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Botanical natural medicinal products and dietary supplements are utilized globally for their positive impacts on health and wellness. However, the effectiveness and safety of botanical products can be compromised by unintentional or intentional adulteration. The presence of adulterated botanical ingredients in the global market has been documented in the published literature but a key question, namely what the extent of adulteration is, remains to be answered. This review aims to estimate the prevalence of adulteration in preparations made from black cohosh rhizome, echinacea root or herb, elder berry, ginkgo leaf, and turmeric root/rhizome. According to the information provided in the 78 publications retrieved for this paper, 818 of 2995 samples were reported to be adulterated and/or mislabeled. Ginkgo leaf samples (n = 533) had the highest adulteration rate with 56.7%, followed by black cohosh rhizome (n = 322) samples with 42.2%, echinacea root/herb (n = 200) with 28.5%, elder berry (n = 695) with 17.1%, and turmeric root/rhizome (n = 1247) with 16.5%. Products sold as licensed or registered herbal medicines were found to have a lower risk of adulteration compared to products sold as dietary/food supplements. The data show that the adulteration rate substantially differs from one ingredient to the other. Due to the significant limitations of the available data upon which the estimated extent of adulteration is based, and the rapidly changing botanical dietary supplement market, conclusions from the five herbs examined in this publication cannot be applied to other botanicals traded in the global market. However, the data clearly show that a substantial portion of the botanical dietary supplements do not contain what is claimed on their labels. [ABSTRACT FROM AUTHOR]

In this article, dust explosion phenomena and the status of research conducted on silos are reviewed. Dust explosions cause loss of life and property in many industrial facilities. There are many recorded dust explosion cases in our country as well as in the world. For example, in our country, in 2023, a dust explosion occurred in the TMO Kocaeli General Directorate (Derince Port Silo), in which 2 people died and great material damage occurred, as reflected in the national press. When we look at the various dust explosion cases that have occurred in the world, it is understood that they mostly occur in silos used for storage in the agricultural and food sectors. Licensed warehouses have been established in many regions of our country in order to store basic and processed agricultural products that can be standardized with the Agricultural Products Licensed Warehousing Law No. 5300, which came into force after being published in the Official Gazette on 17/02/2005, in safe and healthy conditions in warehouses belonging to licensed warehouse enterprise and continues to be established. It is important to understand the many factors affecting dust explosion, such as dust dispersion, properties, discharge, etc., and to design silos according to these factors. These effects are tried to be determined and understood through experimental or CFD simulations. [ABSTRACT FROM AUTHOR]

The article focuses on an investigation led by Senator William V. Allen into allegations of improprieties and fraud in the Osage Nation in 1896. It covers multiple issues including fraudulent withdrawals from the Osage Trust, questionable oil leases, and the mistreatment of Osage Indians by licensed traders, portraying a history of exploitation and conflicts within the Osage community.

Long-acting injectable PrEP, particularly cabotegravir (CAB-LA), has the potential to enhance HIV prevention in Asia, and was the topic of a roundtable held in Singapore in June 2023. Despite proven efficacy, CAB-LA's impact in Asia is hindered by regulatory, manufacturing, and cost barriers. There is an urgent need to address these challenges to expedite CAB-LA's introduction and scale-up, including collaborative research, streamlined regulatory processes, and increased manufacturing capacity. We call for better preparedness in long-acting PrEP in research and implementation science, product licensing and accessibility, and capacity readiness for scale-up, to meet the significant demand among key populations in Asia. In June 2023, a roundtable of experts and stakeholders was held in Singapore focusing on the introduction of long-acting formulations of HIV pre-exposure prophylaxis in Asia, particularly long-acting injectable cabotegravir. This paper describes issues discussed at the roundtable related to preparedness in research and implementation science, product licensing and accessibility, and capacity readiness for scale-up of long-acting injectable pre-exposure prophylaxis and future pre-exposure prophylaxis products. [ABSTRACT FROM AUTHOR]

