Search Results (35)

Audit committees monitor the actions of managers as they pursue the goal of shareholder wealth maximization. The purpose of this study is to measure the impact of audit committee oversight on novel aspects of firm performance, including investor rationality, price expectations, human capital, and research and development expenses. It extends the literature to non-financial outcomes of audit committee oversight. The literature thus far has focused on the financial effects of audit committee oversight, such as return on assets, return on equity, risk, debt capacity, and firm value. Data was collected from 588 publicly traded firms in the U.S. pharmaceutical industry and energy industry from 2010 to 2022. Audit oversight was measured by the novel measurement of the frequency of the term ‘audit committee’ in annual reports and Form 10Ks from the SeekEdgar database. COMPUSTAT provided the remainder of the data. Panel Data fixed-effects models were used to analyze the data. Audit committee oversight significantly increased investor rationality, significantly reduced price expectations, and significantly increased human capital investment. An inverted U-shaped relationship occurred for audit committee oversight and research and development expenses, with audit oversight first increasing research and development expenses, then decreasing them. The study makes several contributions. First, the study uses a novel measure of audit oversight. Second, the study predicts the effect of audit committee oversight on unexplored non-financial measures, such as human capital and research and development expense. Third, the study offers a current test of the Miller model, as the last tests were performed over 20 years ago. Fourth, the study examines the impact of auditing on market measures that have not been explored in the literature, such as investor rationality and short selling. Full article

Background/Objectives: We reviewed Post-Marketing Requirements (PMRs) under the Pediatric Research Equity Act (PREA) for antibiotics approved in adults from 2009 to 2024 to better understand factors associated with PMR study completion. Methods: Initial PMRs, including study design and completion timelines were extracted from Food and Drug Administration (FDA) approval letters. Studies were cross-referenced at clinicaltrials.gov, with follow-up from adult approval to study completion or through 31 December 2024. Results: Eighteen antibiotics were approved in adults from 2009 to 2024, with 53 associated PREA PMRs. A total of nine PMRs were excluded from analysis (six exclusions for projected study completion dates on or after 12/31/2024, one exclusion due to lack of information, and two exclusions because the study type was not categorizable as Phase 1 or Phase 2). Of the 44 remaining PMRs in the analysis set, the median pediatric study follow-up time from adult approval was 5.3 years (range 0.94 to 11.5 years), with a study completion rate of 54.5% (N = 24). Small- and medium-sized companies had a study completion rate of 10% (N = 2/20) over a median of 6.44 years of follow-up, with no pediatric approvals. Large pharmaceutical corporations had a significantly higher study completion rate of 91.6% (N = 22/24; adjusted hazard ratio 20.3 95%CI, 5.02 to 82.4) over a median follow-up time of 4.7 years and achieved pediatric approval with labelling updates for 75% of antibiotics (N = 6/8). Conclusions: Compared to larger organizations, smaller pharmaceutical companies have experienced difficulty in PREA PMR antibiotic study completion, which may be related to financial difficulties in the challenging market for antibiotics. To improve PMR study completion, smaller companies require continued financial support and innovation in study design. For pediatric antibiotic development, the FDA accepts the extrapolation of efficacy from well-conducted randomized adult trials (i.e., pharmacokinetics (PK) and the safety approach). Therefore, sponsors should consider the use of single-arm, non-comparative PK and safety study designs to reduce the size and scope of trials. Sponsors should also assess whether the evaluation of an antibiotic is necessary in adolescents, or if data in a surrogate population of adults (e.g., low-weight adults) may serve as adequate evidence for adolescent approval. Full article

