Last year's user fee legislation, sponsored by Senators Edward Kennedy, D-Mass., and Orrin Hatch, R-Utah, would provide FDA with the funds needed to unclog the drug pipeline. By one estimate, without the legislation, it could have taken up to 13 years to process all pending biotech drug applications. But money is needed to jump-start the program while FDA waits for user fees to begin to flow. In a hearing last night before a subcommittee of the House Appropriations Committee, Richard Godown
Companies customarily communicate a quarterly earnings report to their shareholders and potential investors. Here is BioWorld's learning report, an overview of salient scientific advances in biotechnology during the first quarter of 1993, keyed to reports in BioWorld: Three areas of applied research -- cancer, neuroscience and AIDS -- led the field in January, February and March: CANCER: -- "Co-stimulation" was the buzzword in three separate journal reports describing a new strategy for
Ribi ImmunoChem Research Inc. announced Thursday that it has formally withdrawn its proposed public offering of 3 million common shares. The Hamilton, Mont. company's (NASDAQ:RIBI) decision was made following further consultation with Hambrecht & Quist Inc., the underwriter for the proposed offering, as well as with other financial consultants. "Maintaining registration of the proposed stock offering amid a generally weak market for biotech issues served only to distract attention from
Clinical trials and tribulations overshadowed more positive announcements coming from the biotech community for a good part of 1993's first quarter. The year got off on a resoundingly sour note in mid-January, when Centocor Inc. (NASDAQ:CNTO) announced that it had halted the second Phase III trials on its flagship drug, Centoxin (HA-1A), for treating septic shock because it was killing people in one arm of the study. As a result, the Malvern, Pa., company's stock dropped 63 percent, or $11.13
Argus Pharmaceuticals Inc. announced that it has begun Phase I clinical trials of its anti-cancer compound AR-623 for treating leukemia. The trials on AR-623, a lipid-based formulation of tretinoin (all trans retinoic acid), are designed to determine safety and pharmacology and will be conducted at the University of Texas M.D. Anderson Cancer Center in Houston. Argus is expecting to ultimately enroll from 20 to 25 patients in the Phase I trials, said Kenneth Cohen, the company's vice president
The final version of new U.S. Department of Agriculture (USDA) biotechnology regulations was published Wednesday in the Federal Register. The regulations will go into effect in 30 days. This version alters some changes and reaffirms others proposed by USDA -- and supported by then-Vice President Dan Quayle's Council on Competitiveness -- last November to ease regulations on biotech-derived plants by simplifying the approval process for field tests and exempting adequately tested plants from any
Scientists collaborating at three medical institutions have found that a cousin of the enzyme implicated in Lou Gehrig's disease suppresses the malignant growth of melanoma cells. The scientists reported their research on manganese superoxide dismutase in today's issue of the Proceedings of the National Academy of Sciences. Mammalians have three versions of this enzyme. A gene defect for the copper-zinc version normally found in cell cytoplasm was recently linked to amyotrophic lateral
With just one dissent and one abstention, FDA's Veterinary Medicine advisory committee voted to recommend approval of Monsanto's mammary supercharging hormone for cows, bovine somatotropin (BST) --recombinant bovine growth hormone (BGH). Although committee members agreed unanimously that BGH significantly increases incidence of mastitis, a bacterial inflammation of the teats that leads to abnormal secretions in milk, this increase, they said, was "manageable," and need not contribute to
Immunex Corp. (NASDAQ:IMNX) of Seattle announced Wednesday that it has filed a product license amendment to the FDA to use Leukine for prophylaxis and treatment of chemotherapy-induced neutropenia, an abnormally low white blood cell level. This white blood cell stimulant is used to speed recovery of cancer patients undergoing autologous bone marrow transplantation and to improve survival of cancer patients whose bone marrow transplants have failed. The expanded label application includes data
Liposome Technology Inc. (LTI) announced Wednesday that it has countersued Vestar Inc. over a patent on making lipid- formulated amphotericin B. LTI of Menlo Park, Calif., was awarded U.S. patent No. 5,180,713 on a method of preparing a stable liposome- entrapped amphotericin B in January. Vestar of San Dimas, Calif., sued LTI the following day, Jan. 20, asking the Delaware Federal Court to declare that LTI's patent is invalid, unenforceable and not infringed by Vestar's product AmBisome. LTI
Steven Mendell has resigned as chairman of the Berkeley, Calif., company to take up the reins as president and chief executive officer of privately held Prizm Pharmaceuticals of San Diego, Xoma (NASDAQ:XOMA) announced Wednesday. John Castello, already Xoma's president and chief executive officer, will add the title of chairman. Mendell will continue as a director of the company. (c) 1997 American Health Consultants. All rights reserved.
