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BIOGEN LEADS THE PACK
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 JosephBioWorld Today | Monday, September 21, 1992 -
FDA FEES BILL TOPS BUSY WEEK ON HILL
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 andBioWorld Today | Monday, September 21, 1992 -
IMUTEC REPORTS CANCER DRUG RESULTS
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 thatBioWorld Today | Monday, September 21, 1992 -
ALTERNATIVE STRATEGIES FOR RAISING CAPITAL
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 RobisonBioWorld Today | Friday, September 18, 1992 -
MEDCHEM RESTRUCTURES MANAGEMENT
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 toBioWorld Today | Friday, September 18, 1992 -
IMMUNOMEDICS REPORTS RESULTS
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 andBioWorld Today | Friday, September 18, 1992 -
NEORX HOPES TO TURN CORNER
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 milestoneBioWorld Today | Friday, September 18, 1992 -
NIH TO LICENSE CLONING VEHICLE
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 forBioWorld Today | Friday, September 18, 1992 -
U.S. BIO SEEKS EUROPEAN APPROVAL
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 failedBioWorld Today | Friday, September 18, 1992 -
NORTH AMERICAN GETS $45M CONTRACT
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 recruitmentBioWorld Today | Friday, September 18, 1992 -
ALKERMES GETS 2 SBIR GRANTS
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'sBioWorld Today | Thursday, September 17, 1992 -
REQUEST FOR 1st ANTISENSE GENE THERAPY TRIAL
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 lungBioWorld Today | Thursday, September 17, 1992 -
ABI TO HELP ID RUSSIAN CZAR
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 willBioWorld Today | Thursday, September 17, 1992 -
CYTOGEN STOCK SLUMPS
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 EuropeanBioWorld Today | Thursday, September 17, 1992 -
FIRST-TO-FILE PATENT MAY CUT COURT TIME
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 theirBioWorld Today | Thursday, September 17, 1992 -
SIBIA TO COLLABORATE WITH CIBA-GEIGY
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-SibiaBioWorld Today | Thursday, September 17, 1992 -
GI EXPANDS MANUFACTURING PLANT
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 costsBioWorld Today | Thursday, September 17, 1992 -
FDA FEE BILL PASSES KEY HURDLE
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) applicationBioWorld Today | Wednesday, September 16, 1992 -
AGRISTAR ISSUED CANADIAN PATENT
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 forBioWorld Today | Wednesday, September 16, 1992 -
INNOVET TO ACQUIRE CAMBRIDGE VETERINARY
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.BioWorld Today | Wednesday, September 16, 1992
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