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Early access programs (EAPs) generally refer to patient access to medicines/indications before marketing authorization, possibly extended to price and reimbursement approval. These programs include compassionate use, which is usually covered by pharmaceutical companies, and EAPs reimbursed by third-party payers. This paper aims at comparing EAPs in four European countries (France, Italy, Spain, UK) and providing empirical evidence on EAPs in Italy. The comparative analysis was conducted through a literature review (including scientific and grey literature), complemented by 30-min semi-structured interviews with local experts. The Italian empirical analysis employed data available on the National Medicines Agency website. Although EAPs are very different across countries, they exhibit some common features: (i) eligibility criteria refer to the absence of valid therapeutic alternatives and a presumed favourable risk–benefit profile; (ii) payers do not allocate a pre-determined budget to these programs; (iii) total spending on EAPs is unknown. The French EAPs seem to be the most structured, financed through social insurance, covering pre-marketing, post-marketing and pre-reimbursement phases and providing for data collection. Italy's approach to EAPs has been varied, with several programs covered by different payers, including the cohort-based 648 List (for both early access and off-label use), the nominal-based 5% Fund, and Compassionate Use. Most applications to EAPs are from the Antineoplastic and immunomodulating drug class (ATC L). Some 62% of indications in the 648 List are either not under clinical development or have never been approved (pure off-label use). For those subsequently approved, most approved indications coincide with those covered through EAPs. Only the 5% Fund provides data on economic impact (€ 81.2 million in 2021; average cost per patient € 61.5K). Diverse EAPs are a possible source of inequalities in access to medicines across Europe. A harmonization of these programs, though difficult to achieve, could be modelled on the French EAPs and provide key advantages, not least of which a common effort to collect real-world data in parallel with clinical trials and clear separation between EAPs and off-label use programs. [ABSTRACT FROM AUTHOR]

Simple Summary: The perception of the local production concept significantly varies depending on the weight given to each defining component (e.g., quality and sustainability), which in turn depends both on the considered food product and on the consumers' characteristics. In this research, a survey was conducted to investigate the consumer preferences for milk and cheese quality aspects and their perception of sustainability descriptors of local dairy products. In addition, the effect of socio-demographic variables on consumer preferences and attitudes definition was also explored. From the Principal Component Analysis, four main components were defined (Responsive to quality attributes, Local is better, Local is sustainable, and Availability request), combining the consumer answers about milk and cheese quality preferences and the sustainability and availability opinion. The obtained results highlight the importance of product quality aspects in the considered geographical area (South-East Italy), which is strictly linked to traditional dairy production. Higher availability and visibility of local dairy products on the market were requested by the considered consumer sample. In addition, our results showed that gender, age, place of residence, educational level, and family size significantly affected the local dairy products consumption orientation definition. These findings will support the development of more efficient and transparent communication among dairy producers and consumers in the selected market. Consumers are increasingly aware of the benefits of local foods in terms of quality, sustainability, animal welfare, and safety. This research addresses two main questions: (i) is the perception towards sustainability aspects of local dairy products related to individuals' preferences for milk and cheese quality aspects? (ii) are these perceptions related to people's socio-demographic characteristics? For this purpose, a choice experiment was conducted online in Apulia (South-East Italy) involving a sample of 543 respondents. A Principal Component Analysis (PCA) was applied to analyze the consumer opinion related to dairy products' quality attributes, sustainability, and availability on the market. From the PCA, four main components (accounting the 64.5% of the total explained variance) were defined, highlighting non-overlapping choice styles of consumers, distinguished by attitudes primarily based on quality attributes of dairy products rather than sustainability characteristics or perceived higher quality of local products. Furthermore, the Availability request component described the consumer need for higher availability and/or visibility of local dairy products on the market. The effect of gender, age, and educational status of individuals emerged as significantly important for the resulting component definitions. The obtained results clearly suggest the need to increase the efficiency of communication strategies concerning local dairy products, as well as local dairy products' availability and visibility on the markets. [ABSTRACT FROM AUTHOR]

Ornamental farming is the main source of future diffusion of exotic species, but containment measures for these species are often criticized or disapproved by public opinion, in particular in urban areas in all the European countries. In this paper, the social acceptability of rational solutions for this problem is discussed, thus keeping in mind the importance of the conservation of native species and the impact of exotic ones on agriculture and farmed species. Currently, the most problematic alien vertebrate species in Italy are the gray squirrel, the coypu, the cottontail rabbit and the American mink, while the Rose-ringed parakeet and monk parakeet are considered to be the potentially most dangerous alien bird species. The effects of the presence of these species include competition with autochthonous species, damage to agricultural crops and diffusion of pathologies. Ornamental animal farming is an emerging activity in Italy and throughout Europe, and it is likely that it will be the main source of the introduction of exotic species. The possible solutions to exotic species diffusion are: improving current laws, shared strategies with neighbouring countries, eradication and management of exotic species. This review deals with management of the most invasive terrestrial mammals and birds in Italy as well as with some social and ethical implications. [ABSTRACT FROM AUTHOR]

