Multiple companies make IVIG, but only Gammagard is in advanced clinical testing for use in Alzheimer's.
At HGS seven gene-based drugs have entered trials, but most remain in the earlier stages of clinical testing.
Newman and Robin Feldman are rightfully concerned about what this means for the future of clinical testing.
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Together, the two companies would have 19 medicines in the late stages of clinical testing and four already in front of regulators.
Scangos says companies should start looking for genetic variations that predict a drug's efficacy in the very early stages of clinical testing.
And if we include clinical testing centers, supply chain managers, and other partners, our industry supports 4 million jobs across the nation.
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He realizes that requiring clinical testing for efficacy will slow things down and needlessly keep important drugs out of the hands of suffering patients.
Or they are shepherding through clinical testing one of the nearly 1, 000 molecules targeting cancer that are in the pipelines of the pharmaceutical industry.
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The device, if it passes clinical testing that begins this spring, would be a boon for patients with wide, short or steeply angled abdominal aortas.
Even in the absence of plausible theory (or just common sense), rigorous clinical testing could provide evidence of homeopathy's effectiveness, but the data suggest otherwise.
These products are so successful that clinical testing has already begun!
To save money for consumers, Waxman is willing to allow certain drugs, called biologic drugs, to enter the market without clinical testing that proves their efficacy.
But he foresees a "revolution" in the Indian industry, including an influx of foreign investment in research and clinical testing--if the Indian government implements the patent law.
Clinical testing will take place over the summer, Hall said.
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But one must remember that they were developed at a time when far less was known about medicine and clinical testing was far less vigorous than it is today.
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BioCryst is now developing an injectable version of the drug, and peramivir has shown some success in fighting avian flu in pre-clinical testing involving cell cultures and in animals.
When I was a medical reviewer at the FDA in the 1980s, a completely unexpected side effect occurred in the clinical testing of a new formulation of human growth hormone synthesized in bacteria.
Based on a thorough review of data submitted by Lilly that was obtained from pre-clinical testing in animals and clinical trials in thousands of diabetics, FDA granted marketing approval for human insulin in October 1982.
The FDA has yet to pass judgement on the subject of substitutable or interchangeable biosimilars, but consensus indicates that such a status could be conferred on a biosimilar if it is supported with more extensive clinical testing.
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By searching through patient tumor samples for mutations in these genes, researchers may be able to vastly accelerate the long and expensive clinical testing process by testing new drugs only in patients whose tumors contain the bad genes.
The time required for the FDA to review the data on and approve a new drug--about 18 months--has been essentially unchanged for the past decade, while the duration of clinical testing (largely a function of FDA requirements) has gradually increased.
Dr Fraser and the other specialists called for a standardised guidance system on assessing high risk medical devices, the introduction of rules for newer devices such as electronic medical records that are not currently scrutinised, more consistent advice on clinical testing and more information on standards and study results.
Last year, Tanner was enrolled in a clinical trial testing the drug, called drisapersen.
Amgen has already paid for clinical studies testing whether it is safe to give the two drugs at the same time.
Of these, about 500 have been clinical trials testing meditation for various ailments, but only about 40 trials have been long-term studies.
But shares plummeted 22% as investors fretted over a delay in clinical trials testing Genasense, the oncology drug the two companies are developing.
Schering-Plough has changed the start date listed in a government database for the key clinical trial testing the now-controversial cholesterol pill Vytorin, which Schering shares with Merck .
Isis needs one in order to start a large and expensive clinical trial testing its drug in patients who have high cholesterol that is not caused by a genetic defect.
Meanwhile, Dr. Allayee at USC plans to begin a 200-patient clinical trial testing whether leukotriene blockers like Singulair can prevent atherosclerosis in high-risk patients, as soon as he can obtain government funding.
In a startling break with tradition, the American College of Cardiology and the Society of Thoracic Surgeons will manage and run their own clinical trials testing expanded uses for transcatheter aortic valve replacement (TAVR).
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