This study focuses on the precise forecasting of stock price movement to determine returns, diversify risk, and demystify existing opportunities. It also aims to gauge the difference in terms of the stock volatility of various pharma companies before and during the pandemic era. The prediction of stock market volatility and associated risks is demonstrated by using the GARCH-M model. A sample is collected by clustering daily closing and opening prices from the official websites of the top ten pharmaceutical companies listed on the Bombay Stock Exchange for ten years, from 2012 to 2023. It is evident when using the GARCH-M model, which indicates pharma stock volatility clustering before the COVID-19 pandemic, that a significant relationship is present between risk and return and that these could cause future volatility and significant price movements. Before the COVID-19 pandemic, investors had time to adjust to market conditions, as the volatility was constant but less sensitive to transient shocks. Though it passed faster than ever, the COVID-19 pandemic produced significant market instability. The findings suggest that, especially before the COVID-19 pandemic, the high GARCH(-1) coefficients held Merton’s ICAPM, which maintains that past volatility shapes future returns. This sort of activity is compatible with the way financial markets usually operate. The findings suggest that volatility rose after the COVID-19 pandemic, but this was more because of changes in government policies and vaccines than because of regular market forces. Pricing patterns are dominated by stock interventions, liquidity constraints, and sentiments during a crisis period when volatility becomes irrelevant. Appropriate decision-making by individual investors, portfolio managers, and policymakers regarding the stock market is possible through effective prediction based on time-series analysis. The GARCH-M model is compatible with predicting future stock price changes efficiently. This study uniquely applies the GARCH-M model to the Indian pharmaceutical sector, offering valuable insights into stock volatility and risk–return dynamics, particularly during the COVID-19 pandemic. Full article

This study aimed to investigate: (1) the bioactive profile of seeds, husks, and leaves of selected conilon coffee genotypes (n = 42) from three consecutive crops for the selection of plants to meet health interests, (2) the variability in the content of these bioactive compounds over the crops, and (3) possible correlations among the contents of the evaluated compounds in the different parts of the plant. Selected conilon plants were reproduced by clonal propagation. Bioactive compounds were analyzed using HPLC-DAD. Eight chlorogenic acids (CGA), caffeine, trigonelline, and minor phenolic compounds were quantified (dry basis) in all extracts. CGA contents in seeds, husks, and leaves ranged between 3.71 and 9.71 g/100 g, 0.43 and 1.65 g/100 g, and 0.80 and 2.22 g/100 g, respectively. Caffeine contents ranged between 1.21 and 2.63 g/100 g, 0.13 and 0.84 g/100 g, and 0.33 and 2.01 g/100 g in seeds, husks, and leaves, respectively. Trigonelline contents ranged between 0.83 and 1.12 g/100 g, 0.59 and 1.24 g/100 g, and 0.74 and 1.84 g/100 g, respectively. Variation among the three crops was observed to be higher for CGA. A discrete correlation between CGA and caffeine was observed in the seeds (r: 0.72, p = 0.003). Some of the genotypes showed consistently higher contents of these bioactive compounds than others (not only in the seeds but also in the husks and leaves), being good candidates for cultivar registration to meet various market demands in the food and pharmaceutical industries. Studies that evaluate the potential use of new genotypes and byproducts are important for diversification and maximum use of coffee plants, promoting sustainability and financial return to the farmers and the producing country. Full article

After a period of rapid growth, China’s pharmaceutical industry is facing multiple challenges, including insufficient innovation and severe pollution. Current research on the efficiency of pharmaceutical companies in China primarily focuses on financial or innovation aspects. Therefore, a holistic approach to operational efficiency is needed. To measure the operational efficiency of pharmaceutical companies in China more accurately and holistically, while accounting for environmental pollution, this study employs a three-stage Data Envelopment Analysis (DEA) model with undesirable outputs to evaluate efficiency across five dimensions: market performance, profitability, financial risk control, innovation, and sustainability. This approach integrates financial, innovation, and sustainability indicators to provide a more industry-specific framework for efficiency measurement. Furthermore, integrating with Stochastic Frontier Analysis (SFA) allows for revealing the impact of environmental factors on efficiency. The results show that both technical efficiency (TE) and pure technical efficiency (PTE) are relatively low in the first and third stages, with significant regional disparities. After excluding environmental factors, some regions—typically economically developed areas—showed improved overall efficiency. This indicates that the local environment in these regions is not conducive to the development of pharmaceutical enterprises. The SFA results further demonstrate that investments in education and high-level talent significantly enhance efficiency, whereas pollutant emissions and per capita income reduce operational efficiency. The findings suggest that local governments should enhance the operational efficiency of pharmaceutical enterprises by investing in education, attracting skilled talent, and improving waste infrastructure. Additionally, less efficient firms are encouraged to optimize resource allocation to achieve higher efficiency. Full article

