Bioequivalence Between a New Omalizumab Prefilled Syringe With an Autoinjector or with a Needle Safety Device Compared with the Current Prefilled Syringe: A Randomized Controlled Trial in Healthy Volunteers.

Omalizumab is an anti-IgE monoclonal antibody currently approved for the treatment of asthma, nasal polyps/chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria. Omalizumab is available as an injection in a prefilled syringe (PFS) with a needle safety device (NSD). New product configurations were developed to reduce the number of injections per dose administration, improve patient convenience and treatment compliance. The objective of this randomized open-label 12-week study was to demonstrate pharmacokinetic bioequivalence between (1) new PFS with autoinjector (PFS-AI), (2) new PFS-NSD configuration, and (3) current PFS-NSD configuration. Each new configuration was considered bioequivalent to the current configuration if the confidence intervals (CIs) for the geometric mean ratios (GMR) were contained in the 0.80-1.25 range for maximum concentration (Cmax), area under the concentration-time curve until the last quantifiable measurement (AUClast), and AUC extrapolated to infinity (AUCinf). Safety was assessed throughout the study. In total, 193 healthy volunteers were randomized at 1:1:1 ratio to omalizumab 1×300 mg/2 mL via new PFS-AI (n = 66), omalizumab 1×300 mg/2 mL via new PFS-NSD (n = 64), or omalizumab 2×150 mg/1 mL via current PFS-NSD (n = 63). Comparing new PFS-AI versus current PFS-NSD, the GMRs were: Cmax, 1.085; AUClast, 1.093; AUCinf, 1.100. Comparing new PFS-NSD versus current PFS-NSD, the GMRs were: Cmax, 1.006; AUClast, 1.016; AUCinf, 1.027. The 95% CIs for all GMR parameters were contained within the 0.80-1.25 range. Safety findings were consistent with the known safety profile of omalizumab. Single-dose omalizumab administered as the new PFS-AI or new PFS-NSD was bioequivalent to the current PFS-NSD.

Currencies of greater interest for central Asian economies: an analysis of exchange market pressure amid global and regional interdependence.

Central Asian Economies (CAEs) have diverse exchange rate policies. They have recorded higher volatility in the foreign exchange market since inception. High volatility of the transition era has drifted these economies towards partial dollarization. Monetary authorities in CAEs, (already have a challenge of maintaining monetary policy autonomy) have a gigantic task of price stability and stopping the spread of dollarization. This study is directed towards assessing the drivers and the determinants of foreign exchange market pressure in CAEs. The results, based on panel data analysis and the System GMM model, have provided useful insights about the exchange market pressure determinants particularly USD, Euro, Ruble, and Renminbi. The results show that China and Russia exchange market pressure has a negative effect on the exchange market pressure of CAEs. While the dollar index shows a positive impact on the exchange market pressure of CAEs. Overall, the findings imply that China and Russia currency appreciation results in a trade deficit across CAEs. The policy implication suggests that the floating exchange rate regime (inflation targeting regime) is not in favor of CAEs, and they must use managed-float to reduce their trade deficits.

Climate risk insurance in Pacific Small Island Developing States: possibilities, challenges and vulnerabilities-a comprehensive review.

For the Pacific Small Island Developing States (PSIDS), climate change will greatly exacerbate their vulnerability. The PSIDS have a high ranking in the Climate Risk Index and the World Risk Index. Financial losses due to climate-induced disasters, in terms of gross domestic product (GDP), are also high in the Pacific region. While climate risk insurance solutions could play a key role in the efficient distribution of recovery resources, there are many challenges to their successful implementation. Effective climate risk insurance products for the vulnerable sections of these societies are almost non-existent in this part of the world. Among the worst climate-induced disasters to affect the PSIDS are those related to cyclones and floods. These not only adversely impact the welfare of the households affected by these disasters, but they lower the long-term development potential of the countries involved. There is also evidence to suggest that climate-induced disasters are increasing in frequency and intensity over time due to climate change. It is against this background that an inquiry into the necessity for climate risk insurance products in the context of PSIDS should take place. This paper gives a comprehensive review of the literature addressing climate risk insurance as a risk mitigation or climate adaptation tool for managing the climate-induced financial vulnerabilities in the PSIDS. The paper explores the affordability of climate risk insurance, particularly among the vulnerable sections of society, and discusses the challenges of implementing an appropriate climate risk insurance model in the region. Finally, it examines recent climate risk insurance initiatives that have been attempted by multilateral agencies, such as the United Nations Development Programme (UNDP), the United Nations' Pacific Financial Inclusion Practice (UNCDF), Pacific Insurance and Climate Adaptation Programme (PICAP), and respective local governments.

