• Aradigm Corp., of Hayward, Calif., received a portfolio of inhaled insulin patents free of charge from Novo Nordisk AS, of Bagsvaerd, Denmark. Most of the patents originally belonged to Aradigm but were sold to Novo along with rights to Aradigm's AERx iDMS inhaled insulin product, which Novo stopped developing after the unprofitable launch and subsequent withdrawal of New York-based Pfizer Inc.'s inhaled insulin product, Exubera. Aradigm also expects to receive from Novo a preclinical safety database, clinical data and the rights to a second-generation inhaler. (See BioWorld Today, Oct. 19, 2007, and Jan. 16, 2008.)

• Argos Therapeutics Inc., of Durham, N.C., said preclinical data published in the Journal of Immunotherapy demonstrated that part of the company's Arcelis platform technology can drive the long-term expansion of antigen-specific T cells with enhanced cytolytic activity. Argos is in clinical trials for cancer and HIV with RNA-loaded dendritic cell-based immunotherapies based on the Arcelis technology.

• Biovail Corp., of Toronto, has been sued over allegations that it misled investors about an antidepressant formula. The class-action lawsuit, filed in New York, claims Biovail misled investors about the regulatory approval status of BVF-033 treatment, a salt formulation version of the generic antidepressant Wellbutrin XL, by not disclosing that the FDA required a single-dose study of its effectiveness while the company submitted a multiple-dose study. Biovail said the suit was without merit.

• Cardiome Pharma Corp., of Vancouver, British Columbia, said partner Astellas Pharma US Inc., of Deerfield, Ill., said it scheduled a Nov. 14 end-of-review meeting with the FDA to discuss the new drug application for Kynapid (vernakalant hydrochloride) injection for rapid conversion of atrial fibrillation to sinus rhythm. The product received an approvable letter in August, with the agency seeking updated safety data from ongoing and completed trials, as well as further information about a subset of patients who experienced certain serious adverse events. The upcoming meeting is expected to outline the steps that need to be taken before the NDA can receive final marketing approval. Cardiome also reported that Astellas withdrew its new drug submission for Kynapid with Canadian regulators and plans to revisit its Canadian regulatory strategy following resolution of the FDA process. (See BioWorld Today, Aug. 12, 2008.)

• Emergent BioSolutions Inc., of Rockville, Md., said its BioThrax anthrax vaccine and development-stage Anthrax Immune Globulin received coverage under the Public Readiness and Emergency Preparedness Act, which provides liability protection for the company. Emergent has multiple government contracts for BioThrax and provides the vaccine for the national stockpile. (See BioWorld Today, Oct. 2, 2008.)

• ICo Therapeutics Inc., of Vancouver, British Columbia, said preclinical results showed that iCo-009, its oral formulation of Amphotericin B, demonstrated significant antifungal activity in both aspergillus fumigatus and candida albicans rat models, with no observable kidney toxicity as assessed by serum creatinine concentrations. Results indicated that oral administration of iCo-009 resulted in blood levels that are comparable to a marketed intravenous Amphotericin B product. Further preclinical studies are under way to profile the drug's tissue distribution in the kidney, liver, spleen, lung, brain and heart.

• IntelGenx Corp., of Ville St-Laurent, Quebec, and Cary Pharmaceuticals Inc., of Great Falls, Va., said they will be filing an approval application in the second half of 2009 for CPI 300 as a treatment for major depressive disorder under a 505(b)(2) filing based on a bioequivalence study, which found that the investigational antidepressant is bioequivalent to the reference product. CPI-300, which was formulated using IntelGenx's proprietary controlled-release technology, contains a new strength of antidepressant developed to provide a more convenient dosing option for patients.

• Invitrogen Corp., of Carlsbad, Calif., said that it expects its synergy realization to be at least $80 million rather than $60 million under its $6.7 billion merger with Applied Biosystems Inc., of Foster City, Calif. The firm said the higher amount of synergies, as well as a lower than expected share count of 179 million shares, will lead to higher earnings per share growth than originally anticipated. (See BioWorld Today, June 13, 2008.)

• Watson Pharmaceuticals Inc., of Corona, Calif., received FDA approval of the alpha-1 adrenergic receptor antagonist Rapaflo (silodosin) for benign prostatic hyperplasia. Launch is expected early next year.