Among the studies in the area of organisational performance analysis, little attention is paid to assessing the impact of employee well-being on business performance. Therefore, the aim of this study was to identify the sources of employees’ psychological well-being and assess its impact on business performance. The study was conducted in the form of a diagnostic survey among seven pharmaceutical entities operating in the market in Poland. The analysis and inference were based on the rules of economic and financial analysis, with particular emphasis on the cause–effect approach in the study of relationships. The sample of respondents was made up of seven pharmaceutical companies operating in the market in Poland, so the findings developed relate only to the companies accepted for the study and cannot be transferred to the general population of the country’s pharmaceutical sector. The objective of the study was made possible by appropriately selected methods of qualitative and quantitative nature. The study used the results of our own research (diagnostic survey), methods drawn from the instrumentarium of economic analysis (cause–effect analysis and dependency analysis) and statistical research techniques. The main findings of the paper indicate that the quality of organisational performance and its ability to shape the performance of activity-dependent firms is significantly dependent on the mental well-being of the workforce, as confirmed by the survey results. Firms with very good and good performance in operations demonstrate 88% of their staff achieving mental well-being. A key determinant of the above is job security (very important) and salary. The above leads to the fundamental conclusion that an important aspect of the management of a modern company is care for the comfort of working conditions, proper relations and determining the psychological safety and satisfaction of employees, which is unquestionably in the interest of both parties. The findings developed enrich the source material that can serve the management of organisations in shaping a sustainable HR strategy. Full article

Many countries ban direct-to-consumer advertising (DTCA) of prescription drugs due to potential health and financial risks. However, the internet and social media now offer new ways for pharmaceutical companies to share information and promote products. Covert marketing—indirectly promoting products through news media—has emerged as an alternative. This study explores the digital news landscape for prescription drugs in Latin America, a region that prohibits DTCA. Through content analysis, it examines prescription drug coverage in both traditional and digital news media published between 1 January 2017 and 1 January 2019, as well as its spread via social media platforms in the region’s six largest economies. The findings show that over 62% of news posts lacked neutrality, with articles on new treatments 74% less likely to be neutral, 64% less likely to mention adverse effects, and over eight times more likely to be promotional. Brazilian news had the highest social media sharing rate, with an emphasis on regulatory topics. Overall, digital news in Latin America leans toward promotional content rather than balanced reporting on drug risks and benefits. To support responsible journalism and reduce corporate influence, stronger pharmacovigilance and adherence to professional guidelines prioritizing accuracy, independence, and integrity are needed. Full article

Granger causality can uncover the cause-and-effect relationships in financial networks. However, such networks can be convoluted and difficult to interpret, but the Helmholtz–Hodge–Kodaira decomposition can split them into rotational and gradient components which reveal the hierarchy of the Granger causality flow. Using Kenneth French’s business sector return time series, it is revealed that during the COVID crisis, precious metals and pharmaceutical products were causal drivers of the financial network. Moreover, the estimated Granger causality network shows a high connectivity during the crisis, which means that the research presented here can be especially useful for understanding crises in the market better by revealing the dominant drivers of crisis dynamics. Full article

Investigating the significant “roles” within financial complex networks and their stability is of great importance for preventing financial risks. On one hand, this paper initially constructs a complex network model of the stock market based on mutual information theory and threshold methods, combined with the closing price returns of stocks. It then analyzes the basic topological characteristics of this network and examines its stability under random and targeted attacks by varying the threshold values. On the other hand, using systemic risk entropy as a metric to quantify the stability of the stock market, this paper validates the impact of the COVID-19 pandemic as a widespread, unexpected event on network stability. The research results indicate that this complex network exhibits small-world characteristics but cannot be strictly classified as a scale-free network. In this network, key roles are played by the industrial sector, media and information services, pharmaceuticals and healthcare, transportation, and utilities. Upon reducing the threshold, the network’s resilience to random attacks is correspondingly strengthened. Dynamically, from 2000 to 2022, systemic risk in significant industrial share markets significantly increased. From a static perspective, the period around 2019, affected by the COVID-19 pandemic, experienced the most drastic fluctuations. Compared to the year 2000, systemic risk entropy in 2022 increased nearly sixtyfold, further indicating an increasing instability within this complex network. Full article

