• Advanced Cell Technology Inc., of Worcester, Mass., said it developed five human embryonic stem cells lines without the destruction of embryos. Its method, as published in Cell Stem Cells, calls for single cells to be removed from embryos using a technique similar to preimplantation genetic diagnosis, and then cultured using a methodology designed to recreate the optimal development environment. Results demonstrated substantially improved efficiency in deriving stem cells to rates comparable to using the traditional approach of deriving stem cells from the inner cell mass of a whole blastocyst-stage embryo and showed that the stem cells were genetically normal and differentiated into cell types of all three germ layers of the body.

• Affymetrix Inc., of Santa Clara, Calif., and Illumina Inc., of San Diego, agreed to settle their patent litigation. Illumina will pay Affymetrix $90 million without admitting liability, in exchange for which Affymetrix will dismiss its lawsuits and limit future lawsuits. Affymetrix had filed suit against Illumina in 2004 for infringement of patents relating to arrays, software and hardware. The settlement also calls for Illumina to dismiss its counterclaims. Shares of Affymetrix (NASDAQ:AFFX) fell $1.14, or 4.8 percent, to close at $22.62 on Thursday, while shares of Illumina (NASDAQ:ILMN) gained $9.57, or 15.8 percent, to close at $70.02.

• Amarillo Biosciences Inc., of Amarillo, Texas, raised $1 million through the private placement of convertible preferred shares with Firebird Management LLC. Firebird bought 1,000 Series A shares that are convertible into 4 million common shares at a price of 30 cents per share, a discount to Amarillo's (OTC BB:AMAR) Wednesday closing price of 35 cents per share. Proceeds will be used for ongoing Phase II trials of Amarillo's low-dose oral interferon-alpha.

• Avant Immunotherapeutics Inc., of Needham, Mass., said it has been notified by Nasdaq that the company failed to regain compliance with the minimum bid price requirement of $1 per share for continued listing and is subject to delisting. In response, the company said it expects to execute a reverse stock split in connection with its pending merger with Celldex Therapeutics Inc., of Phillipsburg, N.J. (See BioWorld Today, Oct. 23, 2007.)

• Basilea Pharmaceutica Ltd., of Basel, Switzerland, said its ceftobiprole was assigned a review by the FDA's Anti-Infective Drug Advisory Committee for Feb. 28. The company previously submitted a new drug application for ceftobiprole, a broad-spectrum cephalosporin, in complicated skin and skin structure infections, including diabetic foot infections. Ceftobiprole is partnered with Johnson & Johnson Pharmaceuticals Research and Development LLC, a subsidiary of New Brunswick, N.J.-based Johnson & Johnson.

• BioCurex, of Richmond, British Columbia, has signed a licensing agreement with Inverness Medical Innovations Inc., of Waltham, Mass., giving Inverness semi-exclusive global rights to commercialize products using the BioCurex-discovered RECAF blood tests for cancer detection. BioCurex will be paid up-front fees, product and development milestones plus royalties on product sales. Inverness will handle FDA approvals, manufacturing, marketing and distributing for clinical laboratory testing. Financial terms were not disclosed.

• BioDelivery Sciences International Inc., of Raleigh, N.C., said the FDA accepted for filing its new drug application for BEMA Fentanyl, which was submitted Oct. 31, for the management of breakthrough cancer pain in opioid-tolerant patients. A final decision is expected by the FDA in August. The product is partnered with Meda AB, of Solna, Sweden, which, under the terms of the companies' September agreement, is expected to pay BDSI milestone payments totaling $30 million upon approval, plus royalties on product sales. (See BioWorld Today, Sept. 6, 2007.)

• CSL Ltd., of Melbourne, Australia, hired contract manufacturing firm Celltrion Inc., of Incheon, South Korea, to supply the monoclonal antibody CSL 360, which is undergoing a Phase I trial for acute myeloid leukemia.

• GTC Biotherapeutics Inc., of Framingham, Mass., and LFB Biotechnologies, a wholly owned subsidiary of LFB SA, of Paris, expanded their collaboration to develop recombinant plasma proteins and monoclonal antibodies using GTC's transgenic production platform. The companies had agreed in 2006 to collaborate on recombinant Factor VIIa and now have added a program for recombinant Factor IX. Both companies will share costs and profits, with LFB funding a $500,000 license fee payment due to ProGenetics LLC in the second quarter of 2008. GTC will get North American rights while LFB receives European and Japanese rights.

• Noven Pharmaceuticals Inc., of Miami, said it received an FDA warning letter related to a prior on-site inspection of the company's manufacturing facility. Following the inspection, which concluded in early July, the agency observed difficulties experienced by some patients in removing the release liner of the Daytrana transdermal system, and Noven submitted a response to those concerns at that time. The FDA's warning letter cites current good manufacturing practice deficiencies related to peel force specifications for removal of the liner and data supporting the peel force characteristics of Daytrana's enhanced release liner throughout the product's shelf life. The letter does not restrict production or shipment of Daytrana, though it does ask for additional information and instructs the company to address those concerns.

• OccuLogix Inc., of Toronto, has suspended indefinitely its RHEO System clinical development program in age-related macular degeneration, is selling its SOLX Inc. subsidiary and has ended or will soon end the employment of seven company vice presidents. Gone are the vice presidents of operations, science and technology, marketing, sales, and medical and scientific development. Leaving Jan. 31 will be the vice presidents of clinical research and investor and public affairs. In addition, the chairman and CEO have each agreed to accept a 50 percent pay cut. The company announced in October that it is exploring a full range of options, from obtaining new financing to selling or merging all or part of the company.

• Point Therapeutics Inc., of Wellesley, Mass., said it has received an additional notice of noncompliance from Nasdaq based on the firm's failure to solicit proxies and hold an annual meeting of stockholders by Dec. 31, 2007, as required by rules. Point said it has scheduled a meeting of stockholders for Jan. 29 to consider various proposals, including the proposed merger of the firm's subsidiary and Dara BioSciences Inc., of Raleigh, N.C. Point said it already has mailed the proxy for the annual meeting to its stockholders and intends to request that it be allowed to continue being listed.

• Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., and Wyeth Pharmaceuticals, of Collegeville, Pa., said the FDA has extended the action date to April 30 for its review of the new drug application for subcutaneous methylnaltrexone for the treatment of opioid-induced constipation. Regulators said they needed more time to fully review the results from a recently completed QT study of intravenous methylnaltrexone, which is being developed for the management of postoperative ileus. The study reported that there was no evidence of an effect of methylnaltrexone on QT prolongation, according to the firms.

• Sysmex Corp., of Kobe, Japan, and bioMérieux, of Marcy L'etoile, France, said they have signed an agreement under which Sysmex will take a 34 percent equity stake in bioMérieux's Japanese subsidiary to form a new company called Sysmex bioMérieux Co. Ltd. The new firm will promote and commercialize the entire bioMérieux product range in Japan starting April 1, the companies said. The joint venture will manage the regulatory filing and marketing activities of bioMérieux product ranges in Japan, the firms said, adding that the sales and customer service activities will be contracted to Sysmex.

• Tethys Bioscience, of Emeryville, Calif., completed an undisclosed Series C financing led by Intel Capital, which brings the firm's total funding raised to date to $54 million. The firm, which develops a multibiomarker technology for predicting an individual's risk of developing diabetes, also received the licensing of its clinical lab by the state of California. Tethys anticipates that its Diabetes PreDxTM will be available in the first half of 2009.