Ustekinumab Trials
New emerging therapy has been introduced for CD especially biologic agents, which is commonly reserved for moderate to severe Crohn’s.1 Most of the biologic agents used in the treatment of CD belongs to the family of tumour necrosis factor alpha (TNFα) antagonist.17 This has made it complicated for doctors who are treating patients that are not responding to the drugs, which belongs to this family group.17 Nonetheless, there has been a huge improvement in the management of these patients with the recent introduction of the new biological agent like ustekinumab, which has a different mechanism of actions (MOA) from TNFα antagonists.18
Ustekinumab is a human IgG1k monoclonal antibody that binds exclusively to the p40 protein subunit of both IL-12 and IL-23 cytokines.19 IL-12 and IL-23 are naturally occurring cytokines that are involved in inflammatory and immune responses, including CD4+ T-cell differentiation and activation as well as natural killer cell activation.19 Ustekinumab disturbs the cytokines cascade that causing the chronic inflammation which is a hallmark of Crohn’s disease.19
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Like any other drugs, ustekinumab also has its own side effects such as injection site reactions (bruising, itching, pain, redness, swelling) cold symptoms (stuffy nose, sneezing, sore throat), headache, tiredness, skin rash and itching.19 Due to its role in suppressing the immune responses, ustekinumab may increase the chances of getting infections caused by viruses, bacteria, and fungi.19 It also can increase the risk for certain types of cancer and risk of developing reversible posterior leukoencephalopathy syndrome
Case 1: In this case. As a certified public accountant, Erickson oversaw and initiated an arbitrary adjustment to increase cash and decrease accounts receivable. Also, Erickson signed Form 10-K with full knowledge that the financial statements include therein incorporated entries misstating revenues. As we can see from this case, Erickson’s behavior not only violate the Business and Professions Code, Division 3, Chapter 1, § 5100(g) and (i), but also against the ethical theories.
Crohn’s disease is an inflammatory bowel disease. It is a fairly common disease that affects a large population causing abdominal pain, frequent bloody stools, and fatigue
“Crohn’s disease appears to be caused by a dysfunctional inflammatory response in the gastrointestinal tract” (U. S. News, 2009). Inflammation is the body’s natural way to heal by sending immune cells to the site of the injury or invader. Researchers think that this immune system response may be triggered by bacteria or viruses, material in the intestinal contents, or a defective signal from the body’s own cells, called an autoimmune response. Inflammation results in pain, heat, redness, and swelling of the tissue. Chronic inflammation can harm the function of tissues and organs (U.S. News, 2009).
I chose to research Crohn’s disease because one of my friend’s that I grew up with was diagnosed with Crohn’s disease and I would like to know more about it. Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract (GI tract) that belongs to a group of conditions known as Inflammatory Bowel Diseases (IBD) (What is Crohn's Disease?, 2014). Crohn’s disease is classified as an autoimmune disorder because the antibodies that the body produces work against itself (Your Body and Crohn's Disease, 2014). Individuals with Crohn’s disease have blockage in the intestinal wall that leads to edema—over time the narrowing and stiffness of the intestines stops all bowel movements (Hopper, 2012). This report outlines how Crohn’s disease affects the body, who is at risk, history, various treatment options, and different support groups available for people who have Crohn’s and want to know more about it.
Background: Merck & Co. is an American pharmaceutical company and one of the largest pharmaceutical companies in the world. In 1971 the United States approved the use of an MMR vaccine made by Merck, containing the Jeryl Lynn strain of mumps vaccine. In 1978 Merck introduced the MMR II, using a different strain of the rubella vaccine. In 1997 the FDA required Merck to conduct effectiveness testing of MMRII. Initially it was over 95%; to continue the license; Merck had to convince the FDA that the effectiveness stayed at a similar rate over the years.
Makover, M. & Zieve, D. (2011, February 14). Systemic Lupus Erythematosus. National Center for Biotechnology Information. Retrieved July 14, 2012, from http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001471/
The cause of Crohn’s disease is unknown and there is no proof that the disease is caused by an infection. At the same time researchers have found that it is the result of an abnormal reaction by the body’s immune system. They think that in the disease the immune system fights bacteria, foods, and other substances that are actually harmless or beneficial to the body. The white blood cells that are released to fight off these substances multiply in the lining of the intestine and that’s what creates the inflammation. The inflammation in the digestive tract also involves other factors as well, such as: the gene the person has inherited in the person’s immune system and the environment. Research has also found that Crohn’s disease is not contagious.
