Reshaping study design for faster extrapolation-based drug approval in pediatric inflammatory bowel diseases: An ESPGHAN-NASPGHAN position paper. [PDF]
Turner D +21 more
europepmc +1 more source
Twelve years of European cancer drug approval-a systematic investigation of the 'magnitude of clinical benefit'. [PDF]
Grössmann N +3 more
europepmc +1 more source
We first identified functional murine mitochondrial N‐formyl peptides (MT‐FPs) and investigated their effects on the in vitro myeloid‐derived suppressor cell (MDSC) generation from bone marrow cells. We demonstrated that MT‐FPs acted directly on bone marrow cells to promote MDSC generation and modulated the polymorphonuclear (PMN)‐MDSC/monocyte (M ...
Miyako Ozawa +2 more
wiley +1 more source
The Importance of Cost-Effectiveness in New Drug Approval: Stroke Burden and Tenecteplase Efficacy. [PDF]
Kwon HS, Kim BJ.
europepmc +1 more source
Conditional Drug Approval as a Path to Market for Oncology Drugs in Canada: Challenges and Recommendations for Assessing Eligibility and Regulatory Responsiveness. [PDF]
McPhail M, Weiss E, Bubela T.
europepmc +1 more source
Development of human monoclonal antibodies against TARM1 by yeast display
Human monoclonal antibodies against TARM1 are generated by yeast display‐guided selection. These antibodies bind to soluble and cell‐surface forms of TARM1. Also, these antibodies exhibit agonistic activity in the NFAT‐GFP reporter assay, indicating that TARM1 signaling can be functionally modulated by antibodies and suggesting TARM1 as a potential ...
Rikio Yabe +5 more
wiley +1 more source
Drug development for leukemia: comprehensive analysis of clinical trials from first report to drug approval. [PDF]
Tjioe KC +7 more
europepmc +1 more source
Despite frogs avoiding low temperatures, examination of four salamander species revealed that none avoided cold and all possessed cold tolerance. Functional analysis of TRPM8, a cold sensor, showed that all salamander TRPM8s had lost their cold sensitivity.
Tadahiro Sawao +3 more
wiley +1 more source
Novel drug approval by the FDA: Ekterly (Sebetralstat), oral plasma kallikrein inhibitor for treating acute attacks of hereditary angioedema. [PDF]
Gulalai, Miraj SA, Mahato RK.
europepmc +1 more source

