The Catalyst

What you need to know about PDUFA VI

Posted by Andrew Powaleny on July 27, 2016 at 12:00 PM

The U.S. Food and Drug Administration (FDA) recently released its performance goals letter for the sixth installment of the Prescription Drug User Fee Act (PDUFA). The letter comes after months of technical negotiations between the agency and biopharmaceutical companies, and parallel meetings with patients’ advocacy groups, academia and other stakeholders.

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Topics: FDA, Drug Development, Prescription Drug Safety, PDUFA

PhRMA & BIO release joint principles on communications with health care professionals and payers

Posted by Jeff Francer on July 27, 2016 at 9:00 AM

This blog post is authored by Jeffrey Francer (PhRMA) and Deborah Shelton (BIO).

We are in an era of data-driven medicine. Patients, caregivers, health care professionals and insurers want more information about the safety, effectiveness and value of treatments – and rightly so. But federal regulations governing information-sharing about medicines have not kept up with this new reality.

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Topics: FDA, BIO, healthcare professionals, communication with healthcare professionals, FDA Modernization, Policy Solutions

PhRMA Foundation: 2015 in review

Posted by Eileen Cannon on July 25, 2016 at 12:00 PM

For the past 50 years, the PhRMA Foundation has had the opportunity to support young scientists across numerous disciplines through grants and fellowships. In looking back through the years, and 2015 in particular, we asked past award recipients about the support they received. Here’s what some of them had to say:

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Topics: Science, PhRMA Foundation

Medicare Monday: Happy early birthday, Medicare!

Posted by Nicole Longo on July 25, 2016 at 9:00 AM

As July comes to a close this week, there’s one big birthday left to celebrate – the anniversary of Medicare! On July 30, 1965, Medicare was signed into law by President Lyndon B. Johnson. This week, as we celebrate 51 years of Medicare, we wanted to highlight some of our Medicare resources.

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Topics: Part D, Medicare, Medicare Monday, Part B

Medicare Monday: Access to vaccines for older Americans

Posted by Allyson Funk on July 18, 2016 at 9:30 AM

When you think about vaccines, you may not think about the need for them later in life, but vaccines for older Americans are a critical component of maintaining health as you age. According to the Centers for Disease Control and Prevention, our immune systems weaken over time, which puts older Americans at higher risk for certain diseases. Important vaccines for older Americans include the flu, tetanus, hepatitis A and B, pertussis (whooping cough), pneumococcal, meningococcal, shingles and more.

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Topics: Vaccines, Part D, Medicare, Medicare Monday

4 ways to better engage and empower patients

Posted by Allyson Funk on July 15, 2016 at 10:00 AM

An informed consumer is an engaged and empowered patient. With the right information, consumers are well equipped to be active participants in making decisions about their health care. But it isn’t always that simple. Consumers often face barriers when it comes to finding information about their insurance benefits and out-of-pocket costs. By removing these barriers, we can engage and empower patients to make better-informed decisions about their health care. Here are four ways to do this:

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Topics: Access, Access Better Coverage, ABCs of Coverage, Policy Solutions, Empower Consumers

What you need to know about the federal government’s health spending projections

Posted by Holly Campbell on July 14, 2016 at 12:00 PM

New National Health Expenditure (NHE) projections released today by the Centers for Medicare & Medicaid Services reaffirm how our nation’s competitive marketplace for medicines controls costs while supporting the development of new treatments and cures for patients.

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Topics: drug cost, health care spending

Video: How can biomarkers and surrogate endpoints enhance R&D of medicines?

Posted by Andrew Powaleny on July 14, 2016 at 9:00 AM

In the age of personalized medicine, biomarkers are emerging as important tools in drug development. A biomarker is a measure or physical sign that can be used to determine how the body is functioning. This can help researchers develop more individualized treatments, provide an early warning sign for certain health risks and accelerate the availability of new medicines for patients.

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Topics: FDA, PDUFA, FDA Modernization, biomarkers, Policy Solutions

The importance of the Bayh-Dole Act

Posted by Setareh Samii on July 12, 2016 at 3:00 PM

Over 35 years ago, leaders in Washington D.C. united in what would today be a strikingly bipartisan manner to pass the University and Small Business Patent Procedures Act of 1980 – better known as the Bayh-Dole Act. The legislation created a framework for technology transfer that helped rejuvenate the American economy and continues to be a model for the rest of the world. A new paper, “How the Bayh-Dole Act Propelled U.S. Global Leadership in the Life Sciences”, focuses on the contributions of the Act in fostering technology transfer.

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Topics: Innovation, R&D, IP

What they are saying about ICER’s scoping document for non-small cell lung cancer

Posted by Holly Campbell on July 11, 2016 at 12:00 PM

The Institute for Clinical and Economic Review (ICER) has set its sights on a new target: life-saving treatments for advanced non-small cell lung cancer (NSCLC).

ICER’s latest draft scoping document outlines what it will cover in its forthcoming report assessing treatments for advanced NSCLC. According to the scoping document, ICER’s evidence report will assess several categories of lung cancer treatments, including tyrosine kinase inhibitors (TKIs) and immunotherapies. The value of these treatments in the fight against NSCLC, which accounts for 85 to 90 percent of all lung cancer diagnoses, has been widely recognized.   

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Topics: Value, Personalized Medicine, cancer, Value-Driven Health Care, Policy Solutions

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