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.
The health fund of an electrical workers’ union filed a class action against Warner Chilcott in Pennsylvania federal court over the pharmaceutical company’s alleged efforts to evade development of a generic Doryx by periodically tweaking the design and dosage of the anti-acne and bacterial infection drug. Law360