Porges points out that there is an FDA-mandated safety study of Copaxone in combination with Tysabri.
There are plenty of reasons to delay approval until a big safety study emerges.
On Monday, Novartis said the U.S. Food and Drug Administration wants it to run a new safety study of Galvus.
The 24-week safety study reported to the Conference on Retroviruses and Opportunistic Infections in Los Angeles looked at 1, 000 patients.
Therefore, the Phase III LibiGel (testosterone gel) safety study will continue as per the FDA-agreed protocol, without modifications including continued enrollment of new subjects.
The new drug is by no means ready for the clinic, but it is about to undergo a preliminary safety study in healthy male volunteers.
Aside from the aforementioned stomach safety study, called VIGOR, Merck also did a smaller study, called 090, which compared Vioxx to a placebo over six weeks.
He points out that of 521 patients who took the drug in a safety study, 2 had forms of sleep paralysis, which can be a symptom of narcolepsy.
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On Monday, Novartis (nyse: NVS - news - people ) said the U.S. Food and Drug Administration wants it to run a new safety study of Galvus.
Subjects in the LibiGel safety study are a minimum of 50 years old and up to 80 years of age, and they must have at least two cardiovascular risk factors at enrollment.
Certainly one would agree that the quantity and the quality of the safety data and the involvement of the FDA in the planning of the LibiGel safety study all are positive indications for LibiGel.
The DMC has recommended FIVE times that the LibiGel safety study continue as per FDA-approved protocol, with no modifications, since there are no signals or markers that would indicate that LibiGel is less than safe.
And parents who talk on cell phones, send texts or eat and drink while driving have teenagers who are more likely to do the same, according to preliminary findings of a new safety study by Toyota Motor and the University of Michigan.
BioSante reported that with 2, 869 women enrolled and over 3, 000 women-years of exposure in it LibiGel Phase III cardiovascular and breast cancer safety study, there have been 17 adjudicated cardiovascular (CV) events, with a lower than anticipated event rate of approximately 0.57 percent.
In that study, researchers looked at the data from two already completed studies, the Vioxx Gastrointestinal Outcomes Research study (VIGOR) and Celecoxib Long-Term Arthritis Safety Study (CLASS), and concluded that both drugs might slightly increase the risk of cardiac events such as heart attack and stroke.
Gary Landreth, one of the authors of Thursday's Science paper and a professor of neurosciences at Case Western Reserve University in Cleveland, said he expected to begin a safety study in 12 healthy patients next month, but there weren't any current plans for a larger clinical trial.
The Data Safety Monitoring Board for the APPROVe study recommended that the study be stopped for safety reasons.
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This was the recommendation of the independent Data Monitoring Committee (DMC) based on its 5th unblinded review of all study safety data.
In fact safety data from study 329 had already been submitted to the regulatory authorities and had been presented publicly before this document was written.
Following this initial safety trial a broader study across three European countries is planned.
After Week 26, during the safety phase of the study, adjustments to concomitant lipid-lowering treatments were allowed.
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The Institute of Medicine has just released a visionary report on how we should study the safety of approved drugs.
At a December 2001 meeting with financial analysts, Merck promised to study the safety of Vioxx and a follow-up drug, Arcoxia.
Dodd , a Democrat, is proposing a sweeping set of drug reforms that would give the Food and Drug Administration the muscle to force pharmaceutical companies to study drug safety after the medicines are approved.
"There was a risk of kids not being covered for safety, " said the study author, Lara McKenzie.
One, Marvin Konstam of Tufts University, said he was on the data safety monitoring board for a study of Natrecor.
As most experts on both sides of the safety debate expected, the study, COURAGE, showed no reduction in heart attacks and deaths for patients who got a stent compared to those who didn't.
An independent committee charged with monitoring the safety and ethics of the study from a patient perspective told Lewis that the company might consider tracking the patients longer to see if those that got palifosfamide would live longer.
The Health and Safety Executive has commissioned a British study of MCS from the Institute of Medicine.
BBC: By BBC News Online's Environment Correspondent Alex Kirby
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