Being presented with the problems in the implementation of the SAP ERP system, it is evident that Novartis Pharmaceuticals requires a comprehensive action plan that resolves key issues and the underlying problem. Refer to Exhibit A for a graphical representation of the action plan.
Merck & Co. has to be aware of the economy as with any industry. Within the recession, more and more were looking towards generic substitutes. This can at times not be a problem with patents. However, once a patent is up, a competitor who develops generic versions of Merck’s products becomes a low-cost competitor. However, during the recession from 2008 – 2009, Merck didn’t see any drop in sales. Actually, they were able to keep a continual increase in sales and net income.
Crohn's disease is the generic name for regional enteritis, which is a type of Irritable Bowel Disease. The initial onset of this disease is between the ages of 15 to 30 years old with about 4 out of 1000 people being affected (CDC, 2014). The CDC (2014) also states that the United States has a “1.7 billon dollar” annual financial burden resulting from ”700,000 physician visits, 100,000 hospitalizations, and disability in 119,000 patients” yearly. There is presently no cure for Crohn's, although certain medications and treatments have been proven to take the disease into remission. Crohn’s disease is a realitivly new disease, without a cure, than can be controlled and let the patient live a normal life.
Rheumatoid arthritis affects around 400,000 individuals within the UK, it is the most relentless chronic form of arthritis, and for adults it is the second most common form in patients (1). “RA is more prevalent among women than men, and usually develops in the fourth to fifth decades of life” (A). Rheumatoid arthritis is severe as it is a form of autoimmune disease, this is where the body’s immune system attacks and damages working tissue, due to the failure to recognise the difference between foreign cell and normal cells. For example it damages the synovial membrane surrounding the knee, and bone erosion begins. This damage to the working tissue triggers an inflammatory response causing fluid to build around the knee (2). However it can happen in any joint, this is why it’s such a large problem as you simply can’t inhibit the effects of the immune system, as it would leave you extremely vulnerable to more life threatening diseases. If effective treatment isn’t applied it could be disabling to patients, the inflammation causes pain, stiffness, muscle ache, rheumatoid nodules (lumps of tissue) and tiredness (3).
With the increased cost of manufacturing, pharmaceutical companies have been divesting in their smaller or less profit making operations and focus on large segments. Many Pharmaceutical companies sold their manufacturing sites to contract manufacturing organizations. The dynamics of interfacing with contract manufacturing organization added intricacy in pharmaceutical supply chain network of pharmaceutical companies.
Pfizer Case Study Pfizer Inc. is a large pharmaceutical company that engages in the discovery of new technologies, the manufacture of prescription and "over the counter" (OTC) medicines, as well as the marketing of such products. It operates in three distinct segments that include Human Health, Consumer Healthcare, and Animal Health. For fiscal year 2004, the company generated approximately $53 billion in revenue that contributed to over $11 billion in net income. Pfizer, 2004. "The 'Pfizer'" The Cow and Calf division of the Animal Health segment markets its products direct to cattle ranchers.
The case under analysis, Eli Lilly & Company, will be covering the positives and negatives with regards to the business situation and strategy of Eli Lilly. One of the major pharmaceutical and health care companies in its industry, Lilly focused its efforts on the areas of "drug research, development, and marketed to the following areas: neuroscience, endocrinology, oncology, cardiovascular disease, and women's health." Having made a strong comeback in the 1990's due to its remarkably successful antidepressant Prozac, was now facing a potential loss in profits with its patent soon to expire. The problem was not only the soon to expire patent on Prozac, but the fact that Prozac accounted for as much as 30% of total revenue was the reality Eli Lilly now faced. (Pearce & Robinson, 34-1)
One of the most common mysteries in the world is the development of autoimmune diseases. An autoimmune disease is when the immune system, which usually keeps your body healthy thinks that your healthy cells are antigens and attacks them. This is irony right? It is against properties of evolution for an immune system to attack itself causing sickness and possibly death if untreated. There are about 80 different types of autoimmune diseases, which usually have periods of little to no symptoms and worsening symptoms. What particularly creates confusion in the world is the autoimmune disease, inflammatory bowel disease, which affects almost about five million people worldwide.