Over VX-680 clinical trial 310,000 reads were assembled in a total of 19,631 transcribed contigs, with an average length of 531 nucleotides. Overall 36% of the contigs were annotated to known protein/nucleotide sequences and 35 putative miRNA identified.\n\nConclusions: This study represents the first transcriptome analysis for a critically endangered species. EeelBase, a dedicated database of annotated transcriptome sequences of the European eel is freely available at http://compgen.bio.unipd.it/eeelbase. Considering the multiple factors potentially involved in the decline of the European eel, including anthropogenic factors such as pollution and human-introduced
diseases, our results will provide a rich source of data to discover and identify
new genes, characterize gene expression, as well as for identification of genetic markers scattered across the genome to be used in various applications.”
“Background: Biological sex differences BVD-523 cell line may contribute to differential treatment outcomes for therapeutic products. This study tracks women’s participation in late-phase clinical trials (LPCTs), where efficacy and safety of drugs and biologics are evaluated, of new molecular entity (NME) drugs and biologics approved by the U. S. Food and Drug Administration (FDA) in 2007-2009. Furthermore, presentations of sex-based analyses were assessed from the FDA reviews.\n\nMethods: LGX818 New drug applications (NDAs) and biologics license applications (BLAs) were accessed from the U. S. FDA database and evaluated for women’s participation in LPCTs. Sex-based analyses for efficacy and safety contained in FDA reviews were surveyed. Ratios for women’s LPCT participation (PROPORTION OF STUDY SUBJECTS) to their proportion in the disease population were calculated for each approved therapeutic product and grouped into therapeutic categories.\n\nResults: Sex-specific (n = 5) and pediatric (n = 3) drug applications were excluded. Women’s participation in LPCTs was 39%, 48%, and 42% in NDAs (n = 50) and 49%, 62%, and 58% in
BLAs (n = 11) for 2007, 2008, and 2009, respectively. Sixty-four percent of NDAs and 91% of BLAs had participation to proportion ratios of >= 0.80. Seventy-four percent of NDA reviews and 64% of BLA reviews included safety and efficacy sex analysis. Ninety-six percent of NDA reviews and 100% of BLA reviews included efficacy sex analysis.\n\nConclusion: Women’s participation in LPCTs averaged 43% for NDAs and 57% for BLAs in 2007-2009 and varied widely by indication. As a comparison, the 2001 U. S. Government Accountability Office (GAO) reported 52% of women’s participation for drug clinical trials in 1998-2000 and an FDA study reported 45% for BLAs approved from 1995 to 1999.