This compound is the first in a new class of medicines to advance to this stage of clinical research.
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But at the end of 2011, there were more than 120 potential new treatments, including 16 in the final stage of clinical trials.
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Through quickly organized clinical trials and a strategy that allowed Merck to skip one stage of clinical trials, Merck caught up to Novartis--and even managed to pull a little ahead.
To be specific, Merck (MRK) will test a beta-amyloid precursor protein site-cleaving enzyme, or BACE, inhibitor, which the drugmaker notes is the first drug with this type of mechanism to advance to this stage of clinical research.
Three of these have at least reached the middle stage of the three-step gantlet of clinical trials needed to get a new medicine approved.
He notes that earlier-stage clinical trials of Avastin in breast cancer failed to show any survival trend.
Separately, Millennium Pharmaceuticals (nasdaq: MLNM - news - people ) used similar chips in its late-stage clinical studies of its cancer drug, Velcade.
BioMS moved to late-stage clinical trials of dirucotide in January 2005 and has done them with 611 patients with the progressive form of MS. Testing should wrap up in mid-2010.
Alkermes is starting late-stage clinical trials of Vivitrex, an injectable form of naltroxene--an FDA-approved drug for the treatment of opiate and alcohol dependence, and it has several other drugs in development.
Results of a larger mid-stage clinical trial are due in the second half of 2008.
An initial late-stage clinical trial involving hundreds of patients is already under way, but the FDA will require a second set of tests.
The results of a mid-stage clinical trial were recently reported, and Genzyme plans to continue looking for a partner that could get the drug approved.
The results of the late-stage clinical trials that have been run on Zetia do indicate that when it is given with a statin like Zocor or Lipitor, it can help patients meet their cholesterol targets.
The first of its two clinical-stage product candidates is a potential treatment for acute myeloid leukemia, a cancer that receives about 14, 000 new diagnoses in the U.S. annually.
At Index Ventures, we have modelled the early stage development process (up to proof of clinical concept) on the presumption that the majority of the risk in a discovery programme is not only unknown but it also unknowable (ahead of testing in man).
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In the next stage of the research, scientists will carry out clinical trials on 90 women over the next three years.
It also has a drug that is being tested in late-stage clinical trials and another in the early stages of development.
Such models, which are widely used in the pharmaceutical industry, take inputs such as the costs of clinical trials, the length of each stage of drug development and the probability of success at each stage.
This was a move of Captain-Kirk-like chutzpah on the part of chief executive Mitchell Gold, because the two late-stage studies the company had conducted had both, by the measures of clinical trial statistics, failed.
At the far end of the dumbbell, Gilead has two drugs in early-stage clinical trials.
In June Human Genome Sciences partnered with Swiss pharmaceutical giant Novartis to jointly commercialize Albuferon in the U.S. Novartis will sell the drug outside the U.S. Of course, the risk for investors is that late-stage clinical trials could show it to be a flop.
In June Human Genome Sciences partnered with Swiss pharmaceutical giant Novartis (nyse: NVS - news - people ) to jointly commercialize Albuferon in the U.S. Novartis will sell the drug outside the U.S. Of course, the risk for investors is that late-stage clinical trials could show it to be a flop.
While Vivus registered four Stage III clinical trials with the government registry, no study results from any of those trials have been published, though presumably preliminary data were submitted to the FDA panel.
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OneWorld Health chooses most projects strategically, based on a variety of factors including the disease area and identified therapeutic needs within that area, the technical feasibility of the project and its probability of success, its current development stage (e.g. discovery stage vs. clinical stage) and the potential impact.
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Almost all of these vaccines, however, are in Phase I clinical trials--early-stage tryouts meant to judge safety, not effectiveness.
But deadly side effects--a swelling of the nose and throat that can cause suffocation--turned up in late-stage clinical trials.
In 2003 it even formed a partnership with Ranbaxy Laboratories, one of India's leading drug firms, to identify new drugs and conduct early-stage clinical trials.
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Clinical trials take several years to complete and, even if the vaccine passes this first stage of tests, more research will be needed over the course of many years.
After ten years of work, Medford is finally steering his experimental drug, AGI-1067, into late-stage clinical trials.
Normally, such tests would be only the earliest stages of getting a drug approved, and most medicines that pass these hurdles eventually fail in late-stage clinical trials.
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