General Biometrics Inc. announced Thursday that it has received FDA approval to sell its two tests to detect Lyme disease and related disorders. The San Diego company has been marketing the kits in Europe and for research use in the United States, so the tests are available immediately to clinical laboratories at a cost of $1 to $3. Fred Adler, company general manager, said the U.S. market for the tests is $10 million to $12 million, and $10 million in Europe. The test uses a protein from the
Interferon Sciences Inc. said Thursday that it has received about $3 million through the exercise of warrants to purchase 432,600 shares of common stock. The warrants were exercisable at $6.85 per share. The stock (NASDAQ:IFSC) closed Thursday at $8.38, down 13 cents. The proceeds, together with $10 million raised in a stock offering last October, will be used to develop topical and low- dose oral formulations of natural-source alpha interferon. IFSC sells Alferon N injection to treat
Immune Response Corp. on Thursday said it has developed an assay of HIV infection that supports the company's desire to use viral burden as a surrogate end point in trials of its AIDS vaccine. Reporting in the current AIDS Research and Human Retroviruses, the San Diego company said it has developed a polymerase chain reaction assay that measures the amount of HIV DNA in a patient's blood cells. Use of the assay has shown a correlation between the viral burden in HIV-infected people and the
Scientists at Athena Neurosciences Inc. and collaborators reported today that they have blocked paralysis in an animal model of multiple sclerosis. Using monoclonal antibodies, the researchers concluded that they have blocked the cell adhesion molecules in rats that allow misdirected white cells to enter the brain. A similar monoclonal, targeted to the same molecule in humans, will be developed by Athena (NASDAQ:ATHN) as a therapeutic. The test animals had been treated to create a model of MS
WASHINGTON -- Bristol-Myers Squibb Co. on Wednesday said that it expects to file an application to market taxol for refractory ovarian cancer by midyear. The announcement came at a joint hearing of the House Merchant Marine, Agriculture and Interior committees on the Pacific Yew Act of 1991. The bill provides for management of federal lands containing the Pacific yew tree to ensure sufficient supply of taxol, which currently can only be derived from the tree's bark. Zola Horowitz, vice
T Cell Sciences Inc. has reported data showing its lead therapeutic product reduces tissue injury in animal models of inflammation. The compound, soluble CR1, limited tissue injury by reducing neutrophil content in inflamed areas by at least 68 percent in the animal models studied. sCR1 is a recombinant version of a human regulatory protein of the complement system, a host defense mechanism made up of several proteins that circulate in the blood. Under certain circumstances, the complement
Findings announced in December on a model of Alzheimer's disease have been retracted by the study's authors. Scientists at Mount Sinai Medical Center in New York, collaborating with Yamanouchi Pharmaceutical Co. of Tokyo and the National Institutes of Health, had published in Nature that they had created a transgenic mouse model of the disease. The mice supposedly had shown degenerative changes that more closely mimic the neuronal changes of the human disease, compared to other models. But the
Ecogen Inc. said it has gained regulatory approval for wider use of its Cutlass WP bioinsecticide. The Environmental Protection Agency approval expands its application from vegetables to include fruit and nut trees and field crops such as cotton, soy beans and alfalfa. Ecogen shares (NASDAQ:EECN) closed unchanged at $11.63 on Wednesday. (c) 1997 American Health Consultants. All rights reserved.
