He told the chamber that the manufacturer of the clinical product had specifically requested that it was not used for those who had had chemotherapy.
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.
Some patients appear to respond with improved cognitive functioning, the company found in two, small clinical trials comparing their product with placebo.
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In the Merck deal, GlycoFi may receive up to tens of millions of dollars in clinical milestones for each product that successfully moves through development.
The new discipline could change the drug market by reducing the rate of product failure in clinical trials.
The company announced that its first stem cell product to enter clinical trials, PDA-001, recently showed very early and very dramatic results in a few Crohn's disease patients.
's website, a clinical study found its RevitaLash Advanced product "improved appearance" of eyelashes.
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Its most advanced product, in Phase 3 clinical trials, aims at preventing chemotherapy-induced nausea and vomiting.
Royea says the beta product will be used in clinical trials in Europe and the U.S. this year, and he expects to make a commercial launch in Europe during the first half of 2014.
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Pharming, a Dutch biotechnology firm, recently began clinical trials for alpha-glucosidase, a product designed to treat Pompe's disease, a metabolic disorder causing fatal degeneration of muscle.
With successful conclusion of this Phase III clinical program, LibiGel could be the first product approved by the FDA for women with low sexual desire, HSDD, a significant unmet medical need.
In the third round of financing, T2 is trying to commercialize its technology and hopes to develop a beta version of its product in the summer of 2011 and to begin clinical trials in early 2012.
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Fay oversaw the product go from prototype all the way through the first clinical trials.
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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Although the findings of the studies are mostly consistent in showing a similar magnitude hazard ratio, estimates of the effectiveness of sipuleucel-T are imprecise due to the relatively small total sample size of the clinical trials, and unmeasurable biases due to potential confounding effects of frozen salvage product and post-progression treatments.
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In a risky move, GlaxoSmithKline says it will conduct a 1, 000-patient clinical trial to test its vaccine to prevent cervical cancer, Cervarix, against a rival product made by Merck.
Under these regulations, the manufacturer must conduct additional studies after the product is approved to demonstrate that the drug does, in fact, have a clinical benefit.
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