scholarly journals History of Erythropoiesis-Stimulating Agents, the Development of Biosimilars, and the Future of Anemia Treatment in Nephrology

2017 ◽  
Vol 45 (3) ◽  
pp. 235-247 ◽  
Author(s):  
Kamyar Kalantar-Zadeh

Background: Exogenous replacement of erythropoietin (EPO) by recombinant human EPO has been considered a standard of care for the treatment of anemia in patients with chronic kidney disease for more than 20 years. Genetically engineered biologic proteins derived from human, animal, or microorganism sources are a major area of growth in modern medical care, accounting for one-third of new drug approvals in the past decade. Despite benefit to patients, the use of biologics comes at a significant cost, representing one of the fastest growing segments of strained healthcare budgets around the world. Summary: Biosimilars, or biologic drugs that are designed to be highly similar to approved reference biologic drugs, have been available in Europe for more than 10 years with no unusual or unexpected effects compared to their reference biologics whose patents have expired. Given the success of the biosimilar approval pathway pioneered in Europe, it has served as a global reference for other regulatory authorities to establish and implement biosimilar licensure frameworks, including the United States (US), the largest pharmaceutical market in the world. Given 10 of the top 25 drugs sold in 2014 were biologics, and considering the rising costs of healthcare, biosimilars have the potential to become a significant part of the US market. Key Messages: For the nephrology community, the recent patent expiries for epoetin alfa (Epogen®, Amgen and Procrit®, Johnson & Johnson) have created the opportunity to develop biosimilar EPOs. And while no biosimilar in this therapeutic class is approved in the US, there are proposed biosimilars in development.

Author(s):  
Paula De la Cruz-Fernandez

A multinational corporation is a multiple unit business enterprise, vertically managed, that operates in various countries, called host economies. Operations beyond national borders are controlled and managed from one location or headquarters, called the home economy. The units or business activities such as manufacturing, distribution, and marketing are, in the modern multinational as opposed to other forms of international business, all structured under a single organization. The location of the headquarters of the multinational corporation, where the business is registered, defines the “nationality” of the company. While United Kingdom held ownership of over half of the world’s foreign direct investment (FDI), defined not as acquisition but as a managed, controlled investment that an organization does beyond its national border, at the beginning of the 20th century, the United States grew to first place throughout the 20th century—in 2002, 22 percent of the world’s FDI came from the United States, which was also home to ten of the fifty largest corporations in the world. The US-based, large, modern corporation, operated by salaried managers with branches and operations in many nations, emerged in the mid-19th century and has since been a key player and driver in both economic and cultural globalization. The development of corporate capitalism in the United States is closely related with the growth of US-driven business abroad and has unique features that place the US multinational model apart from other business organizations operating internationally such as family multinational businesses which are more common in Europe and Latin America. The range and diversity of US-headquartered multinationals changed over time as well, and different countries and cultures made the nature of managing business overseas more complex. Asia came strong into the picture in the last third of the 20th century as regulations and deindustrialization grew in Europe. Global expansion also meant that societies around the world were connecting transnationally through new channels. Consumers and producers globally are also part of the history of multinational corporations—cultural values, socially constructed perceptions of gender and race, different understandings of work, and the everyday lives and experiences of peoples worldwide are integral to the operations and forms of multinationals.


2021 ◽  
pp. 174-179
Author(s):  
Jason Lustig

This chapter considers the overall impact of the twentieth-century proliferation of archive activities in Jewish life and the rising paradigm of total archives in particular. By looking at the development of Jewish archiving in Germany, the United States, and Israel/Palestine, we see the concrete manifestation of the impulses of a “time to gather” in Jewish cultures around the world. These efforts represent a kind of community-based archives, but also the internal tensions: What happens when there is a widespread understanding of the value of archives, and they represent resources of cultural capital worth fighting for? This conclusion also places the history of Jewish archives and the struggles to “own” the past in the broader context of the emerging information society. Altogether, this history indicates contentious struggles over what it means to have control over history in its most practical terms.


Author(s):  
Larry M. Bartels ◽  
Joshua D. Clinton ◽  
John G. Geer

We examine the history of political representation in the United States using a multi-stage statistical analysis of the changing relationship between roll call votes in the US House of Representatives and the preferences of citizens (as measured by presidential votes). We show that members of Congress have become considerably more responsive to constituents’ preferences over the past 40 years, reversing a half-century drought in responsiveness stemming from the South’s one-party Jim Crow era. However, the House as a whole has become less representative, veering too far left when Democrats are in the majority and too far right when Republicans are.


2002 ◽  
Vol 8 (2) ◽  
pp. 262-278
Author(s):  
Jerrold Oppenheim ◽  
Theo MacGregor

The system of democratic regulation of privately owned utilities that has evolved in the United States over the past century includes five main elements: participation; transparency; a standard of justice and reasonableness; protection against confiscation of utility assets; and prices that are related to costs. After setting these elements forth and explaining how they are balanced, we describe how the system failed in a series of relatively small but highly visible experiments with deregulation in California and elsewhere in the US. Finally, we outline the history of how democratic regulation evolved in the US and how democracy is reversing the failed experiment with deregulation in California.


