• Accentia Biopharmaceuticals Inc., of Tampa, Fla., said the FDA granted fast-track status to SinuNase, the company's intranasal amphotericin B formulation. SinuNase is the only drug candidate for chronic sinusitis to receive fast-track status, it said. Accentia now is eligible to submit a new drug application on a rolling basis, allowing the FDA to review sections of the NDA in advance of receiving Accentia's full submission and permitting Accentia to apply for expedited review of its NDA. Accentia is preparing to begin a Phase III placebo-controlled trial to treat post-surgical patients suffering from recurrent CS. The study is intended to be a four-month, double-blind comparison of symptomatic relief vs. placebo.

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., said it signed a Cooperative Research and Development Agreement with the U.S. Army Medical Research Institute of Infectious Diseases to discover RNAi therapeutics targeting viral organisms, including hemorrhagic fever viruses. Alnylam's initial drug development programs are focused on Direct RNAi therapeutics, which are siRNAs administered directly to diseased parts of the body. The company also is developing Systemic RNAi therapeutics that travel through the bloodstream to reach diseased parts of the body.

• Amgen Inc., of Thousand Oaks, Calif., said it filed a complaint with the U.S. International Trade Commission requesting an investigation of F. Hoffmann-La Roche Ltd.'s importation of pegylated recombinant human erythropoietin into the U.S. Amgen said the importation is unlawful because peg-EPO and the manufacturing method are covered by Amgen's EPO patents. Amgen is asking the ITC to issue a permanent exclusion order that would prohibit importation. Amgen anticipates the ITC will decide whether to institute a formal investigation within 30 days.

• Cell Signaling Technology Inc., of Beverly, Mass., entered a third agreement with AstraZeneca plc, of London, under which it will continue to use its PhosphoScan technology to identify phosphorylation profiles and prospective biomarkers of kinase-targeted lead compounds. The PhosphoScan proteomics technology enables the discovery of drug target phospho-profiles in cells and disease tissues.

• 4SC AG, of Planegg-Martinsried, Germany, and the Institute of Molecular Virology of the University of Münster, Germany, said they will collaborate in the development of an agent for treating influenza virus infections. The agreement will extend research activities, and will include other types of viruses to demonstrate the safety and efficacy of suitable active agents in subsequent preclinical and clinical studies.

• Genentech Inc., of South San Francisco, posted earnings per share of 46 cents for the first-quarter period ended March 31, topping consensus estimates by 5 cents. The company's earnings were boosted by a 36 percent year-over-year increase in operating revenues, to about $1.99 billion, and $1.64 billion in total product sales, a 39 percent increase over last year's first quarter. Cancer drugs accounted for a large portion of those sales: Rituxan (rituximab) generated U.S. sales of $477 million, an 8 percent increase; U.S. sales of Avastin (bevacizumab) increased 96 percent to $398 million; U.S. sales of Herceptin (trastuzumab) were up 123 percent to $290 million; and Tarceva's (erlotinib) U.S. sales increased 94 percent to $93 million. Going forward, the company forecast higher earnings, projecting about 45 percent to 55 percent growth in non-GAAP earnings per share for the full year due primarily to revised internal forecasts for product sales and royalty revenue. Separately, Genentech filed a supplemental biologics license application with the FDA for Avastin in combination with platinum-based chemotherapy for first-line treatment of advanced, non-squamous, non-small-cell lung cancer. The company also plans to seek further label expansion for the treatment of metastatic breast cancer later this quarter. The drug already is approved as a first-line treatment of metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy.

• Labopharm Inc., of Laval, Quebec, said its recently completed multicenter Phase III trial of its once-daily formulation of tramadol achieved statistical significance for the primary endpoint of pain intensity. The results of the study will be added to the company's NDA for once-daily tramadol in the U.S., which currently is under review by the FDA. Enrollment in the trial consisted of patients diagnosed with moderate to severe pain associated with osteoarthritis of the knee.

• Meridian Bioscience, Inc., of Cincinnati, said it has reached a settlement with Astra Srl, of Sanremo, Italy, regarding Meridian's patented technology for detecting H. pylori, the primary cause of peptic ulcers. In the agreement, Astra acknowledges the existence, validity and scope of Meridian's patent, EPO 0806667. Astra also agreed to cease all promotion and distribution of its infringing products and for any existing customers, to replace the Astra product with Meridian HpSA product.

• Metabasis Therapeutics Inc., of San Diego, said it expects to work with Valeant Pharmaceuticals International Inc., of Costa Mesa, Calif., to maximize the market potential of pradefovir for the treatment of hepatitis B. The comment came in response to the announcement by Valeant, Metabasis' partner, that it planned to out-license pradefovir as part of an overall restructuring of Valeant's operations. Valeant has advised Metabasis that Valeant plans to continue the development of pradefovir through the initiation of Phase III trials while it seeks a partner to complete development and potential commercialization.

• Neoprobe Corp., of Dublin, Ohio, said it has completed a submission to the FDA to respond to information requested by the agency regarding both preclinical toxicity studies and the chemistry, manufacturing and control issues surrounding the commercial production of Lymphoseek. The submission to the FDA included characterization studies of the drug substance, testing protocols and testing validation studies of the final drug product. Lymphoseek is intended to be used as a lymphatic tissue-targeting agent in biopsy procedures for the detection of lymph nodes in breast and melanoma cancers.

• Selexis SA, of Geneva, said it entered into a nonexclusive relationship agreement with Henogen SA, of Charleroi, Belgium. Under the agreement, Henogen will have access to the Selexis technology platform and will have the right to use the Selexis engineered cell lines at its production facility to produce proteins and antibodies for product research, development and manufacturing.