• Apogenix GmbH, of Heidelberg, Germany, said its research programs have received two grants totaling €1.65 million (US$2.38 million) from the German Federal Ministry of Education and Research. Under the terms of the first grant, Apogenix s research collaboration partner at Stuttgart University will receive €500,000 of a grant totaling €1.35 million to study the potential application of stable, apoptosis-inducing ligands of the tumor necrosis factor superfamily for therapeutics against tumors. Another collaboration with the Junior Group Molecular Neurobiology at the German Cancer Research Center will receive €300,000 to study Apogenix' lead candidate APG101 in a new indication, glioblastoma multiforme.

• Bioheart Inc., of Sunrise, Fla., said preclinical data demonstrate that adipose-derived stem cells injected into the hearts of rats following a heart attack resulted in evidence of cardiomyocyte regeneration. Shares of Bioheart (NASDAQ:BHRT) rose 33 cents, or 14 percent, to close at $2.71 on Friday.

• CapitalBio Corp., of Beijing, and the Centre for Proteomic & Genomic Research, of Cape Town, South Africa, are collaborating in the field of genomic medicine and biomarker discovery. Under the agreement, the Chinese biotech will grant the center access to its complete microarray assay platform, including biochip readers, together with a range of proprietary DNA microarrays. In return, CPGR will form a reference center for CapitalBio microarray applications in Southern Africa, including custom-designed applications for tuberculosis strain typing and drug resistance testing.

• Enobia Pharma Inc., of Montreal, said it has received orphan drug designation from the FDA for ENB-0040, an enzyme replacement therapy for hypophosphatasia, a rare, life-threatening genetic bone disease.

• The FDA in its Sept. 18 online Drug Safety Newsletter reported that a postmarket safety review of Revlimid (lenalidomide), marketed by Celgene Corp., of Summit, N.J., identified 14 cases of serious skin reactions, including reports of Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme, associated with its use. Revlimid, an analogue of thalidomide, was approved to treat patients with transfusion-dependent anemia and for use in combination with dexamethasone for the treatment of multiple myeloma in patients who had received at least one prior therapy for their myeloma.

• Graffinity Pharmaceuticals GmbH, of Heidelberg, Germany, and European Molecular Biology Laboratory, also of Heidelberg, were awarded €900,000 (US$1.3 million) in research funding from the German Ministry of Research and Education for the discovery of novel fragment- and structure-based drug discovery technologies to address protein-protein-interaction drug targets.

• iBioPharma Inc., of Newark, Del., selected a plant-produced influenza vaccine as its lead development candidate. The company said it has obtained favorable preclinical data and expects to file an investigational new drug application in the second quarter of 2009. Its plant-based production is designed to address scalability, cost and efficiency issues associated with current flu vaccine production.

• InNexus Biotechnology Inc., of Vancouver, British, Columbia, and St. Joseph's Hospital and Medical Center, of Phoenix, said they are collaborating on the development of treatments for women with endometriosis. Scientific activities of the partnership will be conducted in facilities of both St. Joseph's Hospital and Medical Center and InNexus' Good Lab Practice certified drug development laboratories with funding provided by research grants, the partners and strategic collaborators.

• Napo Pharmaceuticals Inc., of South San Francisco, and Direct Relief International have allied to provide a development stage pharmaceutical product to pediatric patients in disaster situations and resource-constrained geographies. Napo will provide Crofelemer, a late-stage gastro-intestinal agent which treats watery diarrhea, at cost to DRI for distribution to developing countries where cholera and other gastro-intestinal diseases are prevalent. DRI's commitment to distribute the product will depend upon the successful registration of crofelemer as an FDA approved product.

• NovaDel Pharma Inc., of Flemington, N.J., said the FDA requested an extension of up to three months to review the company's 505(b)(2) application for Zolpimist (zolpidem tartrate) oral spray for insomnia. The new action date is Dec. 19, 2008. Zolpimist is bioequivalent to Ambien (zolpidem, Sanofi-Aventis Group). Shares of NovaDel (AMEX:NVD) gained 7 cents, or 25 percent, to close at 21 cents on Friday

• Roche AG, of Basel, Switzerland, and its co-development partner Chugai Pharmaceutical Co. Ltd., of Tokyo, a firm controlled by Roche, said the FDA issued a complete response letter for Actemra (tocilizumab), an interleukin-6 receptor-inhibiting monoclonal antibody, as a treatment for adults with moderately to severely active rheumatoid arthritis. The companies said the FDA is not requiring any new clinical studies for the drug, but wants additional documentation related to the manufacturing of Actemra and certain other outstanding components, such as final labeling. Roche and Chugai said they will work with the FDA to address any outstanding matters.