Hazelnut production and prospects in Spain

For many years, Spain was the fourth largest hazelnut producer worldwide, after Turkey, Italy and the USA. However, Spanish production currently occupies the tenth place with 10,500 t in 2017, due to the reduction of land used for cultivation, coupled with the growing importance of other producing countries: Azerbaijan, China, Georgia, Chile, Iran and France. In Europe, with 16% of world hazelnut production, in 2017, Italy is the main producer country (81%), followed by France and Spain, producing 6,7% and 6,5%, respectively. The hazelnut tree (Corylus avellana L.) grows wild in Spain. In 2017, the total cultivated area dedicated to this species was 12,806 ha, mainly (82%) concentrated in Tarragona, southern Catalonia. Finally, it is worth highlighting the sector's great investment in fruit processing technology. Currently, the main cooperatives offer semi-finished products to many European chocolate industries and have their own production of roasted products, in shell and flour, for direct sale.info:eu-repo/semantics/publishedVersio

Financing and Reimbursement of Approved Advanced Therapies in Several European Countries

Advanced medicinal products; Financing government; Health technology assessmentMedicamentos avanzados; Financiación del gobierno; Evaluación de tecnologías sanitariasMedicaments avançats; Finançament del govern; Avaluació de tecnologies sanitàriesObjectives The uncertainty in the cost-benefit of advanced therapy medicinal products (ATMPs) is a current challenge for their reimbursement in health systems. This study aimed to provide a comparative analysis of the National Health Authorities (NHAs) reimbursement recommendations issued in different European countries. Methods The NHA reimbursement recommendations for the approved ATMPs were compared among 8 European Union (EU) Countries (EU8: Ireland, England/Wales, Scotland, The Netherlands, France, Germany, Spain, and Italy). The search was carried out until December 31, 2021. Results A total of 19 approved ATMPs and 76 appraisal reports were analyzed. The majority of the ATMPs were reimbursed, although with uncertainty in added therapeutic value. No relationship between the type of the European Medicines Agency approval and reimbursement was found. Managed entry agreements, such as payment by results, were necessary to ensure market access. The main issue during the evaluation was to base the cost-effectiveness analyses on assumptions because of the limited long-term data. The estimated incremental cost-effectiveness ratio among countries reveals high variability. Overall, the median time to NHA recommendation for the EU8 is in the range of 9 to 17 months. Conclusions Transparent, harmonized, and systematic assessments across the EU NHAs in terms of cost-effectiveness, added therapeutic value, and grade of innovativeness are needed. This could lead to a more aligned access, increasing the EU market attractiveness and raising public fairness in terms of patient access and pricing

Regulatory framework for advanced therapy medicinal products in Europe and United States

Europe; United States Food and Drug Administration; Legislation and jurisprudenceEuropa; Administración de Alimentos y Medicamentos de los Estados Unidos; Legislación y jurisprudenciaEuropa; Administració d'Aliments i Medicaments dels Estats Units; Legislació i jurisprudènciaAdvanced therapy medicinal products (ATMPs) are a fast-growing field of innovative therapies. The European Union (EU) and the United States (US) are fostering their development. For both regions, ATMPs fall under the regulatory framework of biological products, which determines the legal basis for their development. Sub-classifications of advanced therapies are different between regions, while in EU, there are four major groups, i.e., gene therapy, somatic cell therapy, tissue-engineered therapies, and combined advanced therapies; in US, the sub-classification covers two major groups of products, i.e., gene therapy and cellular therapy. The inclusion criteria that define a gene therapy are equivalent in both regions, and the exclusion criteria are directly related to the indications of the product. In the EU, there is a clear differentiation between cell- and tissue-based products regarding their classification as advanced therapies or coverage by other legal frameworks, whereas in US, there is a broader classification about whether or not these products can be categorized as biologic products. Both in EU and in US, in order to classify a cell- or a tissue-based product as an advanced therapy, it must be ensured that the processing of the cells implies a manipulation that alters their biological characteristics, although the term of manipulation in US differentiates between structural and non-structural cells and tissues. The regulatory terminology used to define ATMPs and their sub-classification reveals some differences between EU and US

