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WHAT'S AT STAKE IN FDA REVIEW
Both Centocor's Centoxin and Xoma's E5 are monoclonal antibodies to endotoxin for the treatment of the gram-negative form of sepsis. Some estimates put the U.S. market for these therapies in excess of $750 million annually. Gram-negative sepsis can lead to septic shock, which is marked by heart, liver and respiratory failure, and severe internal bleeding, resulting in death about half the time. But not all cases are caused by gram-negative bacteria. Synergen Inc. (NASDAQ:SYGN), which isBioWorld Today | Wednesday, September 4, 1991 -
CHIRON CLAIMS PATENT IS KEY TO FACTOR VIII:C
Chiron Corp. and its partner Novo Nordisk A/S on Tuesday received a U.S. process patent that Chiron said has broad applicability to the manufacture of recombinant Factor VIII:C. Factor VIII, which is currently derived from plasma, is used to treat hemophilia. But plasma-derived Factor VIII carries the risk of disease from infectious agents in the original source, is expensive and limited in supply. Patent No. 5,045,455 covers a gene for one of the two subunits necessary for recombinantBioWorld Today | Wednesday, September 4, 1991 -
FDA CONSIDERS COLLAGEN LABEL CHANGE
The Food and Drug Administration is considering requiring a change in the labeling of Collagen Corp.'s injectable bovine collagen products, the company said Tuesday. The FDA met last week with the National Institutes of Health, the Centers for Disease Control and the Texas Department of Health to discuss the relationship between injectable bovine collagen and two rare autoimmune diseases, polymyositis and dermatomyositis, known as PMD. Polymyositis is an inflammatory disease of skeletal muscleBioWorld Today | Wednesday, September 4, 1991 -
BTGC RAISES $2.9 MILLION IN SECOND CLOSING
Bio-Technology General Corp. said it raised $2.9 million in a second closing of a private placement of common stock and warrants, bringing to $6 million the total raised. The New York-based company sold 552,386 units of stock and warrants at $5.25 per unit. In the first closing, announced Aug. 26, BTGC sold 590,471 units, raising $3.1 million. The units include one share of stock and a warrant to purchase one-half share of stock at $8 per whole share. BTGC stock (NASDAQ:BTGC) closed Tuesday atBioWorld Today | Wednesday, September 4, 1991 -
USDA APPROVES CALF'S SCOURS DRUG
ImmuCell Corp. has been granted final product approval from the U.S. Department of Agriculture for First Defense, an antibody-based treatment to prevent calf's scours, or diarrhea. First Defense is a preventative against scours caused by both E. coli and coronavirus bacteria. It is administered in capsule form. The product will be distributed in the United States by the end of the month, the company said. Sales in the United Kingdom and Ireland will begin through Rhone-Merieux Animal HealthBioWorld Today | Wednesday, September 4, 1991 -
POSSIBLE PATH TO BETTER IMMUNOSUPPRESSANTS
Scientists at Harvard and Stanford universities have discovered a common pathway for the actions of two immune suppressing drugs, a route that may lead to improved immunosuppressants with fewer toxic side effects. As reported Friday in the journal Cell, the two teams collaborated to determine that both cyclosporin, the drug isolated from fungi that has allowed heart and lung transplants to succeed, and a new candidate for transplant medicine, FK506, both act at a triad of calcium modulatingBioWorld Today | Tuesday, September 3, 1991 -
EMBREX FILES FOR 1.7 MILLION-SHARE IPO
Embrex Inc. on Friday said it has filed for an initial public offering of 1.7 million shares of common stock and an equal number of warrants. The proposed price is $7 to $9 per share, and the warrants are expected to be priced at 10 cents each. Terms of the warrants werenLt available. After the offering, Embrex of Research Triangle Park, N.C., will have 3.2 million shares outstanding. Underwriter Rosenkrantz Lyon & Ross of New York has an option to buy 255,000 more shares to coverBioWorld Today | Tuesday, September 3, 1991 -
IMMUNOMEDICS BINDS RADIOISOTOPE TO MAb
Immunomedics Inc. said it has successfully used its direct labeling technology to bind a potent beta-emitting radioisotope, rhenium-188, to a monoclonal antibody against human colorectal cancer. The Warren, N.J., company reported its success in mice containing human colorectal cancers in the Sept. 1 issue of Cancer Research. Immunomedics plans to begin Phase I clinical trials in the first half of 1992. Immunomedics has used the labeling technology in cancer diagnostics. But its diagnosticBioWorld Today | Tuesday, September 3, 1991 -
APPOINTMENTS AND ADVANCEMENTS
Escagenetics Corp. of San Carlos, Calif., has appointed Douglas MacMaster, a former senior vice president of Merck & Co. Inc., to its board. In addition, Raymond J. Moshy, Ph.D., Escagenetics' president and chief executive officer, was awarded the 1991 Nicholas Appert Medal by the Institute of Food Technologists for contributions to the field of food technology. He was cited for being the first to combine biotechnology and traditional plant breeding techniques in food processing and new foodBioWorld Today | Tuesday, September 3, 1991 -
AMENDED COMPLAINTS TO REGENERON SUITS
Regeneron Pharmaceuticals Inc. said Friday that it has received amended complaints in two class-action lawsuits related to its April 2 initial public offering. The amended complaints claim that Regeneron of Tarrytown, N.Y., violated securities laws by failing to recirculate an amended preliminary prospectus to reflect an increase in the size of the offering to 4.5 million shares from 3 million shares. The company circulated a final prospectus to all purchasers. Regeneron completed its IPO atBioWorld Today | Tuesday, September 3, 1991 -
