Merck can update its Vytorin label with data suggesting a cardiovascular benefit in patients with kidney disease, the drugmaker said, but may not claim a new indication. That was the FDA’s decision, despite a unanimous vote by an advisory panel in favor of the pre-dialysis outcome. The vote had followed release of data from the SHARP trial, in which Vytorin (ezetimibe/simvastatin) reduced major vascular events in patients with moderate-to-severe chronic kidney disease (CKD). The FDA permitted no such label update for Vytorin’s LDL-lowering cousin, Zetia (ezetimibe).
Biotechs made a showing in Fortune Magazine’s list of 100 Best Companies to Work For, starting with Millennium: The Takeda Oncology Company, which placed at 35 and was followed closely by Novo Nordisk at 43. Genentech was No. 68.
