• Amylin Pharmaceuticals Inc., of San Diego, Eli Lilly and Co., of Indianapolis, and Alkermes Inc., of Waltham, Mass., responded to an FDA request with additional data showing that Bydureon does not slow heart rates. The FDA made its request in 2010. The companies expect to receive an updated PDUFA date within two weeks.

• Cardium Therapeutics, of San Diego, updated its plan for acquisition of La Jolla, Calif.-based Transdel Pharmaceuticals Inc.'s business assets in connection with Transdel's Chapter 11 bankruptcy process. Transdel and Cardum requested that the bankruptcy court approve the sale under section 363 of the bankruptcy code. A creditor of Transdel has opposed the sale, leading to a denial of the motion for expedited approval.

• Cell Therapeutics Inc., of Seattle, received guidance from the FDA's Division of Oncology Drug Products regarding its complete response letter for pixatrone. It will resubmit its new drug application based on PIX 301 data without the need for additional clinical trials. CTI said that the drug could receive approval as early as April 2012.

• The FDA's Center for Biologics Evaluation and Research advised Dynavax Technologies Corp., of Berkeley, Calif., three consecutively manufactured lots of Heplisav hepatitis B vaccine had demonstrated clinical consistency. With confirmation of lot consistency for its Phase III trial, the company can now move forward to prepare a biologics license application for hyporesponsive populations older than 40. Dynavax stock, (NASDAQ:DVAX) closed at $2.84, up 41 cents, or 16.9 percent on Thursday. (See BioWorld Today, July 21, 2011.)

• Merlin Nexus and New Leaf Venture Partners (NLV), stockholders in Durham, N.C.-based Icagen Inc., have contested the planned $56 million acquisition by Pfizer Inc., of New York. The group of stockholders said in a letter to Icagen's board that the purchase price undervalues Icagen's assets. (See BioWorld Today, July 21, 2011.)

• Ironwood Pharmaceuticals Inc., of Cambridge, Mass., licensed worldwide rights to Depomed Inc.'s Acuform, a gastric retentive drug delivery technology. Menlo Park, Calif.-based Depomed will participate in early product formulation, with Ironwood responsible for all development and commercialization of any resulting product. Ironwood will pay an up-front license fee, with additional potential payments based on development and regulatory milestones, as well as royalties on product sales.

• Permeon Biologics Inc., of Cambridge, Mass., reported the discovery of a new class of naturally occurring human supercharged proteins. The sequence and structure of the proteins enable biologics, such as monoclonal antibodies and enzymes, to penetrate and function inside cells to treat disease. The new class is the foundation of Permeon's Intraphilin technology platform, licensed from Harvard University. The technology fuses therapeutic proteins to Intraphilins so they can penetrate cells by stimulating the natural pathway for cell uptake by endocytosis. Data about the new proteins were published online in Chemistry & Biology.

• Soligenix Inc., of Princeton, N.J., expanded its North American licensing partnership with Sigma-Tau Pharmaceuticals Inc., of Rome, for the development and commercialization of orBec (oral beclomethasone dipropionate) in Europe. The amended agreement includes a $5 million up-front payment to Soligenix, along with a possible $11 million in milestones and 40 percent royalties on net sales. Soligenix will supply the drug and maintain worldwide manufacturing rights. All commercialization expense in Europe will be borne by Sigma-Tau. The first milestone, $2 million, will be paid upon the successful completion of a confirmatory Phase III trial of orBec for the treatment of acute gastrointestinal graft-vs.-host disease.

• Viamet Pharmaceuticals Inc., of Research Triangle Park, N.C., reported that its oral antifungal agent for the treatment of cryptococcal meningitis has been selected for inclusion in the National Institutes of Health's Therapeutics for Rare and Neglected Diseases (TRND) program. With the financial support of the TRND program, Viamet expects to be able to rapidly advance the development of the therapy.