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Other News To Note(BioWorld Today Via Acquire Media NewsEdge) , of San Marino, Calif., said Rexin-G has been granted orphan drug status by the FDA for the treatment of all soft tissue sarcomas. This is the third clinical indication for which Rexin-G has received the designation. The designation provides seven years of market exclusivity, a reduction in fees and taxes, and additional regulatory support for ongoing R&D initiatives. ? GlobeImmune Inc., of Louisville, Ky., has signed a cooperative research and development agreement with the National Cancer Institute at the National Institutes of Health to jointly develop products to treat a variety of cancers. GlobeImmune will use its Tarmogen technology to develop multiple immunotherapy products expressing various cancer antigens provided by the NIH, and the NIH will conduct and fund preclinical and early clinical development of the product candidates. ? Health and Human Services Secretary Mike Leavitt today announced two new programs aimed at improving the safety of imported food and medical products. The first initiative is a pilot project in which the FDA and its counterparts in the European Union and Australia will jointly plan, allocate for and conduct inspections of drug-manufacturing facilities. The project will initially focus on makers of active pharmaceutical ingredients. If successful, it could expand to include other types of manufacturing facilities. The second initiative is a third-party certification pilot program involving farm-raised shrimp. The government is seeking the participation of bodies that certify foreign processors of farm-raised shrimp for compliance with the FDA's seafood regulations. The project is designed to help federal agencies learn how to evaluate third-party certification programs and implement them in the field. The steps were revealed at an Import Safety Summit in Washington. ? Immatics Biotechnologies GmbH, of Tuebingen, Germany, has named Paul G. Higham as CEO effective Aug. 1. He previously served as director of commercial development at Ark Therapeutics Group plc where he was responsible for commercial strategy and all business development activities. ? ImmunoCellular Therapeutics Ltd., of Los Angeles, has exclusively licensed from Cedars-Sinai Medical Center certain novel peptides that the company believes can stimulate the immune system to target cancer stem cells in gliomas. These peptides were specifically designed to elicit a T-cell response targeting CD133 positive cancer stem cells that have been identified in a number of cancer types, including gliomas, colon cancer and pancreatic cancer. ? ImQuest Life Sciences, of Frederick, Md., has received National Institutes of Health funding to define the mechanism of action of its dual-acting pyrimidinedione HIV inhibitor IQP-0410. The objective of this one-year Small Business Innovative Research award is to allow ImQuest scientists to better understand how the pyrimidinediones inhibit the replication of HIV. The amount of the grant was not disclosed. ImQuest plans to submit an investigational new drug application to the FDA in the third quarter to initiate Phase I trials. ? MorphoSys AG, of Martinsried, Germany, said Boehringer Ingelheim GmbH, of Mannheim, Germany, has exercised a pre-existing option to use MorphoSys's RapMAT technology as part of the existing technology transfer agreement between the two companies. As a result, Boehringer Ingelheim will have access to MorphoSys's RapMAT technology module alongside the existing installation of the company's proprietary antibody library HuCAL GOLD at Boehringer Ingelheim's research site in Vienna, Austria. MorphoSys will receive annual user fees for the RapMAT technology and for access to its HuCAL platform. Financial details were not disclosed. ? Prana Biotechnology Ltd., of Melbourne, Australia, said recently published research shows that its lead Alzheimer's Disease drug, PBT2 found that it profoundly and rapidly improved cognition in transgenic mice, prevented the formation of soluble abeta oligomers, substantially reduced the amount of all forms of abeta in the transgenic mouse brain, over a nine week period, within hours of oral administration significantly lowered soluble (interstitial) abeta in the brain, and protected neurons in living brain tissue from the toxic effects of abeta which impairs the signaling between neurons in Alzheimer's disease. The results were published in the journal Neuron and will be presented at the International Conference on Alzheimer's Disease July 29 in Chicago. ? Pro-Pharmaceuticals Inc., of Newton, Mass., entered into an agency agreement with Sanghyon Chemical, of Seoul, South Korea, to represent the company with major pharmaceutical companies in Korea. Sanghyon Chemical will provide for the registration of Davanat with the Korean FDA and marketing and sales support for the licensing and distribution of Davanat to treat cancer with chemotherapy drugs. ? Rentschler Biotechnologie GmbH, of Laupheim, Germany, will invest ?14 million in the expansion of its Laupheim site. Recently a ?50 million investment in biotechnological development and production facilities was completed. Construction has begun on a logistics center and the expansion of the administrative building. In a related move, Rentschler Holding GmbH & Co. KG has sold all shares of Rentschler Pharma GmbH to Riemser Arzneimittel AG, of Riems, Germany. ? Sigma-Aldrich Corp., of St. Louis, and Sangamo BioSciences Inc., of Richmond, Calif., have entered a research and license agreement to provide F. Hoffmann LaRoche, of Basel, Switzerland, with non-exclusive, worldwide rights for the use of its proprietary zinc finger nuclease (ZFN) technology to develop cell-lines and transgenic animals that have targeted modifications in a specified gene in a specified species. Roche also has an option to obtain an exclusive, worldwide license for the commercial use of such ZFN-generated transgenic animals in the production of therapeutic and diagnostic products. The research phase of the agreement will be conducted in collaboration with both Sangamo and Sigma-Aldrich, Sangamo's exclusive licensee of ZFN technology for high-value research reagents. ? Uluru Inc., of Addison, Texas, said it has signed a definitive agreement to acquire privately held wound care company Bio Med Sciences Inc., of Allentown, Pa., for $10 million, subject to adjustment based on revenue targets. The purchase price will be paid in two installments, $7 million at closing and $3 million six months after closing. At the election of the company, up to $3 million of the purchase price can be paid in company common stock. The company plans to fund the acquisition through internally generated funds supported by revolving and term debt. ? Upstream Biosciences Inc., of Vancouver, British Columbia, said it has entered into a collaboration with McGill University's Institute of Parasitology in Montreal, Quebec, to begin in vitro testing of the company's second generation of drug candidates for the potential treatment of tropical diseases leishmaniasis, trypanaosomiasis (African sleeping sickness) and malaria. ? Wyeth, of Madison, N.J., said the European Commission has approved marketing authorization for a new 50mg Enbrel (etanercept) once weekly dosage regimen as an alternative to the currently approved 25mg Enbrel twice weekly regimen for the treatment of patients with moderate-to-severe plaque psoriasis. The decision was based on the outcome of the European 318 study in adult patients with moderate-to-severe plaque psoriasis. Enbrel is marketed in Europe by Wyeth, and in North American by Amgen Inc., of Thousand Oaks, Calif., and Wyeth. ? Znomics Inc., of Portland, Ore., said it has entered a collaborative research program with Oregon Health & Science University and Thomas Scanlan, director of its chemical biology program, to design and develop pre-clinical compounds to treat diseases such as rheumatoid arthritis, asthma and inflammatory bowel syndrome. Under the research agreement, Znomics will fund the program and will have the option to exclusively license the rights to the discoveries. ? ? Copyright ? 2008 Thomson BioWorld, All Rights Reserved. |