• ApoCell Inc., of Houston, said it will use its target expression profile technology and immunohistochemistry expertise to analyze biomarkers in a Phase I clinical trial for New York-based Pfizer Inc. Terms were not disclosed.

• Calibrant Biosystems Inc., of Gaithersburg, Md., entered a research collaboration with the Cleveland Clinic. Calibrant will use its Gemini proteomics platform to identify protein networks and drug targets associated with glioblastoma multiforme. Financial terms were not disclosed.

• Cephalon Inc., of Frazer, Pa., said the FDA accepted its supplemental new drug application for Fentora (fentanyl buccal tablet) for the management of breakthrough pain in opioid-tolerant patients with chronic pain. The agency also notified the company that it will convene an advisory panel May 6 to consider the application. The FDA is not bound by the panel's decision but generally follows its recommendation. Cephalon said the PDUFA date is Sept. 13. Fentora was approved in 2006 for the management of breakthrough pain in patients with cancer who already are receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.

• Galapagos NV, of Mechelen, Belgium, said it will receive a €3.4 million (US$4.97 million) milestone payment from Janssen Pharmaceutica NV, of Titusville, N.J. The milestone was triggered by an achievement in the discovery-stage GT146 program, one of 19 possible rheumatoid arthritis targets covered under a potential $1 billion deal the two companies signed last year. (See BioWorld Today, Oct. 25, 2007.)

• IDM Pharma Inc., of Irvine, Calif., said the European Committee for Medicinal Products for Human Use (CHMP) said data recently presented by the company suggested a possible survival benefit of mifamurtide (L-MTP-PE), a drug to treat patients with nonmetastatic, resectable osteosarcoma. However, the firm said, CHMP requested clarification of the existing data to gain assurance about the quality of the data before drawing final conclusions from the data presented. The company is required to address a number of remaining questions relating to chemistry, manufacturing and controls. As a result of the CHMP's nonbinding opinion, the firm was granted a clock stop, or time extension, to allow the company additional time to respond to all the remaining questions regarding the MAA. IDM Pharma said it expects to receive a final opinion from the CHMP in the third quarter and a final decision from the European Commission in the fourth quarter.

• ImaRx Therapeutics Inc., of Tucson, Ariz., said the FDA has approved the company's most current lot release request for urokinase, which is the first lot to be released with extended expiration dating. Urokinase, ImaRx's first commercially available FDA-approved product, is a thrombolytic or clot-dissolving agent indicated for the treatment of acute massive pulmonary embolism.

• Labopharm Inc., of Laval, Quebec, signed a deal with iNova Pharmaceuticals Pty Ltd., of Sydney, Australia, for marketing and distribution of once-daily tramadol in Australia. Financial terms were not disclosed. The product has been launched in Europe and Canada, and Australian approval is anticipated in the first half of 2008. In the U.S., Labopharm's analgesic has received two approvable letters and been denied on appeal, but the company said a new statistical analysis may resolve the matter. Shares of Labopharm (NASDAQ:DDSS) rose 17 cents, or 14.5 percent, to close at $1.34 on Friday. (See BioWorld Today, June 4, 2007.)

• Medisyn Technologies Inc., of Minneapolis, received a Small Business Innovation Research Phase I grant from the Department of Defense to discover and develop nonsteroidal anti-inflammatory drugs with reduced gastrointestinal toxicity. The amount of the grant was not disclosed. Medisyn will use its Forward Engineering technology to identify lead candidates and pursue additional grants to support preclinical studies.

• TransTech Pharma Inc., of Bagsvaerd, Denmark, said it has acquired all rights from Novo Nordisk AS, also of Bagsvaerd, to a portfolio of drug candidates, including H3 receptor antagonists, PPARd agonists, and 11-beta HSD1 inhibitors, being developed to treat metabolic disorders. TransTech's current diabetes and obesity portfolio includes orally administered and novel therapeutic development candidates targeting PTP1b inhibitors, AgRP inhibitors, GLP1R agonists, AMPK activators and glucokinase activators.