• Advanced Cell Technology Inc., of Los Angeles, has completed discussions with the FDA regarding its retinal pigmented epithelial (RPE) cell therapy through a type B, pre-investigational new drug meeting concerning the regulatory pathway and requirements to file an IND to initiate human clinical trials. ACT is working to bring its RPE cell therapy into human clinical trials for the treatment of retinal degenerative diseases such as retinitis pigmentosa, stargardt's disease and dry age-related macular degeneration. Next will be several safety studies. Pilot studies to date have shown the cells to be safe, well tolerated and nonmigratory.

• Alchemia Ltd., of Brisbane, Australia, said it had reached an agreement with FDA on the HA-irinotecan clinical development program following a pre-investigational new drug meeting. The agency agreed on a pivotal trial design, and the company said it will file an IND application to begin the trial soon. The proposed study will enroll about 400 patients with metastatic colorectal cancer who have failed previous treatments.

• AlgoNomics NV, of Gent, Belgium, has entered into a research collaboration with Genmab A/S, of Copenhagen, Denmark, in which AlgoNomics will use its antibody structure database and Tripole technology to aid Genmab in research related to the structural analysis of Genmab's proprietary antibody scaffolds, including the UniBody technology. Financial terms were not disclosed.

• EPIX Pharmaceuticals Inc., of Lexington, Mass., has reached agreement with the FDA on its proposal for the re-read of images of its novel blood pool magnetic resonance angiographic agent, Vasovist (gadofosveset trisodium). EPIX has been notified by the agency that the jointly agreed-upon protocol design and statistical analysis plan adequately address the objectives necessary to support the resubmission of the new drug application for Vasovist.

• The FDA Friday issued an alert about an increased risk of suicidal thoughts and behaviors, or suicidality, associated with certain drugs used to control epileptic seizures, bipolar disorder, migraine headaches and other conditions. An analysis of 11 antiepileptic drugs showed that patients taking those medications have about twice the risk of suicidality, 0.43 percent, compared with patients receiving placebo, 0.22 percent. For about every 1,000 patients, about two more in the drug-treated group experienced suicidality than in the placebo groups. The drugs in the alert include carbamazepine, felbamate, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine, topiramate, valproate and zonisamide.

• Genzyme Corp., of Cambridge, Mass., and Isis Pharmaceuticals Inc., of Carlsbad, Calif., received clearance under the Hart-Scott-Rodino Antitrust Improvements Act for their collaboration announced Jan. 7. Based on the approval, Genzyme will pay Isis $150 million to purchase 5 million shares of Isis common stock for $30 per share. Upon completion of final contracts, Genzyme will pay Isis an additional up-front cash payment of $175 million for the exclusive licensing of mipomersen. (See BioWorld Today, Jan. 9, 2008.)

• Liponex Inc., of Ottawa, Quebec, said it was notified that the TSX is reviewing the eligibility of the common shares of Liponex for continued listing because the market value has been less than $3 million for 30 consecutive trading days. The company has until May 29 to regain compliance.

• Paladin Labs Inc., of Montreal, and its parent company Nycomed, of Zurich, Switzerland, have entered into a Canadian co-promotion agreement for Tridural once-daily tramadol. Paladin acquired the Canadian license to Tridural from Labopharm Inc. last July and launched the drug in September. Under that agreement, Nycomed Canada will share brand responsibilities and expenses with Paladin and will deploy a sales force to promote the product. Paladin will continue to handle distribution and will continue promoting it using its primary care sales force.

• Vyteris, of Fair Lawn, N.J., said it will redirect its business to focus on the development of peptide delivery using its Smart Patch technology, a process that will include the layoff of 32 employees. The decision follows a Phase I clinical trial demonstrating that the transdermal technology delivered a peptide molecule in humans without the use of needles. The company said it will de-emphasize its LidoSite marketing efforts, and the layoffs and other spending reductions will significantly reduce its cash burn.