A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
Dyax’s DX-2930, an experimental treatment for hereditary angioedema, has won FDA orphan drug designation. The human monoclonal antibody is designed to inhibit plasma kallikrein to reduce swelling, pain and inflammation associated with the disease, the drugmaker says.
MedTech Europe, the alliance of European medical technology industry associations, launched at the European MedTech Forum in Brussels. Founded by the European Medical Technology Industry Association Eucomed and the European Diagnostic Manufacturers Association EDMA, the alliance will collaborate closely on common policy interest areas and welcomes other European medtech associations to join. MedTech Europe will be legally established by the end of 2012. MedTech Europe