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.
TGA acts on melatonin imports with infringement notices totalling $99K
Laboratory testing of several imported unregistered melatonin products has confirmed them to be...
Scientists search for cystitis pain 'off switch'
By targeting certain pain receptors in the bladder, Australian scientists believe that the...
Australia's first cases of H5 avian influenza confirmed
Positive results for H5 avian influenza (bird flu) have been confirmed in two seabirds found in...
