Ilex clofarabine gets user fee extension
FDA extends review clock for Ilex' pediatric leukemia agent clofarabine by three months to Dec. 30 following submission of additional clinical data. Ilex completed the rolling NDA filing March 29 for priority review, originally setting a Sept. 29 user fee date. Ilex submitted data on 14 additional patients from Phase II trials in acute lymphoblastic leukemia and acute myeloid leukemia, bringing the total number of patients included in the filing to 84. Genzyme, which is seeking regulatory clearance to acquire Ilex, has conservatively projected approval for late 2005...
You may also be interested in...
FDA's Oncologic Drugs Advisory Committee recommended accelerated approval for Ilex' Clolar (clofarabine) in the treatment of pediatric acute lymphoblastic leukemia, but not pediatric acute myelogenous leukemia, at its Dec. 1 meeting
Can Atlas Biomed unlock Japan's self-care market with its direct-to-consumer DNA and microbiome tests? HBW Insight catches up with the company's co-founder and CEO to discuss this and also how Atlas has been driving its European expansion plans despite coronavirus.
France's ANSES warns women using oral contraceptives not to use a supplement marketed by UK firm Hairburst after linking the product's consumption to two cases of severe acute hepatitis.