Global support and standardization of regulation for biosimilars approval owes much of its legacy to the World Health Organization (WHO), since the first guidance by the organization on the matter was released in 2009. Since then, and with over a decade of research, the 2022 revision provides opportunities for time and financial savings to pharmaceutical manufacturers aiming to prove similarity of a potential biosimilar product to some reference product, particularly by clarifying that the use of a non-local reference product as a comparator in certain studies is permissible. This declaration has important implications, particularly in the emerging biological markets of the Middle East and North Africa region, where WHO guidelines have been integral to the regulatory framework of over a dozen countries for more than a decade. This article aims to review the impact of this revision on these countries and relevant policies on non-local comparator usage. Since 2022, this revision has been adopted only in Egypt. Many North African countries are yet to adopt a first draft of the formalized guidance. This analysis revealed that, although many of these countries reference the WHO guidelines, hesitation remains in terms of sourcing comparator products outside the US or European countries. This likely translates to slow regional development and cooperation of functioning, sustainable biosimilars markets. Future studies will be necessary to evaluate the continued development of guidance within these countries and changes in comparator sourcing norms as more time is allowed for their policies to mature and adapt to new standards. Full article

Biopharmaceutical companies are critical in developing vaccines, treatments, and diagnostics for COVID-19. Thus, understanding the contagion effects of their stock market can have important economic implications, especially in the context of global financial markets. Due to the COVID-19 pandemic, biopharmaceutical companies’ stock markets may have experienced sudden volatility and risk changes, which may have had spillover effects on other sectors and markets. Policymakers can take pre-emptive measures to stabilize financial markets. Analyzing the contagion effects makes it even more relevant to analyze the stock market response of four leading pharmaceutical companies that either developed vaccines against COVID-19 or drugs that help to fight the virus, namely, Pfizer, AbbVie Inc., Sanofi, and Bristol Myers Squibb. The analysis considers two periods, before and during the COVID-19 crisis, and considers the influence of the market volatility and technological market index. In order to capture the contagion effects, DCC-GARCH models have been applied, which estimate time-varying correlation coefficients using a multivariate GARCH framework, allowing for the modeling of time-varying volatility and correlations in financial returns. The results reveal the impact of market volatility on the returns of all four pharmaceutical companies. Additionally, a contagion effect between all four companies, the technological market, and market volatility was observed during the COVID-19 period. Full article

This article addresses the issues of pharmaceutical pollution of the Kura River. Existing published information on the pollution of the world’s rivers and rivers in Georgia was analyzed. Based on laboratory studies of water samples within the city of Tbilisi, which were carried out to identify psychostimulating and analeptic drugs, antibiotics of the macrolide group, nicotine, and analgesic–antipyretics, the places with the highest levels of pollution were identified. Based on the analysis of the dynamics of growth in the sales of pharmaceuticals in the world and Georgia, empirical dependencies were obtained for predicting the growth in sales as an indirect factor that indicates an increase in the pollution of natural water sources. Particular attention is paid to improving the legislative framework for the disposal of products of industrial production sectors that are related to medicine, human health, and agriculture. Full article

Wound care is a global health issue with a financial burden of up to US $96.8 billion annually in the USA alone. Chronic non-healing wounds which show delayed and incomplete healing are especially problematic. Although there are more than 3000 dressing types in the wound management market, new developments in more efficient wound dressings will require innovative approaches such as embedding antibacterial additives into wound-dressing materials. The lack of novel antibacterial agents and the misuse of current antibiotics have caused an increase in antimicrobial resistance (AMR) which is estimated to cause 10 million deaths by 2050 worldwide. These ongoing challenges clearly indicate an urgent need for developing new antibacterial additives in wound dressings targeting microbial pathogens. Natural products and their derivatives have long been a significant source of pharmaceuticals against AMR. Scrutinising the data of newly approved drugs has identified plants as one of the biggest and most important sources in the development of novel antibacterial drugs. Some of the plant-based antibacterial additives, such as essential oils and plant extracts, have been previously used in wound dressings; however, there is another source of plant-derived antibacterial additives, i.e., those produced by symbiotic endophytic fungi, that show great potential in wound dressing applications. Endophytes represent a novel, natural, and sustainable source of bioactive compounds for therapeutic applications, including as efficient antibacterial additives for chronic wound dressings. This review examines and appraises recent developments in bioactive wound dressings that incorporate natural products as antibacterial agents as well as advances in endophyte research that show great potential in treating chronic wounds. Full article

