• 454 Life Sciences, of Branford, Conn., said that Max Planck Institute for Evolutionary Anthropology in Leipzig, Germany, has purchased its second Genome Sequencer FLX system.

• Biovail Corp., of Toronto, said that the FDA has classified the firm's response to the agency's action letter for BVF-033, a salt formulation of bupropion, as Class 2, which means the compound is subject to an additional six-month review period. The FDA has established April 23, 2008, as the Prescription Drug User Fee Act action date for BVF-033.

• Crucell NV, of Leiden, the Netherlands, said it has granted research rights for PER.C6 to Acambis plc, of Cambridge, UK, and Cambridge, Mass. The license agreement allows Acambis to use Crucell's PER.C6 technology for an undisclosed vaccine candidate. Financial details of the agreement were not disclosed.

• CV Therapeutics Inc., of Palo Alto, Calif., said that the FDA has accepted the firm's supplemental new drug application (sNDA) and new drug application (NDA) for Ranexa (ranolazine extended-release tablets). The Prescription Drug User Fee Act action date for both applications is July 27, 2008. The sNDA seeks an expansion to the approved product labeling for Ranexa to include a first-line angina indication and a significant reduction in cautionary language. The NDA filing is seeking a clinical review of a potential labeling change to add reduction of hemoglobin A1c in coronary artery disease patients with diabetes.

• CyDex Inc., of Lenexa, Kan., said it has changed its name to CyDex Pharmaceuticals Inc. to better reflect the firm's focus on developing and commercializing its pharmaceutical product candidates. Previously, the company focused on licensing its Captisol technology to pharmaceutical makers.

• Dyadic International Inc., of Jupiter, Fla., said it has made progress on its value-maximization process and anticipates making a decision by the end of the year about its financial options. The firm said it engaged Gordian Group LLC to serve as the company's investment banker and financial adviser to assist in evaluating and implementing strategic and financial options, including a possible sale, merger, restructuring, recapitalization, reorganization or other strategic or financial transaction.

• Exelixis Inc., of South San Francisco, entered an agreement to sell to Taconic Farms Inc., of Hudson, N.Y., an 80.1 percent stake in its subsidiary, Artemis Pharmaceuticals GmbH, in exchange for about $20 million. Artemis, which develops and commercializes genetically engineered mouse models and engineered mouse embryonic stem cells as genetic model systems, previously established an alliance with Taconic aimed at speeding up the generation, production and distribution of those mouse models to customers. Exelixis retains the option to sell its remaining interest to Taconic, and Taconic has the option to purchase Exelixis' remaining interest during certain times and under certain circumstances through 2015.

• Gene Logic Inc., of Gaithersburg, Md., said it received an undisclosed milestone payment from Pfizer Inc., of New York, related to work on a patent application. Under its drug repositioning agreement with Pfizer, Gene Logic has been seeking new therapeutic applications for selected drug candidates that are no longer in active development. The terms of the agreement provide for payment by Pfizer to Gene Logic of success-based milestones per compound and royalties on the commercialization of drugs whose repositioning results from Gene Logic's drug repositioning program. The firm will receive a nominal initial milestone payment as a result of filing of the patent application.

• GeneGo Inc., of St. Joseph, Mich., said it has granted rights to its MetaDrug, which is designed for predicting biological effects, such as indications, toxicity and off-target effects for new compounds structures, to Utrecht University in the Netherlands for use in its prestige master program for drug innovation.

• HemoBioTech Inc., of Dallas, said that an article published in the Nov. 13, 2007, issue of Scientific American reported that the firm's human blood substitute product, HemoTech, not only suppresses hemoglobin's inherent toxicity, but also serves to improve blood flow and spur the creation of new red-blood cells. According to HemoBioTech, other products using hemoglobin or perfluorocarbon compounds as blood substitutes have shown toxicity problems in their clinical trials.

• Inhibitex Inc., of Atlanta, said it has entered into an exclusive worldwide license agreement with Cardiff University in Wales, UK, and Katholieke Universiteit in Leuven, Belgium, for intellectual property covering a series of highly potent hepatitis C virus (HCV) polymerase inhibitors in exchange for an up-front license fee, future milestone payments and royalties on future net sales. Additional financial details of the transaction were not disclosed. The licensed compounds include a series of nucleoside analogues that inhibit NS5b, an RNA-dependent RNA polymerase that is a critical enzyme in the lifecycle of HCV.