In many polluting industries, firms with high environmental quality (HEQ) products often license their new environmental technology to firms with low environmental quality (LEQ) products. After accepting the licensing arrangement, firms with LEQ products can produce both the HEQ and LEQ products and compete with the licensor. What type of licensing mode is optimal under such circumstance becomes an interesting question and warrants analysis. To analyze this issue, we construct a vertical product differentiation duopoly model with multi-product competition. The results show that two-part tariff licensing is always the optimal strategy for the licensor, and it is the optimal licensing strategy as well to improve the environment and social welfare only when the degree of product environmental quality differentiation is relatively high. [ABSTRACT FROM AUTHOR]

This paper studies the licensing of a product innovation in a duopoly by means of two-part tariff contracts composed of fixed-fee payments combined with per-unit or ad-valorem royalties. When the licensor is a firm within the industry (internal licensor), it licenses the innovation to its competitor by using a pure ad-valorem royalty, and welfare is reduced because the royalty has anticompetitive effects on market performance. On welfare grounds, fixed-fee predominates over per-unit royalty licensing, but has the disadvantage that firms sometimes fail to reach an agreement. A simple regulatory rule is then proposed for a second-best optimal policy on product innovation licensing. However, when the innovator is outside the industry (external licensor), it never uses ad-valorem royalties. Also evaluated is the value of the innovation for an internal and an external innovator, and licensing by both innovators under Bertrand competition. [ABSTRACT FROM AUTHOR]

Infectious disease outbreaks have become increasingly common and require global partnership for adequate preparedness and response. During outbreaks, medical countermeasures (MCMs)—vaccines, therapeutics, and diagnostics—need to reach patients quickly. Recent outbreaks exemplify that products with regulatory approval can expand access and reach patients quicker than investigational products. Unfortunately, insufficient funding globally and differences in funders' prioritization puts gains and future efforts at risk. Of primary concern is (1) lack of a feasible regulatory path and clinical capability to achieve regulatory approval for new MCMs for many diseases; and (2) the need for partners with the mandate, funding, and capabilities to support long-term sustainment of manufacturing capability and stockpiling of licensed products. Without collaboration, the global community runs the risk of losing the capabilities built through years of investment and being underprepared to combat future threats. Synergies between funders are critical to create long-term sustainment of products to ensure access. [ABSTRACT FROM AUTHOR]

Purpose. Studies focusing on safety outcomes typically require large populations to comprehensively characterise the patient groups exposed to the medicines under investigation. However, there is often less information for subpopulations, such as pregnant or breastfeeding women, particularly when new medicines are considered. It is important to understand what information can be obtained from drug utilization studies (DUS) involving pregnant women in the early years postmarketing to provide supportive information for safety studies. The aims of this literature review are to (1) identify and review DUS for new medicines in pregnancy and breastfeeding and (2) list and summarise key information items to be reported in a DUS for new medicines in pregnancy. Methods. To identify postmarketing DUS of new prescription medicines or enantiomers in pregnancy, a systematic literature review was undertaken in PubMed and Embase between January 2015 and June 2022. In addition, the complete database of the ENCePP EU PAS Register was systematically searched to June 2022. Results. We identified 11 published DUS on new medicines in pregnancy from the ENCePP EU PAS Register and none from other sources. No studies on breastfeeding were identified. The 11 identified publications reported the medicine's use for the first 3 to 5 years after marketing approval. No reports assessed utilization in the first 3 years of approval. It was usual to issue interim reports annually (7 studies). All studies concerned conditions managed in ambulatory care (primary care and outpatient facilities) and included some primary care prescribing. Most (n = 8) only had prescribing/dispensing data available at individual level for ambulatory care; outpatient prescribing was included in three of these studies Three studies held a limited amount of in-hospital prescribing data. A DUS can confirm at an early stage whether there are sufficient exposed pregnancies in available data sources to ensure a safety study is powered to detect a difference in the prevalence of adverse pregnancy or infant outcomes or if additional data from other databases are needed. A DUS may also help address methodological considerations such as selection of comparators. DUS can be performed embedded in a DUS in the general population, in a cohort of women of childbearing age, or in a cohort of pregnant women. Conclusion. This review summarises key aspects of a DUS for new medicines in pregnancy. DUS for new medicines in pregnancy should be planned before marketing, scheduled for the first 3 to 5 years after release, with annual interim/progress reports, and reported in peer-reviewed journals. By offering detailed information on data sources, exposure timing, prevalence and location, coprescribing, comorbidities, coexposures, and demographics, a DUS will offer a firm foundation for safety studies and will help to contextualize spontaneous reporting of serious adverse events. [ABSTRACT FROM AUTHOR]

