Product Entry Research Articles

Efficiency of using Vitaferm in broiler poultry farming

The cultivation of poultry without the use of antibacterial drugs is a vital direction of modern production, since the entry of domestic poultry products to the foreign market involves their absence in raw materials of animal origin. As experience confirms, enrichment of feed rations with enzyme preparations and vitamins reduces the waste of young animals, significantly increases the feed absorption, and reduces their feed-gain relations per production unit. This allows enhancing the productivity of poultry farming while simultaneously improving the quality of resulting products. We have studied the effect of the new vitamin-enzyme complex Vitaferm on the broiler-chickens body against the background of the antibacterial drugs exclusion from their antiepizootic measures. Studies have shown a positive effect of Vitaferm on the poultry body which is manifested by an increase in average daily growth, livability enlargement and reduced feed-gain relations per production unit. These changes can be explained by the normalization of the digestive system of broiler-chickens with the Vitaferm use. It is known that antibiotics inhibit the body’s immune system and disturb the balance of intestinal microflora. Thus, the use of vitamin-enzyme complex Vitaferm with broiler-chicken feed at the rate of 15.0 g/kg, starting from the day-old up to 10 days, is proposed for the complete or partial exclusion of antibacterial drugs from the antiepizootic measures scheme.

Anticompetitive Patent Settlements – Where Are We Ten Years After the European Commission’s Pharmaceutical Inquiry?

In 2009, the European Commission published a final report on its market inquiry into the pharmaceutical sector. The report revealed the authority’s concerns regarding market practices of pharmaceutical originator companies aimed at delaying the market entry of cheaper generic pharmaceutical products. One of the delaying practices identified by the European Commission were patent settlements between an originator and a generic company including: (i) a value transfer from the originator to a generic company, and (ii) an obligation of a generic company not to enter the market. These patent settlements were called pay-for-delay agreements since the payment was allegedly made in exchange for the non-market entry obligation. The European Commission continued the investigation of patent settlements by its continuous monitoring. It also initiated antitrust proceedings that terminated with huge fines imposed on pharmaceutical companies. The appeals are now pending before the EU courts. Ten years after the publication of the final report on the market inquiry, this article aims to summarise the development of the case law and provide its critical analysis. The article focuses on the analysis of pay-for-delay agreements as infringements of Article 101 TFEU only and does not consider the conclusion of these agreements as an abuse of a dominant position.

The effect of nitrogen monoxide donors on the indexes of cadmium-induced oxidative stress in different rat tissues

Oxidative stress is considered to be the main mechanism of cadmium ions toxic effect on the cells and is caused by cadmium, as a non-transition metal, indirectly. Oxidative damage to cells due to the action of cadmium ions is tissue-specific and is associated with the antioxidant system inhibition, free heme accumulation and essential metals substitution in metalloproteins. Nitrogen monoxide (NO) exhibits high affinity for heme and proteins and peptides sulfhydryl groups, known to be the main molecular targets for cadmium ions. Taking all the above-mentioned into account, the aim of this work was to study the effect of NO radicals donors on the prooxidant-antioxidant state of mammalian tissues under oxidative stress caused by cadmium chloride administration in vivo. Male Wistar rats weighing 160–200 g were used in the study. CdCl2 was administered subcutaneously at a dose of 14 mg/kg body weight. The direct donor of the NO radical sodium nitroprusside (SNP, 1 mg/kg mass) and the substrate of the NO synthase reaction L-arginine (600 mg/kg mass) were administered intraperitoneally. In order to study the corrective action, donors of the NO radical were injected 0.5 h before the cadmium salt. The objects of investigation were blood plasma and liver, kidneys and spleen homogenates of rats. The cadmium chloride treatment caused a number of prooxidant-antioxidant balance disorders, most of which were revealed a day after injection. The accumulation of lipid peroxidation products was found in rat serum, liver, and spleen. The enhancement of prooxidant processes in these tissues may originate from cadmium ions and hemolysis products entry. In the antioxidant system, significant changes were observed under cadmium action only in the liver: an increase in the reduced glutathione content and SOD activity and a decrease in catalase activity. The precursor of nitric oxide L-arginine did not change the basal level of prooxidant-antioxidant parameters, and in most cases did not affect their dynamics in the organs studied after cadmium chloride administration. A direct NO donor, sodium nitroprusside, acted in liver and spleen mostly as a prooxidant. In liver, the injection of only nitroprusside, as well as the combined administration of SNP and CdCl2, led to free radical processes activation just in two hours. In spleen, the combined treatment by SNP and cadmium salt also caused an earlier development of oxidative stress, as witnessed by an increase in lipid hydroperoxides level and a decrease in reduced glutathione content. Therefore, the injection of a direct NO donor, sodium nitroprusside, and a substrate of NO synthase, L-arginine, in selected doses has insignificant corrective action on cadmium-induced oxidative stress in the liver, kidneys and spleen. However, in blood both donors of NO effectively prevented the accumulation of lipid peroxidation products under CdCl2 treatment; in addition, L-arginine significantly reduced the lactate dehydrogenase release, which may indicate blood cells and blood vessels protection from the damage caused by cadmium ions.

