• Cell Therapeutics Inc., of Seattle, submitted an expanded pediatric investigation plan to the European Medicines Agency in submitting a marketing authorization application for pixantrone in relapsed or refractory, aggressive non-Hodgkin's lymphoma. The pediatric program will test pixantrone, an aza-anthracenedione, in patients ages 6 months to 18 years, with the goal of determining the comparative safety and effectiveness of drug compared to doxorubicin. CTI intends to file the MAA later this year.

• Cornerstone Therapeutics Inc., of Cary, N.C., reacquired all development and commercial rights to its high-mobility group box protein 1 (HMGB1) related technology from MedImmune LLC, of Gaithersburg, Md. The firms in 2003 had entered into a partnership to develop antibodies that bind to the HMGB1 protein to reduce chronic inflammation associated with various conditions. Cornerstone, which had initially licensed the technology from the Feinstein Institute for Medical Research, said it intended to identify a new partner to move the development of its HMGB1 technology platform forward.

• Cortex Pharmaceuticals Inc., of Irvine, Calif., received a grant from the Michael J. Fox Foundation for Parkinson's Research to test selected compounds from its Ampakine platform for their ability to restore brain function in animal models of Parkinson's disease. The amount of funding was not disclosed.

• Dyax Corp., of Cambridge, Mass., said the European Medicines Agency has completed its validation process for the marketing authorization application for DX-88 (ecallantide) and begun its formal scientific review. The drug is approved and marketed in the U.S. under the brand name Kalbitor as a treatment for acute attacks of hereditary angioedema, a rare inflammatory condition characterized by episodes of severe, often painful, swelling of the extremities, gastrointestinal tract, genitalia and in the larynx, in patients 16 or older.

• EUSA Pharma Inc., of Oxford, UK, licensed Japanese development and commercialization rights for its cancer drug Erwinase (L-asparaginase) to Tokyo-based Ohara Pharmaceutical Co. Ltd. Specific terms were not disclosed, but EUSA will receive an up-front fee and royalties. Erwinase is approved in Canada and several countries in Europe, the Middle East and Asia.

• Forest Laboratories Inc., of New York, will see its antibiotic ceftaroline reviewed by the FDA's Anti-Infective Drugs Advisory Committee Sept. 7. Forest, which gained rights to ceftaroline through its 2007 acquisition of Alameda, Calif.-based Cerexa Inc., is seeking approval in community-acquired bacterial pneumonia and complicated skin and skin structure infections.

• Molecular Templates Inc., of Georgetown, Texas, entered an oncology discovery and translation research agreement with ImClone Systems, a unit of Indianapolis-based Eli Lilly and Co. Under the terms, Molecular Templates will identify Engineered Toxin Bodies against an undisclosed oncology target selected by ImClone, while ImClone will be responsible for conducting preclinical studies. The companies then will have the option to continue exclusive development of selected ETBs by ImClone for potential commercialization by Lilly, with Molecular Templates entitled to up-front, milestone and royalty payments. Specific terms were not disclosed.

• MorphoSys AG, of Martinsried, Germany, received a m1 million ($1.25 million) grant from the German Federal Ministry of Education and Research. The money will be used to advance the anti-CD38 antibody MOR202 into clinical development for multiple myeloma and to explore relevant biomarkers. Clinical trials are slated to start in the first quarter of 2011.

• Nektar Therapeutics Inc., of San Carlos, Calif., reported data showing that NKTR-102, a topoisomerase I inhibitor-polymer conjugate, exhibited superior activity compared to irinotecan as part of either a monotherapy or combination regimen in tumor models of gastrointestinal cancers. In the first study, NKTR-102 was administered as a single agent and showed dose-related regression response rates increasing from 30 percent to 100 percent, with several animals at the 150 mg/kg dose level remaining tumor-free at the end of the study. The second study showed that the combination of 100 mg/kg NKTR-102 with 50 mg/kg 5-FU was the most active regimen, yielding the maximum tumor growth delay of 232 percent, a 100 percent regression response rate and demonstrating superiority compared to standard irinotecan plus 5-FU. Those results were presented at the European Society for Medical Oncology's World Congress on Gastrointestinal Cancer in Barcelona, Spain.

• Neurim Pharmaceuticals Ltd., of Tel Aviv, Israel, said the European Commission approved a change in treatment duration with Circadin from three weeks to 13 weeks. Circadin, a prolonged-release melatonin, is indicated for primary insomnia in patients ages 55 and older.

• Sangamo BioSciences Inc., of Richmond, Calif., published preclinical data showing that its zinc finger DNA-binding protein nuclease technology can be used to permanently disrupt the CCR5 gene in stem cells, resulting in a stem cell therapy for HIV. Phase I trials are under way. The data were published in Nature Biotechnology.

• Rosetta Genomics Ltd., of Rehovot, Israel, and Philadelphia, Pa., said that a peer-reviewed article published in the online version of The Journal of Molecular Diagnostics demonstrated the ability of microRNAs to accurately identify four histological types of renal tumors, namely clear cell, papillary and chromophobe renal cell carcinoma, as well as oncocytoma, a benign tumor. Initial studies showed differences in responses of RCC subtypes to targeted therapies, and future therapies may be individualized for each type. The accurate identification of the subtypes may play an important role in patient management and in the selection of patients for clinical trials of RCC drugs in development, the company said.

• Strativa Pharmaceuticals, of Woodcliff Lake, N.J., said the FDA approved Zuplenz (ondansetron) oral soluble film for the prevention of postoperative, highly and moderately emtogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting. The product uses technology from MonoSol Rx, of Warren, N.J.

• Three Rivers Pharmaceuticals LLC, of Warrendale, Pa., received approval from the FDA expanding the labeling of Infergen (consensus interferon) a bio-optimized, selective and highly potent Type I interferon alpha, for daily use with ribavirin as a retreatment for chronic hepatitis C virus. The company noted that about 50 percent of patients with chronic HCV do not respond to their initial course of therapy.

• Urigen Pharmaceuticals Inc., of San Francisco, said the FDA denied the firm's request for an end-of-Phase II meeting at this time, but the agency has "signaled its willingness" to meet with the company as it moves forward with URG101 in painful bladder syndrome/interstitial cystitis. Urigen plans to conduct Phase IIb studies and believes, if those are successful, the data may provide sufficient efficacy and safety for a new drug application submission.