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Tag Archives: drug pricing

505(b)(2): A New Drug Approval Pathway

05 Wednesday Jul 2017

Posted by AAPS Blog in Current Perspectives

≈ 1 Comment

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505(b)(2), Aniruddha Railkar, Drug Approval, drug pricing, FDA, FFDC

By Aniruddha Railkar

According to a 2014 report by the Tufts Center for the Study of Drug Development, the cost of developing a new drug is $2.6 billion. That is a 145% increase, adjusted for inflation, over their 2003 estimates. This report has been criticized and praised, but the reality is that developing a new drug is an expensive and time consuming process (on an average it takes 12 years to go from discovery to commercialization). Continue reading →

Understanding Proteins and Their Importance in the Cost/Benefit of Innovations in Medicine

15 Friday Apr 2016

Posted by AAPS Blog in Current Perspectives

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Angela B. Schmider, basic science, drug pricing, drug targets and pricing, John G. Szeto, macromolecular organization, Matthew D. Godin, protein architecture, specificity

By John G. Szeto, Matthew D. Godin, and Angela B. Schmider

Szeto - final Godin - final Schmider - final

The following opinions and perspectives are our own and do not reflect the views of any institution.

Amino acids are the building blocks of proteins, and proteins are responsible for nearly all reactions that keep our bodies alive. There are 20 amino acids commonly found in proteins that, when ordered in sequences, manage to combine in an almost infinite number of ways. From these sequences, we get four basic levels of protein folding; from primary to quaternary, characteristic alpha helices to beta sheets, these polymers form unique and dynamic structures (see, e.g., the figure) that have various functions. The way proteins organize creates enzymes, structural units, ligands and receptors (keys and locks). These types of proteins are common targets of medicinal drugs. But because of subtleties in protein structure and interactions, there are medicine limitations, such as side effects, that originate from limitations in knowledge, including basic mechanism and biology. Continue reading →

Making Dollars, But Does It Make Sense?

30 Wednesday Mar 2016

Posted by AAPS Blog in Current Perspectives

≈ 3 Comments

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drug pricing, FDA, generics, Medicare, Megan Cooley, predatory pricing, Robert G. Bell

By Megan Cooley and Robert G. Bell

Megan CooleyRobert BellAre pharmaceutical companies in the business of simply treating patient’s symptoms rather than curing diseases? In our opinion there is no grave conspiracy theory amidst pharmaceutical companies toward the general public. After all they are a business, and businesses are out to make profits. With that said, it is hard to ignore the slow advancements in new therapeutics for terminal illnesses such as cancer. Previously, Megan published a post in response to an NPR interview with Ayalew Tefferi from the Mayo Clinic. He was voicing concern over the financial conflicts his patients face with their course of treatment for various forms of leukemia. Treatments can cost upwards of $100,000 per round of treatment, which is above the average U.S. household annual income. Continue reading →

Drug Pricing: Strategic Pricing Principles

15 Tuesday Mar 2016

Posted by AAPS Blog in Current Perspectives

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Ben Locwin, drug pricing, free market, Health

By Ben Locwin

Ben LocwinMany of the pharmaceutical companies that drive the bulk of the revenue in the market spend more on sales and marketing than on R&D. They do this in an attempt to directly recoup the development costs of their pipeline of new drug products. It’s so expensive to research and develop new therapeutic molecules (over $1 billion for each treatment that reaches the market), and the attrition rate of clinical candidates is a statistic you’ve no doubt read a dozen times (more than 19 in 20 candidates that fail). Especially if those companies that conduct early stage trials lower the statistical power of the trials to look for larger effect sizes, the ability to detect ”true positive” results is decreased as well. This results in some false positive results, which are later weeded out upon further trial testing—at a steep financial cost from deciding based on erroneous trial designs. Continue reading →

Drug Pricing: Market Value

14 Monday Mar 2016

Posted by AAPS Blog in Current Perspectives

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Ben Locwin, drug pricing, Health, wellness

By Ben Locwin

Ben LocwinAre prescription drugs too expensive? When given the opportunity, people will most often choose something that is cheaper over something more expensive—so long as all other factors are held equal. Continue reading →

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