Regulating Innovation with Uncertain Quality: Information, Risk, and Access in Medical Devices

We study the impact of regulating product entry and quality information requirements on an oligopoly equilibrium and consumer welfare. Product testing can reduce consumer uncertainty, but also increase entry costs and delay entry. Using variation between EU and US medical device regulations, we document patterns consistent with valuable learning from more stringent US requirements. To derive welfare implications, we pair the data with a model of supply, demand, and testing regulation. US policy is indistinguishable from the policy that maximizes total surplus in our estimated model, while the European Union could benefit from more testing. “Post-market surveillance” could further increase surplus. (JEL D43, I18, L13, L51, L64, O31, O38)

Firm-Level Investment and Exporting: New Empirical Evidence From Ghana and Tanzania

Using firm-level data from two selected African countries, we examine whether firm-level investment in capital is a possible channel through which less productive firms gain entry into export markets. Our findings reveal that non-exporters who invest in capital stock increase their probability of switching status, from non-exporter to exporter, and we provide evidence that firm-level investment is correlated with increased productivity growth among exporters. Consequently, we emphasize that firm-level investment in capital enables non-export to increase their odds of entry to export markets, and provides opportunity for young exporters to grow rapidly and persist long in export markets. Although firm productivity differences can be explained by self-selection factors as one channel, firm-level investment in capital stock provides another explanation as to why less productive firms, gain entry into the export markets. We establish that when firms invest in capital, they improve their productive capacity, raising their productivity in the process. Export promotion policies should target providing support to firms that seek to upgrade or expand their production technology as this would stimulate the probability of export market entry hence promoting exports.

Active labour market policies for young people and youth unemployment

PurposeThe purpose of this paper is to provide quantitative estimates on the impact of active labour market policy (ALMP) on youth unemployment in Europe based on a macroeconomic panel data set of youth unemployment, ALMP and education policy variables and further country-specific characteristics on labour market institutions and the broader demographic and macroeconomic environment for all EU-Member States.Design/methodology/approachThe authors follow the design of an aggregate impact analysis, which aims to explain the impact of policy on macroeconomic variables like youth employment and unemployment (see Bellmann and Jackman, 1996). This follows the assumption that programmes, which are effective in terms of improving individual employment opportunities, are going to make a difference on the equilibrium of youth unemployment.FindingsThe findings show that both wage subsidies and job creation are reducing aggregate youth unemployment, which is in contrast to some of the surveys of microeconomic studies indicating that job creation schemes are not effective. This finding points towards the importance to assist young people making valuable work experience, which is a benefit from job creation, even if this experience is made outside regular employment and/or the commercial sector.Research limitations/implicationsIn terms of the variables to model public policy intervention in the youth labour market, only few indicators exist, which are consistently available for all EU-Member States, despite much more interest and research aiming to provide an exhaustive picture of the youth labour market in Europe. The only consistently available measures are spending on ALMP as a percentage of gross domestic product (in the different programmes) and participation stocks and entries by type of intervention.Practical implicationsThe different effects found for the 15–19 year olds, who seem to benefit from wage subsidies, compared to the effect of job creations benefitting the 20–24 year olds, might relate to the different barriers for both groups to find employment. Job creation programmes seem to offer this group an alternative mechanism to gain valuable work experience outside the commercial sector, which could help form a narrative of positive labour market experience. In this way, job creation should be looked more positively at when further developing ALMP provision, especially for young people relatively more distant to engagement in regular employment.Social implicationsImproving the situation of many millions of young Europeans failing to find gainful employment, and more generally suffering from deprivation and social exclusion, has been identified as a clear priority for policy both at the national level of EU-Member States and for EU-wide initiatives. With this study, the authors attempt to contribute to the debate about the effectiveness of policies which combat youth unemployment by estimating the quantitative relationship of ALMP and other institutional features and youth unemployment.Originality/valueTo research the relationship between youth unemployment and ALMP, the authors created a macroeconomic database with repeated observations for all EU-Member States for a time series (1998–2012). The authors include variables on country demographics and the state of the economy as well as variables describing the labour market regimes from Eurostat, i.e. the flexibility of the labour market (part-time work and fixed-term employment as a percentage of total employment) and the wage setting system (level and coordination of bargaining and government intervention in wage bargaining).

