Essay on Forecasting Denosumab

As I said, this tends to have a positive affects because of the patients willingness to cooperate with treatment given by their physician.

There are multiple health concerns worldwide and more and more drugs are needed every day. Many drugs however, are extremely expensive to develop, test, and produce. According to the Tufts Center for the Study of Drug Development (2002), it costs up to $802 million to bring a new drug to the market. In 2002, pharmaceutical companies spent $34 billion in research and development (Center-Watch, 2003). In addition to the costs, the overall time from the discovery to approve and market the drug can take up to 15 years.

Making the health information available, reducing duplication of tests, reducing delays in treatment, and patients well informed to take better decisions.

Patients are intrigued by the idea that a medication will actually fight for them and be a powerful ally, in comparison to their current treatment that does “just enough” to get them by. They can

They are used both for a cure to the patients as well as for meeting the recreational needs.

Another issue is too much power is given to scientists in decision-making of candidate drugs. Also there were inadequacies and lack of communication between marketing and research. Merck’s marketing and research needed to realize that the making of the drug is not only the most important part in increasing sales, but it also included a strong advertising campaign that will satisfy the needs of the customers.

Many people get benefits if Venetoclax works and becomes popular. The doctors can recommend to their patients. If Venetoclax is a safe drug, many people can Venetoclax in the pharmacy. Many medical factories can produce more to earn money. Many people willing to buy Venetoclax because they need medicine when they are

After finding the target of disease, it gets much easier to find out the specific drug that will target the disease. Dr. Burdette’s lab screened many compounds and found 4 compounds that has already been approved by FDA that could potential

Breakthrough Therapy Designation is introduced as a new designation with the passage of the FDA Safety and Innovation Act of 2012 (FDASIA) [1]. According to section 902 of the FDASIA, the general criteria according to which this new designation can be applied are (1) serious or life-threatening disease or condition and (2) the drug also demonstrates substantial improvement over existing therapies on one or more clinically significant endpoints. Once a drug is designated as a Breakthrough Therapy, the FDA and the drug sponsor work closely to determine the most efficient pathway for generating additional evidence about safety and efficacy. As of March 31, 2015, a total of 293 requests for Breakthrough Therapy designation have been submitted, out of which 82 requests are granted [2].

These agents are therapeutically useful as they are specific against the receptor they are formulated against and have a long half-life which means that they can be used in chronic conditions and disease relapse

These stages include drug development, synthesis, animal testing, human clinical trials, and an FDA submission for possible drug approval. R&D costs fluctuate depending on the stage of drug development (Golec, Hegde and Vernon 2010). At the early stages, R&D costs are low and a company could end an R&D project relatively quickly; however, clinical trials have high R&D costs and companies are less likely to end a project at this stage (Golec, Hegde and Vernon 2010). The closer to the end of the project, costs are very small and companies are less likely to end a project in its final stage (Golec, Hegde and Vernon 2010).

Despite the fact that FDA has gone through an arduous approval process, uncertainty about newly approved drugs always exists. This ambiguity is amplified when drugs are approved on preliminary or interim evidence that is accelerated approval or on alternate outcomes and when new serious harms emerge. The case of Tysabri, a multiple sclerosis drug that received accelerated approval because of the ensuring preliminary evidence, this was quickly withdrawn from the market several months later after the advent of an unexpected, typically fatal harm, progressive multifocal leukoencephalopathy, and was subsequently remarketed with a risk management plan that illustrates many of these uncertainties. This led to quantifying the extent of the media coverage

Patients are more likely to get the correct medication and dosage at the right time, and due to a built-in alert system, there have been fewer instances of patients suffering an allergic reaction to medication.

Through the late 80's to early 90's, Merck was able to boast profits and sales through biochemistry drugs that were seen as breakthrough drugs in this new market.

One factor that must be considered is that the drug had not yet been approved by the FDA, but was in phase III trials. Historical data shows that 65% of drugs in this phase eventually get approved for sale to the market. It was felt that approval of the drug would occur late in 1998.