• 3SBio Inc., of Shenyang, China, said that a special committee of independent directors has retained Jefferies & Co. Inc. as their independent financial advisor. The special committee is evaluating a preliminary nonbinding proposal dated Sept. 12 from its chairman and CEO, Jing Lou, and CPEChina Fund LP to acquire all of the outstanding shares of the company's common stock not currently owned by Lou and his affiliates. (See BioWorld Today, Sept. 19, 2012.)

• A.P. Pharma Inc., of Redwood City, Calif., said it resubmitted its new drug application to the FDA for its lead product candidate, APF530, for the prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting.

• Ariad Pharmaceuticals Inc., of Cambridge, Mass., reported it completed a rolling submission of the new drug application to the FDA for its investigational BCR-ABL inhibitor, ponatinib, in patients with resistant or intolerant chronic myeloid leukemia and Philadelphia-chromosome positive acute lymphoblastic leukemia. The company said it has provided the remaining chemistry, manufacturing and controls data and has requested accelerated approval and a priority review of the application.

• Astex Pharmaceuticals Inc., of Dublin, Calif., said partner Janssen-Cilag International NV, a unit of New Brunswick, N.J.-based Johnson & Johnson, was notified that the European Commission approved Dacogen (decitabine) for treating adults, 65 and older, with newly diagnosed de novo or secondary acute myeloid leukemia (AML) who are not candidates for standard induction chemotherapy. Dacogen also was granted orphan designation for the treatment of AML. The approval was based on data from the Phase III DACO-016 trial showing an increase of 54 percent in median overall survival in patients taking Dacogen (7.7 months compared to five months in the comparator arm, p = 0. 108.) The hypomethylating agent previously gained approval in myelodysplastic syndromes.

• AVEO Oncology Inc., of Cambridge, Mass., and Astellas Pharma Inc., of Tokyo, said AVEO submitted a new drug application (NDA) seeking approval of tivozanib, a drug designed to target vascular endothelial growth factor, in patients with advanced renal cell carcinoma. The submission is based on results from the Phase III TIVO-1 (Tivozanib Versus Sorafenib in 1st line Advanced RCC) trial, in which the drug demonstrated statistically significant improvement over Nexavar (sorafenib, Onyx Pharmaceuticals Inc. and Bayer AG) in progression-free survival (PFS). AVEO and Astellas have maintained that the FDA said it would consider PFS data sufficient for an NDA, though the agency raised concerns last month about the overall survival trends on the ongoing TIVO-1 trial. (See BioWorld Today, Jan. 4, 2012, and Aug. 6, 2012.)

• Cytori Therapeutics Inc., of San Diego, was awarded a contract that could be valued at up to $106 million if all options are executed, by the Department of Health and Human Services' Biomedical Advanced Research and Development Authority. The contract covers preclinical and clinical development of the firm's cell therapy for the treatment of thermal burns combined with radiation injury, with the aim of creating a new countermeasure for thermal burns that would be useful following a mass-casualty event. Cytori's cell therapy is based on a patient's own adipose-derived stem and regenerative cells processed using its Celution System. Shares of Cytori (NASDAQ:CYTX) gained 55 cents, or 14.3 percent, to close Friday at $4.41.

• Elite Pharmaceuticals Inc., of Northvale, N.J., said it has renewed its agreement with PharmaNetwork LLC, of Montvale, N.J., and its wholly owned subsidiary, Ascend Laboratories LLC and will continue to perform manufacturing and packaging for methadone hydrochloride tablets through Dec. 31, 2014.

• Evotec AG, of Hamburg, Germany, and Aspireo Pharmaceuticals Ltd., of Tel Aviv, Israel, said they inked an advisory agreement for support in the development and partnering of Aspireo's Somatoprim (DG3173), a somastatin analogue in Phase I development. Under the terms, Evotec will provide Aspireo with strategic and operational advice on partnering and will consult on matters of clinical and preclinical development. In exchange, Evotec will retain advisory fees as well as participate in the economic success of Somatoprim. Existing somastatin analogues, which generate about $1.5 billion in annual sales, have been approved in the treatment of acromegaly, carcinoid tumors and Cushing's disease and also have demonstrated potential in diabetic retinopathy. Early testing of Somatoprim has shown an improved side-effect profile, with reduced adverse effects on the gastrointestinal tract and metabolic control.

• The National Organization for Rare Disorders, of Danbury, Conn., has commended the Pharmaceutical Research and Manufacturers of America (PhRMA) for adopting principles to guide the interaction between pharmaceutical companies and patient organizations. The principles have been posted on the PhRMA website and are being distributed to all of its companies.

• Osiris Therapeutics Inc., of Columbia, Md., said its collaboration with Genzyme, a unit of Paris-based Sanofi SA, officially ended, with all rights to Prochymal (remestemcel-L) and Chondrogen reverting back to Osiris. Both parties agreed to the conclusion, with no further financial responsibilities for either party. The termination of the potential $1.38 billion partnership, first signed in 2008, came as no surprise; Sanofi said in a February pipeline update that a Phase III Prochymal project had been discontinued. Prochymal, a mesenchymal stem cell therapy, has since gained approval in Canada and New Zealand and is available under expanded access programs in other countries for the treatment of acute graft-vs.-host disease in children. Chondrogen, a similar product to Prochymal, is in development for osteoarthritis of the knee. Osiris also said that Swissmedic will evaluate Prochymal® under the agency's fast-track procedures, which typically cuts the evaluation period for new drugs in half. (See BioWorld Today, Nov. 5, 2008, and May 23, 2012.)

• Premier Biomedical Inc., of Port Richey, Fl., said it has established five new operating divisions following recent successes in laboratory testing of its technology. The company said the divisions will focus on the potential of the technology in the following areas: cancer/leukemia, blood-borne pathologies, cerebral spinal fluid pathologies, Alzheimer's disease and heart attack/stroke.

• Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., said Eylea (aflibercept) received approval in wet age-related macular degeneration in Japan. The drug previously gained approval in the U.S. and Australia and has received a positive recommendation from the European Committee for Medicinal Products for Human Use. (See BioWorld Today, Nov. 22, 2011.)

• Sagent Pharmaceuticals Inc., of Schaumburg, Ill., said it launched vancomycin hydrochloride for Injection, USP, an anti-infective, in a 5-g pharmacy bulk package. The product is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta lactam-resistant) staphylococci and for the infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs.

• Tekmira Pharmaceuticals Corp., of Vancouver, British Columbia, said the Department of Defense (DoD) extended the period of a temporary stop-work order with respect to the firm's TKM-Ebola program. It is expected that by Oct. 31, the company will receive notification whether DoD will cancel the stop-work order, terminate the contract or further extend the stop-work order period. Tekmira reported in August that the temporary stop-work order was imposed to due funding constraints at DoD. (See BioWorld Today, Aug. 7, 2012.)