Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0268596 (EMA)
 2,520 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

The availability of drugs for neonates is limited as evaluation is said more difficult in neonates than in older patients and adults, resulting in off-label drug use. Indeed, diseases may be specific to the neonatal period, the impact of immaturity and rapid developmental changes in the first days/weeks of life is important, and drugs may have short and long-term effects including developmental toxicity. To improve such situation, both the US and the EU have introduce paediatric legislation and the EMA has issued guidelines to optimize drug evaluation in paediatric populations including neonates. In addition, the following collaborative projects were funded by the EU in the co-operative programme of FP7. As preterm and term neonates are prone to infections which result in increase morbidity and mortality, the TINN (Treat Infections in Neonates) and TINN2 projects aim to evaluate off-patent anti-infectious drugs included in the EMEA priority list, ciprofloxacin/fluconazole and azithromycin respectively in the two projects. The final aim is to obtain a Paediatric Use Marketing Authorization for these drugs in neonates. In addition, TINN will build up a network of units with experience in evaluating anti-infective agents in neonates. An additional important initiative called GRIP (Global Research in Paediatrics) will focus on paediatric clinical pharmacology training and will facilitate the development and safe use of medicine in children.
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PMID:Drug policy in Europe Research and funding in neonates: current challenges, future perspectives, new opportunities. 2126 85

Isavuconazole, the active moiety of its prodrug isavuconazonium, is a new extended-spectrum triazole whose activity against yeasts, molds, including Aspergillus and mucorales, and dimorphic fungi has been shown in vitro and in preclinical models. The most relevant pharmacokinetics features are water-solubility of the prodrug, rapid cleavage of the prodrug into active moiety and cleavage product by plasmatic esterases, high oral bioavailability of isavuconazole with an extensive penetration into most tissues and a good safety profile even in case of renal impairment. The results of two main clinical studies have led to an approval by FDA and EMA in the treatment of invasive aspergillosis and invasive mucormycosis. Isavuconazole is non-inferior to voriconazole in terms of response and survival in invasive aspergillosis and has shown improved safety and tolerability. Importantly, less hepatobiliary, skin and eye disorders have been reported in isavuconazole-treated patients. Isavuconazole has therefore been granted a grade A-I recommendation by the European Conference on Infections in Leukemia (ECIL) for the treatment of invasive aspergillosis. Efficacy has also been demonstrated in mucormycosis in an open-label study. Survival was similar to the survival of matched patients from the international Fungiscope registry and treated with an amphotericin B formulation. Isavuconazole failed to show non-inferiority to caspofungin in a large double-blind candidemia trial. The aim of this review is to give the reader an overview of the data available so far to support inclusion of isavuconazole in the anti-mold therapeutic arsenal.
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PMID:Isavuconazole: A new broad-spectrum azole. Part 2: pharmacokinetics and clinical activity. 2955 42

Equine piroplasmosis is an economically significant disease caused by Theileria equi and Babesia caballi, which are tick-borne hemoprotozoan parasites. Infections with these parasite species had never been reported in horses in Indonesia. The aim of the present study was to investigate the prevalence of T. equi and B. caballi in horses reared in parts of Western Java, Indonesia. Blood samples were collected randomly from 235 horses in four different districts (Bandung, Depok, Tangerang, and Bogor) in Western Java, Indonesia. Thin blood smears prepared from the sampled animals were stained by Giemsa and observed under a light microscope. Serum samples prepared from blood were screened by enzyme-linked immunosorbent assays (ELISAs) based on recombinant forms of EMA-2 and BC48 antigens to determine the seroprevalence of T. equi and B. caballi, respectively. DNA samples extracted from the same blood samples were screened by EMA-2 and BC48 gene-based nested polymerase chain reaction (nPCR) assays for T. equi and B. caballi infections, respectively. Of 235 surveyed animals, five (2.1%) and 15 (6.4%) were seropositive for T. equi and B. caballi, respectively, whereas one and four horses were nPCR-positive for T. equi and B. caballi, respectively. All of the surveyed animals were negative for T. equi and B. caballi by microscopy. The T. equi EMA-2 and B. caballi BC48 gene fragments amplified by the nPCR assays were cloned, sequenced, and subjected to bioinformatic and phylogenetic analyses. The T. equi EMA-2 gene sequence from an Indonesian horse was identical to sequences from Florida and Washington strains and clustered together with these sequences in phylogeny. On the other hand, four Indonesian BC48 gene sequences shared 99.8-100% identity scores. This present study is the first to report T. equi and B. caballi in horses in Indonesia. Our findings highlight the need for monitoring horses in Indonesia for clinical piroplasmosis caused by T. equi and B. caballi.
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PMID:Serological and molecular prevalence of equine piroplasmosis in Western Java, Indonesia. 3101 11