From Fetish to Totality Mansoor, Jaleh
Qui parle,
06/2023, Letnik:
32, Številka:
1
Journal Article
Recenzirano
This essay argues that the artwork’s opacity and purposively purposeless quality are a tacit refusal of the compulsory division between intellectual and manual labor, which afford the artwork a ...unique capacity to access an otherwise occluded totality. By analyzing conceptual work by the artist duo Claire Fontaine—who deploy Alfred Sohn-Rethel’s notion of market exchangism in their work—in relation to twentieth-century intellectual debates around representation, abstraction, and social synthesis, the essay develops a model of totality in a descriptive rather than prescriptive register. At issue is the artwork’s potential for dereification, whereby a given work of art may provide perceptual experience of the transactional logic that underpins and structures the social field.
Totality in a Box Menozzi, Filippo
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06/2023, Letnik:
32, Številka:
1
Journal Article
Recenzirano
This essay proposes a reading of the American photographer Allan Sekula’s 1995 essay “Dismal Science” alongside
, an essay film he directed with Noël Burch in 2010. These works are still resonant ...today because they suggest the possibility of picturing the totality of capitalist modernity. Sekula’s representations of the shipping container and the subsequent shifts in maritime economy recuperate the prospect of a panoramic, totalizing view in an era marked by a prevalence of detail and data over meaningful grand narrative. The totality the container embodies and represents, however, is not the whole of a frictionless and seamless accumulation of capital but a nonsynchronous, polemical, and critical totality of struggle and antagonism. Sekula turns the shipping container from a stand-in for a system of commodity circulation to an allegorical sign of the continuing fight between labor and capital. Rather than envisioning this totality of struggle as a merely thematic concern, Sekula’s compositions eschew commodification on the level of form by delving into the constitutive tensions of realism and reintroducing a living context of militancy and resistance into the matter of representation itself.
Introduction
Hyrimoz
®
, (GP2017 SDZ-ADL), is a biosimilar to Humira
®
(REF-ADL). SDZ-ADL was approved in 2018 by both the United States Food and Drug Administration (US FDA) and European Medicines ...Agency (EMA) for the indications of REF-ADL not protected by orphan exclusivity. In 2023, the US FDA and EMA also approved a citrate-free high-concentration formulation (HCF) of SDZ-ADL.
Totality of Evidence—the approach
Approval of SDZ-ADL was based on data gathered using the US FDA, EMA and World Health Organization (WHO)-recommended step-wise Totality of Evidence approach. This approach is a robust dataset confirming high confidence in analytical, functional, pharmacokinetic (PK) and clinical biosimilarity between the biosimilar and reference medicine determined through analytical and clinical investigation.
Evidence of biosimilarity
Evidence supporting the biosimilarity of SDZ-ADL and REF-ADL was reported at each stage of investigation. Comprehensive comparative analytical and functional assessments demonstrated that SDZ-ADL was analytically indistinguishable from REF-ADL in required critical quality attributes, including receptor binding. Phase I clinical data showed PK similarity of SDZ-ADL and REF-ADL in healthy volunteers, with similar safety, tolerability and immunogenicity profiles. Phase III confirmatory efficacy and safety studies, ADACCESS (included in US/EU dossiers) and ADMYRA (separate to US/EU dossiers), both confirmed that SDZ-ADL’s efficacy, safety, and immunogenicity matched REF-ADL in all patient groups with no clinically meaningful differences. More recently, this data package was the basis for a citrate-free HCF of SDZ-ADL to be developed, and its PK, safety and immunogenicity were confirmed against the initially approved formulation of SDZ-ADL.
Conclusion
Overall, the Totality of Evidence provided for biosimilar adalimumab, SDZ-ADL, confirmed the analytical, functional and clinical similarity of SDZ-ADL to REF-ADL, supporting its regulatory approval and providing a data bridge with which to evaluate and support the approval of citrate-free HCF SDZ-ADL for clinical use.
Plain Language Summary
A biosimilar is a type of medicine that is designed to match the structure and function of a ‘reference’ biologic medicine. Hyrimoz
®
(SDZ-ADL) is a biosimilar of the adalimumab reference medicine, Humira
®
(REF-ADL). SDZ-ADL was approved in the US and Europe in 2018. For SDZ-ADL to be approved, a collection of evidence needed to be created, called the ‘Totality of Evidence.’ The purpose of this collection of data is to show there is a high confidence that the new biosimilar medicine matches the reference medicine, from the structure of the medicine to the effect of the medicine on the human body. For SDZ-ADL, this investigation started with comparing the physical structure and other functional properties of SDZ-ADL versus REF-ADL and ended with clinical studies in both healthy volunteers and in patients with diseases treated with adalimumab. This Totality of Evidence gathered for biosimilar adalimumab, SDZ-ADL, confirmed the similarity of SDZ-ADL to REF-ADL and therefore supported the approval of SDZ-ADL. In 2018, a citrate-free high-concentration version (high concentration formulation HCF) of REF-ADL was launched that matched REF-ADL. HCF REF-ADL has since become the primary formulation of REF-ADL used in practice. In 2023, a HCF version of SDZ-ADL was also approved in the US and EU based on evidence confirming that HCF SDZ-ADL matched SDZ-ADL. As SDZ-ADL had been previously confirmed to match the reference medicine, this meant that HCF SDZ-ADL could be directly compared against SDZ-ADL to confirm biosimilarity and support its approval.
