• AmCyte Inc., of Los Angeles, initiated a Phase I/II trial treating diabetic patients with transplanted replacement islets without long-term immune suppression. The study will evaluate islet transplantation in three patients. Its primary safety endpoint will be measured after six months.

• Amersham plc, of London, signed a deal that expands the scope of its rights, under its existing license, to patents in the DNA microarray patent portfolio of Oxford Gene Technology, of Oxford, UK. The expanded rights give Amersham access to OGT's sequence variation patents as well as core patents relating to analyzing polynucleotide sequences. In addition, Amersham has obtained rights to sublicense the technology in the research and clinical diagnostics markets.

• Bio-Rad Laboratories Inc., of Hercules, Calif., completed its offer to exchange $225 million of its 7.5 percent senior subordinated notes due 2013, which were registered after being issued in a private placement. The aggregate principal amount of the private notes were tendered and received prior to expiration of the exchange.

The Biotechnology Industry Organization in Washington issued a statement in support of the FDA's scientific-risk assessment, which concluded that eating foods from animals that have been cloned is safe for human consumption. The agency's conclusion is consistent with last year's National Academy of Sciences' report on animal-based biotechnology, BIO said.

• Celgene Corp., of Warren, N.J., and the National Cancer Institute in Bethesda, Md., initiated a clinical trial with CC-8490, a new cancer compound from Celgene's class of benzopyrans being evaluated as a potential therapy for brain cancer. Recently, Celgene signed a Cooperative Research and Development Agreement with the institute, a component of the National Institutes of Health, to collaborate on clinical and preclinical development of CC-8490 and other agents that specifically target the destruction of brain cancer cells.

• Elan Corp. plc, of Dublin, Ireland, said the lead manager exercised its option to purchase an additional $60 million of guaranteed convertible notes due 2008 to cover overallotments in connection with the convertible notes offering announced Oct. 29, increasing the size of the issue to $460 million. Elan expects to settle the transaction Nov. 11. Late Thursday, Elan priced an offering of 35 million shares at $4.95 apiece and $400 million in notes, which were priced at par and will pay an annual coupon of 6.5 percent, payable semi-annually in arrears.

• Endovasc Inc., of Montgomery, Texas, said it received encouraging results from in vitro studies conducted at the Department of Cardiovascular Pathology at the Armed Forces Institute of Pathology in Washington. The studies were conducted to determine the effect of Liprostin, prostaglandin E1 (PGE-1) the active agent in Endovasc's PROStent coating for cardiac and peripheral stents, on vascular smooth muscle cells and endothelial cells that comprise the vessel walls of the vascular system. Overall, results support PROStent as an anti-restenosis candidate for future animal testing. Endovasc will evaluate PROStent in animal studies in the spring of 2004, it said.

• Life Science Greenhouse of Central Pennsylvania will partner with Lehigh University in Bethlehem, Pa., on a federally funded program to develop a regional biotechnology research infrastructure and work force. The partnership will be supported by a $1.4 million National Science Foundation grant that was awarded to help give the university's year-old bioengineering program a technical entrepreneurial focus.

• MGI Pharma Inc., of Minneapolis, said the Centers for Medicare and Medicaid Services in Baltimore, Md., qualified Aloxi (palonosetron hydrochloride) injection for pass-through status and assigned it to a Healthcare Common Procedure Coding System, whereby hospitals may obtain reimbursement for Aloxi under the hospital outpatient prospective payment system effective Jan. 1. Aloxi was approved in July for the prevention of acute nausea and vomiting associated with chemotherapy and for the prevention of delayed nausea and vomiting associated with chemotherapy.

• Orchid BioSciences Inc., of Princeton, N.J., signed a definitive agreement to sell the assets of its diagnostics unit for $4.3 million to Tepnel Life Sciences plc, of Manchester, UK. Orchid Diagnostics provides systems, consumables and services for HLA testing for organ transplantation matching, tests for cystic fibrosis genetic screening and certain related support services. Tepnel, which will assume certain of the diagnostics business's liabilities, also will gain control of Orchid's facilities in Stamford, Conn., and Brussels, Belgium, and retain all current diagnostics employees.

• Progen Industries Ltd., of Brisbane, Australia, said the terms of the placement agreement announced on Sept. 18 have been renegotiated. As a consequence of the Nasdaq Biotechnology Index falling by more than 10 percent since signing the agreement, the terms of the placement agreement signed with Taylor Collison Ltd. are no longer valid. Progen and Taylor Collison entered a new unconditional agreement in which 3.8 million shares were placed at $1.40 per share raising a total of $5.3 million. The new funds will be applied to pursue a strategic growth strategy for the company that intends to build a pipeline of drug candidates. The company's PI-88 Phase II trial in multiple myeloma has been concluded with PI-88 meeting the trial efficacy endpoints, it said.

• Qiagen NV, of Venlo, the Netherlands, and Affymetrix Inc., of Santa Clara, Calif., entered a collaboration to optimize Qiagen's siRNA-mediated gene silencing technology using Affymetrix's GeneChip microarray technology. The collaboration aims to develop optimized procedures that can be standardized to analyze gene-silencing effects on a genome-wide basis. Financial terms were not disclosed. Separately, Affymetrix entered a non-exclusive agreement with PreAnalytiX GmbH, a joint venture between Qiagen and Becton, Dickinson and Co., of Franklin Lakes, N.J., to optimize the PreAnalytiX PAXgene Blood RNA System for use with the GeneChip technology to improve gene expression profile results on RNA extracted from whole blood.

• Serono SA, of Geneva, said the European Commission approved its new prefilled syringe for Ovitrelle (choriogonadotropin alfa). Designed to make infertility treatment easier for patients, the new Ovitrelle Solution for Injection is designed to enable patients to administer r-hCG in one step. Ovitrelle is used to promote follicle growth, ovulation and maturation of eggs in the ovaries.

• St. Jude Children's Research Hospital in Memphis, Tenn., said a team of scientists led by St. Jude investigators demonstrated that the p53 gene relies on the PUMA gene to trigger apoptosis. Researchers showed that PUMA is the key gene in that process, despite the large number of genes regulated by p53 that were thought to be involved in cell suicide, it said. Separate researchers from the hospital said data published in the October issue of Blood pointed to their identification of the genetic fingerprints of the major subtypes of pediatric acute lymphoblastic leukemia (ALL). More specifically, they used high-density gene chips to uncover the pediatric ALL genes, of which almost 60 percent were new.

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