• BioLineRx Ltd., of Jerusalem, presented preclinical data demonstrating that BL-1040, a resorbable implant to treat acute myocardial infarction, improved cardiac function and prevented deterioration of myocardium in a pig study. The data were presented at the Transcatheter Cardiovascular Therapeutics conference. In June, BioLineRx submitted a request to European regulators to begin Phase I/II studies.

• Can-Fite BioPharma Ltd., of Petach Tikva, Israel, reported that preclinical studies of CF102, its drug for viral hepatitis and liver cancer, was shown to be effective in promoting liver tissue regeneration following partial hepatectomy. The drug is designed to specifically attack liver tumors and hepatitis-infected cells, and Can-Fite is preparing to move the CF102 into Phase I testing in the first quarter of 2008.

• Cardium Therapeutics Inc., of San Diego, said its subsidiary InnerCool Therapies Inc. entered an exclusive license agreement with the University of Texas Health Science Center at Houston for the development and commercialization of Caffeinol for acute ischemic stroke. Caffeinol is a combination of ethanol and caffeine developed by the university. The NIH's National Institute of Neurological Disorders and Stroke has proposed a Phase IIa stroke trial combining Caffeinol with InnerCool's endovascular hypothermia technology and tissue plasminogen activator (tPA).

• Ceragenix Pharmaceuticals Inc., of Denver, said preclinical data indicated systemic administration of CSA-13 prevented sepsis in rats exposed to endotoxin. Previous preclinical data have shown CSA-13 to be effective against various bacterial strains. The drug is a synthetically produced small-molecule known as a Ceragenin compound and is designed to bind the cell membranes of certain viruses, fungi and bacteria. The data were presented at the Society for Leukocyte Biology annual meeting.

• Cytori Therapeutics Inc., of San Diego, said a preclinical study demonstrated that injection of adipose-derived stem and regenerative cells following a heart attack did not increase the incidence of arrhythmia compared to saline control. The data were published in EuroPace, a journal of the European Society of Cardiology.

• Genzyme Corp., of Cambridge, Mass., said it has completed its acquisition of Bioenvision Inc., of New York, in an all-cash transaction valued at $5.60 per share, or about $345 million. Bioenvision shares have ceased trading, and the company will be delisted from Nasdaq. Fifty-six percent of Bioenvision's issued and outstanding shares of common stock and preferred stock, voting together as a single class on an as-converted basis, supported the merger. That represents approximately 67 percent of the total shares voted.

• NexMed Inc., of East Windsor, N.J., filed a new drug submission seeking approval in Canada for its topical drug alprostadil for erectile dysfunction. The agency is expected to accept or refuse the filing within 45 days and then review the drug within 300 days. NexMed filed a new drug application with the FDA last month.

• OSI Pharmaceuticals Inc., of Melville, N.Y., and F. Hoffmann-La Roche Ltd., of Basel, Switzerland, received approval for Tarceva (erlotinib) in Japan for refractory treatment of recurrent non-small-cell lung cancer (NSCLC). The Japanese launch is expected in early 2008. Tarceva was approved by the FDA in 2004 for refractory treatment of NSCLC and has since gained approval in more than 80 countries. It also is FDA-approved for metastatic pancreatic cancer.

• Raptor Pharmaceuticals Corp., of Novato, Calif., acquired from Convivia Inc. various assets including a product candidate targeting aldehyde dehydrogenase (ALDH2) deficiency. Raptor also announced the formation of a wholly owned subsidiary called Bennu Pharmaceuticals Inc. to manage clinical development of in-licensed and internally developed product candidates. Ted Daley, former founder and CEO of Convivia, will serve as Bennu's president. Bennu intends to file an investigational new drug application seeking to begin a Phase II trial in 2008 for the ALDH2 deficiency drug, which is an oral formulation of an intravenous product approved for another indication.

• Sequella Inc., of Rockville, Md., said the FDA and the European Medicines Agency each granted SQ109 orphan drug status for tuberculosis. As an orphan drug, SQ109 could gain regulatory and financial assistance and would guarantee seven years and 10 years of marketing exclusivity upon approval in the U.S. and Europe, respectively. SQ109, a diamine anti-TB drug, has demonstrated in vitro and in vivo activity against drug-susceptible and drug-resistant TB bacteria and has shown an ability to synergize with other TB drugs in experimental animal models.

• Sinovac Biotech Ltd., of Beijing, entered a purchase agreement with the Beijing Public Health Bureau for Sinovac's seasonal influenza vaccine Anflu. The drug is distributed in China by Sinovac and its partner GlaxoSmithKline (China) Investment Co. Ltd., a subsidiary of GlaxoSmithKline, of London. Terms of the deal were not disclosed.