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Scientists have been making artificial human hearts for more than 30 years, but the U.S. Food and Drug Administration (FDA) has never given its full blessing to any of them. That may soon change. A panel of experts last week recommended that the FDA approve the CardioWest Total Artificial Heart for use as a temporary, fully implantable replacement heart that can keep a patient alive until a transplant can be found. That's lifesaving news for the 3,500 Americans waiting for a heart donor. But it's also a sobering reminder that only 2,000 human hearts become available...
...first mistake, clearly, was to sell the ImClone stock, given the impetus for doing so. The bio-tech firm that was then run by her friend Sam Waksal had been riding high on its promising cancer drug. But on Dec. 26, 2001, Waksal got wind that the FDA was going to reject his company's application to move forward with its drug. The Waksal family sent word to Bacanovic, their broker as well as Stewart's, and tried to sell $7.3 million of ImClone stock. Waksal has since pleaded guilty to securities fraud and other charges and is serving...
...FDA rejected erbitux the next day, and ImClone shares promptly dropped 16%. The prescient ImClone sales immediately caught the attention of compliance officers at Merrill Lynch, who on Dec. 31 asked Bacanovic about it. He said it had something to do with tax-loss selling. Later he changed his story, saying he and Stewart had a pre-existing agreement to sell the stock if it dipped to $60, which it did that day. "On Monday, Dec. 31, he said nothing, nothing about any $60 price agreement," assistant U.S. Attorney Michael Schachter argued in his summation. "Four days after the sale...
...When the FDA approved Genentech's colorectal cancer drug Avastin last week, it also validated a cancer-fighting strategy proposed more than 30 years ago. Avastin is the first in what researchers hope will be a whole new class of drugs called angiogenesis inhibitors, which attack tumors by thwarting their ability to create blood vessels--thus starving cancer cells of oxygen and nutrients. In trials, Avastin has been shown to give patients, on average, an additional five months of life. Cost of a 10month course of treatment: about...
...Folkman said the FDA, scientists and current cancer patients must now wait in anticipation to see what developments in cancer therapy these results may yield...