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We are creating a place where we can share ideas, provide the perspective of America's biopharmaceutical companies and, most importantly, listen to you.

What are REMS? These extra steps are helping protect patient health

By Bill Chin, M.D.  |    October 6, 2016
As a physician and chief medical officer at PhRMA, I know how important it is to ensure that patients have access to safe, innovative medicines to help them live longer, healthier lives. But...   Read More

Harnessing the power of real-world evidence to benefit patients through PDUFA VI

By Andrew Powaleny  |    September 6, 2016
America’s biopharmaceutical researchers are in a golden era of medical research, discovery and development for patients. Rapid advances in technology and science have enhanced our ability to use...   Read More

How modernizing FDA regulations can benefit patients, providers and payers

By Andrew Powaleny  |    September 1, 2016
Yesterday, the U.S. Food and Drug Administration (FDA) announced a two-day hearing slated for November 9 and 10, seeking public input as the agency works to review and potentially revise its...   Read More

Improving FDA’s combination product review process could increase epinephrine auto-injector competition

By Stephen J. Ubl  |    August 30, 2016
Combination products that consist of a medicine and delivery device are important treatment options for patients and have the potential to improve public health. Innovator companies invest in...   Read More

Looking ahead to PDUFA VI

By Sascha Haverfield  |    August 11, 2016
Next Monday, PhRMA and BIO will participate alongside patient advocates and key stakeholders in the U.S. Food and Drug Administration’s (FDA) public meeting on the reauthorization of the ...   Read More

What you need to know about PDUFA VI

By Andrew Powaleny  |    July 27, 2016
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...   Read More

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

By Jeff Francer  |    July 27, 2016
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...   Read More

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

By Andrew Powaleny  |    July 14, 2016
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...   Read More

Advancing the science of hope

By Andrew Powaleny  |    June 13, 2016
Developing new medicines is a challenging undertaking, and the science is only getting harder. As our understanding of science grows, so does the complexity of developing new medicines,...   Read More

Why incorporating patients’ perspectives matters

By Andrew Powaleny  |    June 10, 2016
America’s biopharmaceutical research companies have long been dedicated to researching and developing new medicines that enable patients to live longer, healthier lives. Patients’ voices are...   Read More

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