Abstract
Biological sex should be “acknowledged” and “accepted”—but which responses to gender dysphoria might this preclude? Trans-identified people may factually acknowledge their biological sex and ...regard transition as purely palliative. While generally some level of self-deception and even a high level of nonlying deception of others are sometimes justified, biological sex is important, and there is a nontrivial onus against even palliative, nonsexually motivated cross-dressing. The onus is higher against co-opting the body, even in a minor and/or reversible way, to make a false communication concerning one’s sex. Hardest to defend is the destruction of sexual–reproductive functions and causally downstream functions such as lactation: due to the transcendent nature of sexual–reproductive functions, an appeal to the “principle of totality” here is misplaced. This is not to say that social, and milder medical, transition is absolutely excluded even for severe unmanageable dysphoria, nor that subsequent to any transition, detransition is necessarily required.
The present article aims at providing some clarification on the Horkheimer-Neurath 1937 debate, so as to make three main claims: (a) around 1937 (even though perhaps neither in the early 1930s, at ...the time of his review of Mannheim’s
, nor after the Second World War, at the time of Adorno’s disenchanted statement, “the whole is the false”), Horkheimer belonged to the Hegelian-Marxist tradition stemming from Lukács’s
(1923); (b) notwithstanding Neurath’s semantic and epistemological holism, his fallibilism, his rejection of
in the social sciences, his commitment to socialism, there is still a gulf between his position and Horkheimer’s, for Neurath did not accept the main methodological claim made by the latter, namely, the Lukács-inspired view that what “constitutes the decisive difference between Marxism and bourgeois thought” is the Hegelian “point of view of totality”; (c) highlighting the main differences between Neurath’s and Lukács’s versions of Marxism – one concerning the very idea of dialectic, and the other concerning the epistemic privilege of the proletariat – can throw some light on and help understand better the distinctive features of Lukács’s Hegelianization of Marxism.
•Provides coherent interpretation of previous research on slope using APOS Theory.•Proposes framework to classify teaching, learning and researching slope.•Uses APOS notions of transition levels and ...new proposed Totality stage.•Adds cognitive dimension to research on conceptualizations of slope.
In this paper a framework for slope is proposed using APOS (Action-Process-Object-Schema) Theory and conceptualizations of slope previously identified in research. The proposed APOS-slope framework allows for discussion of students’ cognitive development in relation to different conceptualizations of slope. As such, it may be adopted as a means to advance future research or as a way to plan instruction. In particular, the framework uses specific examples to consider interrelations between the ways of thinking about slope that have been reported to provide additional insight on how individuals understand this concept. The proposed framework contributes to the field by bringing together a number of past studies related to slope and providing a common ground under which these works might be interpreted.
El objetivo del artículo es exponerla evolución de Ernesto Laclau del marxismo al posmarxismo entendida como transición de una categoría de totalidad marxista-althusseriana a la de totalidad como ...práctica discursiva. Esta interpretación se sostiene en la recuperación de la obra temprana de Laclau (aquella ubicada entre Política e ideología en la teoría marxista y Hegemonía y estrategia socialista), lo que permite apreciar rupturas y continuidad es en su obra y problematizarla periodización de su biografía intelectual.
Surgical face masks have become commonplace during the COVID-19 pandemic, producing debates on mask practices. This paper explains the semiotic practices of the face mask among Koreans, who accepted ...the mask early and have simultaneously remained uneasy about it until late 2020. It aims to explain this paradox by discovering various meanings Koreans ascribe to the mask. A content analysis of reader responses to news articles finds that Koreans signify what the mask means for life in various voices (i.e., instrumental meanings) in which they concurrently reveal multiple and contradictory meanings of everyday life (i.e., existential meanings) during the pandemic. Eight themes-beneficence, futility, nuisance, routine, privacy, dominance, collective commitment, and intricacy-constitute what the mask and everyday life mean. This study also finds that contradictions among these meanings are resolved either incidentally by their being simultaneously harbored in one piece of the mask that stays and holds tight in most circumstances or semiotically by certain integrative meanings embracing multiple meanings at once. The study argues that the meanings of the mask reflect meanings of life that are often contradictory and yet held together during the pandemic. It demonstrates that mask sociology serves as a promising humanistic inquiry on how the Maussian totality of everyday life is concretely experienced in the context of the pandemic.
This study explores diversity reporting by New Zealand Stock Exchange (NZX) listed companies, arguing that diversity goes beyond gender and includes differences in age, ethnicity, sexuality, ...religious beliefs and physical disability. We argue that gender diversity and deep diversity elements (race, age, sexual orientation, disabilities, ethnicity) have a synergistic relationship and that gender diversity objectives cannot be achieved without attaining diversity objectives in these other elements and vice versa. Designing a 30-item diversity disclosures index, this study undertakes a content analysis of the diversity-related disclosures made by 152 NZX listed companies. Analysing diversity-related disclosures in annual and sustainability reports, we find that the NZX listed companies predominantly relate diversity only to board gender diversity. Deep diversity elements at all organisational levels, however, do not receive much attention, with a few exceptions. Our results highlight that female representation on organisational boards has a positive impact on overall organisational gender and other diversity aspects and vice versa. The results of an emphasis on the totality of diversity have important implications for boards of directors, corporate managers and regulators interested in improving the corporate governance and diversity practices in New Zealand organisations.
Call a truth complete with respect to a subject matter if it entails every truth about that subject matter. One attractive way to formulate a complete truth is to state all the relevant positive ...truths, and then add:
and that’s it
. When the subject matters under consideration are non-contingent, a non-trivial conception of completeness must invoke a hyperintensional conception of entailment, and of the completion operation denoted by ‘that’s it’. This paper develops two complementary hyperintensional conceptions of completion using the framework of truthmaker semantics and determines the resulting logics of totality.
