• Aradigm Corp., of Hayward, Calif., said it received clearance from the FDA for its investigational new drug application for its inhaled liposomal ciprofloxacin product. The firm said the first trial planned under the IND is a multicenter Phase I/IIa study to evaluate the pharmacokinetics, safety and tolerability of once-daily administration of 150-mg ciprofloxacin for inhalation (CFI, ARD-3100) in pediatric patients with cystic fibrosis who have a history of chronic Pseudomonas aeruginosa lung infection. Secondary endpoints will include quality-of-life measurements, lung function changes and improvement of outcomes with respect to exacerbations.

• Cadence Pharmaceuticals Inc., of San Diego, resubmitted its new drug application to the FDA for its investigational injectable acetaminophen drug Ofirmev as a treatment for pain and fever in adults and children. Cadence received a complete response letter Feb. 10 from the FDA, which indicated that the Ofirmev NDA could not be approved due to deficiencies observed during the agency's facility inspection of Cadence's third-party manufacturer. The firm, which met with regulators on April 16 to discuss the deficiencies outlined in the letter, said the FDA did not cite any safety or efficacy issues or require any additional studies prior to approval.

• Discovery Laboratories Inc., of Warrington, Pa., said new data demonstrated that Surfaxin LSTM, the firm's formulation of lyophilized KL4 surfactant, improved lung function and oxygenation while attenuating lung inflammation in a preterm lamb model of respiratory distress syndrome.

• Foresight Biotherapeutics Inc., of New York, said a preclinical study to assess the safety and efficacy of the topical administration of FST-100 showed it was able to reduce titers to a greater degree than either saline or Tobradex (p = 0.05) and was equally as effective as cidofovir. Cidofovir is the standard active control in that model but has shown ocular toxicity in human testing. FST-100 also demonstrated a clinically and statistically significant (p = 0.05) reduction in signs of adenoviral conjunctivitis vs. all other groups tested including saline, Tobradex and cidofovir.

• GlaxoSmithKline plc, of London, suspended its open-label, Phase II study of SRT501 alone or in combination with Velcade (bortezomib), marketed by Millennium Pharmaceuticals Inc., of Cambridge, Mass., in multiple myeloma due to unexpected safety concerns, according to the government's Clinicaltrials.gov website. The study was testing the safety and tolerability of SRT501 with or without concurrent Velcade administration when administered once daily in 21-day cycles in patients with multiple myeloma. GSK acquired the drug, a formulation of resveratrol, through its April 2008 acquisition of Sirtris Pharmaceuticals Inc. for $720 million. (See BioWorld Today, April 24, 2008.)

• Osiris Therapeutics Inc., of Columbia, Md., said it has been granted orphan drug designation from the FDA for Prochymal as a treatment for Type I diabetes mellitus. Osiris already holds orphan drug designation for Prochymal used in the treatment of graft-vs.-host disease. Prochymal, a formulation of adult mesenchymal stem cells designed to provide therapeutic benefit by controlling inflammation, promoting tissue regeneration and preventing scar formation, currently is being evaluated in a double-blind, placebo-controlled Phase II trial for Type I diabetes. Osiris is developing Prochymal in partnership with the Juvenile Diabetes Research Foundation.

• Regimmune Corp., of Mountain View, Calif., reported data from a preclinical study showing enhanced immune suppression when ToleroVax (RGI-2001), its lead product candidate for the prevention of acute graft-vs.-host Disease (GvHD), is combined with anti-thymocyte globulin. The study found that the combination of the two drugs showed a robust synergy and induced proliferation in more than 70 percent of regulatory T cells, a T cell subset that plays a central role in inducing and maintaining immune tolerance. The data were presented at the 2010 American Transplant Congress in San Diego. ToleroVax is in late preclinical development for the prevention of acute GvHD associated with bone marrow transplantation, and Regimmune expects to begin a Phase I study the third quarter.

• S*BIO Pte Ltd., of Singapore, and Onyx Pharmaceuticals Inc., of Emeryville, Calif., said they expanded their development collaboration and option and license commercialization agreement for S*BIO's JAK2 inhibitors, SB1518 (ONX 0803) and SB1578 (ONX 0805), which the firms said builds on their January 2009 development and commercialization collaboration. Under the expansion deal, Onyx is providing $20 million in funding to broaden and accelerate the existing development program for both compounds. The companies said the program is being expanded to include new indications for hematologic malignancies and myeloproliferative disorders. S*BIO will continue to perform the clinical development of SB1518 and preclinical through clinical development of SB1578.

• Sequenom Inc., of San Diego, said that following a hearing, the U.S. District Court for the Southern District of California entered an order approving the stipulation of settlement reached in the class-action securities lawsuits consolidated under the caption In re Sequenom, Inc. Securities Litigation, Master File No. 3:09-cv-00921 LAB-WMC.

• Sinovac Biotech Ltd., of Beijing, said its 30 percent-owned joint venture, Sinovac Dalian, has submitted an application to China's State Food and Drug Administration to begin human trials for its live-attenuated mumps vaccine. Sinovac said postapproval of a mumps vaccine, the company plans to commercialize a combination measles, mumps and rubella vaccine, which it said would be eligible for the government purchasing program. The firm said the R&D process for its rubella vaccine is progressing on schedule and the development plan for measles vaccine is under way.

• Trinity Biotech plc, of Dublin, Ireland, has closed its deal to dispose of its worldwide coagulation business to the Stago Group for $90 million, of which $67.5 million was paid on closing. A further $11.25 million will be paid on the first anniversary of closing, and the remaining $11.25 million on the second anniversary of closing. A further $4 million will be released to working capital following the collection of existing accounts receivables. Trinity has used the first tranche of the proceeds to repay all of its bank debts and to boost its cash reserves to in excess of $45 million.