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news.Protalix begins pivotal Gaucher disease trial
The product, prGCD, is a proprietary plant cell expressed recombinant form of human Glucocerebrosidase (GCD). The Phase III clinical trial will take place in centers in the US,
The product, prGCD, is a proprietary plant cell expressed recombinant form of human Glucocerebrosidase (GCD). The Phase III clinical trial will take place in centers in the US,
Tezampanel will be given as a subcutaneous injection to healthy male and female volunteers once-daily for four consecutive days. The compound is an AMPA/kainate (AK) receptor antagonist that
Pfizer's DGAT-1 discovery program includes advanced preclinical compounds with potential applications for the treatment of metabolic disorders, as well as DGAT-1 inhibitors in-licensed by Pfizer from Bayer in
The FDA has requested data from additional clinical trials to demonstrate the benefit of the drug. In anticipation of a not approvable letter from the FDA, the company
Carl Pelzel has been appointed president and CEO and to the company's board of directors. Mr Pelzel has been Depomed's executive vice president and COO since 2005. Craig
Under the agreement, Ipca will develop and register selected products for US ANDA submission, while Heritage will retain sales and marketing rights to such products. The parties shall
The trial is a multi-centered, double-blind, placebo controlled, randomized cross-over study to evaluate the effects of inhaled CGRP on clinical and inflammatory parameters in adult patients with mild
NP2, the company’s first drug candidate in its nerve targeting drug delivery system (NTDDS) gene therapy platform, will be the subject of a pre-IND meeting with the FDA
The European Commission approved Rasilez alone or in combination with other high blood pressure therapies, based on data from more than 7,800 patients in 44 clinical studies which
Following a meeting with the FDA and subsequent statistical analyses, the company reported that despite the descriptive data showing numerical differences, the drug did not demonstrate a statistically