Methodological Characteristics of Clinical Trials Supporting the Marketing Authorisation of Advanced Therapies in the European Union

Advanced therapies; Clinical trials; Drug developmentTeràpies avançades; Assaigs clínics; Desenvolupament de fàrmacsTerapias avanzadas; Ensayos clínicos; Desarrollo de fármacosSeveral advanced therapy medicinal products (ATMPs) have been approved in the European Union (EU). The aim of this study is to analyse the methodological features of the clinical trials (CT) that supported the marketing authorization (MA) of the approved ATMPs in the EU. A systematic review of the characteristics of pivotal CT of ATMPs approved in the EU until January 31st, 2021 was carried out. A total of 17 ATMPs were approved and 23 CT were conducted to support the MA (median, 1, range, 1–3). Of those studies, 8 (34.78%) were non-controlled and 7 (30.43%) used historical controls. Only 7 (30.4%) were placebo or active-controlled studies. Among all CT, 21 (91.3%) were open-label and 13 (56.52%) had a single-arm design. To evaluate the primary endpoint, 18 (78.26%) studies used an intermediate and single variable. The median (IQR) number of patients enrolled in the studies was 75 (22–118). To date, ATMPs’ approval in the EU is mainly supported by uncontrolled, single-arm pivotal CT. Although there is a trend toward an adaptive or a life cycle approach, a switch to more robust clinical trial designs is expected to better define the benefit and the therapeutic added value of ATMPs

A new empirical model of sea surface microwave emissivity for salinity remote sensing

SMOS (Soil Moisture and Ocean Salinity) is a European Space Agency mission that aims at generating global ocean salinity maps with an accuracy of 0.1 psu, at spatial and temporal resolution suitable for climatic studies. The satellite sensor is an L-band (1400-1427 MHz) aperture synthesis interferometric radiometer. Sea surface salinity (SSS) can be retrieved since the brightness temperature of sea water is dependent on the frequency, angle of observation, dielectric constant of sea water, sea surface temperature and sea surface state. This paper presents a new empirical sea water emissivity model at L-band in which surface roughness effects are parameterized in terms of wind speed and significant wave height. For the SMOS mission these parameters can be obtained from external measurements and model diagnostics. An analysis has been done on the effect on SSS retrieval of different sources for this auxiliary information. Copyright 2004 by the American Geophysical UnionThis study was funded by ESA-ESTEC under WISE (14188/00/NL/DC) and EuroSTARRS (15950/02/NL/SF) contracts, and by the Spanish National Program on Space Research under grant ESP2001-4523-PEPeer Reviewe

Mice with Pulmonary Tuberculosis Treated with Mycobacterium vaccae Develop Strikingly Enhanced Recall Gamma Interferon Responses to M. vaccae Cell Wall Skeleton

Whole heat-killed Mycobacterium vaccae is used as an immunotherapeutic agent in tuberculosis (TB), but the compound(s) that triggers its immunostimulatory ability is not known. Here, we show that among different subcellular fractions, the cell wall skeleton induced a prominent expression of gamma interferon in splenocytes from both non-TB and TB M. vaccae-treated mice

On the path to a new generation of cement-based composites through the use of lignocellulosic micro/nanofibers

Due to its high biocompatibility, bio-degradability, and low cost, cellulose finds application in disparate areas of research. Here we focus our attention on the potential applications of cellulose nanofiber in cement-basedmaterials for the building sector. We first describe the chemical/morphological composition of cellulose fibers, their process and treatment, the characterization of cement-based composites, and their flexural strengthPeer ReviewedPostprint (published version

Regulatory framework for advanced therapy medicinal products in Europe and United States

