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.
AstraZeneca Pharmaceuticals agreed to pay $11 million to settle claims by a proposed class of indirect purchasers of hypertension drug Toprol-XL that the drugmaker used sham patent litigation to prolong a monopoly on the drug by delaying generic versions. Law360