FDA New Drug Approval Times, Prescription Drug User Fees, and R & D Spending

FDA-approval times have declined significantly since the enactment of the Prescription Drug User Fee Act (PDUFA) in 1992. As a result, present value expected returns to pharmaceutical R&D have likely increased. In the current paper we employ a unique survey dataset, which includes for the first time data on firm-level pharmaceutical R&D. We estimate the effects that FDA-approval times have on R&D investments. Controlling for other factors such as pharmaceutical profitability and cash flows, we find that a 10 percent decrease (increase) in FDA-approval times results in a 1.7 percent in increase (decrease) in R&D spending.Combining this estimate with previous research and publicly available data on industry-level pharmaceutical spending between 1992 and 2001, we conclude PDUFA, and its subsequent renewals, stimulated an additional 13.5 billion in pharmaceutical R&D (2005 U.S.), and has presumably continued to do so since 2001. Recent economic research has shown the social rate of return on pharmaceutical R&D is remarkably high; thus, the social benefits of PDUFA (over and above the benefits of more rapid consumer access) are likely to be substantial.

Financial Risk in the Biotechnology Industry

The biotechnology industry has been an engine of innovation for the U.S. healthcare system and, more generally, the U.S. economy. It is by far the most research intensive industry in the U.S. In our analyses in the current paper, for example, we find that, over the past 25 years, average R&D intensity (R&D spending to total firm assets) for this industry was 38 percent. Consider that over this same period average R&D intensity for all industries was only about 3 percent. In the current paper we examine this industry along a number of dimensions and estimate its average financial risk. Specifically, we use Compustat and Center for Research in Securities Prices (CRSP) data from 1982 to 2005 for firms defined by the North American Industry Classification System (NAICS) as biotechnology firms to estimate several Fama-French three factor return models. The finance literature has established this model as the gold standard. Single factor models like the Capital Asset Pricing Model (CAPM) do not capture all of the types of systematic risk that influence firm cost of capital. In particular, the CAPM does not reflect the empirical evidence that supports both a size-related and a book-to-market related systematic risk factor . Both of these factors, based on biotech industry characteristics, will exert a greater influence on biotech firms, on average. Another implication is, of course, that cost of capital estimates for the industry will be underestimated when a single factor model, like the CAPM, is used. This also implies that the cost estimates of bringing a new drug and/or biologic to market will be understated if financial risk and cost of capital are measured using a single-factor model. In the current study we find that biotechnology firms are exposed to greater financial risk than other industries and are also more sensitive to policy shocks that affect, or could affect, industry profitability. Average nominal costs of capital over the 1982-2005 time period were 16.25 percent for biotechnology firms. Of course, these average estimates obscure significant variation in financial risk at the firm level, but nonetheless shed light on some interesting aggregate differences in risk. In the current paper we discuss the theoretical links between financial risk, stock prices and returns, and R&D spending. Several caveats are also discussed.

Why people choose negative expected return assets - an empirical examination of a utility theoretic explanation

Using a theoretical extension of the Friedman and Savage (1948) utility function developed in Bhattacharyya (2003), we predict that for financial assets with negative expected returns, expected return will be a declining and convex function of skewness. Using a sample of U.S. state lottery games, we find that our theoretical conclusions are supported by the data. Our results have external validity as they also hold for an alternative and more aggregated sample of lottery game data.

European Pharmaceutical Price Regulation, Firm Profitability, and R&D Spending

EU countries closely regulate pharmaceutical prices whereas the U.S. does not. This paper shows how price constraints affect the profitability, stock returns, and R&D spending of EU and U.S. firms. Compared to EU firms, U.S. firms are more profitable, earn higher stock returns, and spend more on research and development (R&D). Some differences have increased over time. In 1986, EU pharmaceutical R&D exceeded U.S. R&D by about 24 percent, but by 2004, EU R&D trailed U.S. R&D by about 15 percent. During these 19 years, U.S. R&D spending grew at a real annual compound rate of 8.8 percent, while EU R&D spending grew at a real 5.4 percent rate. Results show that EU consumers enjoyed much lower pharmaceutical price inflation, however, at a cost of 46 fewer new medicines introduced by EU firms and 1680 fewer EU research jobs.

