The Peripheral and Central Nervous System Drugs Advisory Committee of the FDA recommended approval on Thursday of Cognex, the Alzheimer's disease drug being developed by the Parke-Davis division of Warner-Lambert Co. The data supplied by Warner-Lambert of Morris Plains, N.J., to the FDA committee provided statistically significant evidence that Cognex improves cognitive function in Alzheimer's patients. Cognex, an acetylcholinesterase inhibitor, potentiates the activity of the neurotransmitter
Heart attack patients over the age of 75 are less likely to be treated early -- or even at all -- with thrombolytic therapy than younger individuals, according to an analysis of data on 130,367 patients enrolled in the National Registry of Myocardial Infarction (NRMI). Moreover, elderly patients who do receive thrombolytic therapy are more likely to die the longer that therapy is delayed. Joel Gore, the director of the division of cardiovascular medicine at the University of Massachusetts
Two emerging biotechnology companies, Incyte Pharmaceuticals Inc. and Celtrix Pharmaceuticals Inc., announced details of agreements with Genentech Inc. on Thursday. Privately held Incyte of Palo Alto, Calif., has gained exclusive rights to Genentech technology related to a protein being explored for its potential effects against shock-causing endotoxin, bactericidal/permeability increasing protein (BPI). Incyte holds two patents and several pending applications covering the composition and use
ICN Biomedicals Inc. announced late Thursday that it would take a special, non-cash charge and other adjustments for the fourth quarter totaling about $73 million. The charge includes the write-off of $35.5 million of goodwill associated with the company's acquisition of Flow Laboratories, the company said. ICN (ASE:BIM), which is 86 percent owned by ICN Pharmaceuticals Inc. (NYSE:ICN), acquired Flow in 1989 for about $41 million. ICN Biomedical said the charge also includes the write-down or
Univax Biologics Inc. announced Wednesday that clinical trials are under way on its vaccine for fighting Staph infections in kidney failure patients. HyperVax+Staph A vaccine is made from two strains of Staphylococcus aureus, the most common infection of end-stage renal disease (ESRD) patients undergoing peritoneal dialysis. The Phase I trials will be conducted in both ESRD patients and healthy volunteers. The trials, which began Feb. 26, are the latest in a series of National Institutes of
Isis Pharmaceuticals Inc. and PerSeptive Biosystems Inc. announced that they have finalized their agreement on Perisis, the strategic alliance they formed to develop novel tools for manufacturing oligonucleotide therapeutics. Under the agreement, which the companies announced March 1, PerSeptive (NASDAQ:PBIO) of Cambridge, Mass., will have the option to commercialize novel purification, analysis and synthesis products developed by Perisis. Isis (NASDAQ:ISIP) of Carlsbad, Calif., and PerSeptive
Immunex Corp. and American Cyanamid Co. have amended the terms of their merger agreement, the two companies announced Thursday. "The terms of the deal as discussed in December haven't changed," explained Jason Rubin, Immunex's vice president of communications. "At issue is the need to preserve the merger as a tax-free reorganization." Cyanamid of Wayne, N.J., will continue to contribute to the merged entity -- the "new Immunex" -- $350 million in cash and Lederle Laboratories' North American
Scientists at Genelabs Technologies Inc. have developed a new way to track previously undetected levels of HIV at every stage of infection, according to a report in today's issue of the journal Science. The technique is up to 60,000 times more sensitive than current methods and accurately reveals levels of virus present. The study of 66 patients indicates that HIV levels correlate with severity of disease and treatment. The technique eventually may be used to monitor how well anti-viral agents
CytRx Corp. announced Wednesday that it has begun patient enrollment in a new clinical trial on RheothRx Injection in patients with suspected heart attack. The 250-patient study is being conducted by Burroughs Wellcome Co. of Research Triangle Park, N.C., which licensed the compound from CytRx (NASDAQ:CYTR) of Norcross, Ga., in 1990. Two other studies on ReothRx Injection in heart attack patients have been in progress since March 1992 and are now nearing completion, the company said. (c) 1997
Researchers at Baylor College of Medicine have improved a method of delivering genes to liver cells in a system that might one day facilitate using DNA to treat metabolic disorders. Led by Savio Woo, the research team in Houston created 1,000 times the previous amount of an easily visualized "marker" gene product, beta galactosidase, by hitching the gene to an adenovirus. Adenoviruses cause the common cold and have attracted interest as a vehicle to introduce genes to cells for gene therapy
