The "blockbuster" drug model may still have some life in it yet. That's what a number of big pharma and "blue chip" biotechs are hoping anyway as they invest millions of research dollars in their quests to develop the next generation of hepatitis C virus (HCV) drugs. The potential market for HCV drugs is predicted to grow rapidly in the next five years and could get even get bigger following recent draft guidelines from the Centers for Disease Control and Prevention (CDC) proposing that all U.S. baby boomers get a one-time test for the hepatitis C virus. Read More
For the interim analysis of its Phase II study combining VX-809 and Kalydeco (ivacaftor) in cystic fibrosis patients homozygous for the F508del mutation, Vertex Pharmaceuticals Inc. presented data pooled from the three doses from baseline to day 56 of the trial. The release of the final top-line data for study contained efficacy data for just the largest 600 mg dose of VX-809 with Vertex highlighting the improvement in lung function from day 28 to 56. Read More
With the stroke of a pen the prospects of millions of people suffering from rare diseases has improved dramatically. The signing of the Food and Drug Administration Safety and Innovation Act (FDASIA) by President Obama now gives the FDA the provision to work on speeding up the development of "breakthrough therapies" that demonstrate early promise and faster patient access to new medical treatments. Read More