SHAMAN DRUGS FROM TROPICAL PLANTS
Shaman Pharmaceuticals Inc. has filed its first application with the Food and Drug Administration for an investigational new drug, an anti-viral isolated from a medicinal plant. The company, which specializes in drugs developed from tropical plants with a history of folk use, expects to start Phase I trials of the new compound, SP303, this fall. Shaman's first target will be respiratory syncytial virus, a childhood disease. The San Carlos, Calif., company is also pursuing development of SP303BioWorld Today | Tuesday, September 3, 1991 -
'VIRTUALLY UNLIMITED' ANTIBODY FRAGMENTS
Xoma Corp. has developed antibody fragments that can be genetically engineered in large enough quantities to be a cheaper, commercially viable alternative to monoclonal antibodies made in animal cells. At this week's meeting of the American Chemical Society in New York, Xoma researcher Marc Better showed that the portion of antibodies that bind to medically important targets, called the Fab and Fab2 antibody regions, can be cloned and expressed in E. coli bacteria, and the fermentationBioWorld Today | Friday, August 30, 1991 -
JOURNAL SCAN
TRANSGENIC MICE WITH HTLV-1 RETROVIRUS Japanese scientists have created transgenic mice that carry the genome of the HTLV-1 retrovirus, and many of these mice develop symptoms closely matching those of rheumatoid arthritis in people. Viruses have been suspected as the cause of rheumatoid arthritis. Reporting today in Science, the researchers suggest that HTLV-1 is one of the etiologic agents in the disease. The HTLV-1 retrovirus, which causes an adult T cell leukemia and is related to the AIDSBioWorld Today | Friday, August 30, 1991 -
ALPHA 1 EFFECTIVE AGAINST HEPATITIS B
Alpha 1 Biomedicals Inc.'s thymosin alpha 1 effectively treats chronic hepatitis B, according to results of a Phase II clinical trial published Thursday in the journal Hepatology. The trial compared thymosin fraction 5, which is an extract of bovine thymus, with thymosin alpha 1 and a placebo. Alpha 1's TA-1 is a synthetic peptide version of TF5. Chronic HBV can result in liver failure, cirrhosis or liver cancer. It occurs in 5 percent to 8 percent of the 300,000 cases of acute HBV that occurBioWorld Today | Friday, August 30, 1991 -
PROFIT TAKING ON THE LIPOSOME CO. STOCK
After jumping more than 35 percent in the previous two sessions, stock of The Liposome Co. fell 88 cents on Thursday, closing at $11.50. The stock's rise came after Hambrecht & Quist analyst D. Larry Smith recommended more aggressive buying of the Princeton, N.J., company's shares (NASDAQ:LIPO). He based his recommendation on data the company will present at the International Conference on Antibiotics and Antimicrobial Therapy in Chicago from Sept. 29 to Oct. 2. One abstract will presentBioWorld Today | Friday, August 30, 1991 -
AUTOIMMUNE RESPONSES TO GM-CSF
Researchers in the Netherlands reported that two patients developed thyroid problems after receiving granulocyte colony macrophage stimulating factor (GM-CSF). According to their letter this week in The Lancet, the apparent autoimmune response was induced only in these two patients out of 25 with either breast or soft tissue cancers whom the doctors followed. Both required thyroxine therapy for two months, but their thyroid function returned to normal within eight weeks of the last dose of GMBioWorld Today | Friday, August 30, 1991 -
CANCER FIGHTER MADE MORE POTENT
Roberta Friedman, Ph.D. Special to BioWorld Researchers have developed powerful new versions of a simple chemical that already has been shown to work against cancer. The new compounds are so potent that they will work in milligram rather than in gram amounts, according to a presentation Wednesday by Columbia University chemist Ronald Breslow at the Fourth Chemical Congress of North America, meeting in New York. In April, Columbia and Memorial Sloan-Kettering Cancer Center signed an agreementBioWorld Today | Thursday, August 29, 1991 -
EARLY SUCCESS AGAINST MD DEFECT
Scientists at the University of Wisconsin and in England have used gene therapy to repair the genetic defect of Duchenne's muscular dystrophy on a very limited basis in mice. The researchers injected a gene construct for the defect, the missing protein dystrophin, into the muscles of the mice. The mice then expressed the human dystrophin protein. However, both the researchers involved and the company that invented the technology caution that a much larger number of muscle fibers will have toBioWorld Today | Thursday, August 29, 1991 -
DEPRENYL GETS RIGHTS TO CANCER TREATMENT
Deprenyl Research Ltd. of Toronto has signed a licensing agreement with Parteq Research & Development Innovations giving Deprenyl exclusive worldwide rights to a method of treating skin cancer. Under the five-year agreement announced Tuesday, Deprenyl, through a new wholly owned U.S. subsidiary, has paid Parteq an up-front fee and will make milestone payments as well as royalty payments on the sale of the drug, 5-aminolevulinic acid (ALA). The location and name of the subsidiary haven't beenBioWorld Today | Thursday, August 29, 1991 -
FOUR BIOTECH STOCKS POST BIG GAINS
Stocks of four biotech companies posted significant gains Wednesday. Amgen Inc. stock (NASDAQ:AMGN) rose $8 to $162.75 after Montgomery Securities analyst Brandon Fradd raised his earnings estimate for the second quarter ending Sept. 30 to 96 cents a share from 83 cents. Fradd changed his estimate due to lower-than-expected expenses for the quarter. MedImmune Inc. shares (NASDAQ:MEDI) were up $2.25 to $24.25 after Smith Barney analyst Denise Gilbert initiated coverage of the company with a "buyBioWorld Today | Thursday, August 29, 1991
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