News

pharmaphorum5d
Opdivo's subcutaneous PD-1 inhibitor cleared in US
It is the second drug in the PD-1/PD-L1 inhibitor class to be cleared in a subcutaneous injection form by the FDA after Roche's Tecentriq Hybreza (atezolizumab and hyaluronidase) – which got a ...
BMJ3d
A phase I, open-label, multicentre, first-in-human study to evaluate safety, pharmacokinetics and efficacy of AMG 404, a PD-1 inhibitor, in patients with advanced solid tumours
Objective To evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antitumour activity of AMG 404, a fully human IgG1 monoclonal antibody targeting programmed cell death-1, in ...
pharmaphorum3d
FDA won't back Lilly's PD-1 antibody based on Chinese data alone
In briefing documents released by the FDA reviewer, the agency has made it clear that the Chinese clinical results filed in support of the PD-1 inhibitor do not meet the criteria for foreign data ...