The 19th round of Trans-Pacific Partnership (TPP) negotiations in Brunei conclude today, and with countries looking to finalize the agreement by the end of this year, there is much to be done in the coming months.
Making a new treatment available to patients takes more than a decade and a billion dollars. Given the time and resources it takes to successfully bring a drug to market, the need for strong intellectual property (IP) protections in the U.S. and abroad has never been more important.
As we’ve previously noted on the Catalyst, medication adherence continues to be a serious challenge with significant consequences to patient health and costs associated with acute care, hospitalizations and surgery. Today, nearly 145 million Americans suffer from chronic disease, but only one-third take their medications as prescribed.
Across the globe, millions of patients are put at risk by counterfeit, substandard or otherwise unsafe medicines.
At a time when there is growing concern about diversity in clinical trials, we learned yesterday that 26 percent of people who participate in treatment trials at the Medical University of South Carolina's Hollings Cancer Center (HCC) are African American.
The PhRMA Foundation is seeking applications for its Young Investigator Center for Adherence Improvement Award. The award will provide stipend support for individuals who are doing research that will advance and improve medication adherence.
Last month, PhRMA and the European Federation of Pharmaceutical Industries and Associations (EFPIA) endorsed joint Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers.
With the Asia-Pacific Economic Cooperation (APEC) leaders meeting scheduled for October and participating countries emphasizing their desire to complete Trans-Pacific Partnership (TPP) negotiations this year, there is a heightened sense of urgency to come to an agreement. This point was reinforced by the start of the 19th round of negotiations in Brunei – just one month after the previous round concluded in Malaysia.
Many patients are welcoming efforts by biopharmaceutical companies, patient organizations and scientists in academia to actively engage patients in clinical trials and other research opportunities. It can be empowering to learn more about yourself and your disease, and to know that your participation may even help future patients.
The New York Times today put a spotlight on mental health, mistakenly pointing out that we are facing a crisis in innovation for medicines that can help patients suffering
Bringing a medicine to patients, from discovery through FDA review, is a lengthy, costly and sometimes unpredictable process. On average, it takes 10-15 years and an investment of more than $1 billion. As noted previously on the Catalyst, only one out of 5,000-10,000 potential new medicines make it through the multiple and rigorous pre-clinical and clinical trials phases and is ultimately approved by the FDA for patient use.
Despite the great medical advances of the last century, there is still a lot of work to be done when it comes to developing medications and treatments to deal with neurological disorders such as Parkinson’s disease. These conditions pose vexing challenges for researchers trying to unlock the secrets that will improve the lives of millions living with the daily challenges that neurological diseases pose.
As I read the Wall Street Journal’s article this week on gene breakthroughs in cancer treatment, I felt a range of emotions. First was excitement. Decades of devotion to research have taken science to new heights and it’s important that people are aware of the tremendous progress that has been made.
Last week, I highlighted a Hill briefing hosted by the Personalized Medicine Coalition and the great examples it provided of the impact of personalized medicine on patients. I was reminded why we must advocate for policies that support continued progress against disease and fulfill the promise of personalized medicine.
Last week, the U.S. Food and Drug Administration (FDA) announced the prescription drug user fee rates for FY2014 –$2.169 million per application requiring clinical data review. This reflects a significant increase of more than 10 percent over the FY2013 rates – and a twenty-fold increase in the user fees established in the Prescription Drug User Fee Act (PDUFA) of 1992.
We recently released our Medicines in Development for Neurological Disorders report, which includes 38 medicines for multiple sclerosis (MS). It is a condition that impacts approximately 500,000 Americans. We recently had an opportunity to speak with Jodi Dwyer, a health activist who has MS and hope for a cure.
Biomedical research is behind the scientific advances that have helped increase the childhood cancer survivor rate and improve and lengthen the lives of people living with HIV/AIDs, heart disease and cancer.