Clinical efficacy, judged using economic cost data, will have to be proved before new drugs and medical devices are approved.
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But it also included language in the amendment that pharmaceutical companies had to prove significant clinical efficacy enhancements of their drugs over already-patented compounds.
The clinical trials with an agent like this are pretty straightforward and the Advisory Committee agreed that, in terms of clinical efficacy, degludec meets the guidelines for approval.
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What schools need, he said, is something like NICE (the National Institute for Health and Clinical Excellence), the public body that assesses medicines and medical techniques for safety, clinical efficacy and cost effectiveness.
He realizes that requiring clinical testing for efficacy will slow things down and needlessly keep important drugs out of the hands of suffering patients.
Merck, the clear market leader with its blockbuster drugs Januvia and Janumet, is also developing MK-3102, which has exhibited strong efficacy in clinical trials.
Even when not forced to do so by the FDA, pharmaceutical companies often find it advantageous to run well-designed, expensive and lengthy clinical trials to show efficacy.
Further, the American Congress of Obstetricians and Gynecologists echoed the research finding and questioned the lack of clinical data to prove efficacy of robotic hysterectomy over cheaper laproscopic hysterectomy.
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With the strong efficacy exhibited in clinical trials, we believe the probability of T-DM1 getting FDA approval has increased significantly.
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This tool may be useful as an outcome measure in MS clinical trials to assess the efficacy of neuroprotective drugs.
"For the four others investigated, there are no published randomised clinical trials to support their efficacy in weight loss, " Dr Cable added.
We are very close to a clinical trial to test for efficacy.
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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.
Due to the lack of evidence of efficacy in early clinical trials, the drug (a combination of two proven cardiac medicines) had been rejected by the Food and Drug Administration nine years previously for approval for patients of all races.
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If the drug candidate is derived from an herbal medicine that is legally marketed and hasn't caused safety problems, it may be able to skip the early-stage safety trial and go right to midstage clinical trials, which measure efficacy and determine proper dosing.
In addition, the experimental insomnia drug Suvorexant exhibited strong efficacy in phase III clinical trials as the drug helped insomnia patients fall asleep faster and stay asleep longer versus a placebo.
"There is a significant body of scientific and clinical evidence supporting the safety and efficacy of ginkgo extract for both cognitive function and improved circulation, " said Mark Blumenthal, executive director of the American Botanical Council.
The news results from a risky gambit by drugmaker AstraZeneca (nyse: AZN - news - people ) to test the new medicine, Cerovive, in a 1, 700-patient Phase III clinical trial before proof of human efficacy was available.
But Desmond-Hellmann and her colleagues used clinical trials to look for hints of efficacy even when the treatments failed.
According to the company, Nucryst has seen encouraging pre-clinical results in studies looking at the efficacy of NP 32101 for treating inflammatory bowel disease, including ulcerative colitis.
While the FDA approved the vaccine for the above age group last December, the CDC is waiting for the efficacy results of an ongoing clinical study (Pfizer expects to complete the trials by 2013) before deciding on broader recommendations.
Scangos says companies should start looking for genetic variations that predict a drug's efficacy in the very early stages of clinical testing.
Rory Collins, co-director of Oxford University's clinical-trials service unit (which demonstrated the efficacy of aspirin against heart disease) has managed to piggy-back on a commercial trial in order to test the notion that folic acid, a food-supplement commonly given to pregnant women, may also prevent heart attacks.
The day before the opening today of the ASH conference in Atlanta, TG Therapeitics announced it has initiated a phase 1 and 2 clinical trials to evaluate the safety, tolerability and efficacy of its product, TG-1101, a novel third-generation anti-CD20 monoclonal antibody, in combination with Revilimid for patients with relapsed or refractory B-cell lymphoid malignancies who were previously treated with anti-CD20 antibody therapy.
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The National Institute for Clinical Excellence, a government body set up to study the efficacy of drugs and treatments, is currently looking at Taxol.
But the stock has traded at less than a third of its 52-week high since Genentech, building on a string of clinical successes, released data showing that its Lucentis had unprecedented efficacy against some types of AMD, perhaps even reversing the disease.
Still others work on company-funded clinical trials, the main way that medicines are studied for safety and efficacy.
Both drugs and devices must now be pre-certified for efficacy as well as for safety, in stages from lab testing to clinical trials, before ever having a shot at the market.
The 1960s were when the Food and Drug Administration, in the wake of the thalidomide scandal, started requiring proof of efficacy and long-term safety, and when medicine started relying on clinical trials that compared new treatments to old ones or to inert sugar pills.
The memo further states that patients must meet numerous other qualifications relating to clinical trials and not have certain serious diseases or conditions that would lower the implant's efficacy or the patient's likelihood of long-term survival.
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