Author(s):  
Yanli Zhang ◽  
Ruben Xing ◽  
Zhongxian Wang

There was a time in the history of GM when it was the largest corporation in the US. The history of GM also shows that it was the single largest employer in the world. The announcement of GM’s bankruptcy on June 1, 2009 shocked the world and had a tremendous impact on the United States economy. Looking back at the history of GM, there were many indicators which suggested the fate of the company. There were several internal factors that answer the question, what went wrong with GM. These internal factors are management arrogance, not meeting customer demands, the costs and demands of unions, poor forecasting, and internal controls on accounting standards. Similarly, there were several external factors that answer the same question, which include increased competition and loss of market share, rising gas prices and environmental friendliness, and the costs and burdens of meeting government regulations and restrictions. This paper will explore and answer the following questions: What are the fundamental causes of GM’s problems? What can be learned from GM’s mistakes and experiences? How and why an industrial icon came to ruin?


2012 ◽  
Vol 144 (1) ◽  
pp. 5-12 ◽  
Author(s):  
David McKnight

Rupert Murdoch's News Corporation is the most powerful media organisation in the world. Murdoch's commercial success is obvious, but less well understood is his successful pursuit of political goals, using his news media. Murdoch himself is probably the most influential Australian of all time. He says the recent News of the World hacking scandal went ‘went against everything [he stands] for’. But how true is this? He sees himself as an anti-establishment rebel, yet his influence in Australia, the United Kingdom and the United States makes him part of a global elite. He has become one of the key promoters of neo-liberal ideology of small government and deregulation over the past 30 years. The basis of his philosophy was expressed by one of his former editors, David Montgomery, who said ‘Rupert has contempt for the rules. Contempt even for governments.’ Murdoch is also a devotee of the neo-conservative wing of the US Republican Party. The possibility of exercising power through ownership of the news media has been little studied in recent years, but Murdoch's role in English-speaking countries over the last 30 years shows that perhaps we need to look again at such media theories.


2021 ◽  
Vol 27 (6) ◽  
Author(s):  
Huw Roberts ◽  
Josh Cowls ◽  
Emmie Hine ◽  
Francesca Mazzi ◽  
Andreas Tsamados ◽  
...  

AbstractOver the past few years, there has been a proliferation of artificial intelligence (AI) strategies, released by governments around the world, that seek to maximise the benefits of AI and minimise potential harms. This article provides a comparative analysis of the European Union (EU) and the United States’ (US) AI strategies and considers (i) the visions of a ‘Good AI Society’ that are forwarded in key policy documents and their opportunity costs, (ii) the extent to which the implementation of each vision is living up to stated aims and (iii) the consequences that these differing visions of a ‘Good AI Society’ have for transatlantic cooperation. The article concludes by comparing the ethical desirability of each vision and identifies areas where the EU, and especially the US, need to improve in order to achieve ethical outcomes and deepen cooperation.


Health disparities in the United States and around the world carry with them a history of cultural bias, fear of the unknown, racism, sexism, ageism, intolerance of religious beliefs, and a desire to retain the status quo. Some people perceive a majority group as superior to demographic groups that are believed to be inferior. However, as the US population becomes increasingly diverse, changes will come. Internationally, globalization and immigration merge the worlds of the poor and rich, as each social class struggles to find their socioeconomic and healthcare footprint in modern-day society. All US citizens will be affected by a failure to unite.


2009 ◽  
Vol 17 (4) ◽  
pp. 3-43 ◽  
Author(s):  
David Roediger ◽  
Elizabeth Esch

AbstractIn the labour-history of the US, the systematised management of workers is widely understood as emerging in the decades after the Civil War, as industrial production and technological innovation changed the pace, nature and organisation of work. Though modern management is seen as predating the contributions of Frederick Taylor, the technique of so-called 'scientific management' is emphasised as the particularly crucial managerial innovation to emerge from the US, prefiguring and setting the stage for Fordism. This article argues that the management of labour in the US has roots in the particularities of a society which racialised its labour-systems – slave and free – and thus made 'racial knowledge' central to managerial knowledge. Rather than transcending the limits of racial knowledge, the authors argue that scientific management relied on experts to know and develop 'the races' not only for the purpose of accumulating capital but also for the organisation of modern production through the first decades of the twentieth century. Such 'knowledge' became central to the export of managerial and engineering knowledge from the US to the world.


2004 ◽  
Vol 30 (4) ◽  
pp. 583-583 ◽  
Author(s):  
Michael Cox

The words used to describe things sometimes tell us less about the thing itself and more about those telling the story: and in the case of the words ‘American Empire’ one could more or less tell in the past that the story was being told by a critic. Not any longer. Indeed, since 9/11 those who have been at the forefront of promoting the idea have not been radical opponents on the left but defenders of the United States on the neo-conservative right. Under conditions where the US dominates the earth like no other power, Empire they argue not only describes what America has become – even though its own leaders invariably fail to recognise the fact; it also indicates to us what has to be done if we are to tackle the threat posed by catastrophic terrorism. And in this the United States now needs to do what it normally does worst: namely learn from the history of other great powers. As one of the new gurus of Empire has suggested, in a world of failed states and terrorist threats, the US has to abandon the idea that it is unique and see how its predecessors, the British and the Romans, created the conditions of order before.


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