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
Applied Biosystems Inc.'s automated DNA sequencers will be used in a project starting next week in England to identify the genetic pattern in bones thought to be those of Czar Nicholas II and his family. Applied Biosystems is sponsoring the project, which will employ the company's fully automated DNA sequencer, a one- lane sequencing process that uses refined, four-dye fluorescent labeling methods and produces what the company claims are very accurate results. The alleged czar's remains will
As the biotechnology stock indexes slipped, Cytogen Corp.'s stock was walloped Wednesday after its management reported disappointing European sales of its cancer imaging product. Shares of the Princeton, N.J., company (NASDAQ:CYTO) lost $3.50 to close at $15.75. The Chicago Board Options Exchange Biotech Index fell 1.970 to 141.6, and the AMEX Biotechnology Stock Index slid 3.29 to 149.06. Speaking to the New York Society of Security Analysts, Cytogen President Thomas McKearn said European
A proposal that patents be awarded on a first-to-file rather than a first-to-invent basis could help to eliminate time- consuming and costly patent interference court cases. That's the view of industry patent specialists.of a proposal, part of an advisory committee report to the Secretary of Commerce on U.S.patent law reform made public this week. Among the other proposals are that patents be published within 24 months of submission rather than after the patent has issued and that their
Sibia Inc. announced Wednesday a three-year collaboration with Ciba-Geigy Ltd. to develop potential central nervous system drugs from cloned human excitatory amino acid (EAA) receptors. The Swiss drug giant made a $2.5 million equity investment in privately held Sibia of La Jolla, Calif. A second investment in Sibia of equal size is expected within 18 months. Sibia declined to disclose Ciba's equity stake, except to say that it was less than 5 percent. Primary targets of the Ciba-Sibia
Genetics Institute Inc. said Wednesday it would proceed with a planned 80 percent expansion of an existing product development and manufacturing facility in Andover, Mass. GI of Cambridge, Mass., said the expansion is expected to cost $55 million and would add 168,000 square feet of space in two buildings to 210,000 square feet of existing facilities in Andover. The new facilities will also add about 200 employees to GI's payroll, now at about 700, by its expected completion in 1994. The costs
Proposed FDA user fees, specifically aimed at making the wheels of the drug review process spin more smoothly, cleared their first hurdle in Congress on Tuesday. A House subcommittee's unanimous vote started what some observers see as a legislative sprint for a bill that could put the FDA drug application fees in place as soon as Oct. 1. The bill, proposed by U.S. Reps. John Dingell, D-Mich., and Henry Waxman, D-Calif., calls for an initial $100,000 fee on a new drug approval (NDA) application
AgriStar Inc. of Conroe, Texas, said it was issued Canadian patent No. 1,305,933.covering a system for the cloning, micropropagation and preservation of plants and plant materials. It is based on technology using membranes that are permeable to gas and light but impermeable to liquids and bacterial contaminants. It is AgriStar's first foreign patent, though the company has three pending with the U.S. Patent and Trademark Office. The patent applies to the company's Integument and Method for
InnoVet Inc. of West Palm Beach, Fla., signed a letter of intent to acquire Cambridge Veterinary Services of Cambridge, England, InnoVet announced Tuesday. Terms of the agreement were not disclosed. CVS makes veterinary and human diagnostic, and bionutritional products, which it markets in the U.S., Europe and the Far East. InnoVet expects to complete the transaction within 180 days. (c) 1997 American Health Consultants. All rights reserved.
Both biotechnology stock indexes on Tuesday gave back nearly all the gains they made during the previous session, following the lead of the Dow Jones industrial average, which tumbled 48.90 points. Profit-taking and a concern that Germany's cut in its interest rate was not deep enough were blamed for the plunge in the overall market. The Chicago Board Option Exchange (CBOE) index of biotech stocks fell 2.93 points to close at 143.57, and the AMEX Biotechnology Stock Index lost more than it
SciClone Pharmaceuticals Inc. said Tuesday that it will start Phase III trials in Taiwan of its lead compound, Zadaxin, a single-drug treatment administered twice a week for 26 weeks to treat hepatitis B, in November. The company expects results from the blind, randomized, controlled trial of 150 patients in mid-1993, said Thomas Moore, chief executive officer and chairman of the San Mateo, Calif., company (NASDAQ:SCLN). The company also announced the formation of SciClone Taiwan
T Cell Diagnostics, a subsidiary of T Cell Sciences Inc. of Cambridge, Mass., has signed an agreement with Yamanouchi Pharmaceutical Co. Ltd. to market the subsidiary's in vitro diagnostic/monitoring product candidates in Japan and Taiwan. The products are designed to count specific white blood cell types. Cell counting provides clinicians with important information on the immune status of patients with infectious diseases, cancer and immune-related disorders. Under the agreement announced by
Artificial skin grafts are already being tried in the clinic for treating severe burns and chronic venous skin ulcers. The FDA approved expanded clinical trials of Advanced Tissue Sciences Inc.'s Dermagraft to treat decubitis and diabetic ulcers. It is already in human trials for treating severe burns and chronic venous skin ulcers. The La Jolla, Calif., company uses tissue engineering to re-create human skin, cartilage, bone marrow and liver. The initial target population for dermal replacement
One of the two men who developed effective vaccines against poliomyelitis 30 years ago declared Tuesday that effective vaccination against human immunodeficiency virus (HIV) is "improbable." Albert B. Sabin, whose oral, attenuated-virus polio vaccine has been in worldwide use for three decades, made his declaration in writing in the Sept. 15 edition of the Proceedings of the National Academy of Sciences (PNAS). "In my judgment, the available data provide no basis for ... expecting that any HIV
TPI Inc. of Lodi, N.J., will market Meridian Diagnostics Inc.'s products in mainland China -- "one of the largest potential medical marketplaces on the globe," said Jerry Ruyan Meridian's chief executive officer. Meridian (NASDAQ:KITS) of Cincinnati develops, manufactures and markets a variety of immunodiagnostic test kits -- including tests for infectious human diseases -- and purified immunoreagents. Meridian's products require little to no special instrumentation and can be used by hospitals
AgriDyne of Salt Lake City signed a five-year agreement with O.M. Scott & Sons Co. to develop and market its Turplex bioinsecticide. The agreement gives Scotts exclusive rights to market Turplex to the U.S. golf course and professional turf markets. AgriDyne retains the rights to market the product internationally and to a group of national lawn service companies. Turplex has proved to be effective against turf-damaging, surface-feeding insects such as cutworms, armyworms and sod webworms
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