Replimune Won Accelerated Approval on 91 Evaluable Patients and a 24% Response Rate
CBER took a 24% response in 91 evaluable patients, one day after the same committee voted nine to three against Capricor. Measurement, not size.
nivolumab
The EPO Revoked BMS’s 480mg Opdivo Patent Because the Trial Behind It Dosed by Weight
BMS claimed a 480mg flat dose. The only clinical example in its filed application dosed by weight. The EPO revoked the patent on added matter.