The aim of this review is to clarify the relation between Italian aquaculture and the introduction on alien species in Italy. In Italy, the most common aquatic alien species are rainbow trout and Manila clam, and they represent main economic product of Italian aquaculture. Wels catfish and red clawed crayfish have been voluntarily or involuntarily introduced for aquaculture scope, and they are now the most invasive alien aquatic species. Other alien naturalized species, as some salmonid species, are important economic resources in north Italy for inland professional fishery and are considered worthwhile of conservation. Thus, aquaculture is directly or indirectly responsible of the introduction of several alien species in Italy, but its effect on alien species diffusion is peculiar, as few successfully farmed species have become rapidly common. Until now, conventional aquaculture has played main role in the diffusion of alien species in Italy, while ornamental aquaculture will be the main source of alien introductions in the future. [ABSTRACT FROM AUTHOR]

The Italian Piedmontese cattle breed is traditionally housed in tie-stalls and, to a lesser extent, in loose housing systems with free stalls. The present study has compared the same group of 15 cattle before and after stable renovation (tie-stall vs free-stall housing) funded by Regulation (EU) No. 1305/2013. All the animals remained healthy during the trial, no clinical signs were observed and no mastitis occurred. The tested parameters were: locomotion scoring system, salivary cortisol, blood parameters, serum acute phase protein (albumin, haptoglobin, serum amyloid A and lysozyme). Samples were collected 3 times: before the change (T1), 3 days later (T2), 40 days later (T3). The change in housing determined noteworthy variations in the stress parameters: albumin and total protein displayed the lowest value at T2, while lysozyme displayed the lowest value at T3. Among the App, SAA and Hp were not affected by the sampling time. Salivary cortisol displayed the highest value at T1. This study suggests that tie-stall housing can endanger the welfare of animals, and it is hoped that this farming system will be abandoned in the future. [ABSTRACT FROM AUTHOR]

In this paper we propose a novel Bayesian methodology for Value-at-Risk computation based on parametric Product Partition Models. Value-at-Risk is a standard tool for measuring and controlling the market risk of an asset or portfolio, and is also required for regulatory purposes. Its popularity is partly due to the fact that it is an easily understood measure of risk. The use of Product Partition Models allows us to remain in a Normal setting even in the presence of outlying points, and to obtain a closed-form expression for Value-at-Risk computation. We present and compare two different scenarios: a product partition structure on the vector of means and a product partition structure on the vector of variances. We apply our methodology to an Italian stock market data set from Mib30. The numerical results clearly show that Product Partition Models can be successfully exploited in order to quantify market risk exposure. The obtained Value-at-Risk estimates are in full agreement with Maximum Likelihood approaches, but our methodology provides richer information about the clustering structure of the data and the presence of outlying points. [ABSTRACT FROM AUTHOR]

Simple Summary: Leishmaniosis caused by Leishmania infantum is a parasitic disease of people and animals transmitted by sand fly vectors. Although dogs in south and central Italy are most affected, in recent decades feline leishmaniosis (FeL) has become an emerging disease. This study aimed to update information on the presence of FeL in stray cats in Milan, in northern Italy; to compare these results with previous studies performed in the same area; and to report aspects of Leishmania infection in cats. A total of 117 stray cats were included and 10 (8.6%) had L. infantum infection. The parasite was identified in popliteal lymph nodes in five cats and five had antibodies against L. infantum. Most infected cats were from a specific area of Milan. Increased gammaglobulins were seen in infected cats, which also had antibodies against the pathogens Anaplasma phagocytophilum, Chlamydophila felis, and Toxoplasma gondii. There was a high prevalence of FeL in the surveyed area of northern Italy. Further studies are needed to understand if these infected cats are being imported from other areas, or if there is a real Leishmania focus in Milan. Investigation of the presence of sand fly vectors in Milan would be useful. Feline leishmaniosis (FeL) is an emerging vector-borne feline disease, with increasing numbers of cases reported and studies performed internationally. This study aimed to update the epidemiological status for FeL in stray cats in Milan, northern Italy; compare these results with previous studies in Northern Italy; and report clinicopathologic findings and coinfections in cats infected with Leishmania spp. A total of 117 cats were tested for L. infantum and retrovirus infection, hematological, and biochemical parameters. Demographic and clinical data were collected and FeL affected cats screened for selected coinfections. Overall, 10/117 (8.6%) cats tested positive for L. infantum: in five cats L. infantum DNA was found in popliteal lymph nodes and five were IFAT seropositive at titers from 1:80 to 1:160. Infected cats were concentrated in a specific area of Milan (p = 0.0154). No specific clinicopathologic abnormalities or retroviral infections were significantly linked to the infection, other than hypergammaglobulinemia (p = 0.0127). Seroreactivity to Anaplasma phagocytophilum, Chlamydophila felis, and Toxoplasma gondii was found in some infected cats. A high prevalence of FeL was found in a non-endemic area of northern Italy and future studies should continually monitor this data to understand whether these cases are imported or if Leishmania vectors are present in this area. [ABSTRACT FROM AUTHOR]