• Amgen Inc., of Thousand Oaks, Calif., said that Kepivance (palifermin) received regulatory approval in the European Union. Palifermin is now authorized in the EU to decrease the incidence, duration and severity of oral mucositis in patients with hematologic cancers undergoing myeloablative therapy associated with a high incidence of severe oral mucositis, and requiring autologous blood and bone marrow transplant.

• BrainCells Inc., of San Diego, appointed James Schoeneck as CEO and member of the company's board. Schoeneck previously served as CEO at ActivX Biosciences Inc., of La Jolla, Calif., which was purchased in December 2004 by Tokyo-based Kyorin Pharmaceutical Co. Ltd. Previous CEO Harry Hixson will remain at BrainCells at chairman. BrainCells focuses on developing small-molecule therapeutics to manipulate neurogenesis to treat neuropsychiatric disorders and other central nervous system diseases.

• Cellegy Pharmaceuticals Inc., of Huntingdon Valley, Pa., said that 100 percent enrollment was achieved in the Savvy (C31G vaginal gel) Phase III HIV prevention trial in Ghana based on current projected enrollment. A total of 2,142 subjects are now enrolled in the study in Ghana. Enrollment in the second HIV prevention trial in Nigeria has reached 85 percent of projected enrollment, with more than 1,800 subjects enrolled. Cellegy's stock (NASDAQ:CLGY) rose 15.4 percent, or 16 cents, to close at $1.20.

• CeNeS Pharmaceuticals, of Cambridge, UK, said Molecular Psychiatry published a paper this week that further supports the hypothesis that a catechol-O-methyltransferase (COMT) inhibitor that acts in the brain would be a useful agent to address profound cognitive deficits in schizophrenia and bipolar disorder. CeNeS has an ongoing discovery program to develop novel COMT inhibitors to treat Parkinson's disease.

• Centocor Inc., of Horsham, Pa., permanently discontinued enrollment in its Phase III trial of Reopro (abciximab) for the treatment of acute ischemic stroke, based on a recommendation from the independent safety and efficacy monitoring committee. Enrollment was suspended earlier this month after the committee uncovered an unspecified number of deaths and cerebral hemorrhaging among study patients. Centocor and its partner, Indianapolis-based Eli Lilly and Co. said all outstanding follow-up evaluations and data from patients who have been enrolled will continue to be collected, and general unblinding of the trial will occur once the database is locked, which is expected to occur next year. Reopro is approved as an adjunct to percutaneous coronary intervention (PCI) for the prevention of cardiac ischemic complications in patients undergoing PCI, and in patients with unstable angina not responding to conventional therapy when PCI is planned within 24 hours. (See BioWorld Today, Oct. 5, 2005.)

• ChondroGene Ltd., of Toronto, entered an agreement with the Division of Research of the Permanente Medical Group of Northern California., to jointly develop a research database infrastructure that will be used for genomic research.

• Discovery Laboratories Inc., of Warrington, Pa., received orphan drug designation in the U.S. for its lead product, Surfaxin, to treat bronchopulmonary dysplasia, or chronic lung disease (CLD), in premature infants. The company is conducting a double-blind, controlled Phase II trial that will enroll up to 210 very-low-birth-weight premature infants at risk for developing CLD. The FDA issued an approvable letter for Surfaxin in February for the prevention of respiratory distress syndrome in premature infants.

• Genome Express SA, of Grenoble, France, signed a three-way agreement with two French organizations, the Centre Leon Berard in Lyon and the Centre Jean Perrin in Clermont Ferrand, to conduct the Mutacancer research program. Mutacancer is a regional high-throughput sequencing program involving the mutational analysis of 300 gene candidates in human cancers, and is designed to allow the identification of diagnostic and therapeutic targets while contributing to the understanding of critical molecular mechanisms and events. Mutacancer is supported by Frances' National Cancer Institute.