Introduction: Familial Mediterranean Fever (FMF) is a hereditary autoinflammatory disease that significantly reduces occupational productivity and quality-of-life in affected patients. Italy has an estimated FMF prevalence of 1 in 60,000 people. While colchicine is the primary treatment for FMF, biologics are administered to intolerant and non-responder patients. Anakinra and canakinumab are the only biologics approved and reimbursed for FMF in Italy. Both medicines have demonstrated efficacy in FMF patients yet differ in treatment costs. This study aimed to perform a budget impact analysis (BIA) following anakinra’s reimbursement for FMF treatment, considering pharmaceutical costs from the Italian National Healthcare Service (NHS) perspective. Methods: A ‘Reference scenario’ (all patients treated with canakinumab) was compared to an ‘Alternative scenario’, with increased anakinra market shares. The target population was estimated based on the Italian population, epidemiological and market research data. Drugs costs were estimated based on Summary of Product Characteristics and net ex-factory prices. Sensitivity analyses were implemented to test results’ robustness. Results:The base case analysis showed an overall cumulative expenditure of €30,586,628 for ‘Reference scenario’ and € 16,465,548 for ‘Alternative scenario’. A cumulative savings of €14,121,080 (46.2%) was calculated over 3 years as a result of the reimbursement and increasing uptake of anakinra. The sensitivity analyses, even considering a discount of 50% for canakinumab, confirmed the base case results. Conclusions: Anakinra’s introduction, in FMF treatment, provides a financially sustainable option for Italian patients, with savings increasing according to greater use of anakinra. Full article

The Global Financial Crisis (GFC) will cause turbulence in the pharmaceutical market and the stagnation of market liquidity, leading to a deep recession in the pharmaceutical economy. After the COVID-19 outbreak, the pharmaceutical economic recession and the rising pharmaceutical financial crisis caused by the closure and control of the COVID-19 outbreak in China were important reasons for the accumulation of systemic financial risks in China. To realize the pharmaceutical economy and financial stability, this paper studies the weakening mechanism of the stabilization effect in systemic risk scenarios and analyzes how the evolution of systemic risk under the COVID-19 shock affects the stabilization effect of monetary policy. Under the COVID-19 shock, in the stage of falling China Financial Stress Index (CFSI), the systemic risk is relatively low, and the impact of traditional policy on macroeconomic stability is more significant; in the rising stage of CFSI, the systemic risk is relatively high, and the impact of traditional policy on macroeconomic stability is limited. This paper develops a Time-Varying Modified CRITIC weighting method and constructs a Time-Varying CFSI. This paper identifies systemic risk scenarios under the COVID-19 shock based on the Markov-Switching Mean Heteroskedastic Vector Auto-Regressive (MSMH-VAR) model and evaluates the stabilizing effects of monetary policy in different economic and financial regional systems (normal times and systemic risk scenarios). The results show that in normal times, loose monetary policy increases price levels, and tight monetary policy reduces price levels with a time lag. In systemic risk scenarios under the COVID-19 shock, the easing effect of policy on output growth is relatively small, and tighter policy increases output growth and prices in the short run and increases volatility in output growth and price levels in the long run. That is, under the COVID-19 shock in systemic risk scenarios, it is difficult to achieve stable growth and stable prices with monetary policy, and the stabilization effect is weakened. This paper focuses on the relationship between systemic risks, monetary policy, and output stability under the COVID-19 shock, analyzes the weakening of stabilization effects after the crisis, and expands the theoretical path of monetary policy stabilization and enriches the research scope of the new framework. Full article