Browse
Submit Data
Databases
API
Help

Dataset Information

14 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

US FDA Drug Approvals are Persistent and Polycyclic: Insights into Economic Cycles, Innovation Dynamics, and National Policy.

ABSTRACT: It is challenging to elucidate the effects of changes in external influences (such as economic or policy) on the rate of US drug approvals. Here, a novel approach-termed the Chronological Hurst Exponent (CHE)-is proposed, which hypothesizes that changes in the long-range memory latent within the dynamics of time series data may be temporally associated with changes in such influences. Using the monthly number FDA's Center for Drug Evaluation and Research (CDER) approvals from 1939 to 2019 as the data source, it is demonstrated that the CHE has a distinct S-shaped structure demarcated by an 8-year (1939-1947) Stagnation Period, a 27-year (1947-1974) Emergent Period, and a 45-year (1974-2019) Saturation Period. Further, dominant periodicities (resolved via wavelet analyses) are identified during the most recent 45-year CHE Saturation Period at 17, 8 and 4 years; thus, US drug approvals have been following a Juglar/Kuznet mid-term cycle with Kitchin-like bursts. As discussed, this work suggests that (1) changes in extrinsic factors (e.g., of economic and/or policy origin) during the Emergent Period may have led to persistent growth in US drug approvals enjoyed since 1974, (2) the CHE may be a valued method to explore influences on time series data, and (3) innovation-related economic cycles exist (as viewed via the proxy metric of US drug approvals).

SUBMITTER: Daizadeh I

PROVIDER: S-EPMC8009272 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Json Xml

Similar Datasets

Economic openness, innovation and economic growth: Nonlinear relationships based on policy support.

Project description:Whether economic openness (EO) is conducive to promoting economic growth has become a common concern of many scholars and policymakers in China. Based on the panel sample data of 30 provinces in China from 2004 to 2018, this paper adopts an empirical model to test the relationship between EO and regional economic growth. The study identifies that expanding EO increases regional economic growth. After dealing with endogeneity issues, the results remain robust. The results of the mediation effect model show that technological innovation is an important channel for EO to accelerate economic growth. With the improvement of regional economic development, the benefits of EO will increase. However, its positive effect has slowed down in regions with very high levels of economic development. The outbreak of the financial crisis has weakened the driving force of EO on economic growth, while the Belt and Road Initiative has strengthened the positive impact of EO. In addition, when introducing the threshold variable of policy support to examine the nonlinear relationship between variables, it is found that deepening the policy intensity will significantly improve economic growth due to the benefits of EO.

| S-EPMC9852656 | biostudies-literature

Balancing national economic policy outcomes for sustainable development.

Project description:The 2030 Sustainable Development Goals (SDGs) aim at jointly improving economic, social, and environmental outcomes for human prosperity and planetary health. However, designing national economic policies that support advancement across multiple Sustainable Development Goals is hindered by the complexities of multi-sector economies and often conflicting policies. To address this, we introduce a national-scale design framework that can enable policymakers to sift through complex, non-linear, multi-sector policy spaces to identify efficient policy portfolios that balance economic, social, and environmental goals. The framework combines economy-wide sustainability simulation and artificial intelligence-driven multiobjective, multi-SDG policy search and machine learning. The framework can support multi-sector, multi-actor policy deliberation to screen efficient policy portfolios. We demonstrate the utility of the framework for a case study of Egypt by identifying policy portfolios that achieve efficient mixes of poverty and inequality reduction, economic growth, and climate change mitigation. The results show that integrated policy strategies can help achieve sustainable development while balancing adverse economic, social, and political impacts of reforms.

| S-EPMC9415247 | biostudies-literature

'Innovation policy is a team sport' - insights from non-governmental intermediaries in Canadian innovation ecosystem.

Project description:Policy-makers and practitioners alike have increasingly embraced the innovation ecosystem approach to support the flow of knowledge within the Triple Helix framework. This approach focuses on the collaborative and interdependent nature of innovation, which is based on social aspects of knowledge transfer supporting relationships, partnerships, and connections. The important role of intermediary stakeholders that help to facilitate such partnerships is under-researched. This paper examines the work of three intermediary stakeholders in the Canadian innovation ecosystem-the Canadian Science Policy Centre, the MaRS Discovery District, and university Vice Presidents Research. By interviewing 40 experts from the federal and provincial governments, non-governmental organizations, industry, and the higher education sector in Ontario, this study examines how innovation ecosystems are created and what factors influence the success of bringing diverse stakeholders together. The findings suggest that strong political vision and leadership, an inclusive approach to recognizing the needs of diverse stakeholders, and clarity on ways to measure and fund innovation serve as important factors in the Canadian innovation ecosystem.

| S-EPMC6404795 | biostudies-literature

Recent FDA Approvals in the Treatment of Graft-Versus-Host Disease.