Platforms and the Exploration of New Products

A key strategic decision for platforms is the extent to which they should facilitate the entry of untested new products and sellers alongside established products and sellers. Exploration by current buyers helps future buyers better value these products and sellers. This externality across buyers raises the possibility that there may be too little exploration from the platform’s perspective. On the other hand, when sellers have market power and so price strategically, and platforms extract a share of seller revenue (i.e., charge commissions), the direction of any such bias is not obvious. We provide a theory that predicts when the platform will prefer more, less, or the same level of exploration as that induced by sellers in equilibrium. Our theory can explain why platforms will sometimes have no incentive to steer buyers one way or another, or may actually want to steer buyers toward established products and sellers. This paper was accepted by Joshua Gans, business strategy.

Productivity growth and job reallocation in the Vietnamese manufacturing sector

Purpose The purpose of this paper is to measure TFP growth and job reallocation in the Vietnamese manufacturing industry after the Doimoi period. Design/methodology/approach The study uses firm-level panel data from Vietnam’s annual enterprise survey data for 2000–2016 period in the Vietnamese manufacturing industry using Olley–Pakes static and dynamic productivity decomposition methods. Findings The aggregate productivity estimated from the WRDG method increased 2.323 percent, of which over 40 percent is due to the reallocation toward more productive firms. Olley–Pakes dynamic decomposition according to ownership, scale and industry shows that the contribution of private and state-owned firms and the contribution of small and medium firms and large firms to the TFP growth are 133, −33 percent, 58.56 and 41.44 percent, respectively. The within-firm productivity and net entry components are the main reasons for TFP growth rather than reallocation. The results show that the composition of the aggregate TFPs, estimated from WRDG, OP, LP and ACF, is correlated very high (over 80 percent) except for net entry components. Research limitations/implications The major limitation of this study is that the authors compute an aggregate productivity index using actual employment-based shares (still misallocation in labor), rather than optimal employment-based shares (no misallocation in labor). Originality/value Job reallocation between industries is attracting attention in developing countries, especially transition economies. However, knowledge about job reallocation among industries is limited. This paper assesses the level of job reallocation among private and state-owned firms, small and medium firms and large firms in Vietnam.

Procurement Mechanisms for Assortments of Differentiated Products

We consider the problem faced by a procurement agency that runs a mechanism for constructing an assortment of differentiated products with posted prices, from which heterogeneous consumers buy their most preferred alternative. Procurement mechanisms used by large organizations, including framework agreements (FAs), which are widely used in the public sector, often take this form. When choosing the assortment, the procurement agency must optimize the tradeoff between offering a richer menu of products for consumers and offering less variety, hoping to engage the suppliers in more aggressive price competition. We formulate the problem faced by the procurement agency as a mechanism design problem, and we progressively incorporate more complex and often more realistic implementation constraints, including that the allocations should be decentralized (that is, consumers choose what to buy) and that payments must be implemented through linear pricing (in particular, no up-front payments are allowed). We characterize the optimal buying mechanisms that highlight the importance of restricting the entry of close-substitute products to the assortment as a way to increase price competition without much damage to variety. Motivated by the implementation of the Chilean FAs, which are being used to acquire around US$3 billion in goods and services per year, we leverage our characterization of the optimal mechanism to study the design of first-price-auction-type mechanisms that are commonly used in public settings. Our results shed light on simple ways to improve their performance.

