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Frontiers | Emergence of Dengue 4 as Dominant Serotype During 2017 Outbreak in South India and Associated Cytokine Expression Profile

Dengue virus infection is prevalent in tropical and sub-tropical regions of the world, which is fatal if untreated symptomatically. Emergence of new genotype within serotypes led to enhanced severity. The objective of the study is to identify the molecular characteristics of the DENV circulated during 2017 outbreak in Tamil Nadu, India and, to investigate the role of inflammatory cytokines in different ‘serotypes’ and in ‘dengue severity’. A total of 135 suspected samples were tested for DENV infection using IgM, IgG and qPCR assay; where 76 samples were positive for DENV and analysed for twelve inflammatory cytokines using ELISA. Serotyping shows 14 DENV-1, 22 DENV-2, 7 DENV-3 and 33 DENV-4, where DENV-4 was predominant. Among seventy-six, forty-two isolates were successfully sequenced for C-prM region and grouped. A lineage shift was observed in DENV-4 genotype. Irrespective of serotypes, IFNγ was significantly elevated than control and in primary infection indicating its ro ....

United States , United Kingdom , New Delhi , Tamil Nadu , Sri Lanka , Republic Of , North Western , City Of , Andaman And Nicobar Islands , Saudi Arabia , Gonzalez Mateos , Flores Aguilar , Flavivirus Serocomplex Cross , Vellore Cecilia , Cladec Cecilia , Lakshmana Rao , Alwin Prem Anand , Andrea Wizenmann , Cruz Hernandez , Oswaldo Cruz , Gowri Sankar , Triuppur Alagarasu , Pondicherry Hoti , Waal Malefyt , Lopez Martinez , Nadu Manakkadan ,

The End of Enforcement Discretion for Cell & Gene Therapies: Thinking Through Next Steps | King & Spalding


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Beginning this week, the U.S. Food and Drug Administration (“FDA”) ended its compliance and enforcement discretion policy with regard to certain human cell, tissue, and cellular and tissue-based products (“HCT/Ps”). HCT/P manufacturers without an FDA-approved marketing application may find themselves subject to FDA scrutiny under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) and the Public Health Service Act (“PHS Act”). Firms will have to think hard about whether to submit investigational new drug applications (“INDs”) or marketing applications, wind down production, or risk running afoul of applicable laws and regulations governing unapproved biological products. They should also be mindful of how data collected to date can help to inform next steps. ....

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