If approved, Brineura will be the first and only treatment for CLN2 disease, a form of Batten disease.
Postmenopausal women already have a broad menu of locally administered estrogen therapy products to treat vulvar and vaginal atrophy.
XBiotech's efforts to shade Xilonix's clinical failings amounted to little more than hand waving when it mattered most. European regulators at the oral explanation meeting on Thursday were not fooled.
Tesaro's newly approved PARP inhibitor Zejula is really 50% more expensive than its list price implies.