According to Ernst & Young's annual report on the biotechnology industry released last week, the top issues concerning chief executives of biotechnology companies are: -- A complex regulatory environment. -- Insufficient or inaccessible capital. -- An unpredictable patent environment. -- Difficulty in distribution or sales channels. -- The cost of capital. Their importance can vary depending on whether a company has a product in clinical trials or in the development stage. For a very
Transgenic animal developer GenPharm International, Inc. said Wednesday it will collaborate with Eli Lilly & Co. to develop human monoclonal antibodies for targeted cancer therapy. Lilly's equity investment in GenPharm will add up to "less than 5 percent ownership" says Howard Rosen, GenPharm's director of corporate communications. GenPharm of Mountain View, Calif., will receive research and benchmark payments from Lilly, as well as royalties on the resulting products. For its part
DNX Corp. of Princeton, N.J., has obtained rights to blood substitute cross-linking technologies from Columbia University and the University of Maryland, Baltimore. Terms were not disclosed. The company also has begun a clinical pilot purification plant and a new swine production facility capable of producing sufficient quantities of DNX's blood substitute product through Phase I studies. The company estimated its combined capital investment for construction at about $5 million and projects
Hybridon Inc. of Worcester, Mass., said Wednesday the Patent and Trademark Office has allowed it the first patent application claiming certain novel antisense oligonucleotides and their use in treating influenza A virus infections. Hybridon holds a U.S. patent on the use of antisense oligonucleotide compounds against HIV infection. Antisense oligonucleotides are synthetic pieces of DNA. Hybridon's antisense compound is designed to bind with viral RNA to prevent the synthesis of that essential
The FDA today approved for marketing the first DNA probe- based assay that can be used in a physician's office. MicroProbe Corp.'s Affirm VP microbial identification system is configured to test for the two organisms that commonly are linked to vaginal infections: the protozoan Trichomonas vaginalis and the bacterium Gardnerella vaginalis. The company said this is the first DNA probe assay that can be used to identify multiple organisms. simultaneously from a single patient sample. Moreover
An international gathering of researchers shared an unprecedented amount of unpublished genome sequence data at this week's Genome Sequencing and Analysis Conference, according to J. Craig Venter, the former NIH researcher who organized the conference. Venter told BioWorld that about 15,000 new human gene sequences were released for the first time at the conference, which took place in Hilton Head, S.C. "That represents over 10,000 new human genes," he said. And that number doesn't include the
Incyte Pharmaceuticals Inc. of Palo Alto, Calif., reached an agreement with Ciba-Geigy Ltd. that resolves the question of interference in a U.S. patent concerning Protease Nexin-1 (PN- 1), an inhibitor of the proteases involved in connective tissue degeneration and inflammation. Incyte is developing PN-1 as a therapeutic for inflammatory and degenerative disorders. The patent interference, which was declared in July 1991, concerned pending applications covering the PN-1 cDNA and recombinant
Glycomed Inc. has successfully completed Phase I clinical trials in normal volunteers for Galardin MPI, its first product intended to treat corneal ulcers, the Alameda, Calif., company said. The Phase I studies showed that Galardin MPI attacked the ulcers by suppressing the action of enzymes that attack carbohydrate-protein complexes and other components of the cornea's support structure. In the studies Galardin was safe and tolerable at 50, 200, 400 and 800 micrograms per milliliter, the
Michelle Slade Associate Editor Collagen Corp.'s stock plummeted Tuesday after the FDA said it will request additional data and analyses on the company's Contigen Bard Collagen implant product for urinary stress incontinence. The Palo Alto, Calif.-based company's stock (NASDAQ:CGEN) closed Tuesday at $13.63, down $4.38 per share. According to Collagen spokesman David Foster, the notification from the FDA is at least a sign that Contigen is finally getting some attention. The company said the
COLD SPRING HARBOR, N.Y. -- Two years and two weeks ago, a team of clinical gene therapists at the National Institutes of Health put back into the bloodstream of a 4-year-old girl a billion or so of her own T cells, after transfecting them with the gene that expresses adenosine deaminase (ADA). For lack of that enzyme, this first-ever gene therapy recipient suffered from a rare but fatal metabolic disorder, severe combined immunodeficiency disease G-SCID, the "boy-in a- bubble" syndrome. A few
