If you have eczema--especially if you haven't found an effective treatment for your unbearably itchy skin--you may want to schedule an appointment with your dermatologist soon. For the first time in decades, there is a promising new treatment for eczema on the horizon. Dupilumab is being heralded as a breakthrough medication, and stock prices for Regeneron Pharmaceuticals, its developer, are climbing fast. The research is very promising, and physicians are hopeful that they can begin to offer the new medicine to eczema sufferers as soon as 2017. But is this new treatment all it promises to be?…
The antitumor effect of nivolumab in the melanoma regiment was followed by another trial with 107 patients, where 31% of the patients had an impartial response, with a median duration for 2 years. Of these responders, 15 responded to the therapy by 8 weeks during the first assessment, 12 had continued responses for minimum of 4 months after ending the therapy, while 17 had responses but left the program unexpectedly. Now, nivolumab use has achieved an improved outcome in patients with melanoma and NSCLC (Mahoney et al. 764-782). Moreover, a Phase III trial was conducted in melanoma, where nivolumab was compared to dacarbazine.…
The goal of each pharmaceutical company is to develop drug product and get marketing authorization approval. It changes the life of the patients by giving better life. When a company is planning a drug development journey it should have clear thoughts how new product will improve the patient’s life compare to available products in the market or in the pipeline. A Target Product Profile (TPP) is very helpful assistance in recognizing the chosen product characteristics and interactive them to the drug progress team, stakeholders, and regulatory establishments. The drug development process is very lengthy and expensive .TTP facilitates the complicated path which ending with FDA approval by proving all drug related scientific and medical information.…
According to Bloomgren. et at. (2012), natalizumab treatment is connected to development of multifocal leukoencephalopathy (PML). PML is a very rare infection that cannot be treated and cannot be prevented and normally can cause death and disabilities. Natizumab is a monoclonal antibody that attaches the protein that called alpha 4 integrin and this protein can be found on the surface of white blood cells (NIH, 2015).…
GTDR Grants (formerly Post-Baccalaureate Training in Disparities Research Grants, PBTDR) are intended to establish and/or to sustain a training program for students who are seeking careers dedicated to understanding and eliminating disparities in breast cancer outcomes across population groups. GTDR Grants are awarded to a single Mentor/Principal Investigator or a Mentor/PI and Co-Mentor/Co-Principal Investigator to support a minimum of three graduate students/trainees (those in a masters and/or doctoral program) per year. The PI and Co-PIs must serve as the primary mentors for the trainees, but additional mentors may be specified in the application. Direct costs of $135,000 per year are provided for up to three years. Postdoctoral Fellowship…
Adverse events of drugs may be reported as side effects, treatment effects, toxicity etc. (Zorzela 2014; Loke 2011; (Higgins 2011).)(For this review I will consider them all.) The adverse events of Methotrexate are related to body weight especially if more than one dose is used. These are- (Pfeifer 2013;Elson 2016;Hajenius 2009;Song 2016) . Treatment side effects Drug side effects…
Trials started only two years before the release, while most drug trials take 8 times longer than that in order to be proven as safe (CCFA, 2016). This is a “Type I error”, which means that the drug was approved as safe to use and was later found to be harmful (Philipson, 2012). Chemie Grünenthal tried to make a deal with an American company, which was rejected, and so eventually made an arrangement with the William S Merrell company in the United States. Chemie Grünenthal should have taken the rejection from the first company as a warning that the drug should not be marketed as safe for even pregnant women. This drug caused many birth defects that resulted in emotional and physical pain and displacement.…
Under the law, there was no true requirement for FDA "approval" or "clearance" of a new drug. The government had sixty days to complete its safety evaluation. If a company had not received a regulatory response at the end of 60 days it could proceed with marketing its new drug. The value of this document shows how drugs like Thalidomide could be released to the public without proper testing. It shows how a drug could be passed without knowing all the side effects of it.…
Cardiovascular disease is the leading cause of death in the world with its prevalence directly tied to amount of cholesterol in the blood. The Framingham Heart Study showed the tie between high cholesterol and heart disease. The study found that low density lipoprotein (LDL) was more predictive of heart disease than total cholesterol. The study also suggested that family history made the cause of hypercholesterolemia and not a high just a high fat diet. The pharmaceutical class, HMG Co Reductase inhibitors (also known as “statins”) came on the market in 1987 and significantly changed the treatment of hypercholesterolemia.…
Treatment Sadly, despite the complexity and multiple risk factors associated with the condition, no universal recommendations for treatment exist (Smith, 2014). Rather than a single treatment modality most practitioners utilize a symptoms approach. This idea proposes that troublesome symptoms dictate treatment. While effective, this may not be the best course of action to prevent disease progression. Another school of thought is to treat the underlying cause of the symptoms and promote significant lifestyle changes to help decrease comorbidities.…
State of the Problem In its variety of forms, cancer is estimated to affect more than 14 million people per year, and is the cause the death of more than 8 million (National Cancer Institute). Despite millions of dollars of research in the field, and a concentrated effort by researchers around the globe, a panacea for cancer doesn’t exist, although much headway has been made in earlier detection and better treatment methods. Much of the difficulty in treating the disease lies in its diversity; cancer is as varied as it is deadly.…
Due to the decision made by Kelsey and McBride, the FDA decided to place rigid standards on medication approval and require rigorous years of investigation before allowing the distribution of them on the market. In addition, all side effects and health warnings must be informed to the patient receiving the medication. I believe both the pharmaceutical company and the doctors made poor choices because they didn’t look deeper into the side effects of the medications. In addition, the doctors took it upon them to use the medication for other reasons without evaluating if it would be a safe choice for their patients. They identified their problem but didn’t consider well their alternatives.…
Windex, Lipstick, Tissues, When you pick these items up from the store, have you ever wondered what went into producing them? Sometimes testing is required by law to meet legal standards, but some of them aren’t needed and put animals in harm for no reason. Even if they are required, animals are still victims of possibly irreversible damage and harm. The Animal Welfare Act specifically excludes rats, mice, birds and most cold-blooded animals, allowing them to be burned, poisoned, isolated, forcibly restrained, addicted to drugs given irreversible brain-damage with free reign (1).…
Breast cancer is one of the leading cancers that affect a myriad of people in today’s society. “About 1 in 8 U.S. women (about 12%) will develop breast cancer over the course of her lifetime.” (Breast Cancer, 2016). Some people diagnosed with this type of cancer could have the opportunity to detect it early on due to screenings or self-evaluations. However despite early detection, it does not guarantee that the cancer can be treated in its entirety.…
The core of the pharmaceutical industry problems consists of the expiration of patents, rising R&D expenses, and uncertainties facing new researched products and their abnormal methods of circulation of returns from said product. As rooted in the topic of this case AstraZeneca upholds the gold of innovatively changing the way medicine reaches patients. When patents are first granted there are procedures that followed before a drug reaches the marketplace. Due to the extended timeframe that is required for clinical trials, studies and organizational processes to tested and developed the revenue phase of the drug decreases (Hitt, Ireland, & Hoskisson, 2015). More specifically after the developed drug is ready for sale the patent remaining on these products are near expiration.…