Drug Approval Briefs: Cubist, Iroko, Merck Serono, UCB, Genentech, Allergan, GE Healthcare, Zogenix
UCB’s Cimzia wins ankylosing spondylitis claim, but axial spondyloarthritis is not looking good; GE’s Vizamyl joins Amyvid on list of underemployed amyloid imagers; Cubist stretches Entereg label a bit; Iroko builds a safer NSAID; and more.
You may also be interested in...
The final coverage decision for Lilly’s Amyvid sticks with the proposal to limit payment to use in clinical trials. That is a setback for Lilly, but reinforces the Medicare agency’s commitment to the Coverage with Evidence Development pathway.
Cubist will rely on its experience in infectious disease to drive growth of Dificid for Clostridium difficile infection and to launch tedizolid for skin infections, but the commercial market for new antibiotics is daunting and re-creating the success of Cubicin won’t be easy.
Late-stage pipeline is dominated by follicle stimulating hormones, split between “biobetters” and biosimilars. Next-generation oxytocin antagonists are leading candidates for the next novel entities in infertility.