• AdvanDx Inc., of Woburn, Mass., said it received FDA 510(k) clearance for E. coli/P. aeruginosa PNA FISH to identify Escherichia coli and/or Pseudomonas aeruginosa directly from positive blood cultures. The company said the test is the first-ever cleared for identifying E. coli and P. aeruginosa directly from positive blood.

• Amylin Pharmaceuticals Inc., of San Diego, said shareholder Icahn Capital LP and affiliated funds plan to nominate a slate of five directors to stand for election at the company's 2009 annual meeting, though the company had not yet received the required notice with respect to that action. Amylin said its corporate governance committee is in the process of recommending a slate of nominees for election and is reviewing potential nominees, including two that had been discussed with representatives of the Icahn funds. Icahn Capital is headed by billionaire investor Carl Icahn, who previously gained control of New York-based ImClone Systems Inc. in much the same manner, by gaining board seats. ImClone was acquired last year by Eli Lilly and Co., of Indianapolis, in a $6.5 billion deal. (See BioWorld Today, Oct. 7, 2008.)

• Biota Holdings Ltd., of Melbourne, Australia, said partner GlaxoSmithKline plc, of London, was awarded a UK Department of Health contract for 10.6 million treatment courses of Relenza (zanamivir), a neurominidase inhibitor approved for treating influenza. Financial terms were not disclosed, but Biota estimated that the contract could represent a royalty income of up to A$18 million (US$11.4 million).

• Bristol-Myers Squibb Co., of New York, said sales of its Erbitux cancer drug have been hurt by confusion over whether patients should first take a genetic test to predict if the medicine would be effective. Erbitux, developed by ImClone Systems Inc., now a division of Eli Lilly and Co., of Indianapolis, works best on patients with a normal version of a gene called KRAS, which helps regulate cell division. But up to half of patients with a mutated KRAS are not likely to benefit. Both ImClone and Amgen Inc., of Thousand Oaks, Calif., asked an FDA panel to include retrospective biomarker data in the labeling of their colon cancer drugs to inform doctors and patients that there were no responses in study participants with KRAS mutant tumors, about 30 to 50 percent of patients. (See BioWorld Today, Dec. 17, 2008.)

• Enzon Pharmaceuticals Inc., of Bridgewater, N.J., became the latest company to come under fire from shareholders over what they call lack of value. Knott Partners and affiliated funds, which own about 1.8 million shares of Enzon, have criticized the company for "missteps" and recommended certain actions. Noting that the stock price has declined from a high of more than $17 in 2004 to its recent price of approximately $6.60, the shareholders asked that the company: Institute an aggressive share buyback plan; hold a "legitimate auction" for the entire company or at least the entire specialty pharmaceutical business; license out one or more Phase I programs; and communicate better with shareholders, industry professionals and potential investors.

• Exact Sciences Corp., of Marlborough, Mass., said it received a determination from the Nasdaq stock market that it has regained compliance.

• Immunomedics Inc., of Morris Plains, N.J., reported that a single amino acid change in the binding region of veltuzumab improved its potency in preclinical lymphoma models. Results from the preclinical study, which was supported in-part by a grant from the National Cancer Institute, were published in the Jan. 29, 2009, issue of Blood. Veltuzumab, a next generation anti-CD20 antibody, was constructed using the same donor frameworks as epratuzumab, the company's humanized anti-CD22 antibody.

• Pozen Inc., of Chapel Hill, N.C., said the FDA confirmed that gastric ulcer incidence is an acceptable primary endpoint for the company's clinical programs. Those programs include PN 400, which is partnered with London-based AstraZeneca plc and is a fixed-dose combination of enteric-coated naproxen with immediate-release esomeprazole in development for treating symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients at risk for developing NSAID-associated gastric ulcers. A new drug application submission for PN 400 is planned for the middle of this year. The FDA's decision came about three months after it informed Pozen that it was reviewing the acceptability of gastric ulcers as primary endpoints in clinical studies. (See BioWorld Today, Oct. 20, 2008.)

• Progen Pharmaceuticals Ltd., of Brisbane, Australia, said its board of directors has unanimously recommended approval of the proposed merger with Avexa Ltd., of Melbourne, Australia, which was announced in December 2008. Progen said its shareholders will receive extensive information in early February on the proposed buyback offer of A$1.10 per share and the proposed merger. (See BioWorld Today, Dec. 23, 2008.)

• Santarus Inc., of San Diego, submitted a new drug application for an immediate-release, buffer-containing, tablet formulation of its proton pump inhibitor, Zegerid (omeprazole/sodium bicarbonate). The NDA was submitted under the 505(b)(2) pathway, and Santarus hopes to launch the product in the fourth quarter. Zegerid capsules and powder are approved for symptoms associated with gastroesophageal reflux disease, erosive esophagitis and ulcers.