Project description:Graft-versus-host disease (GVHD) is a common complication of allogeneic hematopoietic cell transplantation (HCT) and is associated with significant morbidity and mortality. For many years, there have been few effective treatment options for patients with GVHD. First-line systemic treatment remains corticosteroids, but up to 50% of patients will develop steroid-refractory GVHD and the prognosis for these patients is poor. Elucidation of the pathophysiological mechanisms of acute and chronic GVHD has laid a foundation for novel therapeutic approaches. Since 2017, there have now been 4 approvals by the US Food and Drug Administration (FDA) for GVHD. Ruxolitinib, an oral selective JAK1/2 inhibitor, received FDA approval for the treatment of steroid-refractory acute GVHD in 2019 and remains the only agent approved for acute GVHD. There are currently 3 FDA approvals for the treatment of chronic GVHD: (1) ibrutinib, a BTK inhibitor traditionally used for B-cell malignancies, was the first agent approved for chronic GVHD after failure of one or more lines of systemic therapy, (2) belumosudil, an oral selective inhibitor of ROCK2, for patients with chronic GVHD who received at least 2 prior lines of treatment, and (3) ruxolitinib for chronic GVHD after failure of one or two lines of systemic therapy. In this review, we highlight the clinical data which support these FDA approvals in acute and chronic GVHD with a focus on mechanism of actions, clinical efficacy, and toxicities associated with these agents.

| S-EPMC9355804 | biostudies-literature

The impact of economic policy uncertainty on firms' investment in innovation: Evidence from Chinese listed firms.

Project description:This paper uses data of Chinese listed enterprises and economic policy uncertainty index for empirical analysis, and conducts a study through three channels of monetary policy uncertainty affecting enterprise innovation investment, and finds that economic policy uncertainty has a positive promotion effect on enterprise R&D investment, and its increase in tension is instead a clear signal that can effectively increase enterprise R&D investment, this promotion effect seems unexpected, this paper Through theoretical analysis and combined with the actual practice, this incentive effect is found to be in line with reality. However, in the subsequent heterogeneity analysis, this paper finds that it positively promotes R&D investment when economic policy uncertainty is low and may have a suppressive effect on R&D investment when monetary policy uncertainty is high.

| S-EPMC9665363 | biostudies-literature

FDA Approvals and Consensus Guidelines for Botulinum Toxins in the Treatment of Dystonia.

Project description:In 2016, the American Academy of Neurology (AAN) published practice guidelines for botulinum toxin (BoNT) in the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache. This article, focusing on dystonia, provides context for these guidelines through literature review. Studies that led to Food and Drug Administration (FDA) approval of each toxin for dystonia indications are reviewed, in addition to several studies highlighted by the AAN guidelines. The AAN guidelines for the use of BoNT in dystonia are compared with those of the European Federation of the Neurological Societies (EFNS), and common off-label uses for BoNT in dystonia are discussed. Toxins not currently FDA-approved for the treatment of dystonia are additionally reviewed. In the future, additional toxins may become FDA-approved for the treatment of dystonia given expanding research in this area.

| S-EPMC7290737 | biostudies-literature

Project description:Biosimilar medicines expand the biotherapeutic market and improve patient access. This work looked into the landscape of the European and US biosimilar products, their regulatory authorization, market availability, and clinical evaluation undergone prior to the regulatory approval. European Medicines Agency (EMEA, currently EMA) and Food and Drug Administration (FDA) repositories were searched to identify all biosimilar medicines approved before December 2019. Adalimumab biosimilars, and particularly their clinical evaluations, were used as a case study. In the past 13 years, the EMA has received 65 marketing authorization applications for biosimilar medicines with 55 approved biosimilars available in the EU market. Since the first biosimilar approval in 2015, the FDA has granted 26 approvals for biosimilars with only 11 being currently on the US market. Five adalimumab biosimilars have been approved in the EU and commercialized as eight different medicines through duplicate marketing authorizations. Whilst three of these are FDA-approved, the first adalimumab biosimilar will not be marketed in the US until 2023 due to Humira's exclusivity period. The EU biosimilar market has developed faster than its US counterpart, as the latter is probably challenged by a series of patents and exclusivity periods protecting the bio-originator medicines, an issue addressed by the US's latest 'Biosimilar Action Plan'.

| S-EPMC7824407 | biostudies-literature

How Structural Biologists and the Protein Data Bank Contributed to Recent FDA New Drug Approvals.

