• Alpha Innotech Corp., of San Leandro, Calif., entered a license and supply agreement with UK-based GE Healthcare to develop, manufacture and supply a line of imaging systems to GE. The products will be sold exclusively worldwide under the GE brand in the life science research market.

• Amgen Inc., of Thousand Oaks, Calif., plans to initiate a Phase III trial to evaluate the effect of anemia treatment with Aranesp (darbepoetin alfa) on morbidity and mortality in patients with heart failure. Studies have demonstrated that lower hemoglobin values are associated with increased hospitalizations and mortality in heart failure patients. Results from Amgen's Phase II pilot studies of anemia in heart failure will be released in early 2006. Aranesp was approved by the FDA in September 2001 for the treatment of anemia associated with chronic renal failure.

• Applied Biosystems, of Foster City, Calif., said a U.S. District Court recently issued a permanent injunction against Bio-Rad Laboratories Inc., of Hercules, Calif., and MJ Research Inc., an affiliate of Bio-Rad. This injunction prohibits Bio-Rad and MJ Research from making or selling infringing thermal cycler products in the U.S. that are capable of performing PCR (polymerase chain reaction) methods. The injunction further prohibits the two companies from servicing, repairing, advertising, instructing or otherwise promoting the use of these items with PCR. An enabling technology for research, PCR is a process in which a segment of a nucleic acid is copied and amplified so that it can be more readily analyzed.

• Genentech Inc., of South San Francisco, and the FDA updated cardiotoxicity information related to the use of Herceptin (trastuzumab). The additional notice follows several similar announcements in recent months, as the FDA has focused on drug safety. The latest stems from findings from a randomized Phase III trial called the National Surgical Adjuvant Breast and Bowel Project that was conducted in 2,043 women with operable, HER2-overexpressing breast cancer (IHC 3+ or FISH+). Preliminary analysis of safety data from that study and another of the North Central Cancer Treatment Group revealed a significant increase in the three-year cumulative incidence of New York Heart Association Class III and IV congestive heart failure and cardiac death in patients who were randomized to the Herceptin-containing arm (4.1 percent) as compared to patients who received chemotherapy alone (0.8 percent). Final analysis of both studies is ongoing.

• Immucor Inc., of Norcross, Ga., and some of its officials are accused of misrepresenting financial health to stockholders in a class-action securities lawsuit filed in U.S. District Court. The lawsuit alleges the fraud became known Aug. 26 when Immucor announced the SEC had launched an investigation into payments made by its Italian unit and its president, Gioacchino De Chirico, to a physician connected to a hospital with which the company was doing business. The company said the issue with the Italian subsidiary was "an isolated event" and was rectified, but the lawsuit alleges otherwise. After the market closed on Aug. 29, Immucor announced its chief financial officer had resigned and that it would be revising previously issued results for two quarters to account for an unrecorded employee bonus. It also would not file its Form 10-K on time due to additional accounting, auditing and Sarbanes Oxley Section 404 procedures related to the bonus for the fiscal year ended May 31 and it is now subject to having its common stock delisted from Nasdaq. Immucor said it intends to request a hearing before a Nasdaq Listing Qualifications Panel to stay the delisting pending a decision from the panel. Immucor manufactures and sells reagents and automated systems.

• ImmuneRegen BioSciences, of Scottsdale, Ariz., is launching the Coalition for Countermeasures, a group of biodefense and homeland security companies formed to provide support and education for small companies that develop countermeasures for the biodefense and homeland security fields. The CFC also will look for ways to eliminate the gap between seeking federal approval and reaching market by supporting the lobbying for the Bioshield II legislation. ImmuneRegen Biosciences is a wholly owned subsidiary of IR BioSciences Holdings Inc. and is developing Homspera and its derivatives as countermeasures for multiple homeland security threats.

• Innate Pharma SAS, of Marseille, France, received ISO9001:2000 certification for its research and development activity in immunotherapy. Innate Pharma specializes in cancer immuno-therapeutics and had developed immuno-modulating agents targeting non-conventional lymphocytes. It has two products in Phase I development in cancer.

• Novagen Ltd., of Sydney, Australia, expanded its U.S. subsidiary, Glycotex Inc., a business based on the development of wound-healing glucan compounds. The intellectual property used by Glycotex was developed by Graham Kelly, who agreed to step down from Novagen's board to focus on the development and expansion of the subsidiary.

• SibTech Inc., of Newington, Conn., launched a targeted contrast agent, VEGF/Cy for in vivo imaging of vascular endothelial growth factor receptors. Those receptors are molecular markers of angiogenesis. SibTech said that VEGF/Cy is the first commercially available targeted contrast agent for in vivo VEGFR imaging.

• Solbec Pharmaceuticals, of Perth, Australia, said it was successful in securing an industry collaboration scheme grant from Edith Cowan University in Perth to identify a specific melanoma gene and allow for the potential development of a melanoma diagnostic test. The hoped-for outcome is a diagnostic test which can be used to determine the stage and progression of the melanoma.

• Targeted Genetics Corp., of Seattle, agreed to restructure its $10.7 million payment debt to Cambridge, Mass.-based Biogen Idec Inc., due over the next year. Under the amended agreement, Targeted Genetics paid $2.5 million of the outstanding debt on Sept. 1, and agreed to make an additional payment of about $3.1 million in August 2007 and two payments of $2.5 million for the next two years. Targeted Genetics also granted Biogen Idec a right of co-sale in certain equity financings approved by its board before Nov. 30.

• VaxGen Inc., of Brisbane, Calif., said a study published in the September issue of Virology provides data showing that a single dose of its smallpox vaccine candidate, LC16m8, gives mice 100 percent protection from vaccinia, a relative of the smallpox virus. The purpose of the study was to compare the efficacy of LC16m8 with that of its parent, the Lister strain of vaccinia.

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