GENENTECH, a member of the Roche Group, received a second Breakthrough Therapy Designation from FDA for its anaplastic lymphoma kinase inhibitor, Alecensa (alectinib). The latest BTD was granted for the treatment of adult patients with advanced ALK-positive non-small cell lung cancer who have not received prior treatment with an ALK inhibitor.
The White House Office of Management and Budget has published a “Regulation for Federal Financial Assistance,” a proposed rule that seeks to fundamentally redraw the ground rules for all federally funded research. On the other side are America’s scientists who aren’t just crying foul—they are readying for a political fight.
