Update for September 9, 2021

Regulatory Update

Shanghai Junshi Biosciences submitted a BLA for toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma.

The FDA placed a clinical hold on the Phearless Phase 1/2 study which is evaluating BMN 307 as a treatment for phenylketonuria (PKU). The hold was due to safety findings in a pre-clinical pharmacology study.  

Announced Research Updates

J&J is discontinuing the 2,637 patient, Phase IIb, Imbokodo trial, when the primary analysis failed to find a reduction in the incidence of HIV infection with the J&J HIV vaccine in a population of young women in sub-Saharan Africa at high risk of acquiring HIV. 

Takeda announced that in the 502 patient, Phase III, PANTHER trial, adding pevonedistat to azactidine did not improve event-free survival compared to azactidine alone in patients with higher-risk myelodysplastic syndromes, chronic myelomonocytic leukemia or low-blast acute myeloid leukemia.