Fighting Disease with New Drug Approvals
Biopharmaceutical research companies received approval for 34 new treatments in 2013.
In 2014, the Food and Drug Administration (FDA) approved 51 new medicines - up from 34 in 2013.
Of the 34 approved in 2013, 27 were approved by the Center for Drug Evaluation and Research (CDER) and seven by the Center for Biologics Evaluation and Research (CBER). The 27 approved by CDER were reviewed in an average of 13.2 months, and the seven approved by CBER averaged 21.8 months. The new approvals potentially could be important treatment options beyond their initial approved indication.
The new medicines approved join other notable medicines that America’s biopharmaceutical research companies have already developed to help patients. The medicines in the pharmaceutical industry pipeline hold a promise for millions of patients for an even healthier tomorrow.
7,000+ Drugs in Development Globally
As in past years, there are an increasing number of potential new drugs entering clinical testing. There are more than 7,000 medicines in development globally. These new medicines hold the promise of better prevention, treatments, and cures for a broad range of diseases and conditions. Visit the Innovation Hub for galleries, articles, timelines, videos, and infographics about the processes behind drug development and how innovation improves patients' lives every day.Learn more
The Cost of Developing Drugs
Did you know that only 12% of drug candidates that enter clinical testing are approved for use by patients? When it comes to spending on retail prescription medicines, there is a lot of information out there. There is also a lot of misinformation. Click the image to view four facts about spending on prescription medicines.
Review Times Decreased by 60%
In the last 20 years, the Prescription Drug User Fee Act (PDUFA) has helped expedite patient access to more than 1,500 new drugs and biologics, decreasing review times for these medicines by more than 60 percent while strengthening FDA’s existing high safety and efficacy standards.
$2.6 Billion to Create New Drug
The average cost to research and develop a new medicine is $2.6 billion which takes 10 years on average. Only 12% of drug candidates that enter clinical testing are approved for use by patients.Learn more
Medicines in the Pipeline
There are 7,000 medicines in development around the world today. More than 500 have been approved since 2000, and 51 were approved in 2014 alone.
In the last 2 decades, advances in treatment have contributed to a nearly 85% decline in death rates and transformed the disease from an acute, fatal illness to a chronic condition.
New therapies have contributed to a nearly 22% decline in cancer deaths since the 1990s. Today, 2 out of 3 people diagnosed with cancer survive at least 5 years.
Rheumatoid Arthritis (RA)
Therapeutic advances have transformed the RA treatment paradigm over the last 20 years, shifting from a focus on symptom management to now aiming for slowed disease progression and even disease remission.
New treatments targeting both the symptoms and root cause of the disease have contributed to improvements in quality of life for patients as well as increases in life expectancy
View resources to learn more about new drug approvals and medicines in development:
View the 2013 report on new medicine approvals.
Visit PhRMA's page that houses all PDF reports on medicines in the pipeline for patients.
The annual 2015 Pharmaceutical Industry Profile provides an overview of the sector, highlighting the latest medical advances, the impact of biopharmaceutical companies on the economy and the future of innovation.
I am Research. Progress. Hope. provides an opportunity for scientists to showcase their exciting and meaningful work in drug discovery and development.
View PhRMA's Myths vs Facts PDF on clinical trials.
Learn more about the important role that clinical trials play in the FDA approval process.
Watch the video on Innovation Hub.