• MorphoSys AG, of Martinsried, Germany, said it has been granted the rights to a variety of its phage display-related patents and other patents under an agreement with Dyax Corp., of Cambridge, Mass. As part of the deal, MorphoSys gains the right to sublicense the patents in conjunction with its proprietary technology. The agreement grants MorphoSys the flexibility for future technology development to further diversify its antibody technology portfolio and improve its offering for therapeutic, diagnostic and research customers. Financial terms were not disclosed. MorphoSys also unveiled a multiyear technology development program which the firm said will lead to a significantly enhanced version of its antibody generation platform.

• Morphotek Inc., of Exton, Pa., reported experimental data showing that endosialin/TEM1, the target of one of the company's therapeutic programs, can elicit cell binding to extracellular matrix proteins via direct interaction. The extopic expression of the protein in endosialin/TEM1-negative cells also mediated cell-cell contact via altered cellular morphology and promoted migration of cells exposed to chemotactic stimuli, both of which are classic characteristics of angiogenesis. Data were published in the recent issue of The Proceedings of the National Academy of Sciences.

• Neuralstem Inc., of Rockville, Md., said it has been granted the exclusive, worldwide licensing rights to the University of California, San Diego's Spinal Multisegmental Cell and Drug Delivery System. Under the agreement, Neuralstem gains the right to all fields of use and the ability to grant sublicenses. The deal calls for UCSD to receive undisclosed milestone payments and royalties. Neuralstem will assume the cost of development, manufacture and approval of the product, the firm said.

• Neurobiological Technologies Inc., of Emeryville, Calif., said it was notified on Nov. 19 by the Nasdaq stock market that it has regained compliance with continued listing standards. The firm said it regained compliance following the closing on Nov. 2 of its underwritten stock offering, in which it raised gross proceeds of $60 million and net proceeds of about $55 million through the offering and sale of nearly 22 million shares of common stock.

• NexMed Inc., of East Windsor, N.J., said the FDA accepted for review its new drug application for a topically applied alprostadil cream for erectile dysfunction. That product is partnered with Warner Chilcott Co., of Rockaway, N.J.

• Qiagen NV, of Venlo, the Netherlands, said that Health Canada has granted licensure for the firm's hepatitis B virus (HBV) assay kit, known as the artus HBV LC PCR Kit. The ready-to-use molecular diagnostic detection kit for the quantitation of hepatitis B viral DNA from plasma helps to monitor ongoing drug therapy treatments for people chronically infected with hepatitis B. The kit uses the polymerase chain reaction amplification technology and is configured for the widely available LightCycler Instrument.

• Rosetta Genomics Ltd., of Rehovot, Israel, and the New York University School of Medicine said they have expanded their collaboration to screen for specific microRNA biomarkers and signatures that may be used to diagnose and target congenital heart disease in newborns.

• Sanofi-Aventis Group, of Paris, and Bristol-Myers Squibb Co., of New York, said the FDA approved their supplemental new drug application for Avalide (irbesartan-hydrochloothiazide), an antihypertensive agent, for initial use in patients with hypertension who are likely to need multiple drugs to achieve their blood pressure goals. That approval is based on data from two clinical trials, including results showing that Avalide demonstrated mean blood pressure reductions of 30.8/24 mm Hg vs. 21.1/19.3 mm Hg for irbesartan alone at five weeks.

• Synthetic Blood International Inc., of Costa Mesa, Calif., said that company founder Robert Larsen has assumed the position of interim CEO following the resignation of Robert Nicora, who will remain as a consultant on matters related to clinical trials and U.S. regulatory requirements. In addition, Chris J. Stern and Richard Kiral have joined the firm's board of directors. Synthetic Blood also said it has received a $1 million loan as an advance against a proposed $12 million five-year convertible note with 10 percent interest and a conversion price of 22 cents per share that will provide the firm with sufficient funds to move forward on preclinical and clinical trials.