Hafslund Nycomed AS, Molecular Biosystems Inc.'s European licensee, has filed a new drug application (NDA) for Albunex in the United Kingdom as part of the European Community multistate approval procedure. Albunex, a cardiac ultrasound imaging agent, has already been recommended for marketing by the U.S. FDA., and is also under review in Japan. Molecular Biosystems (NYSE:MB) of San Diego develops and manufactures contrast agents for medical imaging, including ultrasound, magnetic resonance and
Sepracor Inc. of Marlborough, Mass., has received exclusive rights from Research Corporation Technologies Inc. to sublicense a novel chiral synthesis technology invented by researchers at the University of Illinois.. Known as catalytic asymmetric epoxidation, the technology has been shown to facilitate the large-scale, cost-effective production of single-isomer pharmaceuticals. Sepracor will use the technology to produce single-isomer drugs that may have greater therapeutic and safety benefits
NeoRx Corp. and Sterling Winthrop Inc. said Monday they have signed a definitive agreement announced in June. Sterling Winthrop gains a nonexclusive license to use some of NeoRx's proprietary technology for labeling antibodies and other kinds of targeting proteins with therapeutic radiometals for cancer therapy. NeoRx also gave Sterling Winthrop exclusive rights to certain antibodies for use in radioimmunotherapy of cancer and nonexclusive rights to these antibodies for other forms of cancer
Glycomed Inc. of Alameda, Calif., announced Monday that it has agreed in principle with Alza Corp. (NYSE:AZA) to jointly develop implantable, controlled-release products for delivering drugs to heart surgery patients. The initial therapeutic products, said Alan R. Timms, Glycomed's (NASDAQ:GLYC) president and chief executive officer, will incorporate carbohydrate-based compounds that company scientists have made by chemically modifying heparin. One has anti-thrombotic properties, and the other
Ecogen Inc. of Langhorne, Pa., announced Monday a three-year, $9.5 million research agreement with Italy's 3A S.r.l. to develop biofungicide products. According to John Davies, Ecogen's chairman and chief executive, Ecogen will not give up any of its product rights and will not have to pay any royalties to 3A. Ecogen is essentially being paid to carry out its research at a state-of-the-art facility in Umbria, Italy, Davies said. "3A let us design our own lab space and equipment specifications
Alteon Inc. is wheeling in some experienced full-time help as one of the company's biggest challenges takes shape before the FDA -- moving its lead compound, aminoguanidine, over the regulatory hurdles. The drug is proposed as a treatment for reversing diabetic complications The Northvale, N.J.-based company announced last week that former FDA Commissioner Jere E. Goyan will join the company full-time as senior vice president of research and development on Jan. 4. Goyan, who has been an Alteon
Canguard Health Technologies Inc. of Vancouver, British Columbia, announced Friday that it has completed a private placement of 200,000 units at C15 cents (about 12.3 cents U.S.) each. The units consist of one common share and one warrant. The warrants are exercisable to buy common shares at U.S.12.3 cents for one year from the date of unit purchase. All stock so purchased must be held for a year. Canguard was recently granted $30,000 by the Canadian government to investigate means for
Collaborative Research Inc. of Waltham, Mass., has been awarded a $500,000 award from the National Cancer Institute to develop a DNA probe test for the prediction of the debrisoquine metabolism phenotype. The grant began Sept. 1. The company intends to develop a polymerase chain reaction- based test that would be able to diagnose the status and form of the gene in more than 98 percent of the population. The current test covers 95 percent. The status of the gene can determine risk for
Several stocks showed hefty gains over the past four weeks, led by Biogen (BGEN), which was up almost 44 percent by Friday from its close of $22.75 a share on Aug. 31. The AMEX Biotechnology Stock Index and the Chicago Board Options Exchange closed Friday at 152.97 and 145.09, respectively, down slightly from where they were a month ago, at 150.49 and 142.68, respectively. "Biogen has done really well, and people have upped their interest on the news of its big royalty streams," said Joseph
Proposed FDA drug application fees top a busy agenda of biotechnology-related issues before Congress this week. The FDA fee package, which is expected to collect $330 million over five years for improvements to the agency's drug-review process, could clear the Congress "as early as Thursday or Friday," said Lisa Raines, vice president of governmental affairs for the Industrial Biotechnology Association (IBA) of Washington, D.C., which helped draft the bill. With broad industry backing and
Imutec Corp. of Toronto said Wednesday it observed no toxic side effects from the 570 injections of Virulizin in 22 pancreatic cancer patients in its Phase II safety and efficacy studies in Canada and Mexico. The company has proposed the drug as an alternative to chemotherapy and therapeutic radiation. Imutec said that in the 17 patients studied for efficacy, Virulizin extended the normal three-to-six-month median survival rate from diagnosis to between eight and 27 months. Tests showed that