Conformal symmetry and the Balitsky-Kovchegov equation

Solutions to the Balitsky-Kovchegov equation are considered which respect an SO(3) subgroup of the conformal group. The symmetry dictates a specific dependence of the saturation scale on the impact parameter. Applications to deep inelastic scattering are considered.Comment: 21 pages, 1 figure. v2: References adde

Hunters like skewness, not risk: evidence of gambling behaviors in the Alaska hunting permit lottery

Thesis (M.S.) University of Alaska Fairbanks, 2018In Alaska, hunting permits are distributed by traditional lottery. The absence of a preference point system means that applicants have little invested in their applications, and there are a variety of fallback hunting opportunities. Not unlike a jackpot-style state lottery, the cost to play is low relative to the potential prize winnings. These factors may cause risk-averse or risk-neutral individuals to exhibit a preference for positive skewness in their bets. Analysis in this paper is focused on four prevalent game species: moose, dall sheep, mountain goat, and bison. Pooled Ordinary Least Squares regression models were constructed to predict permit application levels as a function of various hunt characteristics, qualities, and restrictions. Permit descriptions are provided to applicants in a published document called the drawing supplement, which is the primary source of data for this study. Additional hunter-reported data is obtained from the Alaska Department of Fish and Game website. A comparison of calculated permit values and private ranch hunting opportunities validates many of the observations drawn from the models. Permit values are also used to fit a cubic model of bettor utility. Even when awarded prizes are not monetary, applicants exhibit a preference for positive skewness and aversion from risk that is typically associated with gambling

Does Fund Size Matter: An Analysis of Small and Large

Mutual funds have become a staple for retirement savings and have received much research attention. Bond funds, though, have received little attention to date, and the effects of fund size on performance are still in dispute. Using cross sectional and time series regression analysis, the performance of high yield and corporate bond funds are contrasted, with potential causes for the differences identified. A few fundamental economic variables are found to explain a large portion of fund returns. Bond index returns are found to have the greatest impact of any variable on fund returns, with the most pronounced effect on large corporate bond funds. The impact of fund size on performance is also examined, with evidence suggesting that after a point fund returns are negatively impacted as net assets grow. This poses a key microeconomic question regarding the benefits and costs of fund scale

A study on influencers of total sales revenue of generic pharmaceutical companies in Indonesia

This paper empirically examines the influence of firms’ one-year lagged of total new products (t-1), one-year lagged profitability (t-1), and market share of new products to firms’ amount of sales revenue in pharmaceutical generic companies in Indonesia. The data used in this study was panel dataset, gathered from six large pharmaceutical generic companies in Indonesia, during the period 2006 to 2010. The regression analysis method uses fixed effect models, with generalized least squares (GLS) method. The result shows that firms’ one-year lagged of total new product (t-1), one-year lagged profitability (t-1), and market share of new products to be positive and affect significantly the firms’ sales revenue in the pharmaceutical generic companies in Indonesia.Pharmaceutical Generic Companies, Profitability, New Generic Product, Market Share, Sales Revenue

The role of collective narcissism in populist attitudes and the collapse of democracy in Hungary

What are the psychological processes responsible for the recent spread of populist political systems and movements? All political systems essentially reflect the mental representations of their populations, and collective narcissism has recently emerged as a contributing factor in the rise of populism. This article presents two studies examining the role of collective narcissism in predicting populist attitudes and voting intentions in Hungary. Hungary offers a particularly important case study of state-sponsored populism and illiberalism in Europe, as this country has gone furthest in undermining democratic principles and practices within the EU. To establish the pervasive role of collective narcissism we first review the historical evidence, survey research, and narrative analyses of Hungarian political representations. We then present two empirical studies where we predicted and found that collective narcissism was a significant predictor of negative attitudes toward the EU (Study 1), conservatism, and support for the ruling populist party (Studies 1 and 2). Collective narcissism predicted these variables independently from other factors, such as in-group positivity or perceived relative deprivation. However, once conservatism was controlled for the effects of collective narcissism faded out in some cases. The results nevertheless indicate that collective narcissism plays important role in promoting populist politics. The implications of these findings for understanding the psychological appeal of populism and illiberalism are discussed