Over the past decades, US Congress enabled the US Food and Drug Administration (FDA) to facilitate and expedite drug development for serious conditions filling unmet medical needs with five special designations and review pathways: orphan, fast track, accelerated approval, priority review, and...

Collaboration among various organizations is important for the sustainable creation of new innovative drugs. Previously, drug discovery was dominated by large pharmaceutical companies; however, various new players are now actively involved in this endeavor. Nevertheless, the factors affecting...

The COVID-19 crisis intensified decade-long debates on the interaction between intellectual property rights (IPRs), competition law and access to affordable life-saving treatments and vaccines. Compulsory licensing of patented medicines is a tried-and-tested method to expand access, particularly...

The purpose of this report is to analyze the impact that the COVID-19 pandemic has had on the vaccine industry from an international perspective. The objective is to learn from the experience and contribute to the design of better tools for future vaccine development and manufacturing, as we...

This paper analyzes the debate over the international dissemination of data exclusivity as a form of protection for clinical trial data. This is a critical demand for pharmaceutical companies seeking larger market shares and longer periods of monopoly in order to recover investments in research...

While artificial intelligence has successful and innovative applications in common medicine, could its application facilitate research on rare diseases? This study explores the application of artificial intelligence (AI) in orphan drug research, focusing on how AI can address three major...

This study investigates the impact of Information Technology and employee engagement on the implementation of Knowledge Management within the Research and Development processes of pharmaceutical companies. Based on Dynamic Capabilities Theory, this research examines the interaction between these...

This paper analyzes M&A patterns of R&D projects in the antidiabetics industry. For this purpose, we construct a database with all corporate individual antidiabetics R&D projects over the period 1997 - 2017, and add detailed information on firms' technology dimension using patent information,...

Background: Rising cancer drug prices pose a challenge for patients and healthcare systems in the US. Whilst prices are routinely assigned to a drug’s original indication receiving US Food and Drug Administration (FDA) approval, the influence of supplemental indication approvals on prices...

In this paper, we present how to investigate the postulation for cost reduction and competitive advantage in industries similar to the pharmaceutical companies by analysing the research and development cost in those companies, where we predict this cost to be low if such postulations are...

The TRIPS Agreement obligated India to amend its patent laws to meet the minimum standard of patent protection and patentability. In 2005, India amended its Patent Act to comply with TRIPS, which resulted in the removal of several provisions that facilitated the production and importation of...

Health is a fundamental human right, and achieving equal access to medicines is crucial to ensuring public health. The current system of pharmaceutical innovation relies strongly on the private sector, and remuneration of innovation is mainly based on exclusivities. This system presents several...

On the 20th anniversary of the Doha Declaration on the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and Public Health adopted by the World Trade Organization, we realize that its impact is beyond issues of public health stricto sensu. The Doha Declaration...

Pharmaceutical companies are greatly regulated and monitored by both the government and the public. R&D is mandatory, core, and plays a significant role in the pharmaceutical industry. Considering this aspect, a qualitative study is done taking information from eleven key pharma scientists from...

The unequal global distribution of vaccines against the deadly COVID-19 virus has cast a spotlight on the lack of access to vaccines on the African continent, and the vulnerability that such a lack places on both the economies of African nations and the health of their people. Various...

This paper examines the role of spillover learning in shaping the value of exploratory versus incremental R&D. Using data from the pharmaceutical industry, we show that novel drug candidates generate more dynamic spillovers than incremental ones. That is, despite being more likely to fail in the...

The COVID-19 pandemic and war in Ukraine have highlighted the dependence of the European Union (EU) on individual trading partners. One of the tasks of the European Commission’s new Directorate-General, the Health Emergency Preparedness and Response Authority (HERA), established in 2021, will...

(1) Background: Any disturbance in the pharmaceutical supply chain (PSC) can disrupt the supply of medicines and affect the efficiency of health systems. Due to shortages in the global pharma supply chain over the past few years and the complex nature of free trade and its limitations when...

Capitalizing a Cure takes us into the struggle over accessing a medical breakthrough to investigate the power of finance over business, biomedicine, and public health. When sofosbuvir-based medicines launched in 2013, they promised a cure for millions of patients worldwide with hepatitis C. But...

European countries have been experiencing medicine shortages due to disruptions in the supply chain. Reshoring the productions of active pharmaceutical ingredients (APIs) is considered as an approach to secure the supply. This study informs about the state-of-play of API production in the...

During World War II, the U.S. Committee on Medical Research (CMR) undertook an integrated, cross-sectoral effort to develop medical science and technology for war, representing the U.S. government's first substantial investment in medical research. Using data on all CMR research contracts, we...

Solving complex problems- in medicine, engineering, and other technological domains- often requires exploring multiple approaches, particularly when significant uncertainty exists about which one will lead to success. Conventional wisdom assumes that having many experimenters independently...

In medicine today, we face an innovation paradox. The companies that develop new medicines are highly dependent on a period of exclusive marketing after approval, to fund their research and development programs. But longer research and development programs are not associated with longer periods...

The innovation in the field of biotechnology has opened up new venues in the field of drug development like biosimilar drugs. The expiry of patents for many biopharmaceutical substances in various jurisdictions paved the way for the introduction of biosimilars in the market with reduced prices....

The use of “pay-for-delay” settlements in patent litigation – in which a branded manufacturer and generic entrant settle a Paragraph IV patent challenge and agree to forestall entry – has come under considerable scrutiny in recent years. Critics argue that these settlements are collusive...