• Halozyme Therapeutics Inc., of San Diego, initiated patient enrollment for the Chemophase Phase I trial and dosed two patients. Chemophase is a recombinant therapeutic being developed to enhance the delivery of chemotherapy. The initial clinical protocol for Chemophase is designed to evaluate a single intravesical administration of Chemophase along with the widely used anticancer drug mitomycin in patients with superficial bladder cancer.

• Hemosol Corp., of Toronto, laid off about two-thirds of its employees in order to conserve cash and to continue to pursue strategic relationships and various financing options. The company, which develops and manufactures blood-related protein-based therapeutics, requires additional capital early this quarter in order to continue as a going concern. Its stock (NASDAQ:HMSL) dropped 21 percent Friday, or 8 cents, to close at 30 cents.

• Introgen Therapeutics Inc., of Austin, Texas, said data show that the mechanism of action for its mda-7/IL 24-based therapy, INGN 241, inhibits angiogenesis by blocking production of vascular endothelial growth factor protein. Results of the studies, performed by researchers at Introgen and the University of Texas M.D. Anderson Cancer Center, were published in the recent issue of Molecular Therapy.

• Invitrogen Corp., of Carlsbad, Calif., reported earnings that pulled its stock down by more than $7 Friday. The third-quarter numbers included a 15 percent decrease in net income from the same quarter in 2004, which the company said was related to the recent acquisition of Oslo, Norway-based Dynal Biotech. The company reported total revenue of $289.6 million for the three months ending Sept. 30, and posted an earnings-per-share at 42 cents, well below the $307.2 million in revenue and 88 cents per share projected by analysts. Invitrogen's stock was downgraded by William Blair from "outperform" to "market perform." Its shares (NASDAQ:IVGN) fell 12.7 percent Friday, or $9.02, to close at $61.76.

• Nektar Therapeutics, of San Carlos, Calif., said New York-based Pfizer Inc. and Sanofi-Aventis, a member of Paris-based Sanofi-Aventis Group, were notified that the FDA is extending its original review period for Exubera (insulin [rDNA origin] powder for oral inhalation) by three months to review additional technical chemistry data submitted by the companies. The original PDUFA date had been set for late October. An FDA Advisory Committee recommended approval in September for the treatment of adults with Type I and Type II diabetes, though the FDA is not obligated to follow the committee's recommendation. (See BioWorld Today, Sept. 12, 2005.)

• Onyx Pharmaceuticals Inc., of Emeryville, Calif., and Bayer Pharmaceuticals Corp., of West Haven, Conn., reported the selection of Nexavar (sorafenib tosylate) tablets as the global trade name for sorafenib, the oral investigational drug under FDA review for the treatment of advanced renal-cell carcinoma.

• Praecis Pharmaceuticals Inc., of Waltham, Mass., said its stockholders authorized the company's board to implement a reverse stock split at a ratio of 1-for-5, which it expects to take effect after the close of trading Nov. 1. Following the split, the company will have about 10.5 million shares outstanding.

• PrimeGen Biotech LLC, of Irvine, Calif., said it will present results of its research on the therapeutic reprogramming of murine germ-line stem cells at the Keystone Symposium on Stem Cells, Senescence and Cancer being held in Singapore. The data demonstrate that post-natal murine germ-line stem cells, which normally differentiate only into sperm and eggs, can be reprogrammed to be pluripotent. The cells, which PrimeGen has termed PrimeCell, express embryonic stem cell-specific markers and were directed to differentiate into multiple tissue types, including cardiac muscle and neural cell types.

• Schering-Plough Corp., of Kenilworth, N.J., said that following a recommendation from the independent Data Safety Monitoring Board, it discontinued a Phase II study of its CCR5 receptor antagonist, vicriviroc, used in combination with Combivir in treatment-na ve HIV patients. The decision was due to a return of detectable virus in some patients late in therapy compared to the control regimen of Combivir and Sustiva, the current standard-of-care treatment. It was not based on hepatotoxicity or other significant safety issues in the study or in a second Phase II study in treatment-experienced HIV patients, which is continuing.