• Advancis Pharmaceutical Corp., of Germantown, Md., resubmitted its new drug application for a once-daily Amoxicillin Pulsys product for treating adolescents and adults with pharyngitis/tonsillitis. The company received a refusal-to-file letter in February from the FDA, requesting additional information on commercial manufacturing processes, and followed up by meeting with the agency. The FDA is expected to review the NDA for filing acceptance within 60 days, and if accepted, Advancis anticipates an action date in January 2008.

• Celgene Corp., of Summit, N.J., said Revlimid (lenalidomide) received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, for use in combination with dexamethasone in multiple myeloma patients who have received at least one prior therapy. That opinion will be forwarded to the European Commission, which is expected to announce a decision within two to three months. Revlimid has orphan status in the EU for multiple myeloma. It already is marketed in the U.S. for previously treated patients.

• Gilead Sciences Inc., of Foster City, Calif., said London-based GlaxoSmithKline plc's marketing authorization application for ambrisentan for treating pulmonary arterial hypertension was validated by the European Medicines Agency. The dossier will be distributed to members of the Committee for Medicinal Products for Human Use for formal review. The validation triggered a milestone payment to Gilead from GSK, which has rights to ambrisentan outside the U.S. Ambrisentan is a non-sulfonamide, propanoic acid-class, endothelin receptor antagonist that is selective for the endothelin type-A receptor. The FDA has accepted for review Gilead's new drug application on the product in the U.S.

• Medarex Inc., of Princeton, N.J., said partner MedImmune Inc., of Gaithersburg, Md., initiated a Phase I trial of MEDI-545, a fully human antibody, in psoriasis. The study is designed to evaluate patients for 126 days following a single dose of MEDI-545, including blood and skin analysis at regular intervals. The product, which was generated using Medarex's UltiMAb Human Antibody Development System, also is being developed in systemic lupus erythematosus in an ongoing Phase I trial. MEDI-545 is one of two antibodies included in the November 2004 collaboration between Medarex and MedImmune. Under the agreement, MedImmune is responsible for all ongoing clinical development activities. Medarex could opt to co-develop the product prior to starting pivotal trials; otherwise, the company would receive milestone and royalty payments. (See BioWorld Today, Nov. 24, 2004.)

• Pozen Inc., of Chapel Hill, N.C., said the FDA accepted for review the amended response to a previous FDA approvable letter for Trexima. Trexima is the proposed brand name for Pozen's combination of sumatriptan succinate and naproxen sodium in a single tablet for the acute treatment of migraine. The FDA expects a Class II review (six months) for the product, which could result in a new decision date of Aug. 1, Pozen said. The new drug application was filed in August 2005. The FDA approvable letter almost a year later called for additional safety data. (See BioWorld Today, June 6, 2006.)

• Procognia Ltd., of Maidenhead, UK, entered a collaboration with GlaxoSmithKline plc, of London, to explore the use of Procognia's arrays within the GSK drug-development processes. They will combine Procognia's functional protein array technology and GSK's fluorescently labeled broad-specificity kinase inhibitors. Procognia will supply arrays containing more than 300 functional human kinases. They also will work to assess integrating Procognia's protein array technology into GSK's screening process. Terms of the deal were not disclosed.

• Synosis Therapeutics, of San Francisco, changed its name to Synosia Therapeutics. Synosia is a privately held company focused on developing treatments for disorders of the central nervous system.

• Ziopharm Oncology Inc., of New York, said data were presented showing ZIO-201, the company's formulation of the therapeutic active metabolite of ifosfamide, was 10- to 30-fold more active than IFOS in most in vitro and in vivo models of lymphoma. ZIO-201 also killed IFOS-resistant lymphoma in cancer-bearing mice. Ziopharm also presented encouraging toxicity and safety data from a Phase I trial. Data were presented at the International Society of Hematology meeting in Punta del Este, Uruguay.