• Amarin Corp., of Dublin, Ireland, said the FDA may once again delay a decision on whether triglyceride-lowering drug Vascepa (icosapent ethyl) qualifies for five-year exclusivity as a new chemical entity. Based on communications with the agency earlier this month, Amarin does not expect the August 2012 supplement to the Orange Book, to be released Friday, to include an entry about the prescription-grade fish oil, according to an SEC filing. The decision is crucial to holding off generic competition for the drug, which was approved in July. (See BioWorld Today, July 27, 2012, and Aug. 6, 2012.)

• Cell Therapeutics Inc. (CTI), of Seattle, is rolling out its European launch of Pixuvri (pixantrone) this month with initial entry into Denmark, Finland and Sweden. The launch will continue next month in Austria and Norway, with marketing to begin in November in Germany, the Netherlands and the UK. CTI plans to expand to other European countries next year. Granted conditional marketing authorization by the European Commission in May, Pixuvri is the first drug licensed in the European Union to treat adults with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma. Shares (NASDAQ:CTIC) were up 38.5 percent on the news, or 99 cents, closing at $3.56 Tuesday.

• Cold Genesys Inc., of Irvine, Calif., reached agreement with the FDA under a special protocol assessment for a proposed Phase II/III pivotal BOND (Bladder Oncolytic virus for Non-muscle invasive bladder cancer Disease) trial of intravesical CG0070 in non-muscle invasive bladder cancer patients with carcinoma-in-situ with Ta and/or T1 who previously failed BCG (Bacillus Calmette-Guerin, a standard intravesical treatment) and refused cystectomy. In 2008, CG0070 was tested by South San Francisco-based Cell Genesys Inc. in a Phase I/II trial in 35 patients with non-muscle invasive bladder cancer. In 2010, Cold Genesys acquired the intellectual property rights related to CG0070 from Cell Genesys, following its merger with Lincolnshire, Ill.-based BioSante Pharmaceuticals Inc. in 2009.

• Helix BioMedix Inc., of Bothell, Wash., filed a Schedule 13E-3 and related preliminary proxy statement with the SEC in connection with a proposed reverse stock split designed to result in the suspension of the company's public reporting obligations under the Securities and Exchange Act. In conjunction with the reverse 1:300 split of the company's common stock, stockholders owning fewer than 300 shares would be cashed out at a price of 60 cents per pre-split share and will no longer be company stockholders. After completion of the reverse stock split, if Helix has fewer than 500 stockholders of record, it intends to suspend reporting obligations under the Exchange Act by filing a Form 15 with the SEC, relieving it of requirements to comply with the Sarbanes-Oxley Act and to file periodic reports with the SEC, including annual and quarterly reports. The company's common stock would no longer be quoted on the OTCQB, but Helix expects shares to be traded on the Pink Sheets. On Tuesday, the company's shares (OTCQB:HXBM) gained 11 cents, jumping 58 percent, to close at 30 cents.

• InterMune Inc., of Brisbane, Calif., said the Comite Economique des Produits de Sante (CEPS) granted reimbursement for Esbriet (pirfenidone), making it the first drug for the treatment of idiopathic pulmonary fibrosis (IPF) to be reimbursed in France. The drug's price is expected to be published in France's Journal Officiel in the fourth quarter. The CEPS authorized an ex-factory reimbursed price of €1,923 (US$2473) for a four-week treatment pack of the drug, corresponding to €25,000 per patient per year. Esbriet will be reimbursed by the French National Health Insurance system in mild-to-moderate forms of IPF in adults. (See BioWorld Insight, Jan. 3, 2011.)

• Navidea Biopharmaceuticals Inc., of Dublin, Ohio, said it received a complete response letter from the FDA on its new drug application (NDA) for Lymphoseek (technetium Tc 99m tilmanocept) injection. The receptor-targeted radiopharmaceutical, designed to identify the lymph nodes that drain from a primary tumor, has been studied in lymphatic mapping procedures performed to help stage breast cancer and melanoma. The company said the FDA's concerns related to issues with third-party contract manufacturing and not to efficacy or safety data filed in the NDA. On Tuesday, Navidea shares (NYSE:NAVB) lost 87 cents, or 24.8 percent, closing at $2.64.

• OncoSec Medical Inc., of San Diego, secured an exclusive license for patented technology from the University of South Florida Research Foundation related to the delivery of gene-based therapeutics through intratumoral and intramuscular electroporation. The company said the patent is directly related to ongoing Phase II trials in metastatic melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma using its ImmunoPulse therapy and extends patent protection for the technology to 2024. Financial terms were not disclosed.

• Osmotica Pharmaceutical Corp., of Wilmington, N.C., said Hungarian subsidiary Osmotica Kft. executed a strategic alliance agreement with Panacea Biotec Ltd., of New Delhi, India, for the research, development and commercialization of brand and generic products in the U.S. and strategic global markets. Panacea Biotec will lead product development and manufacturing while Osmotica will lead product registration and legal matters as well as commercialization. Products developed under the collaboration are expected to be sold under an Osmotica and Panacea Biotec label, based on equal sharing of risk, investment and profits by the companies. Financial terms were not disclosed.

• Pro Bono Bio Group plc, of London, reported the successful conclusion of a series of preclinical trials in hemophiliac subjects conducted with subcutaneous, long-acting blood Factors VIIa, VIII and IX. The biotech plans to optimize the products to provide the first prophylactic once-a-week regimens via shallow subcutaneous injections.