Determinants of Exports in a Small and Vulnerable Economy: Fiji Islands-A Disaggregated Analysis.

The previous studies of exports performance in Fiji were carried out at the aggregate level. We conduct a disaggregated analysis of exports of three major products, namely, sugar, tourism, and gold. This analysis is useful for developing sector-based export promotion policies. The long run as well as dynamic export demand functions are estimated at the aggregate and disaggregate levels. The results identify a number of factors such as trading partner income, relative prices, productivity shocks, natural disasters, political disturbances, and the exchange rate that affect the export demand for sugar, tourism, and gold, though not in the same way. For instance, tourism and sugar enjoy the highest income elasticity. Sugar export is adversely affected by natural calamities and political upheavals. The political upheavals also affect tourism adversely in Fiji. The exchange rate affects the export of sugar more than others. The idea that devaluation will promote exports in Fiji needs careful investigation because results show that this will happen with a high cost, i.e. 5% nominal devaluation will be required to increase real exports by 1%.

Les études précédentes sur la performance des exportations aux Fidji ont été réalisées au niveau global. Nous effectuons une analyse désagrégée des exportations de trois produits principaux, à savoir le sucre, le tourisme et l'or. Cette analyse est utile pour développer des politiques sectorielles de promotion des exportations. Nous estimons au niveau global et au niveau désagrégé des projections sur le long terme, ainsi que des fonctions dynamiques de demande d'exportation. Les résultats identifient un certain nombre de facteurs, tels que le revenu des partenaires commerciaux, les prix relatifs, les chocs de productivité, les catastrophes naturelles, les troubles politiques et les variations du taux de change, qui affectent la demande d'exportation pour le sucre, le tourisme et l'or, bien que l'impact soit différent. Par exemple, le tourisme et le sucre bénéficient de l'élasticité du revenu la plus élevée. L'exportation de sucre est affectée par les catastrophes naturelles et les bouleversements politiques. Les bouleversements politiques affectent également le tourisme dans les îles Fidji. Les variations du taux de change affectent l'exportation de sucre plus que les autres produits. Il faut soigneusement étudier l'idée selon laquelle, aux Fidji, la dévaluation monétaire va favoriser les exportations, car les résultats montrent que cela ne se produira qu'avec un coût élevé, c'est-à-dire qu'une dévaluation nominale de 5% sera nécessaire pour augmenter les exportations réelles de 1%.

Projecting populations for major Pacific Island countries with and without COVID-19: pro-active insights for population policy.

The paper projects aggregate populations of six Pacific Island countries in both pre- and post-COVID19 scenarios using a Cohort Component Method for the period 2020-2060. It uses baseline indicators resembling China and Italy's experiences and finds that Pacific countries could experience a fatality rate between 5 and 20% due to the pandemic. It also finds that most Pacific Island countries would experience higher fatalities in the older age groups, consistent with what is being witnessed in other countries around the world. The analysis also shows that while the risk escalates for people over 50 years onward in all other sample countries, in Fiji, those in the age range of 60 years or more are at higher risk. The findings also indicate that for all countries, the fatality rate for 80 years and older is about 50%. The population projections show that Fiji will be most impacted, while others will experience around 2% initial population decline. The convergence to baseline is found to be slow (except for Tonga) in most Pacific countries. Consequently, the paper suggests a cautious approach in dealing with the current crisis.