Selected Bloomberg Clips
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Drugmakers Submit Fewer Medicines for Review in 2001, FDA Says Jan. 30, 2002
_____ The U.S. Food and Drug Administration received 20 percent fewer new drug applications in fiscal year 2001 than in the previous year, contributing to a recent slowdown in approvals.
_____ The number of drug applications dropped to 111 last year, from 138 in 2000. The number of approvals of new drugs also slipped: 66 new medicines were approved in 2001, compared with 94 in the previous year.
_____ The diminishing number of new drug submissions reflects the fact that there are fewer medicines in late-stage development, investors said. Some experts say the FDA has tightened safety rules, slowing trials. As a result, many companies are looking to acquisitions and joint ventures to gain products and maintain growth.
Red Wine Relaxes More Than Inhibitions, Chemical Tests Suggest Dec. 19, 2001
_____ Red wine's reputation as a elixir of good health may stem from its ability to relax blood vessels, according to a study to appear in tomorrow's edition of the journal Nature.
_____ A component of red wine may block the effect of a vessel-constricting protein called endothelin-1, which has been linked to heart disease and hardening of the arteries, laboratory research suggested. Other wines did not demonstrate the same effect.
_____ The experiment may bring researchers one step closer to understanding the ``French paradox.'' People in France have a lower rate of heart disease than people in other Western industrialized nations though they eat a similar diet. The French drink an average five times more wine than the British and nine times more than Americans.
Medtronic, Guidant Use 'Placebo' Devices to Test New Therapy July 7, 2001
_____ Over the span of two years, more than 200 patients had a unique type of Medtronic Inc. pacemaker implanted near their collarbones. The experimental device is designed to help failing hearts beat more effectively.
_____Once the InSync devices were in place, doctors did something almost as novel as the pacemaker itself -- they made sure it wasn't turned on. The placebo devices helped researchers better compare those patients to another group of more than 200 people whose devices had been activated.
_____Device makers such as Medtronic and Guidant Corp. have begun using placebos to test the effectiveness of their products. Both companies will ask a U.S. Food and Drug Administration advisory panel Tuesday to recommend approval of their heart-failure treatments, which appear to help patients with weakened hearts that can't pump blood effectively.
Novartis's Gleevec Drug Foiled by Mutations, Researchers Report June 21, 2001
_____ Novartis AG's breakthrough cancer treatment, Gleevec, may stop working in the sickest patients, when there is a gene mutation or when the body makes too much of a protein that triggers cancer cell production, researchers said.
_____The drug treats chronic myelogenous leukemia, a rare and lethal blood cancer. The U.S. Food and Drug Administration approved Gleevec last month after the agency's shortest cancer drug review. About 88 percent of patients who received the drug in clinical trials went into remission.
_____Still, researchers said the most advanced form of the disease, ``blast crisis,'' which is marked by a surge in cancer cells, is likely to return within six months of treatment. That occurs because the cancer-causing proteins either become drug-resistant or are so numerous that the treatment is rendered ineffective, said a study on the Science journal's Web site.
AstraZeneca's Venerable Tamoxifen Drug Facing New, Safer Rivals Dec. 19, 2000
_____ AstraZeneca Plc's tamoxifen drug, Nolvadex, which revolutionized the treatment of women with breast cancer in the past two decades, may play a smaller role in as drugmakers prepare a new generation of therapies.
_____ Tamoxifen has been the workhorse of breast cancer therapy and remains the most-prescribed drug for a disease that the American Cancer Society estimates will strike 183,000 people this year. It's used for everything from prevention in women with a family history of breast cancer to treatment of patients in the disease's most advanced stages.
_____ A new class of drugs known as aromatase inhibitors, including drugs from AstraZeneca, Novartis AG and Pharmacia Corp., is edging out tamoxifen as the first choice in therapy for advanced breast cancer. The U.S. Food and Drug Administration has approved AstraZeneca's Arimidex as a first-line drug, and Novartis next week will ask an FDA advisory panel to recommend a similar use for its Femara.
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