Biotechnology companies that have been unable -- or chose not -- to enter the cold public offering market since last April are devising alternative strategies for enticing capital from investors who appear to be tightly gripping their wallets. "This year's been a little more work in raising money than in the past," said David Robison, Calypte Biomedical Corp.'s president and chief executive. The company is looking for up to $10 million in a third-round private-placement funding. But Robison
MedChem Products Inc. of Woburn, Mass., named Jonathan D. Donaldson chief executive officer. Donaldson has been president of the company since 1986. David Swann will become chief executive officer of Anika Research Inc., MedChem's hyaluronic acid research and development subsidiary, while retaining his positions as chairman of the board and chief scientific officer at MedChem. The company also promoted Edward F. Covell to executive vice president and chief operating officer, Bradford Gay to
Immunomedics Inc. of Morris Plains, N.J., said it has had favorable results from its monoclonal antibody-based imaging agents to detect colorectal cancers, lung cancers and lymphomas, the company said Thursday. ImmuRaid-CEA identified occult cancers in more than 70 percent of patients in whom tumors were strongly suspected and pinpointed the most likely sites of tumors in more than 40 percent of the cases. A second study provided enhanced cancer detection in 50 percent of patients and
NeoRx Inc. expects to formally announce today the start of both a clinical trial and a strategic collaboration focused on a colon cancer therapeutic that targets malignant cells with a completely human monoclonal antibody (MAb). NeoRx of Seattle said its partner, Organon International B.V., will finance clinical trials of the therapeutic, which this month entered a Phase I clinical trial at the Virginia Mason Medical Center in Seattle. In addition, Organon agreed to make licensing and milestone
Two biotechnology companies dedicated to gene therapy are about to acquire exclusive rights to novel cloning vehicles developed at the National Institutes of Health. The Federal Register recently announced that Theragen Inc. of Ann Arbor, Mich., would obtain from the NIH Office of Technology Transfer (OTT) a royalty-bearing license to U.S. Patent No. 4,797,368, "Adeno-Associated Virus as Eukaryotic Expression Vector." The company will limit the vector's use to "gene therapy treatments for
U.S. Bioscience Inc. said Thursday that it filed for marketing approval of Ethyol with the European Community's Committee on Proprietary and Medicinal Products (CPMP) and the health ministries of the individual EC member nations. As a designated high-technology product, the chemoprotective and radioprotective agent qualifies for review under an EC provision that grants a drug developer 10 years of marketing exclusivity upon marketing approval. A U.S. FDA advisory committee last February failed
North American Biologicals Inc. of Miami has been awarded a multiyear plasma supply contract, valued at $45 million for the first two years, from a multinational biologicals company based in Europe. North American Biologicals did not name the company. The contract, which begins after the current $10 million contract expires at the end of this year, is mostly for source plasma. The company said it is responding to increased worldwide demand for plasma products through new donor recruitment
Alkermes Inc. of Cambridge, Mass., was awarded two grants by the National Institutes of Health through the Small Business Innovation Research (SBIR) program to continue research into delivery of pharmaceuticals across the blood-brain barrier. One of the grants, for two years and $500,000, covers the continued testing the delivery of nerve growth factor to the brain in advanced animal models. Nerve growth factor has been proposed as a therapeutic for neurodegenative disorders such as Alzheimer's
Jack A. Roth of the M.D. Anderson Cancer Center in Houston on Wednesday requested FDA approval of human trials for an antisense gene therapy treatment. This would be the first in vivo antisense clinical trial, Jordan U. Gutterman, chairman of the department of clinical immunology and biological therapy at M.D. Anderson told Bioworld. The Recombinant DNA Advisory Committee on Tuesday granted permission for the treatment involving 14 patients suffering from non-small cell carcinoma of the lung
Hafslund Nycomed AS, Molecular Biosystems Inc.'s European licensee, has filed a new drug application (NDA) for Albunex in the United Kingdom as part of the European Community multistate approval procedure. Albunex, a cardiac ultrasound imaging agent, has already been recommended for marketing by the U.S. FDA., and is also under review in Japan. Molecular Biosystems (NYSE:MB) of San Diego develops and manufactures contrast agents for medical imaging, including ultrasound, magnetic resonance and