ChemGenex agrees with FDA on potential regulatory path to progress OMAPRO for CML ChemGenex Pharmaceuticals Small announced today it offers agreed with the U www.lafinasterida.com .S. Based on the discussion with the FDA, ChemGenex intends to combine data from its two pivotal research, Study 202 and Research 203, and submit a New Drug Program for OMAPRO for those patients with CML who have failed prior treatment with two or more currently approved tyrosine kinase inhibitors . The proposed indication of the new NDA will end up being for the treatment of CML patients who have failed two or more TKIs, of their mutation status regardless. Related StoriesProtein-coding gene defined as tumor suppressor for severe myeloid leukemiaPenn study forms basis for new treatment methods for Sezary syndromeYK-4-279 compound functions against some types of leukemia: Study The FDA’s agreement that a combined data set could serve as the basis of an NDA in a third-range establishing provides us with a pathway to an expanded indication for OMAPRO to take care of CML sufferers who are resistant to at least two TKIs, said Adam Craig, MD, Chief Medical Officer of ChemGenex.
Neither of the parties endorse or suggest any commercial products, services, or equipment.. Changing iv catheters only when necessary ‘could benefit millions’ By Liam Davenport, medwireNews Reporter Peripheral intravenous catheters need be removed only when clinically indicated, instead of every 72 to 96 hours, as is currently recommended, conclude Australian researchers in results that could have dramatic individual and cost benefits. Related StoriesGastric balloon in a tablet helps patients lose weight without surgery or endoscopyLiposomal sizing and the Coulter basic principle: an interview with Professor Melvin E. KlegermanMiriam Medical center enrolling local participants for Parachute implant scientific trial to treat center failureWriting in The Lancet, the investigators state their data strongly suggest that routine replacement does not prevent complications but instead causes many needless invasive procedures.