Recently Diovan's marketers added a new weapon: a big study showing that adding the drug to standard medications reduces complications from heart failure.
One trial is pitting the drug against standard therapy among colon cancer patients with liver metastases, looking to slow the time it takes the cancer to progress.
The traditional procedure would have been to first conduct larger trials in several hundred patients comparing the experimental drug to standard treatment, and only then to seek approval.
Pharmacia and Upjohn stress that there have been very few incidences, and that the drug carries a standard drowsiness warning.
These are just four of the side effects of interferon, a standard drug used to treat the liver disease hepatitis C.
Standardizing the process by which companies strike deals to do clinical trials that compare an experimental drug to a standard regimen made by another company.
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Under Gore's plan, the government would continue to run most of the Medicare program and would offer a standard drug benefit that seniors could either take or leave.
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In a study out today at a big infectious disease conference, it compared its best selling antibiotic Zyvox to the older gold-standard drug vancomycin in patients with hospital-acquired pneumonia.
The giant trial showed that was somewhat better than the standard drug warfarin in preventing strokes, at least among those who stayed on the drugs during the whole trial period.
She started the infant on a three-drug cocktail of antiretroviral medications for HIV treatment, as opposed to the standard two-drug regimen for prophylaxis (prevention) of infection.
No resistance to PolyMedix' drug has emerged in standard lab tests.
The industry's trade organization, Pharmaceutical Research and Manufacturers of America, frequently points out that the FDA already sets the worldwide standard for drug safety and that many of the medicines drug firms invent are lifesavers.
The market for Erbitux will likewise initially be limited to colon cancer patients whose disease has progressed despite treatment with the standard chemotherapy drug Camptosar, sold by Pfizer (nyse: PFE - news - people ).
The discovery of aspirin was inspired by Felix Hoffman's attempt to find a drug to ease his father's arthritis without causing the severe stomach irritation associated with the standard anti-arthritis drug of the time, sodium salicylate.
Allowing one drug through on a lighter standard will at the least cause more biotech companies to push forward with applications following failed trials.
Moreover, it would look for a difference in the mortality rate of patients on the drug and those on the standard of care after six months.
On Oct. 23, Bristol Chief Financial Officer Frederick S. Schiff said that such lean times are going to become a standard for the drug industry, which is used to double-digit earnings growth.
An earlier study showed that elderly women would also benefit from surgery and the drug tamoxifen, the gold standard of care for breast cancer, but many were not receiving the treatments because of ageism.
John Tsai, the worldwide team leader for Lipitor, argues that Lipitor's efficacy may save insurers cost in the long run, and that his drug clearly provides a benefit over standard of care.
He said he thought the drug would be most useful for patients for whom standard treatment had failed and in a "minority" of patients as a first-choice drug.
"There is no precedent in oncology to say that a drug would work alone but not with standard chemo, " he says.
The standard for approving a new drug was lower in the past.
To complicate matters, Genentech did do such a study for its cancer treatment Avastin--and the drug extended survival, making it the standard of care for colorectal cancer patients whose cancer has started to spread.
Among those are maternity care, substance abuse and mental-health services and prescription-drug coverage, which aren't standard in individual policies today, says Sarah Lueck, a senior policy analyst at the Center on Budget and Policy Priorities, a nonprofit group in Washington.
While most new drugs are reviewed in 10 months, the standard review time for a generic drug is 30 months.
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Gay said her standard is to use a three-drug regimen to treat an infection.
The patient who saw his tumour completely disappear was given the vaccine plus a drug called IL-2, already given as standard treatment for kidney cancer.
When trying to find out if something will work - be it a new policy, a new drug, a new teaching method - the gold standard of evidence is what comes out of a properly conducted random controlled trial.
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In an initial trial last year, the drug delayed growth of sarcoma by about three months versus standard treatment.
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It's another scientific failure for big pharma, and perhaps also a sign that the Food and Drug Administration is holding new heart pills to a tougher standard.
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