Two teams of researchers report in today's issue of Nature that they have successfully introduced large segments of human DNA into mice using yeast artificial chromosomes, or YACs. The DNA remains intact, its presence doesn't interfere with the development of the engineered embryonic stem cells into adults, and it is passed through the germline. It now becomes feasible -- at least in theory -- to study precisely the regulation and expression of human immunoglobulin genes, for instance, or to
GenPharm International Inc. announced Wednesday that it has received a $5.3 million, three-year grant from the National Institute of Standards and Technology (NIST) to support the development of its transgenic technology using yeast artificial chromosomes (YACs) to insert large genes into transgenic animal models. GenPharm has incorporated the sequences, including human DNA, into its YACs via lipofection. In this method, "the lipid micelles containing the YACs are cultured with mouse embryonic
WASHINGTON -- U.S. lawmakers are considering two pieces of biotechnology-related legislation. The Biotechnology Patent Protection Act is expected to be reported out of the Senate Judiciary Committee next Thursday, and voted on shortly thereafter. And Rep. Ron Wyden, D-Ore., is floating a bill that would require the federal government and its private grantees to negotiate a pricing formula before signing grant agreements. The bill would also require the National Institutes of Health, whenever
In an attempt to protect the position of the first product it took to market, Genentech Inc. has filed a patent infringement complaint against two other producers of recombinant human growth hormone. Protropin, the South San Francisco, Calif., company's (NYSE:GNE) first product, was approved in 1985, but lost its seven years of market exclusivity under the Orphan Drug Act in October 1992. Genentech still controls 75 percent of the hGH market in the U.S., however, and is developing a second
Initial Phase III clinical trial results on Centocor Inc.'s heart drug, CentoRx, are promising enough that the Malvern, Pa., company intends to file a product license application (PLA) with the FDA this year. Researchers associated with the multicenter, 2,100-patient Phase III trial reported Tuesday at the American College of Cardiology Meeting in Anaheim, Calif., that CentoRx can reduce by nearly 40 percent the occurrence of heart attack and the need for emergency repeat angioplasty in
Gensia Pharmaceuticals Inc. on Tuesday announced detailed results of two Phase III clinical trials testing its drug Arasine as a protective agent against the sometimes fatal complications of coronary artery bypass graft surgery. A U.S. trial showed that Arasine provided a statistically significant reduction in heart attacks and other adverse cardiac events, including strokes, while an international trial did not produce statistically significant results in the primary endpoints measured. Using
Centocor Inc. said it has terminated all but one trial for its anti- infective, HA-1A. The Malvern, Pa., company (NASDAQ:CNTO) had suspended its second Phase III trial on Jan. 18 due to excessive deaths, and announced it would decide whether to continue after analyzing the data. The company's monoclonal antibody to the endotoxin that causes an immune overreaction in patients whose blood is infected with Gram-negative bacteria, HA-1A, was intended to help some 200,000 Americans who develop Gram
Therion Biologics Corp. is joining forces with the Harvard researcher who first isolated a strain of HIV in monkeys to develop a live, attenuated AIDS vaccine. Privately held Therion was formed in 1991 when Oncogene Sciences Inc. purchased the cancer therapy and diagnostics components of Applied bioTechnology Inc. Therion of Cambridge, Mass., has spent the past 18 months searching for vaccines that can mimic a live, attenuated virus that Harvard researchers have shown has protected six rhesus
The Securities and Exchange Commission on Tuesday announced a new policy exempting emerging biotechnology companies, as well as other research and development intensive companies, from the Investment Company Act of 1940. The new policy will enable biotechnology companies to invest funds in higher-yielding investments than previously allowed, without becoming regulated as investment companies, the Industrial Biotechnology Association said. The SEC made the announcement in a letter mailed
Repligen Corp. on Tuesday started enrolling patients in its Phase I clinical trial on recombinant platelet factor-4 (rPF4) to evaluate its safety in neutralizing heparin in patients undergoing cardiac catheterization. Upon completion of certain cardiovascular procedures, including angioplasty and cardiopulmonary bypass surgery, it's necessary to reverse the anti-coagulant effects of heparin "before the surgeon can close," explained Sanford Smith, Repligen's president and chief executive officer
The Peripheral and Central Nervous System Drugs Advisory Committee of the FDA recommended approval on Thursday of Cognex, the Alzheimer's disease drug being developed by the Parke-Davis division of Warner-Lambert Co. The data supplied by Warner-Lambert of Morris Plains, N.J., to the FDA committee provided statistically significant evidence that Cognex improves cognitive function in Alzheimer's patients. Cognex, an acetylcholinesterase inhibitor, potentiates the activity of the neurotransmitter