Suchergebnisse

Background In 2007, the priority review voucher (PRV) was implemented in the US to incentivize research and development (R&D) for tropical diseases. The PRV is issued by the US FDA and grants a quicker review to manufacturers upon successful development of a product for a disease eligible for the program. Objective The objective of this analysis was to assess whether the PRV has incentivized R&D (measured as clinical trial activity) for the intended tropical diseases. Method We used a difference-in-difference-in-differences (DDD) strategy by exploiting variation in its implementation across diseases and registries around the world. Clinical trials were retrieved from the World Health Organization International Clinical Trials Registry Platform for the years 2005–2019. Results We found a positive, but not statistically significant, effect of the PRV on stimulating R&D activity. Delayed effects of the policy could not be found. Conclusion Our findings, which were robust across a series of robustness tests, suggest that the PRV program is not associated with a trigger in innovation for neglected diseases and therefore should not be considered as a stand-alone solution. It should be supplemented with other government measures to incentivize R&D activity. To increase the value of the program, we recommend that the PRV only be awarded to novel products and not to products that have already been licensed outside the US. Doing so would restrict the number of vouchers awarded and slow down their ongoing market depreciation. Finally, we propose that product sponsors be required to submit an access plan for PRV-awarded products.

Context. The lack of high-precision long-term continuous photometric data for large samples of stars has impeded the large-scale exploration of pulsational variability in the OB star regime. As a result, the candidates for in-depth asteroseismic modelling have remained limited to a few dozen dwarfs. The TESS nominal space mission has surveyed the southern sky, including parts of the galactic plane, yielding continuous data across at least 27 d for hundreds of OB stars. Aims. We aim to couple TESS data in the southern sky with ground-based spectroscopy to study the variability in two dimensions, mass and evolution. We focus mainly on the presence of coherent pulsation modes that may or may not be present in the predicted theoretical instability domains and unravel all frequency behaviour in the amplitude spectra of the TESS data. Methods. We compose a sample of 98 OB-type stars observed by TESS in Sectors 1-13 and with available multi-epoch, high-resolution spectroscopy gathered by the IACOB and OWN surveys. We present the short-cadence 2 min light curves of dozens of OB-type stars, which have one or more spectra in the IACOB or OWN database. Based on these light curves and their Lomb-Scargle periodograms, we performed variability classification and frequency analysis. We placed the stars in the spectroscopic Hertzsprung-Russell diagram to interpret the variability in an evolutionary context. Results. We deduce the diverse origins of the mmag-level variability found in all of the 98 OB stars in the TESS data. We find among the sample several new variable stars, including three hybrid pulsators, three eclipsing binaries, high frequency modes in a Be star, and potential heat-driven pulsations in two Oe stars. Conclusions. We identify stars for which future asteroseismic modelling is possible, provided mode identification is achieved. By comparing the position of the variables to theoretical instability strips, we discuss the current shortcomings in non-adiabatic pulsation theory and the distribution of pulsators in the upper Hertzsprung-Russell diagram. ; With funding from the Spanish government through the "María de Maeztu Unit of Excellence" accreditation (MDM-2017-0737)