Sports clubs, as one of the stakeholders in the continuously increasing sports business, value licensed products. Clubs attempt to make cash while also increasing fan loyalty by selling licensed merchandise to their supporters. However, not all fans purchase legal things, and they may also seek out counterfeits of licensed products for a variety of reasons. Therefore, the research focuses on the intention to acquire licensed products and counterfeits of sports clubs. As a result, the research aims to determine the effects of fanaticism, morality, and a sense of shame on fans' intentions to acquire licensed products of the sports clubs they support, as well as their counterfeits of these products. The survey technique was employed to reach the fans, who are the research population, in order to achieve this goal. An online survey was chosen to collect data at a reduced cost and in less time, and 566 participants were contacted during the data collection procedure. The data of these persons were studied using statistical programs, and the analysis revealed that fanaticism and morality have a positive effect on the intention to acquire licensed products, but the sense of shame has no statistically significant effect. Furthermore, while the negative effects of morality and sense of shame on the propensity to buy counterfeit goods were discovered, fanaticism had no statistically significant influence. These results provide important conceptual and practical contributions in terms of sports marketing and fan behavior. [ABSTRACT FROM AUTHOR]

More than one hundred countries, including major economies such as China, Japan, Germany, and Brazil, offer a form of innovation protection known as the utility model (UM). Unlike patents, UMs are generally not examined substantively, have shorter terms, and vary in their enforceability in litigation. Yet UMs, like patents, are increasingly being declared as "essential" to global industry standards, licensed together with standards essential patents (SEPs), and now even enforced in litigation. This study finds that nearly 1,000 standards essential utility models (SEUMs) have been declared essential to broadly adopted industry standards. And though far less than other SEPs, SEUMs have been subject to litigation in China and Germany, and there appears to be no structural barrier to their litigation in other jurisdictions. These findings raise questions concerning the legal requirement to disclose and license SEUMs, the value of SEUMs for purposes of calculating FRAND royalty rates for individual firm portfolios and for determining top-down aggregated royalty rates for standards, as well as larger questions concerning the use of UMs to protect complex technological inventions that are also covered by patents. [ABSTRACT FROM AUTHOR]

Since the 1980s, advertising in Spain has used anime characters to promote licensed products or products related to their commercial exploitation. However, despite the enormous growth in manga and anime consumption in recent years, there has been no corresponding growth in the use of anime narratives in advertising campaigns of products or services of brands outside the manganime universe. To this end, we aim to determine the elements that cause the disparity between the increase in anime consumption and its continual absence in advertising creativity in Spain, specifically, in advertising campaigns for products or services that are not directly related to anime series. An interpretive construction is proposed by means of a focus group with university students that allows us to determine their reactions to advertising campaigns from other countries that use anime narratives. Among other aspects, our results reveal the need to understand the narrative universe of anime, its characters and subtext. Similarly, we believe that there should be aesthetic and audiovisual coherence and shared values between anime and brand so that the public accepts it positively and not as an intrusive element. Finally, we define four main variables on which to design advertising campaigns based on anime narratives. [ABSTRACT FROM AUTHOR]

Rare and ultrarare diseases have been central to the field of gene therapy since its earliest stage, and we are now witnessing more and more effective treatments entering the clinical realm for patients in need. However, despite promising results across a range of rare diseases, transformative gene therapies may not be available and accessible to patients for nonmedical reasons. Traditional regulatory and commercialization pathways to licensed products seem to be prohibitive for ultrasmall patient populations. Here, we highlight some of the challenges of delivering gene therapies in rare diseases and discuss innovative solutions being proposed by the gene therapy community. [ABSTRACT FROM AUTHOR]