call for Merck Serono to make a project commencement payment to COTI, and additional payments will be earned upon achievement of individual milestones in the preclinical development of drug candidates. Specific terms were not disclosed.

• CSL Biotherapies, of King of Prussia, Pa., started shipment of its influenza virus vaccine in the U.S. for the 2007-2008 season, following expedited approval by the FDA of the inactivated, trivalent vaccine. The company will make about 2 million doses immediately available to the U.S. market.

• Gilead Sciences Inc., of Foster City, Calif., Bristol-Myers Squibb Co., of Princeton, N.J., and Merck & Co. Inc., of Whitehouse Station, N.J., said Atripla, a triple-drug HIV product, received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency. CHMP recommended the drug for treating HIV-1 infection in adults with virologic suppression to HIV-1 RNA levels of less than 50 copies/ml on their current combination antiretroviral therapy for more than three months. The European Commission will review the CHMP's recommendation and is expected to issue its decision toward the end of the year. Atripla, which combines BMS' Sustiva (efavirenz) and Gilead's Emtriva (emtricitabine) and Viread (tenofovir disoproxil fumarate), previously gained approval in the U.S.

• Hemispherx Biopharma Inc., of Philadelphia, said its partner, Japan's National Institute of Infectious Diseases, reported preclinical results showing that intranasal inoculation with the seasonal influenza vaccine plus the Toll-like receptor-3 agonist Ampligen might overcome the problems of a limited supply of H5N1 virus vaccine by providing cross-protection mucosal immunity against H5N1 viruses with pandemic potential. Compared to noninoculated mice, those inoculated intranasally with the trivalent inactivated influenza vaccine licensed to Japan for the 2005-2006 season plus Ampligen manifested cross-reactivity of mucosal IgA and serum IgG with H5N1 virus, indicating cross-protection against varying strains of H5N1. Data were published in The Journal of Infectious Diseases.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., added a new diabetes drug to its pipeline. ISIS 388626, a generation 2.2 antisense drug, targets the sodium-dependent glucose transporter Type 2 (SGLT2) to increase glucose secretion. It's the fourth compound to emerge from the company's metabolic disease drug discovery program. Isis expects ISIS 388626 to advance toward proof-of-concept studies as quickly as possible.

• Ortho-McNeil Inc., of Titusville, N.J., a unit of Johnson & Johnson, said the FDA approved Doribax (doripenem for injection) to treat complicated intra-abdominal and complicated urinary tract infections, including pyelonephritis. In trials, the compound demonstrated activity against a range of Gram-positive and Gram-negative bacteria, including pseudomonas, that cause those infections.

• Pluristem Life Systems Inc., of New York, said results from the Fraunhofer Institute's ongoing in vivo study using the company's PLacenta eXpanded (PLX) showed initial promise as a potential therapy to treat ischemic stroke victims. PLX cells are mesenchymal stem cells obtained from the placenta and expanded using Pluristem's 3D PluriX technology. Scientists at the institute systemically injected the cells into spontaneously hypertensive rats that had undergone middle cerebral artery occlusion, and results from the PLX group showed a significant advantage in functional recovery over a control group that did not receive PLX cells.

• Repros Therapeutics Inc., of The Woodlands, Texas, scheduled a Type B meeting with the FDA for Nov. 30, 2007, to review results from the trials of Proellex conducted to date and to discuss the initiation of Phase III studies. The company plans to pursue two separate indications: as a four-month preoperative treatment for the improvement of the hematologic condition in women with severe menorrhagia, and for chronic management of the symptoms of uterine fibroids. Repros also plans to discuss the potential of conducting studies of the drug in another indication, anemia associated with excessive menstrual bleeding. Proellex is a selective blocker of the progesterone receptor.

• SemBioSys Genetics Inc., of Calgary, Alberta, said it achieved the commercial threshold of apolipoprotein AI (native Apo AI) accumulation in safflower seed. The company reported earlier this year that it had achieved commercially viable levels of the Apo AI (Milano) variant. SemBioSys now intends to complete preclinical work on its safflower-produced Apo AI and anticipates initiating clinical trials in 2009.