• Amgen Inc., of Thousand Oaks, Calif., said the FDA approved the company's new manufacturing facilities in West Greenwich, R.I., and Juncos, Puerto Rico. The plant in Rhode Island will produce Enbrel (etanercept), which is used to treat moderate to severe rheumatoid arthritis, psoriatic arthritis and moderate to severe plaque psoriasis. The Puerto Rico facility is licensed for commercial bulk manufacturing of Neupogen (filgrastim), which is used to decrease the incidence of chemotherapy-related infections, and Neulasta (pegfilgrastim), which is used to decrease the incidence of neutropenic infections associated with cancer chemotherapy treatments.

• BioCryst Pharmaceuticals Inc., of Birmingham, Ala., filed a shelf registration statement to offer, from time to time, up to $85 million of common stock. Details, including the prices and terms, will be disclosed through a separate prospectus supplement at the time of each offering.

• CellCentric, of Cambridge, UK, received new funding of £150,000 (US$276,569) from the National Endowment for Science, Technology and the Arts. The investment will be used to increase the company's discovery capacity for epigenetic-related cancer targets and therapeutics.

• Chemokine Therapeutics Corp., of Vancouver, British Columbia, discovered another therapeutic application for its chemokine analogue, CTCE-0214. The discovery, which is published in the journal Stem Cells, demonstrated that CTCE-0214 multiplied the number of stem cells and related progenitor-cell subsets from human cord blood through a process called ex vivo expansion.

• CV Therapeutics Inc., of Palo, Alto, Calif., said patients receiving the calcium channel blocker amlodipine plus or minus the angiotensin-converting enzyme inhibitor perindopril experienced a reduction in major cardiovascular endpoints and in all-cause mortality compared to patients receiving the beta-blocker atenolol plus or minus the diuretic bendroflumethiazide. The data were presented at the European Society of Cardiology Congress 2005 in Stockholm, Sweden, and published in The Lancet. CV Therapeutics also presented data in Sweden showing that perindopril improved cardiac function, including left ventricular remodeling, in elderly patients following a heart attack.

• Cytokinetics Inc., of South San Francisco, started a Phase I trial of CK-1827452, a small-molecule activator of cardiac myosin, for heart failure. The trial is a double-blind, randomized, placebo-controlled study in healthy volunteers. It will identify the maximum tolerated dose of a six-hour intravenous infusion and will evaluate the drug's effect on the left ventricular function through serial echocardiograms.

• Encysive Pharmaceuticals, of Houston, presented data on Thelin (sitaxsentan) from its STRIDE clinical trials in pulmonary arterial hypertension at the European Society of Cardiology 2005 Congress in Stockholm, Sweden. The data are under review by European and U.S. regulatory authorities, and the company anticipates commercialization in Europe in 2006.

• Endo Pharmaceuticals Holdings Inc., of Chadds Ford, Pa., filed a shelf registration statement with the SEC providing for the secondary sale, from time to time, of 19 million currently issued and outstanding shares of the company's common stock. Once declared effective, the shelf registration statement would enable one or more offerings of common stock, subject to market conditions. Endo focuses on pain management products.

• Geron Corp., of Menlo Park, Calif., reported publications demonstrating efficacy of GRN163L, its pan-cancer telomerase inhibitor drug, in mouse models of human hepatocellular carcinoma and human metastatic lung cancer. GRN163L is in a Phase I/II trial in patients with chronic lymphocytic leukemia. Additional trials are being planned. The liver cancer study appeared in the current online publication of Hepatology. The second report was published in Cancer Research.

• Hemispherx Biopharma Inc., of Philadelphia, said two new preclinical studies on double-stranded RNA, including Ampligen, suggest a role of dsRNA therapeutics in improving the efficacy of the current standards of care in both influenza prevention and treatment of acute disease. The first preclinical report compared the relative protection conveyed by Tamiflu and Ampligen, alone and in combination, against the avian flu virus. Japanese researchers also have found that dsRNAs increase the effectiveness of influenza vaccine by more than 300 percent and might also convey cross-protection ability against variant viruses.

• Immunomedics Inc., of Morris Plains, N.J., received a letter from the Nasdaq National Market notifying the company that it may remain listed on the stock exchange. Nasdaq decided in June to delist the company's stock because the company's financing in April did not comply with certain rules in which stockholders must approve an issuance of securities equal to 20 percent of the common stock for less than the greater of book or market value of the stock outstanding. Nasdaq's decision is in response to the company's appeal and a majority stockholder approval for the financing.

• Kinex Pharmaceuticals LLC, of Buffalo, N.Y., said KX2-377 was selected as a lead drug candidate for clinical development. The compound is an orally available selective small molecule that inhibits Src kinase phosphorylation, the company said. Src kinase plays a role in tumor growth and metastasis.

• Ligand Pharmaceuticals Inc., of San Diego, reported that the Nasdaq listing qualifications panel has denied the company's request to extend the deadline for the company to come into full compliance with the Nasdaq requirements related to filing of SEC reports and has determined to delist the company's securities effective with the open of business today. The panel did grant the company's request to relist under the Nasdaq National Market maintenance standards for bid price rather than the $5 per share initial listing requirement.

• Pharmos Corp., of Iselin, N.J., initiated a Phase I trial with cannabinor, a CB2-selective synthetic cannabinoid drug candidate. The study will enroll up to 48 healthy male subjects in a randomized, double-blind, placebo-controlled, intravenous, escalating single-dose study. It is expected that the study will be completed and the results analyzed by year-end.

• Solexa Inc., of Hayward, Calif., said its researchers, in collaboration with the Delaware Biotechnology Institute and the University of Delaware, reported the most comprehensive analysis to date of the small RNA component of the transcriptome. The research was published in the Sept. 2, 2005, issue of Science.

• Spectrum Pharmaceuticals Inc., of Irvine, Calif., initiated a new Phase II study of EOquin intravesical instillation in patients with high-risk superficial bladder cancer. The product has shown encouraging activity and safety in superficial bladder cancer in Phase I and Phase II studies performed in 68 patients with multiple, recurrent disease.

• Stem Cell Sciences, of Edinburgh, Scotland, formed a major licensing deal with Deltagen Inc., of Redwood City, Calif., for use of SCS's internal ribosome entry site technology. In addition to an up-front license fee of $1.2 million, the agreement includes royalties based on revenues generated by Deltagen. As part of the deal, SCS will receive genetically engineered mice from Deltagen.

• ViroLogic Inc., of South San Francisco, is changing its name to Monogram Biosciences Inc. The stock now will trade on the Nasdaq National Market under the "MGRM" ticker symbol. The new name reflects the company's commitment to extend its individualized medicine efforts beyond viral diseases and into oncology and other serious diseases. The change also reflects the company's broader technology base and capabilities in the field of molecular diagnostics for cancer, which came from its merger with Aclara Biosciences Inc., of Mountain View, Calif., in December.

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