ChemGenex on a roll
Tuesday, 01 July, 2008
ChemGenex [ASX: CXS] has submitted the non-clinical section of its New Drug Application [NDA] to the US FDA for omacetaxine, the company's chronic myeloid leukaemia treatment.
The non-clinical section is the first of three in the company's rolling submission: the next steps are the chemistry and manufacturing controls segment and the clinical section.
ChemGenex expects that both remaining submissions will be complete by mid-2009.
The FDA has already granted fast-track designation to the drug, omacetaxine mepesuccinate, for treatment of patients who have failed prior treatment with Novartis' imatinib mesylate, or Glivec.
Heart muscle regeneration genes mapped
Researchers have uncovered insights into how stem cells develop and mature into heart muscle...
The cause of 2022's mpox outbreak revealed
Researchers have discovered that the strain of mpox behind the 2022 outbreak was a weakened form...
New gene therapy treats liver disorder in growing children
Researchers have developed a genome-editing approach that repairs a faulty gene directly at its...