Advanced therapy medicinal products (ATMPs) are a fast-growing field of innovative therapies. The European Union (EU) and the United States (US) are fostering their development. For both regions, ATMPs fall under the regulatory framework of biological products, which determines the legal basis for their development. Sub-classifications of advanced therapies are different between regions, while in EU, there are four major groups, i.e., gene therapy, somatic cell therapy, tissue-engineered therapies, and combined advanced therapies; in US, the sub-classification covers two major groups of products, i.e., gene therapy and cellular therapy. The inclusion criteria that define a gene therapy are equivalent in both regions, and the exclusion criteria are directly related to the indications of the product. In the EU, there is a clear differentiation between cell- and tissue-based products regarding their classification as advanced therapies or coverage by other legal frameworks, whereas in US, there is a broader classification about whether or not these products can be categorized as biologic products. Both in EU and in US, in order to classify a cell- or a tissue-based product as an advanced therapy, it must be ensured that the processing of the cells implies a manipulation that alters their biological characteristics, although the term of manipulation in US differentiates between structural and non-structural cells and tissues. The regulatory terminology used to define ATMPs and their sub-classification reveals some differences between EU and US

Análisis exploratorio del potencial de los enoturistas chinos: retos y oportunidades

El objetivo de este trabajo es describir las principales características del perfil del enoturista chino que visita España. La metodología aplicada ha sido cualitativa, con 19 entrevistas a turistas chinos que han visitado o tenían previsto visitar una bodega. Los resultados muestran que en España, los enoturistas chinos están en una fase inicial, no solo por su reducido número sino que también porque el motivo de su visita no es el vino y prefieren complementar la visita a las bodegas con otras actividades adicionales, como la gastronomía o la cultura; pero con una previsión de crecimiento. Se han podido identificar dos perfiles en base al objetivo del viaje (por trabajo o por otros motivos) y según la edad (entre 35-45 años y entre 50-60 años). Además, se han comparado estos perfiles con los definidos en otros países sin detectar diferencias muy significativas. Este es uno de los primeros estudios que analizan, aunque de manera exploratoria, el perfil del enoturista chino en España

Passive smoking at home is a risk factor for community-acquired pneumonia in older adults: a population-based case-control study

OBJECTIVE: To assess whether passive smoking exposure at home is a risk factor for community-acquired pneumonia (CAP) in adults. SETTING: A population-based case-control study was designed in a Mediterranean area with 860 000 inhabitants >14 years of age. PARTICIPANTS: 1003 participants who had never smoked were recruited. PRIMARY AND SECONDARY OUTCOME MEASURES: Risk factors for CAP, including home exposure to passive smoking, were registered. All new cases of CAP in a well-defined population were consecutively recruited during a 12-month period. METHODS: A population-based case-control study was designed to assess risk factors for CAP, including home exposure to passive smoking. All new cases of CAP in a well-defined population were consecutively recruited during a 12-month period. The subgroup of never smokers was selected for the present analysis. RESULTS: The study sample included 471 patients with CAP and 532 controls who had never smoked. The annual incidence of CAP was estimated to be 1.14 cases×10(-3) inhabitants in passive smokers and 0.90×10(-3) in non-passive smokers (risk ratio (RR) 1.26; 95% CI 1.02 to 1.55) in the whole sample. In participants ≥65 years of age, this incidence was 2.50×10(-3) in passive smokers and 1.69×10(-3) in non-passive smokers (RR 1.48, 95% CI 1.08 to 2.03). In this last age group, the percentage of passive smokers in cases and controls was 26% and 18.1%, respectively (p=0.039), with a crude OR of 1.59 (95% CI 1.02 to 2.38) and an adjusted (by age and sex) OR of 1.56 (95% CI 1.00 to 2.45). CONCLUSIONS: Passive smoking at home is a risk factor for CAP in older adults (65 years or more)