Drug Trials

A controversial prostate cancer vaccine that previously had been rejected by the Food and Drug Administration improves survival of patients with the advanced form of the disease more than existing treatments and should be brought to market, researchers said Tuesday.

Biotech giant Amgen Inc. saw its largest single-day stock-price jump in four years after announcing that its experimental bone-strengthening medicine worked better than a potential rival in a study comparing the two drugs in breast cancer patients. On Wednesday, the Thousand Oaks company's shares rose $7.27, a day-over-day increase of 13.9%, to close at $59.50 on the Nasdaq exchange.

Drug companies were hit with a series of bad breaks Monday, led by Novo Nordisk's announcement that it discontinued its experimental AERx inhaled insulin system and is expected to fire most of its 360-person team on the project in Hayward, Calif. In addition, Merck & Co. and Schering-Plough Corp. said their cholesterol pill Vytorin worked no better than an older, cheaper drug, threatening the medicine's sales. And U.S.

Fred Hassan rode to the rescue of a foundering Schering-Plough Corp. in 2003, and by 2006, with a remarkable turnaround declared complete, the company was back on a growth trajectory. But the highly regarded chief executive unexpectedly finds himself at the center of a firestorm involving the cholesterol drug that fueled the company's reversal of fortune. The furor over Vytorin threatens the reputation of the drug industry's golden boy and, some say, his job. Schering-Plough and Merck & Co.

An experimental treatment for multiple sclerosis that targets a portion of the immune system not previously subjected to therapy reduced damaging lesions of the nervous system by 91% and relapses of the disease by 58%, researchers report today. A single course of the drug, called rituximab, helped patients for the full 48 weeks of the trial and suggests a new way to treat relapsing-remitting MS, the most common form of the disabling disease.

A small trial of an experimental vaccine designed to activate the immune system against breast cancer suggests it may reduce the risk of death for most patients, U.S. military researchers said Sunday. The vaccine, designed to treat women with tumors that generate a protein called HER-2, has been licensed to privately held Scottsdale, Ariz.-based Apthera Inc. under the brand name NeuVax.

Pharmaceutical companies have agreed to pay millions in new fees to help federal health officials step up the review of drug commercials before they are aired on television, the industry and government said Thursday. Under the five-year plan, drug makers will pay the Food and Drug Administration a one-time fee plus additional charges for each commercial submitted. The fees, which will bring in about $6.

The fight to stop the spread of AIDS suffered a serious setback this week when researchers shuttered two high-profile trials of one of the most promising anti-AIDS compounds. Researchers had hoped that the so-called microbicide, a topical gel designed to block the transmission of the human immunodeficiency virus during sexual intercourse, would be particularly effective in stemming the epidemic of AIDS in Africa and Asia.

Amgen Inc. said Thursday that it discontinued a key clinical trial of colon cancer treatment Vectibix after discovering that the drug reduced chances of survival. Amgen said an interim look at the trial found that colon cancer patients treated only with chemotherapy and Avastin, a biologic cancer drug sold by Genentech Inc., were more likely to live than patients who also received Vectibix.

Whose responsibility is it to ensure a product sold to millions of Americans is safe? In the drug industry, it's no simple question. Take, for example, the case of Amgen Inc. The Thousand Oaks biotech giant Thursday released the results of a highly anticipated safety study of the company's popular anemia drug Aranesp, which along with similar anemia medications is taken by more than a million people in the U.S. each year.