Acella Pharmaceuticals LLC, of Atlanta, reported approval of an abbreviated new drug application (ANDA) for Tranexamic Acid Injection 1,000 mg/10 mL (100 mg/mL). The FDA determined that Acella's ANDA is bioequivalent to the reference listed drug, Cyklokapron (tranexamic acid; Pharmacia & Upjohn Inc.). Tranexamic acid is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. It will be manufactured by Bioindustria L.I.M. SpA in Italy.

Alnylam Pharmaceuticals Inc., of Cambridge, Mass., reported preclinical results at the International Conference on Complement Therapeutics in Olympia, Greece, showing that ALN-CC5, a subcutaneously delivered RNAi therapeutic targeting complement component C5 for complement-mediated diseases, led to an up to 98.7 percent knockdown of serum C5 and up to 96.8 percent inhibition of complement activity in nonhuman primates with weekly administration. ALN-CC5 uses the company's Enhanced Stabilization Chemistry-GalNAc-conjugate technology. Alnylam said it is on track to file an investigational new drug application late this year, with initial clinical results in mid-2015.

Aradigm Corp., of Hayward, Calif., said its common shares were approved for listing on Nasdaq. Trading on Nasdaq is set to start on June 11, and shares will be listed under the ticker ARDM.

Batu Biologics Inc., of San Diego, disclosed FDA development plans for its lead product, Vallovax, a cancer immunotherapeutic vaccine designed to target the endothelium and stimulate the immune system of patients suffering from cancer. Vallovax comprises isolated cells from the placenta, which are characterized and treated with a set of compounds to increase the immune system's ability to respond to the vaccine. The company plans to complete isolation and characterization of active cells in the placental preparation responsible for induction of anticancer immunity next month and to complete animal efficacy experiments in September aimed at identifying the optimum vaccine formulation. Animal safety studies are expected to wrap up in December, with an investigational new drug application filed in the first quarter of 2015 for testing in non-small-cell lung cancer.

Biodelivery Sciences International Inc., of Raleigh, N.C., said the FDA approved its new drug application for Bunavail (buprenorphine and naloxone) buccal film for maintenance treatment of opioid dependence as part of a complete treatment plan to include counseling and psychosocial support. Bunavail is expected to be launched in the third quarter.

Edison Pharmaceuticals Inc., of Mountain View, Calif. gained FDA orphan drug status for EPI-743 (vatiquinone) for the treatment of Leigh syndrome, an inherited lethal, progressive, predominately pediatric, neuromuscular disorder for which there are no approved treatments. Edison is testing the drug in a phase IIB randomized double-blind placebo-controlled trial in the U.S., and a combined phase IIb/III trial in Japan with its partner, Dainippon Sumitomo Pharma Co. Ltd., of Osaka, Japan. (See BioWorld Today, Feb. 3, 2014.)

Immunomedics Inc. of Morris Plains, N.J. reported that IMMU-132, its antibody-drug conjugate, achieved a second orphan drug designation from the FDA. The new designation, for treatment of pancreatic cancer, builds on the first for treatment of patients with small-cell lung cancer. IMMU-132 is a humanized antibody that binds to the trophoblast cell-surface antigen. Immunomedics shares (NASDAQ:IMMU) gained 26 cents Monday to close at $3.74. (See BioWorld Today, Aug. 15, 2013.)

MGB Biopharma Ltd., of Glasgow, Scotland, received a £1.3 million (US$2.2 million) grant from the UK's Technology Strategy Board's Biomedical Catalyst program to help fund a phase I trial of its lead candidate, MGB-BP-3, an oral therapy for Clostridium difficile. CEO Miroslav Ravic said he expects that the grant, along with additional funds the company is looking to raise, should allow MGB to start the trial by the end of 2014 or start of 2015. The company spun out of Strathclyde University in 2010. (See BioWorld Today, Apr. 28, 2010.)

Ophthalix Inc., a subsidiary of Can-Fite BioPharma Ltd., terminated development of CF101, an A3 adenosine receptor agonist, for the treatment of dry eye syndrome indication. The decision, based on a lack of correlation between patients' response to CF101 and overexpression of the drug target, follows last year's phase III trial failure, in which the drug met neither primary nor secondary efficacy endpoints in moderate-to-severe dry eye. Ophthalix, of Petach Tikva, Israel, is still developing CF101 for the treatment of glaucoma, with an ongoing phase II study in Israel and Europe. Meanwhile, the company said it's on the lookout for new ophthalmic drugs to in-license. Can-Fite shares (NYSE:CANF) gained 22 cents Monday to close at $4.18. (See BioWorld Today, Dec. 31, 2013.)

Pharmacyclics Inc., of Sunnyvale, Calif., said the FDA accepted its supplemental new drug application to support review of Imbruvica (ibrutinib) in the treatment of patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who have received at least one prior therapy. The application is based on data from a randomized, multicenter, open-label phase III trial, in which ibrutinib was compared head-to-head with Arzerra (ofatumumab, Genmab A/S). The PDUFA date is Oct. 7. Pharmacyclics shares (NASDAQ:PCYC) gained $3.57 Monday to close at $97.07. (See BioWorld Today, June 5, 2014.)

Rockwell Medical Inc., of Wixom, Mich., said it won its appeal for size determination as a small business and is now working with the FDA to have its $2.2 million PDUFA user fee for filing its new drug application for Triferic refunded. Triferic is an iron-replacement drug for treating iron deficiency in chronic kidney disease patients receiving hemodialysis. The company's NDA for the compound was accepted for filing by the FDA on May 28 with a PDUFA action date of Jan. 24, 2015.

Scinopharm Taiwan Ltd., of Tainan, Taiwan, and Taigen Biotechnology, of Taipei, Taiwan, jointly announced the signing of a manufacturing contract for the clinical supply of the API of Burixafor, a new chemical entity and stem cell mobilizer discovered and developed by Taigen.

Tetralogic Pharmaceuticals Corp., of Malvern, Pa., said results from its collaboration with the Walter and Eliza Hall Institute of Medical Research, of Melbourne, Australia, indicate that second mitochondrial activator of caspases (SMAC) mimetics, including its lead compound birinapant, may have broad applicability in the treatment of infectious disease. The company entered a license agreement with the Institute for worldwide exclusive rights to a patent application relating to a method of treating intracellular infections with administration of an inhibitor of apoptosis proteins. Previous preclinical studies performed at the Institute have indicated that birinapant decreases the viral burden in mice infected with human hepatitis B virus (HBV) by inducing apoptosis of virally infected liver cells resulting in the reduction of circulating HBV and surface antigen. Recent studies have extended these findings and indicate that other novel SMAC mimetics from the company's library share this activity in HBV.