The patient population is too small for clinical trials to develop a statistical base necessary for a formal product approval, said Glenn Kazo, vice president of corporate development
said it has started clinical trials of its TelioDerm wound healer in two additional applications, skin grafting in the elderly and for second-degree burns in children
Our rapid progress in human clinical trials has accelerated the necessity for challenging these patents in order to bring about a rapid and final resolution of this matter," said CellPro President Richard Murdock
The moves came as a result of the FDA's April 15 decision that Centoxin (HA-1A), the company's monoclonal antibody to treat gram-negative sepsis, is not approvable based on the company's clinical trial data...Management made an extraordinary error in only doing a single clinical trial, and the bitter fruit of that error has matured," he said
The anti-sepsis monoclonals E5 and HA-1A should remain experimental treatments until clinical trials can show a reproducible, beneficial effect, according to an opinion published today in the New England Journal of Medicine
The committee will discuss Roche's new drug application for ddC today and will consider whether to recommend approval based on interim data from clinical trials of ddC alone and in combination with AZT
People are looking for earnings and not clinical trial progress, so there's very little this industry has to offer now, even though some stocks are cheap," said Jay Silverman of Nomura Research Institute
said Thursday that CenTNF, its tumor necrosis factor antibody to treat gram-negative and gram-positive sepsis, could suffer delays if the company decides to put money into more clinical trials of Centoxin, its first anti-sepsis drug
Asahi will conduct clinical trials, pursue regulatory approvals and market three CELLector applications in the Pacific Rim, except for Australia and New Zealand, where AIS retains rights
In addition to turning down Centoxin and informing Xoma that E5 isn't approvable on data from its first clinical trial, an FDA advisory committee in February gave a thumbs- down to a non-biotech drug: U.S. Bioscience Inc.'s Ethyol chemoprotective
The FDA said it requested the additional study because premature unblinding of clinical trial results prior to revision of a Phase III trial protocol could have introduced bias and therefore invalidated the results...Late Tuesday, the Berkeley, Calif., company announced that the FDA had determined that its initial clinical trial data was insufficient to warrant approval of its E5 sepsis treatment
The patient population is too small for clinical trials to develop a statistical base necessary for a formal product approval, said Glenn Kazo, vice president of corporate development