Firm-Level Investment and Exporting: New Empirical Evidence from Ghana and Tanzania

Using firm-level data from two selected African countries, we examine whether firm-level investment in physical capital is a possible channel through which less productive firms gain entry into export markets. Our findings reveal that non-exporters who invest in physical capital increase their probability of switching status, from non-exporter to exporter, and we provide evidence that firm-level investment is correlated with increased productivity growth among exporters. Consequently, we emphasize that firm-level investment in physical capital enables non-exporters to increase their odds of entry to export markets and provides opportunity for young exporters to grow rapidly and persist long in export markets. Although firm productivity differences can be explained by self-selection factors as one channel, firm-level investment in physical capital provides another explanation as to why less productive firms gain entry into the export markets. We establish that when firms invest in physical capital, they improve their productive capacity thereby raising their productivity in the process. Export promotion policies should target providing support to firms that seek to upgrade or expand their production technology as this would stimulate the probability of export market entry hence promoting exports.

Another Rush to Judgment: The Imaginary Worlds of ICER and Recommendations in Duchenne Muscular Dystrophy.

Previous commentaries in the Formulary Evaluation section of INNOVATIONS in Pharmacy have pointed to the lack of credibility in modeled claims for cost-effectiveness and associated recommendations for pricing by the Institute for Clinical and Economic Review (ICER). The principal objection to ICER reports has been that their modeled claims fail the standards of normal science: they are best seen as pseudoscience. The purpose of this latest commentary is to consider the recently released ICER report for Duchennemuscular dystrophy (DMD). As ICER has continued in the case of DMD to apply its modeled cost utility framework with consequent recommendations for pricing adjustments, these recommendations also lack credibility. This commentary emphasizes again not only why the ICER methodology fails to meet the standards of normal science but to point to the importance in rare diseases for accelerated approval, while recognizing that evidence generation will continue.While this assessment of the ICER DMD model does not imply any support for this methodology, a key point is the application of quality of life measures which fail to capture the experience of patients with DMD and, importantly, the interests of both patients and caregivers. While ICER would argue that even with a limited evidence base it is important to address issues of pricing and access for new products, their reports are used as justification for coverage and reimbursement by insurers and health system decision makers without recognition of their lack of scientific merit. This rush to judgement by ICER must raise concerns about potentially adverse formulary decisions that result in access restrictions on new products. If ICER is to make a contribution to the entry of new products in the health market place then it should consider an alternative methodology that generates claims that are empirically evaluable in a timeframe relevant to health decision makers. As it stands, ICER's recommendation should be rejected. This is not a research program that meets accepted scientific standards but one that relies on the willingness of an audience to accept the proposition that evidence is constructed not discovered.

An Examination of Influence of Competition on Destination Marketing Performance by Public Organizations in Kenya

Kenya faces intense competition in the tourism from countries such as Tanzania that have similar tourism offering in the game reserves and related products. Both countries have game parts and the world famous wildebeest migration phenomenon. This has often resulted in intense competition for the tourists to the national parks. The country also faces stiff competition from competing destinations such as Malaysia, South Africa, Egypt, Ethiopia and Tanzania and has led to the decline of arrivals. Competition from the rest of the world -Countries like Switzerland has beautiful scenery and some other tourist attraction sites. The country Kenya therefore is sharing the market getting a small portion reducing its revenue. This study sought to examine the manner in which tourism influences destination marketing aspects within the country. The results also indicate that the there exists a positive significant non- causal relationship between competition and destination marketing in Kenya (r = 0.451, p < 0.05). The regression analysis found that there exist a statistically significant positive relationship between competition and destination marketing performance in public organizations in Kenya (β =0.606, p<0.05). This means that the null hypothesis (Ho) was rejected by implying that “there is significant effect of competition on destination marketing performance by public organizations in Kenya”. The study concluded that competition (new markets offering similar products, destination competitiveness and branding) have significant effect on destination marketing performance in public organizations in Kenya. Conclusions can also be made that that tourism destination in Kenya face stiff competition from East African countries e.g. Tanzania as well as South Africa and Mauritius who are offering offer similar products to those Kenya offers, thus affecting the competitiveness of destination tourism in Kenya. It can be concluded that Kenya faces severe competition in infrastructure (communication, roads), parks entry charges, promotion of culture of heritage cast line along the coast region and beach tourism. Further conclusions can be made that the development in travel and the tourism sector has led to the sector’s effectiveness leading to rapid market entry of innovative products in other markets. It was therefore concluded that new markets offering similar products as well as destination competitiveness and branding have a positive influence on destination marketing performance in public organizations in Kenya. Keywords: Competition, Destination Marketing, Public Organizations DOI : 10.7176/JMCR/60-04 Publication date :September 30 th 2019

