• Anthera Pharmaceuticals Inc., of Hayward, Calif., placed a voluntary hold on its PEARL-SC Phase IIb study of A-623 in systemic lupus erythematosus due to cracking in a number of clinical product vials. Patient enrollment was suspended, and patients currently enrolled will discontinue dosing while the company completes an analysis. Anthera said there have been no reports of patient-related side effects or problems with drug administration that could be attributed to the problem to date, and no serious adverse events have been reported to the company in the PEARL-SC trial. Piper Jaffray analyst Edward Tenthoff wrote in a research note that he anticipates only a short delay and a "worst case scenario" of about six months to make all new trial material. Shares of Anthera (NASDAQ:ANTH) fell 45 cents, to close Tuesday at $5.67.

• AVEO Pharmaceuticals Inc., of Cambridge, Mass., started patient enrollment in a Phase Ib trial of tivozanib, an inhibitor of VEGF receptors 1, 2 and 3, in combination with Xeloda (capecitabine, Roche AG) in metastatic breast and colorectal cancers. The 24-patient study is designed to assess safety, tolerability and maximum tolerated dose.

• MannKind Corp., of Valencia, Calif., reported data on its drug delivery, device and particle technologies demonstrating the bioequivalence, ease of use and efficiency of its platform at the Diabetes Technology Society meeting in Bethesda, Md. Among the findings of those studies include bioequivalence of the inhaler used in the company's Phase III trials of inhaled insulin Afrezza (MedTone) and the next-generation delivery system to be marketed with Afrezza (Gen2), with all parameters and dose groups passing the bioequivalence criteria as measured using two separate methods of analysis. An additional study also demonstrated the bioequivalence of the Gen2 device and the clinical inhaler. Afrezza received a complete response letter in March. MannKind recently resubmitted its new drug application for Afrezza, and the FDA has set a target action date of Dec. 29. (See BioWorld Today, March 16, 2010.)

• Merrion Pharmaceuticals plc, of Dublin, Ireland, is gearing up for a Phase III study of Orazol (zoledronic acid), following a consultation with the FDA earlier this month, with plans to file for approval under the 505(b)(2) pathway. The upcoming study is designed to compare Orazol vs. placebo as an adjuvant breast cancer treatment with the primary endpoint of disease-free survival. Merrion said it continues licensing discussions for Orazol and anticipates that, in conjunction with a license partner, it would request a special protocol assessment from the FDA. Phase III trials are expected to start next year.

• Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., said collaborator Ono Pharmaceutical Co. Ltd., of Osaka, Japan, started Phase II testing in Japan of subcutaneous methylnaltrexone, which is designated ONO-3849 in Japan and marketed as Relistor in the U.S. The study is expected to enroll patients with advanced illness such as cancer suffering from opioid-induced constipation and is designed to demonstrate safety and efficacy in Japanese subjects. Progenics and Ono entered the Japanese deal in 2008. (See BioWorld Today, Oct. 20, 2008.)

• Regado Biosciences Inc., of Basking Ridge, N.J., said substudy data from its ongoing Phase IIb RADAR trial showed that RB006 resulted in consistent and near complete inhibition of Factor IX in patients with acute coronary syndrome with stable anticoagulation throughout catheterization. Data were presented at the American Heart Association's Scientific Sessions in Chicago. RB006 is part of the REG1 anticoagulation system, which involves the intravenous bolus administration of two agents: Factor IXa inhibitor RB006 (pegnivacogin) and complementary active control agent RB007 (anivamersen).

• Tengion Inc., of East Norriton, Pa., said the first implanted bladder patient in its ongoing trial completed the one-month, postoperative clinical assessment, allowing the second patient to be enrolled as planned. The study is testing the firm's Neo-Urinary Conduit in patients requiring a urinary diversion following bladder removal and is designed to provide safety data and to optimize the surgical technique. Tengion expects to implant five patients by the middle of next year.