Showing posts with label Industry updates. Show all posts
Showing posts with label Industry updates. Show all posts
Tuesday, February 7, 2012
Saturday, February 4, 2012
FDA and European Medicines Agency sharing work....:)
This article about sharing inspections work between FDA and European Medicines Agency. The European Medicines Agency and the United States Food and Drug Administration (FDA) are launching an initiative to share work on inspections of manufacturing sites in each other's territories. This is a three-year pilot program to share work on facility inspections - including those making finished dosage forms - in each other's territories.
Monday, January 23, 2012
World's first stem cell based allogenic drug approved.
Researchers and biotech executives foresee the day when the effects of many catastrophic diseases can be reversed. The damaged brains of Alzheimer's disease patients may be restored. Severed spinal cords may be rejoined. Damaged organs may be rebuilt. Stem cells provide hope that this dream will become a reality.
What is Cartistem?
"Cartistem is... the world's first approved allogeneic (taken from different individuals of the same species) stem cell drug, that can offer new opportunity for treatment of patients with degenerative arthritis," the administration said in a statement.
Who developed it?
Cartistem, developed by Seoul-based Medipost, will help regenerate knee cartilage using stem cells developed from newborns' umbilical cord blood, the drug agemcy said.
What is the drug-development process?
