• Biogen Idec, of Weston, Mass., said the FDA and European Medicines Agency accepted its marketing applications for review of BG-12 (dimethyl fumarate), for multiple sclerosis. The applications are based on positive data from the DEFINE and CONFIRM Phase III trials. BG-12 is also being evaluated in a long-term Phase III extension study, ENDORSE.

• Cell Therapeutics Inc., of Seattle, received conditional marketing authorization from the European Commission for Pixuvri (pixantrone) as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas. Pixuvri is the first approved treatment in the European Union in this patient setting.

• Nasdaq informed EntreMed Inc., of Rockville, Md., it regained compliance with Listing Rule 5550(b), which requires companies to have a minimum $2.5 million in stockholders equity, $35 million in market value of listed securities or $500,000 net income from continuing operations.

• Galena Biopharma Inc., of Lake Oswego, Ore., received notification that RXi Pharmaceuticals Corp.'s stock will commence trading under the symbol RXII. That completes the spinout of Worcester, Mass.-based RXi from Galena, which was announced in Sept. 2011.

• Immuron Ltd., of Melbourne, Australia, signed an agreement with IntegraMed Asia for sale of Travelan in Thailand, Hong Kong, Cambodia, Vietnam and Laos for traveler's diarrhea. The company said it has been found to be up to 90 percent effective in preventing traveler's diarrhea. IntegraMed is required to gain regulatory approval for the sale of Travelan in those countries, and to sell specific minimum volumes.

• Repros Therapeutics Inc., of The Woodlands, Texas, met with the Division of Reproductive and Urologic Products to discuss registration requirements for Androxal, for secondary hypogonadism. The FDA said safety data for 100 subjects exposed for one year, and 800 subjects exposed for six months would be adequate. The company has data on 70 subjects for one year and 150 subjects for six months. Repros contended that secondary hypogonadism causes more than 90 percent of incidences of low testosterone in the U.S.

• Teijin Pharma Ltd., of Tokyo, launched febuxostat, for hyperuricemia of gout, in Taiwan. The drug will be marketed there by Astellas Pharma Taiwan Inc., part of Astellas Pharma Inc., of Tokyo, under the brand name Feburic. Teijin licensed Taiwan rights to febuxostat to Astellas in 2009, and in 2011 Astellas obtained marketing approval from the Taiwan Department of Health.

• The Federal Trade Commission requested additional information and documentary material from Spectrum Pharmaceuticals Inc., of Henderson, Nev., and Allos Therapeutics Inc., of Westminster, Colo., under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, relating to the acquisition of Allos by Spectrum. Both parties are cooperating with the FTC's investigation. As a result, Spectrum has extended the offer period of its previously announced tender offer to purchase all outstanding shares of Allos for $1.82 per share in cash. It was previously scheduled to expire at midnight on May 10, but will now expire on May 24. (See BioWorld Today, April 6, 2012.)

• Theratechnologies Inc., of Montreal, began a preclinical safety program for TH1173, a growth hormone-releasing factor in development for metabolic disorders. The compound already has shown superior pharmaceutical properties to tesamorelin, and has potential for subcutaneous, nasal and dermal routes of delivery. Theratechnologies plans to begin clinical testing in the first quarter of 2013.