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news.Adherex granted orphan drug designation for melanoma drug
The FDA orphan drug designation provides potential incentives such as funding for clinical studies, study design assistance, waiver of FDA user fees, tax credits and, importantly, up to
The FDA orphan drug designation provides potential incentives such as funding for clinical studies, study design assistance, waiver of FDA user fees, tax credits and, importantly, up to
FDA has requested a survival primary endpoint, which could potentially increase the total number of patients required for the trial. The trial design proposed by the company has
The company will open the IND with two identical registration quality Phase III studies. The work has been awarded to an appropriate CRO. This IND is based on
The approval is based on safety and efficacy results from a clinical study of JIA patients four to 17 years of age. According to the company, JIA is
Pursuant to the proposed amendment, the number of shares of Oracle common stock used in the calculation of the exchange ratio pursuant to which shares of PTI common
The approval is based on a Phase III study (E2100) that showed that Avastin in combination with paclitaxel chemotherapy resulted in a 52% reduction in the risk of
The potency, tolerability, pharmacokinetic and pharmacodynamic properties of NXD30001 and its derivatives indicate that it, or an analog, may be useful in the treatment of breast and other
The decision was made in response to recent reports related to additional events identified in a cohort of volunteers in a safety study involving the drug. The decision
The Recovery trial is a single-blinded, randomized trial that compared the ClosureFAST catheter with endovenous laser ablation in 62 limbs. Dr. Proebstle of Heidelberg, Germany, said: “Our study
The trial was designed to evaluate the effect of MC-1, versus placebo, on the incidence of cardiovascular death or nonfatal myocardial infarction up to and including 30 days