Word: fda
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Dates: during 1980-1989
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...succeed, go back to the laboratory. That is what Genentech (1986 revenues: $134 million) must do now that the Food and Drug Administration has at least temporarily rejected t-PA, the company's revolutionary new, genetically engineered drug that dissolves blood clots, which often lead to heart attacks. The FDA asked South San Francisco-based Genentech to come up with further test data in support of the company's claim that the drug can increase the survival rate of heart-attack victims...
...decision was a shocker on Wall Street, where biotechnology stocks had been big winners. After the FDA ruling, the price of Genentech's shares plunged 11 1/2 points in one day, to 36 3/4. By the end of last week the price stood at 37 3/4. A domino effect also knocked down the stocks of rival biotech firms, some of which are developing drugs similar to t-PA. Such futuristic- sounding companies as Amgen, Biogen, Centocor, Cetus and Chiron saw their shares drop anywhere from 7% to 11% before recovering some of those losses...
...young industry's setback is likely to be short lived, however. Genentech is expected to win FDA authorization for t-PA, perhaps within a year or so. Says Robert Kupor, an industry analyst with the Seattle-based Cable, Howse & Ragen brokerage firm: "It's great stuff, and there's no doubt it will ultimately be approved." Once that happens, experts expect to see a $1 billion-a-year market for clot-dissolving drugs...
There has also been little progress in developing AIDS drugs that interfere with viral reproduction. The only drug approved by the FDA is azidothymidine, or AZT. An experimental drug, ribavirin, made by ICN Pharmaceuticals of Costa Mesa, Calif., seems to be less effective than had been claimed. Dr. Andrew , Vernon, a member of a study group at Johns Hopkins University, reported that in a 28-week experiment, 217 male pre-AIDS patients who took ribavirin showed no significant benefits...
...curbing the virus, received mixed reviews. Last December, Neuroscientist Candace Pert of the National Institute of Mental Health reported that the chemical, a synthetic portion of a protein on the AIDS virus that helps it bind to cells, seemed to prevent the virus from entering cells. In May the FDA approved clinical trials, and last week Oncogen, a Seattle biotechnology company, announced that its researchers had confirmed Pert's findings. But Dr. William Haseltine, a virologist at Harvard's Dana Farber Cancer Institute, said neither his laboratory nor six others around the world had been able to reproduce Pert...