European Medicines Agency

Cangrelor, a potent intravenous, reversible, platelet P2Y12 inhibitor, was recently approved by both the United States (U.S.) Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as an adjunct for percutaneous coronary intervention (PCI). The approval was based on Cangrelor versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION) PHOENIX (1), a multi-center, double-dummy, double-blind trial, which randomized 11,145 patients with stable angina,

Genzyme 's Focus on Orphan Drugs In this fast paced world that we live in now it is all but impossible to expect any one to wait for anything these days. We through the innovative technological ideas and inventions you can make anything with in minutes what use to take hours. Everyone wants to be a Chief Executive Officer, (CEO) of a major corporation making millions and billions of dollars over night. No one wants to think through how can they take a company that is barley able to keep it’s door

Sanofi Genzyme is a branch of the Sanofi Corporation that specializes in the development and manufacturing of products to treat a variety of rare diseases. The Allston Landing Facility (ALF) currently produces a single enzyme replacement therapy which treats patients with Type 1 Gaucher disease. This treatment falls within the classification of an Orphan drug which is a drug or biologic that treats a patient population of less than 200,000 within the United States. There is an entire segment of

1. Background BioMarin is a biotechnology company headquartered in Novato, California and with operations in Europe, South America, USA and Asia. BioMarin originally began developing carbohydrate enzymes for rare diseases. Their first candidate drug was Aldurazyme® which is currently being used to treat patients of Mucopolysaccharidosis (MPS-I). MPS-I patient census consists of about 3,400 patients in developed countries; 1,000 of which reside in the United States of America. Because of the rare

There have been 5,000 rare diseases that have been identified. The disease is considered rare in the United States if less than 200,000 people have it. The pharmaceutical industry will not develop a cure for the disease since it does not affect most of a population. For this reason, Congress passed the Orphan Drug Act (ODA) in 1983. Under the Ronald Reagan administration the Orphan Drug Act allows the federal government to help out in the making of new drugs for these rare diseases. Incentives

# P1 - Q26 ###Therac-25 The Therac-25 incident is one of the more difficult to understand. AECL, the company which designed and manufactured Therac-25 is opaque, and gives little to no information on how the software was developed. There is no one incident report, as this took place over two years and 6 unrelated accidents. Many institutions did not even realize the cause patients’ radiation burns and later medical issues until months after. Most of what follows is based on a paper by Nancy Leveson

suggests that in an issue such as European integration there will be more variation seen in countries that have more diverse social and economic factors involved in policy making. The article suggests that with this hypothesis that issues will be decided on by parties potentially depending on what is in the best interest at tat time based on the national feeling that is present in their respective countries. This hypothesis is certainly well-founded in the idea of European integration as if national interests

In the past, citizens held mostly absent minded opinions on European Union politics, but today there exists great polarization in attitudes about European integration. The apparent rise in “Euroskepticism” in the post-Maastricht Treaty political environment has been widely discussed and debated in EU scholarship, and marks a stark change from the elite dominated days bygone. EU issues have increasingly made their way into the politics of national governments, and subsequently national citizens have

Title: Ulysses, the 18-Year Mission Table of Contents Page # 1. Introduction 2. Space Craft A. Components B. Journey C. History D. Launch 3. Objectives A. Secondary Objectives 4. Partnerships A. ESA B. NASA C. Contribution 7. Future A. Challenges B. What we learned C. Future Missions 8. Conclusion // Summary 9. References 1. Introduction: Space is made of many secrets yet to be discover, but every day we tend to move closer. However, due to size of space we will never stop learning. For example

1971 was the year NASA’s Acting Administrator, George Low approved the space telescope. This project was going to cost roughly 400-500 million with all the right parts. The House of Appropriations Subcommittee turned down the funding. So the European Space Agency also known as ESA, they were offered to help with the paying of the parts. The ESA was willing to help but the only negative thing about this was they had to knock the price down to 200 million dollars, so they had to buy smaller parts. The