Abbott Laboratories announced on Monday that the FDA has given marketing approval for an automated test for monitoring cyclosporine drug levels. TDx Cyclosporine Monoclonal Whole Blood assay was launched in Europe in 1990, according to spokeswoman Traci Lance. Cyclosporine is a powerful immunosuppressive drug administered to transplant recipients to reduce the risk of organ rejection. It is necessary to monitor and regulate cyclosporine blood levels throughout the recipient's lifetime to
Amgen Inc. has filed its first FDA marketing application in more than a year, seeking to extend indications for its Neupogen granulocyte colony stimulating factor to treat severe chronic neutropenia, including congenital, acquired or cyclical neutropenias. Neupogen, a white blood cell stimulator, was approved in February 1991 to prevent infection as an adjunct to chemotherapy. The Thousand Oaks, Calif., company (NASDAQ:AMGN) had previously stated that its next products would be added
Scientists at Immunex Corp. have cloned the convertase enzyme that makes interleukin-1, and have pinpointed its gene to a region on chromosome 11 that is involved in certain forms of cancer. The cytokine is implicated in septic shock, wound healing and the growth of certain leukemias. "The finding that the convertase gene maps to band 11q23 raises the possibility that altered production of the (enzyme) contributes to some of these disease states," the scientists and colleagues at Thomas
Oclassen Pharmaceuticals Inc., which in-licenses drugs for development, has filed for an initial public offering of 2.5 million shares of common stock with a proposed price range of $12 to $14 per share. The San Rafael, Calif., company develops products originally discovered by pharmaceutical companies and research institutions, which typically have conducted at least limited human trials. Its focus is drugs to treat bacterial and viral diseases, with an initial emphasis on dermatology and
Although Immunex Corp. shares staged a small rebound Friday, gaining $1.13 to $32.63 after plunging $10.50 on Thursday, the AMEX Biotechnology Index closed the week seeking a new bottom. Friday's closing of 162.79 was off nearly 10 percent for the week. The index has attained its base of 200 only three times since the beginning of March. (c) 1997 American Health Consultants. All rights reserved.
Stanford University researchers have reported mixed results of Phase I clinical testing of their myoblast transfer technique to treat Duchenne's muscular dystrophy. The therapy is aimed at compensating for a missing or defective muscle protein, dystrophin, by injecting patients with healthy muscle cells. In the disease, a genetic defect results in insufficient quantities of the protein, leading to severe muscle wasting and death in early adulthood. The researchers reported last week in Nature
James M. Gower, a former senior vice president at Genentech Inc., has been named president and chief executive officer of Tularik Inc., a Menlo Park, Calif., developer of transcription factor-based therapeutics. David J. Gury, president and chief operating officer of North American Biologicals Inc., has been named chief executive officer. The Miami company (NASDAQ:NBIO) provides human blood plasma elements to the health care industry. Oncor Inc. has named David Ledbetter vice president of
Neogen Corp. has received a $250,000 National Science Foundation grant to develop an immunoassay that may enable producers and packers to choose more precisely when to harvest pome fruits such as apples and tomatoes to preserve taste and freshness. The Lansing, Mich., company (NASDAQ:NEOG) is developing a kit to detect pAp5, a protein that governs the natural ripening process. If a fruit contains the protein, it can be stored and ripened later. If the protein isn't present, the fruit will be
Bio-Rad Laboratories Inc. has lost a patent infringement suit against Pharmacia Inc. for monoclonal antibody purification technology. A jury in U.S. District Court in San Francisco found last week that Pharmacia did not infringe Bio-Rad's U.S. patent No. 4,704,366. The jury also invalidated the patent on grounds of obviousness, anticipation and failure to disclose the best mode for practicing the invention. The '366 patent, issued in 1987, covers a process to purify MAbs using Protein A with a
The stock market sheared 25 percent off the value of Immunex Corp.'s shares on Thursday after the company announced that it would post a loss instead of a profit for the first quarter and not meet previous expectations for the year. The Seattle company's stock (NASDAQ:IMNX) fell $10.50 to $31.50. Immunex also said that it was suing co-marketing partner Hoechst AG and its subsidiaries Behringwerke AG and Hoechst Roussel Pharmaceuticals Inc. for breach of contract, business interference and
Hycor Biomedical Inc. has received FDA clearance to market a new version of its allergy tests that cuts in half the time required for results. The Garden Grove, Calif., company's enzyme immunoassay can detect 250 specific allergies by measuring antigens in patients' blood, using a patented monoclonal and polyclonal antibody technology. The new version takes only one day, compared with two days for the previous system. The new tests will not be more expensive, the company said. Its stock
