Sentences with phrase «pivotal study»

We plan to initiate a large, randomized, controlled pivotal study in the coming months, which is aimed at definitively showing the benefits of our intervention for children with ADHD.

Queen's University's Professor Stuart Elborn, an international authority in respiratory medicine, with colleagues from the United States and Australia have led pivotal studies of a new treatment for people with Cystic Fibrosis.

Our current multi-centre pivotal study has shown that in many patients, by using a radiotracer with a novel receptor - based mechanism, the SN can be reliably identified and removed for biopsy without having to undertake more extensive surgery.

«The continued significant investment shows up in the fact that currently we have more than 25 phase 3 and pivotal studies ongoing in a range of diseases,» Geissman says.

Florham Park, N.J. — August 13, 2013 — Results of a new pivotal study show that APOQUEL ® (oclacitinib tablet) provides effective and safe control of pruritus associated with allergic dermatitis in dogs with a rapid onset of efficacy within 24 hours and without the commonly reported side effects of steroids.

For ALKS 3831, we recently completed enrollment of the ENLIGHTEN - 2 pivotal study, with topline data expected in the fourth quarter of 2018.

Management continues to believe that the refined manufacturing process utilized in pivotal studies will ranslate into improved normalization of total hemoglobin levels across all genotypes.

Abeona Therapeutics (ABEO)- Data for ABO - 102 in MPS IIIA appears encouraging to me (decreases in heparan sulfate, neurocognitive benefits), initial data for ABO - 101 in MPS IIIB showed early promise, EB - 101 in RDEB could see an expedited path to market if the pivotal study yields fruit, and other gene therapy candidates are soon to enter the clinic.

«We are encouraging people to come in and to get to the place where they are ready to do their pivotal studies and to submit a premarket approval application,» says Stayce Beck, chief of the FDA's Diabetes Diagnostic Devices Branch.

The authors say: «Prolonged 6 - to 24 - month multinational closed - loop clinical trials and pivotal studies are underway or in preparation including adults and children.

Bluebird Bio (NASDAQ: BLUE) and Novartis (NYSE: NVS) have the most advanced CAR - T programs for myeloma, with Bluebird and partner Celgene (NASDAQ: CELG) planning a pivotal study this year.

The pivotal study is published in the scientific journal, Scientific Reports, on Tuesday, 13 September 2016.

NYU Langone was the first hospital in the tri-state area to use MarginProbe ®, and our physician - researchers were part of a pivotal study of over 600 women that led to its approval by the FDA.

The pivotal study published in the New England Journal of Medicine in 1997 showed that the DASH diet substantially reduced blood pressure.

(The primary author of that pivotal study,...

Ranging from early phase to pivotal studies, Dina has had the ideal experiences needed to ensure high quality conduct across a multitude of study settings.

A pivotal study done in the early 1970's by Albert Mehrabian showed that words only -LSB-...]