• Abraxis BioScience Inc., of Los Angeles, said the European Medicines Agency accepted for review the company's application for Abraxane for injectable suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) for the treatment of breast cancer. The company also said it is looking for a global commercialization partner.

• AMDL Inc., of Tustin, Calif., said the acquisition of Jade Pharmaceutical Inc. and its two wholly owned China based subsidiaries closed for an aggregate of about 2.7 million post-reverse split (13.7 million pre-reverse split) shares of AMDL. The acquisition was closed Sept. 28, immediately after the filing of a certificate of amendment to AMDL's certificate of incorporation increasing AMDL's authorized common stock and reverse splitting the outstanding shares of common stock.

• Asklepios Biopharmaceutical Inc., of Chapel Hill, N.C., entered a cross-license agreement with GlaxoSmithKline plc, of London, to develop and commercialize gene therapy-based treatments. Asklepios will gain exclusive access to selected recombinant adeno-associated virus vector serotypes that GSK licensed from the University of Pennsylvania for the treatment of three orphan drug indications, including muscular dystrophy, heart failure suffered by muscular dystrophy patients, and hemophilia B. Other terms of the agreement, including the technology licensed to GSK and the monetary terms, were not disclosed.

• Celera Genomics Group, of Rockville, Md., said findings published in the online edition of Arteriosclerosis, Thrombosis and Vascular Biology described a genetic polymorphism in the gene encoding the myeloid IgA Fc receptor, the FCAR Asp92Asn polymorphism, associated with increased risk for myocardial infarction and coronary heart disease. The risk of coronary events associated with the FCAR Asp92Asn polymorphism was independent of other known risk factors in two studies, but such increased risks could be significantly reduced in treatment with Pravachol (pravastatin, Bristol-Myers Squibb Co.).

• Discovery Laboratories Inc., of Warrington, Pa., filed a briefing package and requested a meeting with the FDA to gain the agency's agreement on the appropriate path toward Surfaxin (lucinactant) approval for the prevention of respiratory distress syndrome in premature infants. The package covers certain key chemistry, manufacturing and controls matters in the April 2006 Surfaxin approvable letter from the FDA, and details the firm's investigation and remediation of the process validation failure. Discovery expects to meet with the FDA in the fourth quarter. The firm's stock (NASDAQ:DSCO) closed Thursday at $2.10, up 14 cents. (See BioWorld Today, April 26, 2006.)

• Exelixis Inc., of South San Francisco, is offering to sell 9 million shares of its common stock pursuant to a shelf registration statement. Exelixis also intends to grant the underwriters a 30-day option to purchase up to about 1.4 million shares to cover overallotments, if any. The company's stock (NASAQ:EXEL) closed at $8.99 Thursday, down 6 cents.

• Immunicon Corp., of Huntingdon Valley, Pa., entered two agreements with MolMed SpA, of Milan, Italy. The first agreement funds work to develop a biomarker for tumor endothelial cells. In the second agreement, Immunicon will perform analysis of circulating tumor cells and circulating endothelial cell in a Phase I dose-escalation trial designed to assess safety of a MolMed agent. Planning is under way for the Phase II extension of that trial.

• Neurochem International Ltd., of Ecublens, Switzerland, said European regulators accepted its submission to market Kiacta (eprodisate, formerly Fibrillex) in that territory. The company is seeking approval for the treatment of amyloid A amyloidosis.

• Pharmacopeia Drug Discovery Inc., of Princeton, N.J., agreed to extend its collaboration with Schering-Plough Corp., of Kenilworth, N.J., until April 2007. The terms of the extension call for Schering-Plough to continue to pay Pharmacopeia research funding for 10 full-time chemistry employees until April 2007 and, as before, to pay pre-clinical, clinical and regulatory milestones. Further, Pharmacopeia will be entitled to receive royalty payments. The goal of the collaboration is to deliver development-ready therapeutic candidates for the Schering-Plough pipeline.

• Speedel Group AG, of Basel, Switzerland, said Novartis AG, also of Basel, announced the second regulatory submission of SPP100 (aliskiren, Rasilez). The European Medicines Agency has accepted for review Novartis' submission for SPP100 as a treatment for hypertension both as monotherapy and in co-administration with other anti-hypertensives. The submission includes data from more than 7,800 high blood pressure patients.

• Threshold Pharmaceuticals Inc., of Redwood City, Calif., said the FDA granted orphan drug designation for glufosfamide, for the treatment of pancreatic cancer. Last month the company completed enrollment in a pivotal Phase III trial evaluating glufosfamide for the potential second-line treatment of pancreatic cancer and a Phase II trial evaluating glufosfamide in combination with gemcitabine for the potential first-line treatment of pancreatic cancer.

• XOMA Ltd., of Berkeley, Calif., and AVEO Pharmaceuticals Inc., of Cambridge, Mass., announced a $6 million agreement under which XOMA will manufacture and supply AV-299, AVEO's anti-HGF antibody, in support of early clinical trials. The companies also announced that XOMA has completed the Human Engineering of AV-299. The agreement further strengthens the collaboration between the companies that began with the humanization of AV-299.

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