Ribi ImmunoChem Research Inc. said Thursday that it has sold 1.3 million units of common stock and warrants for $11 million in a private placement with Hambrecht & Quist Inc. and D. Blech & Co. Inc. Each unit consists of one share of common stock (NASDAQ:RIBI) and a warrant to purchase one-half share of stock. The warrants are exercisable immediately at $11.55 per share. They expire three years from the closing date or 30 days following notice from the company that the stock has achieved
WASHINGTON -- Sen. Mark Hatfield on Thursday introduced legislation mandating a three-year moratorium on biotechnology patents, and then withdrew it before the measure was put to a vote as part of a deal negotiated with the Senate leadership. The Oregon Republican said he is fighting to shift the responsibility for biotechnology policy making from the administration to the Congress. Wall Street and the Patent and Trademark Office have by default been given the power to determine what
Biovail Corp. International, a developer of sustained-release drug delivery products, said that it has filed for an initial public offering of 2.7 million shares of common stock with a proposed price of $11 to $13 per share. Of the shares being sold, 2.3 million are being sold by the Toronto company and 400,000 are being sold by Trimel Corp., Biovail's sole shareholder. If the offering is completed, Trimel, a holding company that also has a medical electronics information division, will hold
PerSeptive Biosystems Inc. has filed for an initial public offering of 2.5 million shares of common stock priced between $11 and $13 per share. The Cambridge, Mass., company develops, manufactures and markets products for the purification and analysis of biomolecules. PerSeptive markets a Perfusion Chromatography system to analyze proteins rapidly and a related Modular Surface Chemistries product that coats the Perfusion media. The company has raised $11.4 million in venture funds since 1988
Genetic Therapy Inc. said it has licensed the gene for interleukin-1beta (IL-1B) from Cistron Biotechnology Inc. for use in genetic therapies for cancer. Genetic Therapy (NASDAQ: GTII) will make undisclosed up- front and royalty payments. The license gives GTII worldwide exclusive use of the gene for genetic therapies to treat cancer, according to Marc Schneebaum, GTII's chief financial officer. It does not cover use of the gene for other applications. The cytokine is involved in regulating
Biomira Inc. on Thursday said it would consolidate its diagnostics production and marketing operations with its ADI Diagnostics Inc. affiliate. ADI will be responsible for manufacturing and distributing Biomira's Truquant products, including three in vitro diagnostic kits to detect gastrointestinal, ovarian and breast cancers, and a human anti-mouse antibody (HAMA) diagnostic. Biomira will receive royalties and other payments. The transfer will allow Biomira to focus on development of its
WASHINGTON -- Sen. Mark Hatfield planned to introduce legislation today that would place a three-year moratorium on the issuance of patents on all genetic materials. The iconoclastic Republican's proposal has elicited a flurry of activity this week aimed at sidetracking the bill, a proposed amendment to the budget reauthorization of the National Institutes of Health. A proposed compromise was not finalized on Wednesday. The legislation would impose a three-year moratorium on patents for "human
Regeneron Pharmaceuticals Inc. on Wednesday said it has filed to begin Phase I trials of its ciliary neurotrophic factor (CNTF) as a treatment for amyotrophic lateral sclerosis. CNTF is a protein that binds to the surface receptors on motor neuron cells that control muscles, and which degenerate in ALS patients. The binding sets off signal transduction events in the cell, leading to changes in gene expression that ultimately support the survival of the motor neuron cells, said Mark Furth, vice
Seragen Inc. became the third consecutive reduced-price biotech IPO on Wednesday, raising $36 million through the sale of 3 million shares of common stock at $12 a share. The offering, which was slashed from a proposed price of $17 to $20, follows scaled-down prices on offerings by CytoTherapeutics Inc. (NASDAQ:CTII) and Telios Pharmaceuticals Inc. (NASDAQ:TLIO). Seragen shares (NASDAQ:SRGN) closed at $12.25 on Wednesday. The Hopkinton, Mass., company is developing drugs based on fusion
Abbott Laboratories announced on Monday that the FDA has given marketing approval for an automated test for monitoring cyclosporine drug levels. TDx Cyclosporine Monoclonal Whole Blood assay was launched in Europe in 1990, according to spokeswoman Traci Lance. Cyclosporine is a powerful immunosuppressive drug administered to transplant recipients to reduce the risk of organ rejection. It is necessary to monitor and regulate cyclosporine blood levels throughout the recipient's lifetime to