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Coherus said the observationcommunicated in an FDA Form 483is readily addressable and the company continues to anticipate potential approval for toripalimab by year end 2023. Coherus and its partner Junshi Biosciences received a CRL for toripalimab in this indication requesting a quality process change in May 2022

After reconstitution: Store at 28 C , protect from light, use aliquots to reduce handling, and avoid repeated temperature cycling

59 Notably, we found that dmPFC neurons were capable of boosting T-cell responses in the absence of social interactions, indicating that dmPFC neurons did not change immune responses indirectly by altering social behavior such as grooming or acts of subordination, but instead controlled social behavior and peripheral immune responses in parallel

Clinical assessors had relevant clinical backgrounds and certification in the instruments used

Label each vial clearly to avoid cross-dose errors

PMID 11823528