• Akorn Inc., of Buffalo Grove, Ill., said the FDA approved a supplemental biologics license application for a unit dose preservative-free tetanus diphtheria vaccine, expected to be launched in the first quarter of 2008. Akorn signed a distribution agreement earlier this year with Massachusetts Biologic Laboratories for the vaccine.

• Argenta Discovery Ltd., of Harlow, UK, and Dr. Reddy's Laboratories Inc., of Hyderabad, India, selected a lead candidate in their program to develop an inhaled, disease-modifying, anti-inflammatory drug for chronic respiratory diseases, including chronic obstructive pulmonary disease and severe asthma. The companies plan to begin clinical trials in mid-2008.

• Cohen, Milstein, Hausfeld and Toll PLLC, of Washington, said it filed a lawsuit on behalf of its clients in the U.S. District Court for the Southern District of Florida asserting that Dyadic International Inc., of Jupiter, Fla., and one of its officers and directors violated the Securities Exchange Act of 1934 by omitting or misrepresenting material adverse facts about the firm's financial condition, business prospects and revenue expectations between April 5, 2006, and April 23, 2007. The complaint alleges that during that period the defendants issued numerous materially false and misleading statements, which caused Dyadic's securities to trade at artificially inflated prices. Specifically, the complaint alleges operational and financial improprieties perpetrated by the firm and its Asian subsidiaries, and knowingly or recklessly approved by the defendants, which culminated in an internal investigation and subsequent firing of the company's CEO.

• Diamyd Medical AB, of Stockholm, Sweden, said it executed a clinical trial agreement with the U.S. National Institute of Diabetes and Digestive and Kidney Diseases for a planned clinical study with the firm's Diamyd GAD-alum diabetes vaccine in 126 patients with new onset Type I diabetes. Under the terms of the agreement, Diamyd Medical will supply the vaccine and placebo for the trial, which will include extensive immunological studies to clarify the mechanism of action and to evaluate the correlation between the clinical and immunological outcomes of GAD-alum Diamyd treatment in patients with recent onset Type I diabetes. The firm previously announced plans for a Phase III program to test the vaccine in patients with recent onset Type I diabetes in the U.S. and Europe. (See BioWorld Today, Oct. 26, 2007.)

• Inviragen LLC, of Fort Collins, Colo., received a grant from the Pediatric Dengue Vaccine Initiative to support manufacturing of Inviragen's dengue vaccine in preparation for clinical trials slated to begin in the second half of 2008. Financial terms were not disclosed.

• Maxygen Inc., of Redwood City, Calif., and partner F. Hoffmann-La Roche Ltd., of Basel, Switzerland, agreed to terminate their development of MAXY-alpha (R7025), a pegylated interferon-alpha product for hepatitis B and hepatitis C. Rights to the compound, licensed to Roche in 2003, will return to Maxygen. Roche placed a hold on the program last month after a preliminary analysis of Phase Ia data showed there were lower drug levels in serum than expected. (See BioWorld Today, Sept. 24, 2007.)

• Mercury Therapeutics Inc., of Woburn, Mass., said it used kinase and cell metabolism assays to identify multiple small molecules that directly and indirectly activate AMP kinase. The company is filing patents and initiating preclinical studies.

• OncoMethylome Sciences, of Liege, Belgium, entered a collaboration with GlaxoSmithKline Biologicals, a division of London-based GlaxoSmithKline plc, to identify DNA methylation biomarkers for certain GSK cancer immunotherapeutics. The project is being funded by a Wallonia (BioWin) research grant. Further terms were not disclosed.

• Orexo AB, of Uppsala, Sweden, completed its acquisition of Biolipox AB, of Solna, Sweden, and appointed former Biolipox CEO Torbjörn Bjerke CEO of the combined company. That deal was announced in October. Former Orexo CEO Zsolt Lavotha will serve as senior advisor to the firm's board. Claes Wenthzel also was appointed executive vice president and chief financial officer. In addition, the firm said that its board of directors prepared a prospectus regarding listing of shares in Orexo in connection with the acquisition of Biolipox. (See BioWorld Today, Oct. 16, 2007.)

• Pipex Pharmaceuticals Inc., of Ann Arbor, Mich., entered a cooperative research and development agreement with the Ann Arbor, Mich.-based Veterans Affairs Medical Center to conduct preclinical studies of Coprexa (tetrathiomolybdate) in Huntington's disease. Coprexa, an oral, small-molecule, anti-copper agent, also is in clinical trials for idiopathic pulmonary fibrosis and primary biliary cirrhosis and has completed Phase III trials in Wilson's disease. (See BioWorld Today, Nov. 9, 2006.)

• Veridex LLC, a subsidiary of New Brunswick, N.J.-based Johnson & Johnson, said the FDA approved the CellSearch System to aid in monitoring metastatic colorectal cancer. The system, which was approved in 2004 to aid in monitoring metastatic breast cancer, identifies and counts circulating tumor cells in blood samples.

• Wyeth Pharmaceuticals, of Collegeville, Pa., said the European Commission approved Torisel (temsirolimus) as a first-line treatment in patients with advanced renal-cell carcinoma who have at least three of six prognostic risk factors. Torisel, an mTOR (mammalian target of rapamycin) kinase inhibitor, previously gained FDA approved in advanced RCC.