The National Institutes of Health (NIH) announced that it has opened the first trial of experimental HIV vaccines in children who are infected with HIV but are manifesting no disease symptoms. The Phase I trial will compare the safety of three experimental HIV vaccines, from Chiron/Ciba Geigy, Genentech Inc. and MicroGeneSys Inc., in 90 children between the ages of one month and 12 years. The trial will test two doses each of the three experimental subunit vaccines. The vaccines have so far
Jeremy Rifkin announced last week that a national boycott of genetically engineered bovine growth hormone (BGH)-treated dairy products and meat would begin as soon as FDA approves the product. An advisory committee to the FDA will address health issues of BGH today. John Stauber, national organizer for the Pure Food Campaign, told BioWorld that the organization's concerns are both economic and health-related. An increase in milk production combined with a decline in milk consumption would lead
BioSurface Technology Inc. and Toho Pharmaceutical Co. Ltd. announced Tuesday that they have agreed to commercialize BioSurface's Epicel epidermal skin grafts in Japan for permanent skin replacement in severe burn patients. The companies did not disclose the financial aspects of their agreement. BioSurface will produce the skin grafts at its manufacturing facility in Cambridge, Mass., and Toho will handle product marketing and distribution. "Toho is currently working on marketing development
Genentech Inc. announced Tuesday that it has filed a product license application (PLA) with FDA for Pulmozyme, its recombinant human DNase, for treating cystic fibrosis. The South San Francisco, Calif., company also has submitted marketing applications for Pulmozyme in Europe and Canada. Genentech (NYSE:GNE) completed its Phase III clinical trials on Pulmozyme last December, and reported those results in January at the Intermountain Thoracic Society Meeting. The 968-patient trial demonstrated
Magainin Pharmaceuticals Inc. said Tuesday that it has been issued a U.S. patent for the composition and use of squalamine as a broad-spectrum antibiotic. Scientists believe that squalamine, an aminoterol antibiotic first isolated from tissues of the dogfish shark, represents a new class of antibiotic agent. It has shown activity against bacteria, fungi and protozoa, said Magainin (NASDAQ:MAGN) of Plymouth Meeting, Pa. Company scientists believe that squalamine, a member of the steroid
In an effort to reduce its burn rate by 50 percent and streamline operations, Cellcor Inc. announced Tuesday that it has begun a major overhaul of its corporate structure and business strategy. Cellcor's business is autolymphocyte therapy (ALT), a kind of personalized approach to cancer therapy that it has been marketing through outpatient cellular therapy centers connected with hospitals in Boston, Atlanta and Orange County, Calif. Not only will the Newton, Mass., company close its commercial
Xoma Corp. said Wednesday it was issued a fundamental U.S. patent covering DNA sequences and the production of human bactericidal/permeability increasing protein (BPI) using recombinant technology. Xoma (NASDAQ:XOMA) of Berkeley, Calif., said it is the exclusive licensee of the patent, No. 5,198,541, for human therapeutic and diagnostic applications. The company is investigating BPI for use in the treatment of Gram-negative sepsis, acute and chronic focal infections and other possible clinical
Regeneron Pharmaceuticals Inc. said Tuesday that it has begun a Phase III study to determine the safety and efficacy of its recombinant human ciliary neurotrophic factor (rhCNTF) to treat amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease). The double-blind, placebo-controlled study, scheduled to begin this week, will include two dose levels of rhCNTF and will involve more than 700 patients in more than 30 clinical sites in the U.S., according to Regeneron (NASDAQ:REGN) of Tarrytown, N
Protein Design Labs Inc.'s (PDL) humanized antibody for treating relapsed acute myeloid leukemia has caused no immune response in eight patients evaluated in a Phase I trial, the company announced. David Scheinberg, chief of the leukemia service at New York's Memorial Sloan Kettering Cancer Center reported on the Phase I results at an international conference on leukemia sponsored by the University of Texas M.D. Anderson Cancer Center in Houston. Twelve patients with relapsed acute myeloid
Last year's user fee legislation, sponsored by Senators Edward Kennedy, D-Mass., and Orrin Hatch, R-Utah, would provide FDA with the funds needed to unclog the drug pipeline. By one estimate, without the legislation, it could have taken up to 13 years to process all pending biotech drug applications. But money is needed to jump-start the program while FDA waits for user fees to begin to flow. In a hearing last night before a subcommittee of the House Appropriations Committee, Richard Godown