Neurogen Corp. said it has received an exclusive worldwide license from the National Institutes of Health for a class of anti- convulsant chemical compounds. The lead compound under development is ADCI, which blocks certain voltage-dependent sodium channels the way conventional anti-convulsants do. But it also modulates the glutamate receptor, one of the brain's major excitatory neurotransmitters that is known to play a role in the regulation and control of seizures. Anti-convulsant drugs
Isis Pharmaceuticals Inc. on Tuesday said it will begin Phase I trials of ISIS 2105, an antisense drug designed to inhibit the growth of papilloma viruses. The compound is the first injectable antisense drug to gain investigational new drug approval from the FDA. The trials will use intralesional injections to treat the virus. Papilloma viruses cause several diseases, including genital and common warts. Preclinical data of ISIS 2105 suggest that it may cure genital warts and eliminate the
Cephalon Inc. said it has received a patent for the use of Myotrophin insulin-like growth factor-1 to treat amyotrophic lateral sclerosis (ALS) and other disorders in which cholinergic neurons are at risk of dying. U.S. patent No. 5,093,317 issued Tuesday. The West Chester, Pa., company (NASDAQ:CEPH) plans to file in June to begin trials of Myotrophin to treat ALS. ALS, or Lou Gehrig's disease, is a fatal disorder that affects about 30,000 U.S. patients and almost 100,000 people worldwide. It
Columbia Laboratories Inc. said Wednesday that it has reached an agreement to share technology with Insite Vision Inc. Columbia (AMEX:COB) of Hollywood, Fla., obtained exclusive worldwide rights to market veterinary ophthalmic products using Insite's sustained-release gel technology. Columbia also obtained the right to market in all parts of the world except North America and parts of Asia ophthalmic over-the-counter drugs using Insite's technology. In exchange, Alameda, Calif.-based Insite
DynaGen Inc. has received its first product marketing approval from the FDA, for urine test strips that determine whether patients are taking their anti-tuberculosis medicine. Isoniazid treatment for tuberculosis, which is becoming more widespread in the United States, requires daily doses for up to a year. Skipping pills can cause the microbe to become drug- resistant. The Cambridge, Mass., company (NASDAQ:DYGN) will market the strips worldwide through direct sales and distributors. (c) 1997
Amgen Canada Inc., a subsidiary of Amgen Inc. (NASDAQ:AMGN), has launched product sales in Canada of Neupogen granulocyte colony stimulating factor. Neupogen stimulates white blood cells in cancer patients undergoing chemotherapy. The drug, which was approved in the United States in February 1991, received Canadian government approval last month. Amgen had $232 million in worldwide Neupogen sales last year. (c) 1997 American Health Consultants. All rights reserved.
Karen Bernstein BioWorld Staff Genzyme Corp. and Neozyme II Corp. on Tuesday said they have filed for a public offering of 2.1 million units to fund treatments for cystic fibrosis. Neozyme II will receive the proceeds of the offering and will contract with Genzyme to develop protein replacement and gene therapy treatments for CF. If the offering is completed, Genzyme will exercise its option to purchase from Neozyme Corp. by Dec. 31 the rights and technology for Neozyme I's CF protein
Genentech Inc. on Tuesday announced a collaborative agreement with F. Hoffmann-La Roche Ltd., a subsidiary of Swiss-based Roche Holding Ltd., for the international development and promotion of DNase to treat cystic fibrosis and chronic bronchitis. Under the 10-year agreement, Genentech Europe, a wholly owned subsidiary of Genentech (NYSE:GNE), will be established using DNase as its first product. The subsidiary will focus on the promotion of DNase for cystic fibrosis. Roche, which owns 60
WASHINGTON -- Sen. Howard Metzenbaum, author of legislation to limit revenues for orphan drugs, has come under increasing industry allegations that the lawmaker is using distorted statistics to support his bill. The Ohio Democrat has used revenue and expense data to support his contention that pharmaceutical and biotechnology companies are reaping exorbitant profits on drugs that have been awarded orphan status to treat rare diseases. Several companies, however, contend that Metzenbaum's
Glycomed Inc. has signed an agreement with the University of Washington giving Glycomed an option to an exclusive license for a drug delivery system to treat diseases of the heart and blood vessels, the company said Tuesday. The system uses a polymer impregnated with a drug to prevent grafted arteries from reclosing following coronary artery bypass surgery. The degradable polymer is placed outside the rejoined blood vessels during surgery for localized delivery of the drug over time. The
Genetics Institute Inc. and American Home Products Corp. said Tuesday that they have formed a collaboration to discover and develop new small molecule drugs. GI (NASDAQ:GENIZ) of Cambridge, Mass., will receive funding over the next several years, and the companies will share marketing rights for any resulting products. Further terms weren't disclosed. AHP owns 60 percent of GI. In the first phase, the companies will focus on blocking cellular adhesion proteins with small molecules. The
WASHINGTON -- At a contentious Senate hearing on Tuesday, FDA Commissioner David Kessler expressed opposition to proposed amendments to the Orphan Drug Act that would withdraw orphan status from drugs that exceed $200 million in sales. "A sales cap provision is both bad policy and unadministerable," Kessler told the Senate Committee on Labor and Human Resources. "I don't think we know enough about the market forces to be certain that whatever adjustments we make will not have a negative effect
General Biometrics Inc. announced Thursday that it has received FDA approval to sell its two tests to detect Lyme disease and related disorders. The San Diego company has been marketing the kits in Europe and for research use in the United States, so the tests are available immediately to clinical laboratories at a cost of $1 to $3. Fred Adler, company general manager, said the U.S. market for the tests is $10 million to $12 million, and $10 million in Europe. The test uses a protein from the