Regulatory Requirements and Innovation: A Comparison of the Dermatologic Antifungal Drug Product Markets in Brazil and United States

Development of novel dermatological topical products for the treatment of cutaneous fungal infections is a constant necessity, especially in developing countries. Through public health policies, many developing countries have facilitated in the last decades the entry of generic products, which can be superficially seen as a threat to innovation. To verify whether regulatory requirements, or the waiving of some requirements, could have an impact on innovation, we performed a detailed technical comparison of the dermatologic antifungal markets of Brazil and of the United States, taking Brazil as an example of a developing country with more lenient requirements regarding the registration of generic topical drug products. The official databank of ANVISA (DATAVISA) and of US Food and Drug Administration (Orange Book) were assessed for valid topical dermatological antifungal drug products registered. The Brazilian market has a greater number of registered drug products encompassing a greater variety of drug substances than the US, but the latter comprises more products with novel technologies. In both countries, cream was the predominant dosage form and imidazoles were the major substance group. Ketoconazole was the lead active substance in Brazil and ciclopirox was the lead drug in the US. Generic products dominated both markets. Despite the great number of registered products, the Brazilian market lacks the latest technologies, reflecting that the ease of generics registration is not accompanied by innovation.

РОЗВИТОК ІНТЕЛЕКТУАЛЬНОГО ПІДПРИЄМНИЦТВА ЗАКЛАДУ ВИЩОЇ ОСВІТИ

The identification of the nature of intellectual entrepreneurship in institutions of higher education has enabled to justify its specific principles, map the key problems of intellectual entrepreneurship development in Ukrainian universities and outline the pathways to their solution. The paper offers a concept of innovative entrepreneurship in institutions of higher education based on commercialization of intellectual activity results (IAR) viewed as a separate type of activity aimed at creation and realization of the commercial potential of university R&amp;D results which relies on its own principles and is ensured through specific instruments within the University's infrastructure and is implemented in unique organizational forms. To ensure the implementation of the suggested organizational and economic mechanism, the content, principles and objectives of infrastructural support for commercialization of intellectual activity results in institutions of higher education have been developed. The heart of the organizational model for commercialization of IAR in institutions of higher education is an engineering centre. A multi-project mechanism for managing the commercialization of IAR in institutions of higher education has also been proposed, the core of which is a permanent project office operating within the engineering centre with engaged cross-functional teams on commercialization and respective project organizational structures to promote the entry of innovative products based on advanced developments of institutions of higher education into the market. The use of the developed assessment criteria for evaluating the innovation and commercial potentials of intellectual activity results facilitates a reasonable selection of intellectual activity results for commercialization (subject to their innovative and commercial potential assessment) along with providing an objective comparison of IAR and innovative products by various criteria combinations to set the priorities and make rational decisions in the area of financing and resourcing which enhances the overall efficiency of innovation activities and intellectual entrepreneurship performance in institutions of higher education.

The use of prebiotics in broiler poultry as an alternative to antibacterial drugs

Breeding animals without the use of antibacterial drugs is a relevant branch of modern science, because the entry of national agricultural products into the foreign market provides for the antibacterial drugs absence in raw materials of animal origin. Therefore, in order to improve livability and productivity of animals, it is necessary to constantly monitor the resistance of their bodies, use antibacterial drugs more carefully and eliminate unnecessary or ineffective drugs completely. Thus, an important task facing the veterinary service of the Russian Federation is the complete elimination or reduction of the antibiotics use in animal breeding and the use of drugs that can replace antibacterial ones. We first studied the effect of heteropolysaccharides “raspol” and “gemiv” on broiler bodies. It is established that the used drugs allow eliminating the antibacterial drugs from the broiler ration. In the period of antibacterial drugs exclusion from the broiler preventive treatment scheme these prebiotics cause an increase in poultry gain, increase its livability and natural resistance, while the use of antibiotics in broiler control group negatively affects the body. Recommendations for the use of prebiotics raspol and gemiv in broilers, as an alternative to antibacterial drugs, are provided.

