• Abbott, of Abbott Park, Ill., said the FDA approved an infant-specific dose of Creon (pancrelipase) delayed-release capsules to treat exocrine pancreatic insufficiency due to cystic fibrosis.

• Actinobac Biomed Inc., of New Brunswick, N.J., reported in vivo data showing that the company's psoriasis candidate Leukothera was effective in treating the disease in a humanized mouse xenograft transplantation model. Studies showed that Leukothera, which is designed to work by targeting leukocyte function antigen-1 on diseased white blood cells, was as effective or more effective than once-marketed Raptiva (efalizumab, Genentech Inc./Roche AG), even when using significantly lower drug dosage levels. Data were published in the Journal of Investigative Dermatology.

• Amarantus BioSciences Inc., of Sunnyvale, Calif., said it completed its capital restructuring initiatives, which included a 25-for-1 forward stock split. The firm, which is working on drugs for diseases related to protein misfolding and apoptosis, has about 67 million shares issued and outstanding.

• Agenus Inc., of Lexington, Mass., announced that its wholly owned subsidiary Antigenics signed a license agreement with Integrated BioTherapeutics Inc., of Gaithersburg, Md., for the use of Antigenics' QS-21 Stimulon adjuvant in the development of a vaccine against Ebola and Marburg viruses. Agenus said it is entitled to receive a license fee and potential milestone payments and worldwide royalties on net sales. Integrated BioTherapeutics was awarded a multi-year contract in September 2008 by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, for development of a vaccine to protect against Ebola and Marburg viruses.

• Cell Therapeutics Inc., of Seattle, said a recent meeting with the FDA's Division of Oncology Drug Products produced a pathway for resubmitting the company's new drug application for pixantrone for relapsed or refractory aggressive non-Hodgkin's lymphoma, including the potential for accelerated approval based on the PIX301 study results. The company said it anticipates filing additional information later this year, and could obtain FDA approval in the first half of 2012.

• Evolva Holding SA, of Reinach, Switzerland, announced that Roche AG, of Basel, Switzerland, will make a milestone payment of an undisclosed amount related to the achievement of diverse, purified active compounds that derive from Evolva's synthetic biology platform. Evolva said the collaboration with Roche, which began in January 2010, uses Evolva's technology platform to create compounds with activity on targets in oncology and infectious disease.

• IntelGenx Corp., of Saint Laurent, Quebec, executed a binding term-sheet with RedHill Biopharma Ltd., of Tel Aviv, Israel, to co-develop and license an antipsychotic oral thin film product based on its VersaFilm drug delivery technology. The termsheet sets out criteria for a future agreement, under which RedHill would obtain exclusive worldwide rights to market and sell IntelGenx's product in exchange for up-front, milestone and external development fees totaling up to $2.3 million. Upon commercialization, IntelGenx would receive up to 50 percent of all proceeds. The company also reported that the FDA accepted the company's resubmission of its new drug application for antidepressant CPI-300, in response to a February 2010 complete response letter, as a complete, Class 2 response and set Nov. 13 as the target PDUFA date.

• Pacira Pharmaceuticals Inc., of Parsippany, N.J., reported that the FDA extended the PDUFA date for its review of the new drug application for Exparel (bupivacaine extended-release liposome injection), for postoperative analgesia by infiltration, by three months to Oct. 28. The company said it submitted additional information requested by the FDA, which determined that the information constituted a major amendment.

• Teva Pharmaceutical Industries Ltd., of Jerusalem, and Cephalon Inc., of Frazer, Pa., announced that each company has received a request for additional information from the U.S. Federal Trade Commission in connection with Teva's pending acquisition of Cephalon. The companies said they have been and intend to continue cooperating with the FTC to obtain clearance. (See BioWorld Today, May 3, 2011.)