Project description:Discovery and development of 210 new molecular entities (NMEs; new drugs) approved by the US Food and Drug Administration 2010-2016 was facilitated by 3D structural information generated by structural biologists worldwide and distributed on an open-access basis by the PDB. The molecular targets for 94% of these NMEs are known. The PDB archive contains 5,914 structures containing one of the known targets and/or a new drug, providing structural coverage for 88% of the recently approved NMEs across all therapeutic areas. More than half of the 5,914 structures were published and made available by the PDB at no charge, with no restrictions on usage >10 years before drug approval. Citation analyses revealed that these 5,914 PDB structures significantly affected the very large body of publicly funded research reported in publications on the NME targets that motivated biopharmaceutical company investment in discovery and development programs that produced the NMEs.

| S-EPMC7325526 | biostudies-literature

New insights into projected Arctic sea road: operational risks, economic values, and policy implications.

Project description:As Arctic sea ice continues to retreat, the seasonally navigable Arctic expected by mid-century or earlier is likely to facilitate the growth of polar maritime and coastal development. Here, we systematically explore the potentials for opening of trans-Arctic sea routes across a range of emissions futures and multi-model ensembles on daily timescales. We find a new Transpolar Sea Route in the western Arctic for open water vessels starting in 2045 in addition to the central Arctic corridor over the North Pole, with its frequency comparable to the latter during the 2070s under the worst-case scenario. The emergence of this new western route could be decisive for operational and strategic outcomes. Specifically, the route redistributes transits away from the Russian-administered Northern Sea Route, lowering the navigational and financial risks and the regulatory friction. Navigational risks arise from narrow straits that are often icy choke points. Financial risks arise from the substantial interannual sea ice variability and associated uncertainty. Regulatory friction arises from Russian requirements imposed under the Polar Code and Article 234 of the UN Convention on the Law of the Sea. These imposts are significantly reduced with shipping route regimes that enable open water transits wholly outside Russian territorial waters, and these regimes are revealed most accurately using daily ice information. The near-term navigability transition period (2025-2045) may offer an opportunity for maritime policy evaluation, revision, and action. Our user-inspired evaluation contributes towards achieving operational, economic and geopolitical objectives and serves the goal of planning a resilient, sustainable, and adaptive Arctic future.Supplementary informationThe online version contains supplementary material available at 10.1007/s10584-023-03505-4.

| S-EPMC10026796 | biostudies-literature

Trends and Perspectives of Biological Drug Approvals by the FDA: A Review from 2015 to 2021.

Project description:Despite belonging to a relatively new class of pharmaceuticals, biological drugs have been used since the 1980s, when they brought about a breakthrough in the treatment of chronic diseases, especially cancer. They conquered a large space in the pipeline of the pharmaceutical industry and boosted the innovation portfolio and arsenal of therapeutic compounds available. Here, we report on biological drug approvals by the US Food and Drug Administration (FDA) from 2015 to 2021. The number of drugs included in this class grew over this period, totaling 90 approvals, with an average of 13 authorizations per year. This figure contrasts with previous periods, which registered between 2 and 8 approvals per year. We highlight the great potential and advantages of biological drugs. In this context, these therapeutics show high efficacy and high selectivity, and they have brought about a significant increase in patient survival and a reduction of adverse reactions. The development and production of biopharmaceuticals pose a major challenge because these processes require cutting-edge technology, thereby making the drugs very expensive. However, we believe that, in the near future, biological medicines will be more accessible and new drugs belonging to this class will become available as new technologies emerge. Such advances will enhance the production of these biopharmaceuticals, thereby making the process increasingly profitable and less expensive, thereby bringing about greater availability of these drugs.

| S-EPMC9496574 | biostudies-literature

OmicsDI is part of the ELIXIR infrastructure

OmicsDI is an Elixir interoperability service. Learn more ›

Tweets

OmicsDI Databases

PRIDE
PeptideAtlas
MassIVE
JPOST Repository
Physiome Model Repository

EGA
EVA
ENA
LINCS
PAXDB
Cell Collective

MetaboLights
Metabolomics Workbench
MetabolomeExpress
GNPS
BioModels
FAIRDOMHub

ArrayExpress
dbGaP
ExpressionAtlas
GEO
NODE

Information

Databases
Help
API
Contact us
Code on GitHub
Terms of use
Submit Data