• Alexion Pharmaceuticals Inc., of Cheshire, Conn., said the FDA granted its request for priority review of a supplemental biologics license application for Soliris (eculizumab) in atypical hemolytic uremic syndrome (aHUS). That could make the drug available to patients in the fourth quarter. Soliris also is under review in Europe for use in aHUS. Soliris, a terminal complement inhibitor, previously gained approval for paroxysmal nocturnal hemoglobinuria.

• BioAlliance Pharma SA, of Paris, said the company filed an appeal to the French Supreme Court on a procedural matter in arbitral proceedings it had initiated against SpePharm Holding BV, of Amsterdam, the Netherlands, and SpeBio BV, which the two companies formed as a joint venture to commercialize Loramyc in Europe (excluding France) under a 2007 agreement. The Paris Court of Appeals earlier had rejected an appeal by BioAlliance to overturn two tribunal decisions stemming from BioAlliance's termination of a licensing and supply agreement and ordered BioAlliance to refund nearly $719,000 in legal costs to SpePharm and SpeBio. (See BioWorld Today, March 5, 2010.)

• Through a combination of program support from Princeton, N.J.-based BioWa Inc., and antibody technologies from Immunocellular Therapeutics Ltd., of Los Angeles, a new biotechnology company, Caerus Discovery LLC, has been launched. Based in Manassas, Va., Caerus will identify differentially expressed targets using adjuvants, high zone tolerance and subtractive immunization. ICT received equity in the new company, while BioWa is taking away rights to future technologies developed by Caerus.

• Cell Therapeutics Inc., of Seattle, regained compliance with Nasdaq's minimum bid price rule after having been notified previously that it was out of compliance. CTI's stock (NASDAQ:CTICD) will continue to trade on the Nasdaq stock market.

• Diamyd AB, of Stockholm, Sweden, said it regained rights to diabetes therapy Diamyd from Ortho-McNeil-Janssen Pharmaceuticals, a subsidiary of New Brunswick, N.J.-based Johnson & Johnson. Diamyd had licensed rights to J&J last year in exchange for a nonrefundable $45 million payment. The decision to terminate the collaboration followed disappointing data from a Phase III trial showing that Diamyd failed to meet its primary endpoint of preserving beta cell function at 15 months in patients newly diagnosed with Type I diabetes. In separate news, the firm also said it would not complete the follow-up period for the Phase III study. Diamyd's liquid assets as of Feb. 28, amounted to SEK474 million (US$76.1 million). The company's stock (Stockholm:DIAM-B) fell nearly 12 percent, or SEK1.40, to close Wednesday at SEK10.55. (See BioWorld Today, June 23, 2010, and May 10, 2011.)

• Evotec AG, of Hamburg, Germany, acquired South San Francisco-based Compound Focus Inc., a division of BioFocus, part of Galapagos NV. Compound Focus specializes in small-molecule design and automated storage. Evotec will pay Galapagos $14.74 million and a potential $3.23 million in performance-based milestones. Evotec said the acquisition would help in supporting partner compound libraries, improve its hit identification capabilities and boost overall company earning.

• Generex Biotechnology Corp., of Worcester, Mass., announced that it intends to dividend a portion of the shares it receives upon completion of a definitive licensing agreement to license its RapidMist buccal drug delivery technologies to Amarantus BioScience Inc., of Sunnyvale, Calif., and will seek Generex shareholder approval of a reverse stock split proposal. Amarantus will pay a license fee of $10 million to Generex in Amarantus common stock valued at not less than $5 million and a three-year promissory note.

• Orexigen Therapeutics Inc., of San Diego, saw shares jump 18 percent Wednesday on news that will disclose a regulatory update before markets open Friday. Orexigen received a complete response letter for its obesity drug Contrave (naltrexone HCl/bupropion) early this year and recently submitted a proposal to the FDA to address the agency's concerns about cardiovascular risks. Contrave is partnered with Osaka, Japan-based Takeda Pharmaceutical Co. Ltd. Shares of Orexigen (NASDAQ:OREX) gained 51 cents to close at $3.34. (See BioWorld Today, Feb. 2, 2011.)

• Pfizer Inc., of New York, said the European Medicines Agency accepted its filing for axitinib in patients with renal cell carcinoma after failure of prior systemic treatment. Axitinib is a selective inhibitor of VEGF receptors 1, 2 and 3.

• PPD Inc., of Wilmington, N.C., received a $45.5 million U.S. Army contract to provide global regulatory and biostatistical services for Army clinical development projects. The contract covers a five-year period starting April 15, and will support Army clinical, biodefense and vaccine initiatives. PPD has been a contractor with the U.S. government for 21 years and has collaborated on more than 900 government and public health projects.

• RegeneRx Biopharmaceuticals Inc., of Rockville, Md., reported that researchers found Thymosin beta 4 (Tβ4), in a dose-dependent manner, stimulated oligodendrogenesis, the process by which central nervous system (CNS) progenitor cells (immature specialized brain cells) become oligodendrocytes that secrete myelin, the covering of nerve fibers. This process is important for the repair, regeneration and function of CNS tissue damaged by disease or trauma. Findings were presented at the Society of Academic Emergency Medicine annual meeting in Boston.

• Repligen Corp. completed a pre-new drug application (NDA) meeting with the FDA for its imaging product, RG1068. The Waltham, Mass.-based company is developing RG1068, a synthetic form of human secretin that stimulates the pancreatic ducts to fill with water, for magnetic resonance imaging of the pancreas. The outcome of the meeting was that Repligen will submit its NDA as previously planned.

• Tioga Pharmaceuticals Inc., of San Diego, said the FDA has granted fast-track designation to its irritable bowel syndrome candidate, asimoadoline. The drug is in a Phase III trial for diarrhea-predominant IBS, which is being carried out under a special protocol assessment from the FDA.

• The FDA granted orphan drug status to recombinant human erythropoietin by XTL Biopharmaceuticals Ltd., of Herzliya, Israel, for multiple myeloma. The drug is in a Phase II trial for that indication.