• Accentia Biopharmaceuticals Inc., of Tampa, Fla., acquired exclusive worldwide rights to autoimmune disease drug Revimmune from Revimmune LLC. Accentia is preparing an investigational new drug application for severe refractory multiple sclerosis and is proposing a Phase III clinical trial program to support licensure under the 505(b)(2) regulatory pathway. The drug, which was developed at Johns Hopkins University School of Medicine, delivers a high intensity, short course of intravenous cyclophosphamide to re-boot the immune system by temporarily eliminating peripheral immune cells while selectively sparing bone marrow stem cells. Separately, Accentia entered an agreement for a four-year term, $20 million convertible debenture financing with several institutional investors.

• Advancis Pharmaceutical Corp. of Germantown, Md., says it has reached agreement with the FDA on additional information required for its new drug application to be accepted. Last month the company received a "refusal to file" letter from the FDA for the company's once-daily Amoxicillin PULSYS new drug application. The FDA said the application did not include a proposed commercial batch record or a detailed commercial process description with process parameters and in-process controls. Amoxicillin is indicated for a range of infections, but is not approved for a once-daily dosing in pharyngitis. The company said it anticipates providing the additional information this month, and it expects final FDA review to be completed in January. Under that timetable, the company said it expects commercial launch of the product in late February 2008.

• Athersys Inc., of Cleveland, said it successfully produced a clinical-grade master cell bank and initial product doses intended to support clinical trial activities of MultiStem in 2007 and 2008. The master cell bank and dose production runs were completed by Lonza Group Ltd., of Basel, Switzerland. MultiStem is a multipotent adult progenitor cell-based product being developed in a number of indications.

• EpiVax Inc., of Providence, R.I., said it received a $368,157 Innovative Research Grant from the National Institute of Neurological Disorders and Stroke, a division of the National Institutes of Health. The grant will fund studies on reengineering botulinum toxin, a protein used for cosmetic purposes and for movement disorders. The goal is to show a reengineered botulinum toxin protein does not cause antibody responses in a special strain of humanized mice. EpiVax will use its Deimmunization of Functional Therapeutics protein-redesign technology in the effort.

• EPIX Pharmaceuticals of Lexington, Mass., has filed a formal appeal with the FDA seeking approval of its blood-pool imaging agent Vasovist. The filing included a request that an advisory committee be considered as part of the appeal process. The compound has been approved in the European Community, Canada, Norway, Iceland, and Australia for the visualization of abdominal and peripheral vascular disease and in Switzerland for magnetic resonance angiography (MRA) of the whole body, but has encountered three denials by the FDA. The agency has asked for more information relating to the comparator scans used in past clinical trials - non-contrast MRA that the FDA recommended for comparative use prior to the studies and the statistical treatment of uninterpretable images.

• Evotec AG, of Hamburg, Germany, and Interprotein Corp., of Amagasaki-City, Japan, signed a collaboration to develop Interprotein's interleukin-6 (IL-6) inhibitors program for inflammatory disease. Evotec will use its expertise in medical chemistry, computational chemistry and profiling to optimize compounds discovered using Interprotein's in silico drug design. Financial terms were not disclosed.

• Molecular Partners of Zurich, Switzerland, has signed a collaboration with Roche, of Basel, Switzerland, for designed repeat protein (DRP) technology for a variety of undisclosed applications. Molecular will select DARPins to a variety of targets provided by Roche, and Roche will do analyses and development. Financial terms also were not disclosed. DARPins are a novel class of binding proteins based on Molecular's technology.

• Salix Pharmaceuticals Ltd., of Raleigh, N.C., purchased U.S. rights to Pepcid oral suspension and Diuril oral suspension from Whitehouse Stations, N.J.-based Merck & Co. Inc., for $55 million up front and up to $6 million in potential sales-based milestone payments. Salix also entered a credit facility with Bank of America NA for up to $100 million to help finance that transaction, as well as for working capital, capital expenditures, other acquisitions and general corporate purposes. The company has borrowed about $15 million at this time.

• Symbollon Pharmaceuticals Inc., of Framingham, Mass., said German regulatory authorities agreed to allow the company to submit its ongoing Phase III study of IoGen in support of regulatory marketing approval for moderate to severe cyclic breast pain and tenderness associated with fibrocystic breasts. The German agency did, however, request a non-rodent species, repeat-dose toxicity study and a combined fertility and reproductive rodent development study. Symbollon anticipates conducting those studies prior to its planned regulatory submission in 2009.

• The Biotechnology Industry Organization in Washington said actor Michael J. Fox, founder of The Michael J. Fox Foundation for Parkinson's Research, will deliver the keynote address at the 2007 BIO International Convention on May 7 at the Boston Convention & Exhibition Center. The convention runs May 6-9. Fox's address is titled, "Driving the Development and Availability of Novel Therapies," and will address strategies to "de-risk" investment in biotechnology products.

• The Mayo Clinic in Rochester, Minn., said researchers safely transplanted cardiac preprogrammed embryonic stem cells into diseased hearts of mice, successfully regenerating infarcted heart muscle without precipitating the growth of a cancerous tumor. To avoid tumor formation, researchers secured guided differentiation of stem cells to produce cardiopoietic cells. Two months after cardiopoietic stem cell transplantation, a 35 percent improved output was reported in the treated hearts. Results of the study are published in the Journal of Experimental Medicine.

• TM Bioscience of Toronto says an Ontario court has approved a plan to complete the acquisition of TM by Luminex Corp. of Austin, Texas. In December the companies announced they had entered into a definitive agreement in which each TM Bioscience share would be exchanged for 0.06 shares of Luminex common stock. At the time that represented a 41.5 percent premium. Shareholders and optionholders of TM Bioscience approved the sale on Feb. 23, and the closing is expected immediately. Tm shareholders will own about 9 percent of Luminex outstanding stock.

• Valentis Inc., of Burlingame, Calif., received a letter from Nasdaq stating that the company did not regain compliance with the minimum price bid requirement for continued listing during the 180-day grace period allowed by Nasdaq. The company received a letter in August indicating that the price had closed below $1 per share for 30 consecutive business days. A hearing is set for today before the Nasdaq's qualifications panel to determine Valentis' continued listing.