BioMarin initiates Phase I phenylketonuria trial
The Phase I clinical trial is an open-label, multi-center study to be conducted in approximately 35 phenylketonuria (PKU) patients in a series of seven dose- escalating cohorts ranging

The Phase I clinical trial is an open-label, multi-center study to be conducted in approximately 35 phenylketonuria (PKU) patients in a series of seven dose- escalating cohorts ranging

The new dosage strength was approved by the FDA on February 25, 2008. The recommended oral dose of Prezista for treatment-experienced adult patients with HIV-1 is 600mg (one

Most recently, Mr Dro was chairman and CEO of Endoart, a medtech company developing telemetric driven implants for cardiac disease and obesity, which was sold to Allergan. Mr

The company is also working with Novo Nordisk under separate license agreements to develop GlycoPEGylated versions of recombinant Factors VIIa and VIII. A Phase I trial of GlycoPEG-Factor

The study demonstrated superior results for the primary and all secondary endpoints. For the primary endpoint, the relative magnitude of bone mineral density (BMD) improvement at the total

Continuing on with the planned dose-escalations of Rexin-G which began in 2005 using lower doses of Rexin-G in a Phase I safety study, the current Phase I/II study

The primary objective of the study was to assess the accuracy of PillCam Colon in detecting polyps as compared to traditional colonoscopy. The eight-center trial enrolled 320 patients,

The agreement allows the biotech company to take full advantage of OmniComm’s First in Functionality, EDC solution, TrialMaster for up to 10 concurrent trials per year. The biotech

The primary endpoint of the registration trial, objective disease response rate (ORR) in patients who had failed previous therapy, was successfully achieved with an ORR of 40.3% (29/72

Under the terms of the agreement, Wyeth and Elan may pay Intellect potential future milestone payments and royalties based on sales of potential products, if it is determined