SECRETARY OF STATE FOR HEALTH v SERVIER LABORATORIES LTD

Abstract H1 Patents – European patents - Pharmaceuticals – Generic products – Economic torts – Unlawful means – Strike out application – Necessary elements of the tort – Whether the unlawful means relied upon had to interfere with claimant’s liberty to deal with third party against whom the unlawful act relied upon had been committed – Invalid patents – Proceedings for patent infringement – Interim injunctions – Market entry of third party generic product delayed – Prices thereby maintained – Patent later invalidated – Claim struck out at first instance – Appeal to Court of Appeal

Market size and entry in international trade: Product versus firm fixed costs

AbstractThis paper develops a theoretical framework to infer the nature of fixed costs from the relationship between entry patterns in international markets and destination market size. If fixed costs are at the firm level, firms take advantage of an intrafirm spillover by expanding firm‐level product range (scope). Few firms enter with many products and dominate international trade. If fixed costs are at the product level, an interfirm spillover reduces the fixed costs to export for all firms producing the product. The resulting entry pattern consists of many firms exporting different varieties of the same product. Using cross‐country data on firm and product entry, I find empirical evidence consistent with product‐level costs. More firms than products enter in larger markets offering their consumers lower prices and a greater variety of goods within the product category.

Adenovirus Entry: From Infection to Immunity.

More than 80 different adenovirus (AdV) types infect humans through the respiratory, ocular, or gastrointestinal tracts. They cause acute clinical mani-festations or persist under humoral and cell-based immunity. Immuno-suppressed individuals are at risk of death from an AdV infection. Concepts about cell entry of AdV build on strong foundations from molecular and cellular biology-and increasingly physical virology. Here, we discuss how virions enter and deliver their genome into the nucleus of epithelial cells. This process breaks open the virion at distinct sites because the particle has nonisometric mechanical strength and reacts to specific host factors along the entry pathway. We further describe how macrophages and dendritic cells resist AdV infection yet enhance productive entry into polarized epithelial cells. A deep understanding of the viral mechanisms and cell biological and biophysical principles will continue to unravel how epithelial and antigen-presenting cells respond to AdVs and control inflammation and persistence in pathology and therapy.

Molecular Mechanism of HIV-1 Entry

HIV-1 envelope glycoprotein [Env; trimeric (gp160)3 cleaved to (gp120/gp41)3] attaches the virion to a susceptible cell and induces fusion of viral and cell membranes to initiate infection. It interacts with the primary receptor CD4 and coreceptor (e.g., chemokine receptor CCR5 or CXCR4) to allow viral entry by triggering large structural rearrangements and unleashing the fusogenic potential of gp41 to induce membrane fusion. Recent advances in structural biology of HIV-1 Env and its complexes with the cellular receptors have revealed molecular details of HIV-1 entry and yielded new mechanistic insights. In this review, I summarize our latest understanding of the HIV-1 membrane fusion process and discuss possible pathways for productive viral entry.

Molecular organization and dynamics of the fusion protein Gc at the hantavirus surface.

The hantavirus envelope glycoproteins Gn and Gc mediate virion assembly and cell entry, with Gc driving fusion of viral and endosomal membranes. Although the X-ray structures and overall arrangement of Gn and Gc on the hantavirus spikes are known, their detailed interactions are not. Here we show that the lateral contacts between spikes are mediated by the same 2-fold contacts observed in Gc crystals at neutral pH, allowing the engineering of disulfide bonds to cross-link spikes. Disrupting the observed dimer interface affects particle assembly and overall spike stability. We further show that the spikes display a temperature-dependent dynamic behavior at neutral pH, alternating between 'open' and 'closed' forms. We show that the open form exposes the Gc fusion loops but is off-pathway for productive Gc-induced membrane fusion and cell entry. These data also provide crucial new insights for the design of optimized Gn/Gc immunogens to elicit protective immune responses.