Skin cancer drug pembrolizumab obtains NICE approval
Pembrolizumab is said to be the first drug to be approved in March through the Medicines and Healthcare Products Regulatory Agency’s Early Access to Medicine Scheme (EAMS). The
Akeso has received approval from China’s National Medical Products Administration (NMPA) for gumokimab (AK111), an anti-Interleukin-17 (IL-17) monoclonal antibody, to treat adults with moderate-to-severe plaque psoriasis.
The primary efficacy endpoint is the summed pain intensity difference (SPID) over 1-hour (SPID1). Safety endpoints, such as adverse events and vital signs will also be assessed, as
The FDA has determined MPI’s Hydroxyprogesterone Caproate Injection USP, 250 mg/ mL (1.25 g/5 mL vials) to be bioequivalent and, therefore, therapeutically equivalent to Delalutin Injection, 250 mg/mL
The trial is a randomized, double blind, active control, multi-center, global study in patients with chronic plaque psoriasis to compare the safety, efficacy and immunogenicity of M923 with