Trading in the stock of U.S. Bioscience Inc. was halted on Tuesday because of an order imbalance. The stock closed Monday at $8.75, down 50 cents. Analysts at Alex. Brown lowered their rating on the stock (ASE:UBS) on Tuesday to "neutral" from "strong buy." The analysts, David Webber and Angeli Kolhatkar, based their recommendation on a report in the July issue of The Cancer Letter. According to the report, the Oncologic Drugs Advisory Committee of the FDA will delay approval of Ethyol, the
The AIDS research community reacted negatively on Tuesday to news of a move by MicroGeneSys Inc. and the Walter Reed Army Institute to add a $20 million AIDS vaccine grant proposal to a Department of Defense appropriation bill. Industry sources said the bill has already passed the House and Senate. If no written opposition is presented by the Secretary of Defense, the director of the National Institutes of Health (NIH) or the FDA commissioner within six months of enactment, the amendment will
Applied Biosystems Inc. and Ribozyme Pharmaceuticals Inc will collaborate on the large-scale synthesis of ribonucleic acids for Ribozyme's commercial development of ribozyme technology. Applied Biosystems spokeswoman Jackie Cossman said the company would not disclose the financial nature of the commitment. She described the agreement as an "important strategic move" for the company. Applied Biosystems of Foster City, Calif., will provide Ribozyme of Boulder, Colo., with synthesizers, high
British Bio-technology Group plc announced Monday that it will begin work this week in a new laboratory dedicated to viral engineering, as part of a five-year research collaboration with Oxford University to pursue new treatments for viral infections and cancer. BBL has committed $3.18 million to the project, part of which has been used to fund the new facility within the university's biochemistry department. The remainder, according to Alan Kingsman, director of the new laboratory, will be
The FDA approved an application by Bristol-Myers Squibb Co. to expand sales of Videx (ddI) to AIDS patients who had previously taken the more widely prescribed AZT. Videx was approved in 1991 for patients with advanced HIV who are intolerant to AZT. New studies have shown that patients who switched to Videx at 14 months did better than those who remained solely on AZT, though those studies did not provide any optimal time period at which doctors should switch their patients to ddI. Liz Sigler
Genetics Institute Inc. (GI) is opting out of its interest in WelGen, the manufacturing partnership it formed in 1986 with Burroughs Wellcome Co. of Research Triangle Park, N.C. GI will get $24 million from Burroughs, which the Cambridge, Mass., company will plough right back into its manufacturing facility in Andover, Mass. "At one time, WelGen provided us with flexibility for rapidly expanding manufacturing capacity," said Garen Bohlin, GI's vice president. "However, with our sizeable and
Novo Nordisk A/S opened a research and development group in Davis, Calif., for its Bioindustrial Group. Called Novo Nordisk Biotech Inc., the unit will focus on the identification of new and better enzymes for industry, as well as on improving their manufacture. Industrial enzymes replace chemicals in many industrial processes, improving them while adding no harmful byproducts to industrial waste. Novo Nordisk Biotech, one of eight Novo Nordisk affiliates in the U.S., plans to employ 30
Cancer imaging company NeoRx Corp. announced today the details of its strategic alliance with the international pharmaceutical giant Boehringer Ingelheim International GmbH for nearly $22 million. Boehringer has already purchased 2 million shares of NeoRx common stock (NASDAQ:NERX) for $8 million, and will pay NeoRx another $3.6 million when it files with the FDA equivalency data to qualify Boehringer as the manufacturer of its OncoTrac products. NeoRx shares closed Monday at $2.67, up 3 cents
Michelle Slade Associate Editor The U.S. Senate on Friday adopted an amendment to pending tax legislation that if enacted would provide substantial tax benefits to investors in start-up companies, including new biotechnology companies. The amendment was proposed by Sen. Dale Bumpers, D-Ark., chairman of the Senate Small Business Committee, and Sen. Hank Brown, R-Colo., co-chairman of the Congressional Biotechnology Caucus. Supported and co-drafted by the The Industrial Biotechnology
SEATTLE -- Pledging his agency's efforts to find solutions, not problems, the director of the Food and Drug Administration's Office of Biotechnology has outlined recent moves to accommodate more biotechnology product applications. In appearances before industry meetings here last week, Henry I. Miller said, "We will be at the front line, probing for and providing solutions." The agency would not block "the horn of plenty that is being created by the new technology." The FDA, he said, is
According to Ernst & Young's annual report on the biotechnology industry released last week, the top issues concerning chief executives of biotechnology companies are: -- A complex regulatory environment. -- Insufficient or inaccessible capital. -- An unpredictable patent environment. -- Difficulty in distribution or sales channels. -- The cost of capital. Their importance can vary depending on whether a company has a product in clinical trials or in the development stage. For a very