Long-term safety studies on drugs being developed today are far more vigorous than drugs developed years ago.
It is clear if the FDA is asking manufacturers to do new studies on these drugs, it does not 100% trust its effectiveness and safety.
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It would put data from all major company-funded studies of drugs up on the Web.
Genentech, in contrast, has insisted on large, controlled clinical studies that prove its drugs work beyond a reasonable doubt.
The studies they have done are on kids that have been taking other drugs so it's hard to disconnect.
In the 1980s, clinical trials were mostly either conducted by academics, sometimes without industry support, or by drug companies who kept in-house expertise on not only designing but running the studies that got their drugs approved.
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The three drugs in the studies essentially work by releasing the brakes on the immune system to allow it to recognize and go after tumor cells.
The reason to be optimistic is simple: Both the Wyeth and PTC drugs failed to show a benefit in much larger studies on the same six minute walk test on which eteplirsen showed a six-minute benefit.
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In several recent studies, placebos have performed as well as drugs that Americans spend millions of dollars on every year.
The researchers concluded that additional studies on cannabinoids and herpesviruses are warranted, as they may lead to the development of drugs that inhibit the reactivation of these oncogenic viruses.
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It's possible that doctors will use it with other drugs of the same type, so the FDA may want more studies on the combination of sugammadex with other muscle relaxants.
It often insists that foods already on supermarket shelves be treated like drugs and run through a gauntlet of preliminary studies before large-scale human studies can begin.
Those already on the drugs might benefit from a higher dose--a spate of recent studies has shown that more statins means fewer heart attacks.
Many investors expect that these drugs might be approved, at least in some patients, based only on studies of their cholesterol-lowering potency, not hard proof they prevent heart attacks and strokes.
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Hospitals also are cutting back on prescribing several medications, including antibiotics and anti-reflux drugs, for infants because studies show they confer few benefits and increase risk of adverse reactions.
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Peter Hill, a consultant child psychiatrist, says that some patients wait 18 months for therapeutic help despite studies in America which show that behavioural therapy can work, on its own or combined with low doses of drugs.
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On the basis of these studies, Dr Dybul estimated that a patient could probably go seven days without the drugs with no ill effects.
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