• Discovery Laboratories Inc., of Warrington, Pa., said it submitted its complete response to the May 2008 approvable letter for Surfaxin (lucinactant) in the prevention of respiratory distress syndrome in premature infants. The FDA's guidelines provide that by Oct. 31, the agency will determine the classification of the submission and notify the firm of the target date for potential approval. Discovery Labs said a Class 1 resubmission would result in a target review period of 60 days and possible approval of Surfaxin this year. The May approvable letter was Surfaxin's third such letter from the FDA, and requested that Discovery Labs resolve issues regarding lipid-related impurities and conduct additional preclinical studies. No additional clinical trials were requested. (See BioWorld Today, May 5, 2008.)

• Glycotex Inc., of Rockville, Md., has finalized an agreement with Cheshire, UK-based Advanced Medical Solutions to study the use of GLYC-101 with wound dressings manufactured by AMS. Glycotex and AMS have agreed to an initial phase of testing of the use of GLYC-101 with AMS' wound dressings. The agreement may be extended if the tests are favorable.

• Horizon Discovery, of Cambridge, UK, has extended its commercial relationship with Millennium Pharmaceuticals Inc., of Cambridge, Mass., to include the development of custom X-MAN cell-lines that comprise a set of double cancer-gene 'knock-in' lines designed to evaluate known mechanisms of patient resistance to putative targeted agents. Horizon will use Genesis, its virally-mediated isogenic gene targeting technique, to provide a model in vitro system for testing a potential cancer drugs. Millenium will pay Horizon undisclosed up-front, milestone and renewal fees per-cell-line pair for a work program that will begin in November.

• Ipsen SA, of Paris, said stockholders of Tercica Inc., of Brisbane, Calif., have voted to approve its previously announced acquisition of Tercica for $663 million. More than 90 percent of the approximately 68.5 million total votable shares were cast in favor of the transaction. The merger took effect Oct. 16. (See BioWorld Today, June 6, 2008.)

• LifeCycle Pharma A/S, of Horsholm, Denmark, appointed Jim New as the president and CEO. New was co-founder and CEO of Abrika Pharmaceuticals, a specialty pharma company, and before that spent more than 20 years with Novartis, Pfizer Inc., GlaxoSmithKline plc and Bristol-Myers Squibb.

• MediGene AG, of Martinsried, Germany, said drug candidate RhuDex for the treatment of rheumatoid arthritis will be examined in a series of laboratory tests under the auspices of the UK Medicines and Healthcare products Regulatory Agency. The in vitro studies will examine potential detrimental interactions between RhuDex and arteriosclerotic blood vessels. MediGene expects the studies to be conducted in the first half of 2009. The tests are in response to Medigene's decision last July to put a Phase I study of a new formulation of RhuDex on hold after a volunteer died of myocardial infarction during the trial. An autopsy revealed that the volunteer had been suffering from severe impairment of cardiac function before admission to the trial. Other than in the patient, no clinically relevant cardiac symptoms have been observed in any clinical trial of RhuDex. (See BioWorld Today, July 9, 2008.)

• Valeant Pharmaceuticals International, of Aliso Viejo, Calif., has closed on its exclusive worldwide agreement with GlaxoSmithKline plc, of London, for the investigational drug retigabine, a first-in-class neuronal potassium channel opener for the treatment of adult epilepsy patients with refractory partial onset seizures. Under the terms of the agreement, Valeant received an up-front payment of $125 million from GSK. (See BioWorld Today, Aug. 29, 2008.)